November / December 2008 The Journal of Test Positive Aware Network HIV Treatment and Health

Transcription

1 November / December 2008 The Journal of Test Positive Aware Network HIV Treatment and Health

2 INDICATIONS ISENTRESS is an anti-hiv medicine that helps control HIV infection. ISENTRESS is used along with other anti- HIV medicines in patients who are already taking or have taken anti-hiv medicines that are not controlling their HIV infection, such as patients with HIV resistant to more than one type of anti-hiv medication. The safety and effectiveness of ISENTRESS have not been established for the treatment of HIV infection in adult patients who have never taken HIV medications before or in patients under 16 years of age. The use of other medications active against HIV in combination with ISENTRESS may increase the likelihood of your overall response to treatment. Your doctor will work with you to find the right combination of HIV medications. The long-term benefits and side effects of treatment with ISENTRESS are unknown at this time. It is important that you remain under your doctor s care. There are no study results demonstrating the effect of ISENTRESS on clinical progression of HIV-1. ISENTRESS will NOT cure HIV infection or reduce your chance of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood. ISENTRESS must be used with other anti-hiv medicines. IMPORTANT RISK INFORMATION Immune reconstitution syndrome can happen in some patients with advanced HIV infection (AIDS) when anti-hiv treatment is started. Signs and symptoms of inflammation from opportunistic infections may occur as the medicines work to control the HIV infection and strengthen the immune system. Call your doctor right away if you notice any signs or symptoms of an infection after starting ISENTRESS. Contact your doctor promptly if you experience unexplained muscle pain, tenderness, or weakness while taking ISENTRESS.

3 Presenting ISENTRESS. A different way to treat HIV when used as part of HIV combination therapy. The first drug in a class of HIV medications called integrase inhibitors. Based upon studies of up to 24-weeks: ISENTRESS when taken in combination with other anti-hiv medications may reduce viral load to undetectable (less than 400 copies/ml, or less than 50 copies/ml) a and may increase CD4 (T) cell counts. ISENTRESS may not have these effects in all patients. ( a depending upon the test used) Talk to your doctor about ISENTRESS. Visit isentress.com for more information. Need help paying for ISENTRESS? Call the patient SUPPORT program at When ISENTRESS has been given with other anti-hiv drugs, the most common side effects included diarrhea, nausea, and headache. People taking ISENTRESS may still develop infections, including opportunistic infections or other conditions that occur with HIV infection. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA For additional information about ISENTRESS, please read the information on the following page. Tell your doctor about all of your medical conditions, including if you have any allergies, are pregnant or plan to become pregnant, or are breast-feeding or plan to breast-feed. ISENTRESS is not recommended for use during pregnancy. Women with HIV should not breast-feed because their babies could be infected with HIV through their breast milk. Tell your doctor about all the medicines you take, including prescription medicines such as rifampin (a medicine used to treat some infections such as tuberculosis), non-prescription medicines, vitamins, and herbal supplements. ISENTRESS is a registered trademark of Merck & Co., Inc. Copyright 2008 Merck & Co., Inc. All rights reserved (6)(101)-ISN-CON

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5 Departments 6 TPAN Programs, Meetings & Events 7 Editor s Note Table of Contents A World Without AIDS 12 Readers Forum 12 PA Online Poll 13 News Briefs by Enid Vázquez 16 Ask the HIV Specialist This issue s Specialists Daniel Pearce, D.O., AAHIVS and Ellen Tedaldi, M.D., AAHIVS 59 The Buzz Sexual Encounters with Undetectable HIV-Positive Men A controversy about HIV transmission by Daniel S. Berger, M.D. 62 The Wholistic Picture A World Together? Health care, not just insurance by Sue Saltmarsh Articles 21 Ambassador of Healing YouthAIDS ambassador Seane Corn circles the globe teaching the healing power of yoga by Jeff Berry 31 The Beating of Your Heart Special conference looks at what s known and not known about cardiovascular disease in HIV by Enid Vázquez November / December 2008 Volume 19 Number Articles continued 37 XVII International AIDS Conference 37 Treatment Round-up from the International AIDS Conference New and improved drug information by Jeff Berry 40 Race, Sex, and Pregnancy A round-up of news in special populations by Enid Vázquez 41 Metabolic Complications and Hepatitis Co-infection News from the International AIDS Conference by Liz Highleyman 43 Can Ziagen Hurt Your Heart? Research presented at the International AIDS Conference weighs in on the controversy by Liz Highleyman 45 The Epidemic at Home Takes Center Stage Reflections on the XVII International AIDS Conference by Keith R. Green 48 Oh, the Humanity Homophobia multiplied nineteen times by Jim Pickett 52 World AIDS Day 2008 Some thoughts on leadership 55 Statistics 101 A basic guide to the numbers game behind research by Amy G. Cutrell Reader Survey On the cover Seane Corn, see story page 21. Photo by Erik Asla. Distribution of is supported in part through an unrestricted grant from GlaxoSmithKline A model, photographer, or author s HIV status should not be assumed based on their appearance in. You can view these (and other stories from previous issues) online at and 5

6 TPAN Programs and Meetings Support Groups Rapid HIV Testing Yoga, Reiki and Massage Needle Exchange Program Buddy Program Access Medical Clinic at TPAN PULSE, an HIV-positive Weekly Social Party at Hydrate POWER (Positive Outcomes for Wellness, Education, and Recovery) TEAM (Treatment Education Advocacy Management) SMART Sex Prevention and Outreach Program Monthly Educational Forums and Trainings For detailed descriptions of programs, including dates, times, and locations, visit and click on Client Services, or call (773) TPAN Events Chicago Takes Off Saturday, March 7th, 2009 Two shows! (see ad on back cover) visit Other Special Events For detailed descriptions of these and other TPAN events visit and click on Events, or call (773) Test Positive Aware Network 5537 North Broadway Chicago, IL phone: (773) fax: (773) Editor Jeff Berry Associate Editors Keith R. Green Enid Vázquez Editorial Assistants Sue Saltmarsh Gregory Tate Contributing Writers Liz Highleyman, Laura Jones, Jim Pickett, Sue Saltmarsh, Matt Sharp Medical Advisory Board Daniel S. Berger, M.D., Patrick G. Clay, Pharm.D., Rupali Jain, Pharm.D., and Ross M. Slotten, M.D. Art Direction Russell McGonagle Advertising Inquiries Distribution Joe Fierke (ISSN: ) is published bi-monthly by Test Positive Aware Network (TPAN), 5537 N. Broadway, Chicago, IL Positively Aware is a registered trademark of TPAN. All rights reserved. Circulation: 85,000. For reprint permission, contact Jeff Berry. Six issues mailed bulkrate for $30 donation; mailed free to TPAN members or those unable to contribute. TPAN is an Illinois not-for-profit corporation, providing information and support to anyone concerned with HIV and AIDS issues. A person s HIV status should not be assumed based on his or her article or photograph in Positively Aware, membership in TPAN, or contributions to this journal. We encourage contribution of articles covering medical or personal aspects of HIV/AIDS. We reserve the right to edit or decline submitted articles. When published, the articles become the property of TPAN and its assigns. You may use your actual name or a pseudonym for publication, but please include your name and phone number. Opinions expressed in are not necessarily those of staff or membership or TPAN, its supporters and sponsors, or distributing agencies. Information, resources, and advertising in do not constitute endorsement or recommendation of any medical treatment or product. TPAN recommends that all medical treatments or products be discussed thoroughly and frankly with a licensed and fully HIV-informed medical practitioner, preferably a personal physician. Although takes great care to ensure the accuracy of all the information that it presents, staff and volunteers, TPAN, or the institutions and personnel who provide us with information cannot be held responsible for any damages, direct or consequential, that arise from use of this material or due to errors contained herein. 6

7 Editor s Note A World Without AIDS Photo Russell McGonagle The theme of this year s World AIDS Day is leadership. A world without AIDS requires strong leadership leadership from governments, institutions, organizations, coalitions, and individuals. In this issue we asked a few individuals within the HIV/AIDS community what leadership means to them. As you ll see from their responses, leadership can mean different things to different people. I feel fortunate to have known and worked with some individuals in my lifetime who I consider to be leaders. A leader to me is someone who leads by example someone who creates a spark within me, a desire to emulate the manner in which they carry themselves throughout life. It s not necessarily the specific thing they do that s important, but rather it is the truth within them that reaches out to me, and speaks to my heart, and my passion. Leaders I have known have oftentimes been charismatic, but they ve also at times been quite unassuming. Their aspirations always seem to include the betterment and welfare of others who may or may not be as fortunate as they are. They invariably seek to uncover the qualities in another which make that individual unique and special, and work to bring out the best in them and they frequently do so without the other person realizing it s taking place, which is a gift in itself. As we in the U.S. and around the world turn to our leaders for direction during these worrisome and troubling economic times, so too do we in the HIV/AIDS community yearn and hunger for strong leadership. Leadership which will guide and steer us towards better treatment options that are more tolerable and easier to take; improved access to care worldwide, as well as for the millions of those in the U.S. who lack insurance; more effective prevention methods, including behavioral interventions, microbicides (both vaginal and rectal) and PREP; and the research and development of immune-based therapies and vaccines. Of course all this takes a great deal of forethought, funding, and a concerted and collaborative effort an international AIDS strategy based on sound science and policy. We cannot afford a bailout in this current AIDS crisis, it s much too late for that. We ve already paid the price in rising infection rates, spiraling healthcare costs, and millions of AIDS orphans and the ultimate price 60 millions deaths worldwide since the beginning of the epidemic. We need leaders who can step back, look at the big picture, and take us to the next level. But to lay out a broad and effective plan, one that includes all of the many elements and stakeholders, we first need to be able to visualize what our final objective is a world without AIDS. As I approach 50, and having tested positive when I was still only 30 years old, I have known AIDS, like many of you, most of my adult life, and known it intimately. While I feel fortunate to still be here, I wonder if I have become too complacent in my seeming acceptance of AIDS as part of my world, the world as I see it. Is it insurmountable? Will HIV/AIDS ever be eradicated, or will we ever find a cure? Or will it always be here to remind us of our failure to respond soon enough, or of something which can never be achieved? Maybe it s an opportunity to learn what it is we as human beings need to do to in order to leave this world a better place than it was when we entered into it. In this issue you ll read about Seane Corn, who s featured on the cover, and her fascinating journey of self-discovery a journey which has taken her around the world, teaching the healing power of yoga to individuals who are infected with and at risk for HIV. As I interviewed Seane and listened to her tell her story, I kept hearing that famous quote over and over again in my mind, We must be the change we wish to see in the world. We have a special section in this issue with a report back on some of the highlights from the International AIDS Conference in Mexico City, which took place earlier this year, including some of the interesting prevention discussions that took place. But what would coverage from a conference be without data, right? So we ve included an article by Amy Cutrell, which is sort of a primer on statistics, to help you decipher all the data. We d also like to hear from you, our readers, and what leadership means to you. So visit us online at and take our online poll and please fill out our 2008 Reader Survey on page 63, which is also available online, to help us better serve you. And join our growing online community to discuss with your peers the important issues which we all face on a daily basis. In the end, and at the risk of sounding too clichéd, it does take a village. And it will ultimately require some added effort, extra precautions, and in some cases further sacrifices, from each and every one of us, to get through not only the current economic crisis, but to ultimately create the village where we all eventually want to reside one that exists in a world without AIDS. Take care of yourself, and each other. Jeff Berry Editor publications@tpan.com 7

8 Important Information INDICATION ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate [DF] 300 mg) is a prescription medication used alone as a complete regimen or with other medicines to treat HIV-1 infection in adults. ATRIPLA does not cure HIV-1 and has not been shown to prevent passing HIV-1 to others. See your healthcare provider regularly. IMPORTANT SAFETY INFORMATION Contact your healthcare provider right away if you experience any of the following side effects or conditions associated with ATRIPLA: Nausea, vomiting, unusual muscle pain, and/or weakness. These may be signs of a buildup of acid in the blood (lactic acidosis), which is a serious medical condition. Light colored stools, dark colored urine, and/or if your skin or the whites of your eyes turn yellow. These may be signs of serious liver problems. If you have HIV-1 and hepatitis B virus (HBV), your liver disease may suddenly get worse if you stop taking ATRIPLA. Do not stop taking ATRIPLA unless directed by your healthcare provider. Do not take ATRIPLA if you are taking the following medicines because serious and life-threatening side effects may occur when taken together: Vascor (bepridil), Propulsid (cisapride), Versed (midazolam), Orap (pimozide), Halcion (triazolam), or ergot medications (for example, Wigraine and Cafergot ). In addition, ATRIPLA should not be taken with: Combivir (lamivudine/zidovudine), EMTRIVA (emtricitabine), Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), SUSTIVA (efavirenz), Trizivir (abacavir sulfate/lamivudine/ zidovudine), TRUVADA (emtricitabine/tenofovir DF), or VIREAD (tenofovir DF), because they contain the same or similar active ingredients as ATRIPLA. Vfend (voriconazole) or REYATAZ (atazanavir sulfate), with or without Norvir (ritonavir), should not be taken with ATRIPLA since they may lose their effect and may also increase the chance of having side effects from ATRIPLA. Fortovase or Invirase (saquinavir) should not be used as the only protease inhibitor in combination with ATRIPLA. Taking ATRIPLA with St. John s wort or products containing St. John s wort is not recommended as it may cause decreased levels of ATRIPLA, increased viral load, and possible resistance to ATRIPLA or cross-resistance to other anti-hiv drugs. This list of medicines is not complete. Discuss with your healthcare provider all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take. Contact your healthcare provider right away if you experience any of the following side effects or conditions: Please see Patient Information on the following page. Severe depression, strange thoughts, or angry behavior have been reported by a small number of patients. Some patients have had thoughts of suicide and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness. Dizziness, trouble sleeping or concentrating, drowsiness, unusual dreams, and/or hallucinations are common, and tend to go away after taking ATRIPLA (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir DF 300 mg) for a few weeks. Symptoms were severe in a few patients and some patients discontinued therapy. These symptoms may become more severe with the use of alcohol and/or moodaltering (street) drugs. If you are dizzy, have trouble concentrating, and/or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery. Kidney or liver problems. If you have had kidney or liver problems, including hepatitis infection or take other medicines that may cause kidney or liver problems, your healthcare provider should do regular blood tests. Pregnancy: Women should not become pregnant while taking ATRIPLA and for 12 weeks after stopping ATRIPLA. Serious birth defects have been seen in children of women treated during pregnancy with one of the medicines in ATRIPLA. Therefore, women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control. Breast-Feeding: Women with HIV-1 should not breast-feed because they can pass HIV-1 through their milk to the baby. Also, ATRIPLA may pass through breast milk and cause serious harm to the baby. Rash is a common side effect that usually goes away without treatment, but may be serious in a small number of patients. Seizures have occurred in patients taking a component of ATRIPLA, usually in those with a history of seizures. If you have ever had seizures, or take medicine for seizures, your healthcare provider may want to switch you to another medicine or monitor you. Bone changes. If you have had bone problems in the past, your healthcare provider may want to check your bones. If you have ever had mental illness or use illegal drugs or alcohol. Changes in body fat have been seen in some people taking anti-hiv-1 medicines. The cause and long-term health effects are not known. Other common side effects of ATRIPLA include tiredness, headache, upset stomach, vomiting, gas, and diarrhea. Skin discoloration (small spots or freckles) may also happen. You should take ATRIPLA once daily on an empty stomach. Taking ATRIPLA at bedtime may make some side effects less bothersome. ATRIPLA is one of several treatment options your doctor may consider. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA Bristol-Myers Squibb & Gilead Sciences, LLC. All rights reserved. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. EMTRIVA, VIREAD, and TRUVADA are trademarks of Gilead Sciences, Inc. SUSTIVA is a registered trademark of Bristol-Myers Squibb Pharma Company. REYATAZ is a registered trademark of Bristol-Myers Squibb Company. All other trademarks are owned by third parties. 697US08AB01407/TROO93 06/08

9 ATRIPLA helps me stay on top of my HIV with one pill daily. Individual results may vary. ATRIPLA. The #1 prescribed complete HIV regimen. * It may be taken alone or with other HIV medicines. Effective HIV Treatment Through 3 years of clinical studies, proven to lower viral load to undetectable and help raise T-cell (CD4+) count to help control HIV One Pill, Once a Day Take ATRIPLA once a day on an empty stomach and preferably at bedtime, which may make some side effects less bothersome Ask your doctor if ATRIPLA is right for you. Please see Important Safety Information, including information on lactic acidosis, serious liver problems, and flare-ups of hepatitis B (HBV) on adjacent page. visit * Synovate Healthcare Data; US HIV Monitor, Q Defined as a viral load of less than 400 copies/ml.

10 FDA-Approved Patient Labeling Patient Information ATRIPLA (uh TRIP luh) Tablets ALERT: Find out about medicines that should NOT be taken with ATRIPLA. Please also read the section MEDICINES YOU SHOULD NOT TAKE WITH ATRIPLA. Generic name: efavirenz, emtricitabine and tenofovir disoproxil fumarate (eh FAH vih renz, em tri SIT uh bean and te NOE fo veer dye soe PROX il FYOU mar ate) Read the Patient Information that comes with ATRIPLA (efavirenz/emtricitabine/ tenofovir disoproxil fumarate) before you start taking it and each time you get a refill since there may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. You should stay under a healthcare provider s care when taking ATRIPLA. Do not change or stop your medicine without first talking with your healthcare provider. Talk to your healthcare provider or pharmacist if you have any questions about ATRIPLA. What is the most important information I should know about ATRIPLA? Some people who have taken medicine like ATRIPLA (which contains nucleoside analogs) have developed a serious condition called lactic acidosis (build up of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your healthcare provider right away if you get the following signs or symptoms of lactic acidosis: You feel very weak or tired. You have unusual (not normal) muscle pain. You have trouble breathing. You have stomach pain with nausea and vomiting. You feel cold, especially in your arms and legs. You feel dizzy or lightheaded. You have a fast or irregular heartbeat. Some people who have taken medicines like ATRIPLA have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get the following signs or symptoms of liver problems: Your skin or the white part of your eyes turns yellow (jaundice). Your urine turns dark. Your bowel movements (stools) turn light in color. You don t feel like eating food for several days or longer. You feel sick to your stomach (nausea). You have lower stomach area (abdominal) pain. You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog-containing medicines, like ATRIPLA, for a long time. If you also have hepatitis B virus (HBV) infection and you stop taking ATRIPLA, you may get a flare-up of your hepatitis. A flare-up is when the disease suddenly returns in a worse way than before. Patients with HBV who stop taking ATRIPLA need close medical follow-up for several months, including medical exams and blood tests to check for hepatitis that could be getting worse. ATRIPLA is not approved for the treatment of HBV, so you must discuss your HBV therapy with your healthcare provider. What is ATRIPLA? ATRIPLA contains 3 medicines, SUSTIVA (efavirenz), EMTRIVA (emtricitabine) and VIREAD (tenofovir disoproxil fumarate also called tenofovir DF) combined in one pill. EMTRIVA and VIREAD are HIV-1 (human immunodeficiency virus) nucleoside analog reverse transcriptase inhibitors (NRTIs) and SUSTIVA is an HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI). VIREAD and EMTRIVA are the components of TRUVADA. ATRIPLA can be used alone as a complete regimen, or in combination with other anti-hiv-1 medicines to treat people with HIV-1 infection. ATRIPLA is for adults age 18 and over. ATRIPLA has not been studied in children under age 18 or adults over age 65. HIV infection destroys CD4 + T cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops. ATRIPLA helps block HIV-1 reverse transcriptase, a viral chemical in your body (enzyme) that is needed for HIV-1 to multiply. ATRIPLA lowers the amount of HIV-1 in the blood (viral load). ATRIPLA may also help to increase the number of T cells (CD4 + cells), allowing your immune system to improve. Lowering the amount of HIV-1 in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections). Does ATRIPLA cure HIV-1 or AIDS? ATRIPLA does not cure HIV-1 infection or AIDS. The long-term effects of ATRIPLA are not known at this time. People taking ATRIPLA may still get opportunistic infections or other conditions that happen with HIV-1 infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infection. It is very important that you see your healthcare provider regularly while taking ATRIPLA. Does ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate) reduce the risk of passing HIV-1 to others? ATRIPLA has not been shown to lower your chance of passing HIV-1 to other people through sexual contact, sharing needles, or being exposed to your blood. Do not share needles or other injection equipment. Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades. Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom or other barrier to reduce the chance of sexual contact with semen, vaginal secretions, or blood. Who should not take ATRIPLA? Together with your healthcare provider, you need to decide whether ATRIPLA is right for you. Do not take ATRIPLA if you are allergic to ATRIPLA or any of its ingredients. The active ingredients of ATRIPLA are efavirenz, emtricitabine, and tenofovir DF. See the end of this leaflet for a complete list of ingredients. What should I tell my healthcare provider before taking ATRIPLA? Tell your healthcare provider if you: Are pregnant or planning to become pregnant (see What should I avoid while taking ATRIPLA? ). Are breast-feeding (see What should I avoid while taking ATRIPLA? ). Have kidney problems or are undergoing kidney dialysis treatment. Have bone problems. Have liver problems, including Hepatitis B Virus infection. Your healthcare provider may want to do tests to check your liver while you take ATRIPLA. Have ever had mental illness or are using drugs or alcohol. Have ever had seizures or are taking medicine for seizures. What important information should I know about taking other medicines with ATRIPLA? ATRIPLA may change the effect of other medicines, including the ones for HIV-1, and may cause serious side effects. Your healthcare provider may change your other medicines or change their doses. Other medicines, including herbal products, may affect ATRIPLA. For this reason, it is very important to let all your healthcare providers and pharmacists know what medications, herbal supplements, or vitamins you are taking. MEDICINES YOU SHOULD NOT TAKE WITH ATRIPLA The following medicines may cause serious and life-threatening side effects when taken with ATRIPLA. You should not take any of these medicines while taking ATRIPLA: Vascor (bepridil), Propulsid (cisapride), Versed (midazolam), Orap (pimozide), Halcion (triazolam), ergot medications (for example, Wigraine and Cafergot). ATRIPLA also should not be used with Combivir (lamivudine/zidovudine), EMTRIVA, Epivir, Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine),trizivir (abacavir sulfate/lamivudine/zidovudine), SUSTIVA, TRUVADA, or VIREAD. Vfend (voriconazole) should not be taken with ATRIPLA since it may lose its effect or may increase the chance of having side effects from ATRIPLA. Do not take St. John s wort (Hypericum perforatum), or products containing St. John s wort with ATRIPLA. St. John s wort is an herbal product sold as a dietary supplement. Talk with your healthcare provider if you are taking or are planning to take St. John s wort. Taking St. John s wort may decrease ATRIPLA levels and lead to increased viral load and possible resistance to ATRIPLA or crossresistance to other anti-hiv-1 drugs. It is also important to tell your healthcare provider if you are taking any of the following: Fortovase, Invirase (saquinavir), Biaxin (clarithromycin); or Sporanox (itraconazole); these medicines may need to be replaced with another medicine when taken with ATRIPLA. Calcium channel blockers such as Cardizem or Tiazac (diltiazem), Covera HS or Isoptin (verapamil) and others; Crixivan (indinavir); Methadone; Mycobutin (rifabutin); Rifampin; cholesterol-lowering medicines such as Lipitor (atorvastatin), Pravachol (pravastatin sodium), and Zocor (simvastatin); or Zoloft (sertraline); these medicines may need to have their dose changed when taken with ATRIPLA. Videx, Videx EC (didanosine); tenofovir DF (a component of ATRIPLA) may increase the amount of didanosine in your blood, which could result in more side effects. You may need to be monitored more carefully if you are taking ATRIPLA (efavirenz/ emtricitabine/tenofovir disoproxil fumarate) and didanosine together. Also, the dose of didanosine may need to be changed. Reyataz (atazanavir sulfate) or Kaletra (lopinavir/ritonavir); these medicines may increase the amount of tenofovir DF (a component of ATRIPLA) in your blood, which could result in more side effects. Reyataz is not recommended with ATRIPLA. You may need to be monitored more carefully if you are taking ATRIPLA and Kaletra together. Also, the dose of Kaletra may need to be changed. Medicine for seizures [for example, Dilantin (phenytoin), Tegretol (carbamazepine), or phenobarbital]; your healthcare provider may want to switch you to another medicine or check drug levels in your blood from time to time.

11 These are not all the medicines that may cause problems if you take ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate). Be sure to tell your healthcare provider about all medicines that you take. Keep a complete list of all the prescription and nonprescription medicines as well as any herbal remedies that you are taking, how much you take, and how often you take them. Make a new list when medicines or herbal remedies are added or stopped, or if the dose changes. Give copies of this list to all of your healthcare providers and pharmacists every time you visit your healthcare provider or fill a prescription. This will give your healthcare provider a complete picture of the medicines you use. Then he or she can decide the best approach for your situation. How should I take ATRIPLA? Take the exact amount of ATRIPLA your healthcare provider prescribes. Never change the dose on your own. Do not stop this medicine unless your healthcare provider tells you to stop. You should take ATRIPLA on an empty stomach. Swallow ATRIPLA with water. Taking ATRIPLA at bedtime may make some side effects less bothersome. Do not miss a dose of ATRIPLA. If you forget to take ATRIPLA, take the missed dose right away, unless it is almost time for your next dose. Do not double the next dose. Carry on with your regular dosing schedule. If you need help in planning the best times to take your medicine, ask your healthcare provider or pharmacist. If you believe you took more than the prescribed amount of ATRIPLA, contact your local poison control center or emergency room right away. Tell your healthcare provider if you start any new medicine or change how you take old ones. Your doses may need adjustment. When your ATRIPLA supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to ATRIPLA and become harder to treat. Your healthcare provider may want to do blood tests to check for certain side effects while you take ATRIPLA. What should I avoid while taking ATRIPLA? Women taking ATRIPLA should not become pregnant. Serious birth defects have been seen in the babies of animals and women treated with efavirenz (a component of ATRIPLA) during pregnancy. It is not known whether efavirenz caused these defects. Tell your healthcare provider right away if you are pregnant. Also talk with your healthcare provider if you want to become pregnant. Women should not rely only on hormone-based birth control, such as pills, injections, or implants, because ATRIPLA may make these contraceptives ineffective. Women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control. Do not breast-feed if you are taking ATRIPLA. The Centers for Disease Control and Prevention recommend that mothers with HIV not breast-feed because they can pass the HIV through their milk to the baby.also,atripla may pass through breast milk and cause serious harm to the baby. Talk with your healthcare provider if you are breastfeeding. You should stop breast-feeding or may need to use a different medicine. Taking ATRIPLA with alcohol or other medicines causing similar side effects as ATRIPLA, such as drowsiness, may increase those side effects. Do not take any other medicines, including prescription and nonprescription medicines and herbal products, without checking with your healthcare provider. Avoid doing things that can spread HIV-1 infection since ATRIPLA does not stop you from passing the HIV-1 infection to others. What are the possible side effects of ATRIPLA? ATRIPLA may cause the following serious side effects: Lactic acidosis (buildup of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your healthcare provider right away if you get signs of lactic acidosis. (See What is the most important information I should know about ATRIPLA? ) Serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get any signs of liver problems. (See What is the most important information I should know about ATRIPLA? ) Flare-ups of Hepatitis B Virus (HBV) infection, in which the disease suddenly returns in a worse way than before, can occur if you have HBV and you stop taking ATRIPLA. Your healthcare provider will monitor your condition for several months after stopping ATRIPLA if you have both HIV-1 and HBV infection and may recommend treatment for your HBV. Serious psychiatric problems. A small number of patients may experience severe depression, strange thoughts, or angry behavior while taking ATRIPLA. Some patients have thoughts of suicide and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness. Contact your healthcare provider right away if you think you are having these psychiatric symptoms, so your healthcare provider can decide if you should continue to take ATRIPLA. Kidney problems. If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider should do regular blood tests to check your kidneys. Changes in bone mineral density (thinning bones). It is not known whether longterm use of ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate) will cause damage to your bones. If you have had bone problems in the past, your healthcare provider may need to do tests to check your bone mineral density or may prescribe medicines to help your bone mineral density. Common side effects: Patients may have dizziness, headache, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams during treatment with ATRIPLA. These side effects may be reduced if you take ATRIPLA at bedtime on an empty stomach. They also tend to go away after you have taken the medicine for a few weeks. If you have these common side effects, such as dizziness, it does not mean that you will also have serious psychiatric problems, such as severe depression, strange thoughts, or angry behavior. Tell your healthcare provider right away if any of these side effects continue or if they bother you. It is possible that these symptoms may be more severe if ATRIPLA is used with alcohol or mood altering (street) drugs. If you are dizzy, have trouble concentrating, or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery. Rash may be common. Rashes usually go away without any change in treatment. In a small number of patients, rash may be serious. If you develop a rash, call your healthcare provider right away. Other common side effects include tiredness, upset stomach, vomiting, gas, and diarrhea. Other possible side effects with ATRIPLA include: Changes in body fat. Changes in body fat develop in some patients taking anti-hiv-1 medicine. These changes may include an increased amount of fat in the upper back and neck ( buffalo hump ), in the breasts, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these fat changes are not known. Skin discoloration (small spots or freckles) may also happen with ATRIPLA. Tell your healthcare provider or pharmacist if you notice any side effects while taking ATRIPLA. Contact your healthcare provider before stopping ATRIPLA because of side effects or for any other reason. This is not a complete list of side effects possible with ATRIPLA. Ask your healthcare provider or pharmacist for a more complete list of side effects of ATRIPLA and all the medicines you will take. How do I store ATRIPLA? Keep ATRIPLA and all other medicines out of reach of children. Store ATRIPLA at room temperature 77 F (25 C). Keep ATRIPLA in its original container and keep the container tightly closed. Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away make sure that children will not find them. General information about ATRIPLA: Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ATRIPLA for a condition for which it was not prescribed. Do not give ATRIPLA to other people, even if they have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about ATRIPLA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ATRIPLA that is written for health professionals. Do not use ATRIPLA if the seal over bottle opening is broken or missing. What are the ingredients of ATRIPLA? Active Ingredients: efavirenz, emtricitabine, and tenofovir disoproxil fumarate Inactive Ingredients: croscarmellose sodium, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate. The film coating contains black iron oxide, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, and titanium dioxide. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. EMTRIVA,TRUVADA, and VIREAD are trademarks of Gilead Sciences, Inc. SUSTIVA is a trademark of Bristol-Myers Squibb Pharma Company. Reyataz and Videx are trademarks of Bristol-Myers Squibb Company. Pravachol is a trademark of ER Squibb & Sons, LLC. Other brands listed are the trademarks of their respective owners. SF-B0001B GS-004 ST0023 June 2008

12 Readers Forum join us on MySpace at Add us as your friend and check out our community partners. Cherished In your September/October 2007 issue, I read the article An Open Letter: Woman to Woman by Heidi Nass. Because of it, I realize that whether you have HIV or not, the human desire to be cherished, loved, and supported, to experience life s goodness and joys never goes away and you shouldn t ignore it. I have HIV and I want those things and will have them. But this virus is tricky and overbearing. In time I will come to accept my HIV status, and learn to live a happy life again. Now I have a starting point. Thank you. James Cotromanes, Wheaton, IL e will treat all communications (letters, faxes, , etc.) as letters to the editor unless otherwise instructed. We reserve the right to edit for length, style or clarity. Please advise if we can use your name and city. Write to:, 5537 North Broadway Chicago, IL Fax: (773) readersforum@tpan.com Stay Current with PA Updates Sign-up today for our newsletter and receive regular updates on HIV treatment news and information. Visit or and click on Subscribe. Once you receive a confirmation , you can update your TPAN profile to include Updates. PA Online Poll September / October Poll results No 15% Have you or your partner ever experienced a loss of erection when using a condom? November / December Poll Question This month s question: Yes 85% Yes=85% No=15% The theme of this year s World AIDS Day (December 1) is leadership. What does leadership mean to you? Vote at www. positivelyaware. com Comments The problem I ve found with condoms is sometimes they restrict the proper friction. I used to have more trouble with keeping an erection when using a condom, but with more and more use it happens less frequently. But I still have trouble from time to time. 12

13 News Briefs by Enid Vázquez Photo Russell McGonagle HIV and aging In September, at the U.S. Conference on AIDS held in Fort Lauderdale, Florida, the AIDS Institute launched its first National HIV/ AIDS and Aging Awareness Day. The initiative seeks to highlight the complex issues related to HIV prevention, care, and treatment for aging populations in the United States. The Institute noted that according to 2005 figures from the U.S. Centers for Disease Control and Prevention, people over 50 made up 24% of all people with HIV in this country, and 15% of new HIV/AIDS diagnoses. In regards to AIDS alone, individuals over 50 made up 19% of all AIDS diagnoses 29% of all people living with AIDS 35% of all deaths of people with AIDS The rate of HIV/AIDS was 12 times higher among blacks and five times higher in Latinos compared to whites in people over 50. Three important groups of aging individuals for the awareness campaign are people already living with the virus, people at risk for the virus especially the Baby Boomers and people raising their grandchildren after parents with HIV/AIDS have died. The Institute has offices in Washington, D.C. and Tampa, Florida. Visit Gardasil in HIV Gardasil, the vaccine against the very common sexually transmitted disease HPV (human papilloma virus) is now being tested in adult women, including a study in HIV-positive women. The vaccine is currently FDA-approved for girls and young women ages 13 to 24, but it has shown to be effective in women up to age 45. That research, however, did not include HIV-positive women, a group at great risk of HPV complications, including cervical cancer (cancer of the lower end of the uterus or womb). The study with positive women is from the AIDS Clinical Trials Group, and is study A5240. In Chicago, it is being conducted at Rush University Medical Center. Please Joan_A_Swiatek@Rush.edu for eligibility and enrollment information. Physician fellowships From the HIV Medicine Association (HIVMA): [The association] is now accepting applications for its second annual Minority Clinical Fellowship. The one-year fellowship enables underrepresented minority post-residency physicians to gain HIV clinical experience. Two Fellowships will be awarded to African-American and Latino applicants who have demonstrated interest in HIV medicine. The deadline for applications is February 15, For more information, visit HIVMA is part of the Infectious Diseases Society of America (IDSA). Measuring hep B viral load The U.S. Food and Drug Administration (FDA) in September approved a new test for measuring hepatitis B viral load. The Roche COBAS TaqMan HBV Test is the first real-time PCR test with automated sample amplification and detection of the hep B virus. Potential drug problem reports The FDA in September kicked off a new report for consumers based on its Adverse Events Reporting System (AERS). The new quarterly report, titled Potential Signals of Serious Risks/New Safety Information, is a result of recent federal legislation directing the FDA to make such concerns more public. The AERS database contains millions of reports of adverse events submitted to the FDA by drug makers, health care providers, and patients. According to a press release from the FDA, The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because FDA has identified a potential safety issue. The FDA also quoted the director of its Center for Drug Evaluation and Research (CDER), Janet Woodcock, M.D., as saying, My message to patients is this: Don t stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently. Because the potential risk is so preliminary, the information provided is solely the name of the product and the possible side effect. For example, one HIV drug made the first list in September. The only information given was Intelence (etravirine), hemathrosis. (See page 39 for more information on this issue.) Patients can report serious adverse events or quality problems to If you do not have Internet access, you can call a number for your state to report serious reactions. Each state has a different number to call. In Illinois, that number is (312) See the entire list of state numbers at opacom/backgrounders/complain.html. A toll-free service to call U.S. government agencies from TTY devices is available from Federal Relay Services, The FDA also makes a specific HIV drug update available, and people can sign up for this list. Go to and select join this list. Mexico conference toxicities Viread (tenofovir DF or TDF), also found in the medications Truvada and Atripla, is a popular HIV drug known for being easy to take. Some kidney toxicity, however, is associated with the medication, and clinics continue to look at that issue with this important drug. Researchers at Duke University Medical Center looked to see if they could find something to predict who gets kidney toxicity 13

14 News Briefs continued with tenofovir. In their abstract, they stated that, Tenofovir (TDF) is an efficacious [effective] and widely used antiretroviral agent. Although it is usually well-tolerated, TDF-associated renal toxicity is not uncommon. Clinical predictors of such toxicity are not fully characterized. From a cohort study of more than 1,500 individuals with HIV, they found 744 who had taken tenofovir for more than three months. This group of 744 had in their records a baseline creatine (Cr) level from at least a year before they started the tenofovir. Of the 744, 56 were identified as having tenofovir-associated nephrotoxicity (kidney toxicity). Here, it was defined as a doubling of Cr with or without a Cr level above 1.4 mg/dl in men or 1.2 in women. So what happened? Every last one of the 35 individuals who had both high blood pressure and other kidney-toxic medications developed significant Cr elevations. More information on these patients is being collected for future reports. On the other hand, individuals were less likely to develop nephrotoxicity if they started tenofovir as part of their first HIV drug combination, and when a NNRTI (non-nucleoside reverse transcriptase inhibitor) was part of that regimen. This is great news for Atripla, which has the NNRTI Sustiva in it along with tenofovir and Emtriva. The researchers concluded that, Clinical risk factors for significant TDF-associated nephrotoxicity are readily identifiable. TDF use should be avoided in patients with hypertension requiring other nephrotoxic drugs, especially if given with a PI. Use as part of initial NNRTI-based therapy is low risk for nephrotoxicity. Castleman s disease British researchers reported that there are fewer cases of Kaposi s sarcoma, a rare cancer that has been seen in people with AIDS, but the incidence of one form of Castleman s disease is up in people with the virus. The researchers wrote in their abstract, Multicentric Castleman s disease (MCD) and Kaposi s sarcoma (KS) are causally related to infection with human herpesvirus-8 (HHV-8). Castleman s disease is a non-cancerous enlargement of lymph nodes, found throughout the body. Symptoms can range from mild to severe. One HIV doctor who saw patients here in the United States said the disease could be terrible. Other similar conditions should be ruled out, for example, lymphoma, lupus, and rheumatoid arthritis. The conference abstract said the increasing incidence rate of the disease was not related to the degree of immunosuppression, the duration of HIV infections, gender, prior AIDS or HAART [highly active anti-retroviral therapy] use. This is in contrast to the incidence of KS, which was commoner in men, fell dramatically with HAART, and decreased with improved immune function. The incidence of HIV-MCD is increasing, and this rise is not related to HAART use. SurvivorshipAtoZ.org David S. Landay, an activist whose life partner died of HIV complications, has launched a website for people with life-threatening illnesses that includes such uncommon information such as what not to say to insurance agents and how to get them from a no to a yes. Landay became an activist in the early days of AIDS. He was a founder of Broadway Cares/Equity Fights AIDS, a board member of several AIDS organizations (including the National Association of People With AIDS and National AIDS Fund), and Board Chair in New York City of Community Research Initiative (the predecessor to ACRIA), a grassroots organization which conducted medical research about HIV/AIDS. After the loss of his life partner, Landay had a strong desire to help keep people from constantly reinventing the wheel with all the blind alleys and stress involved. As a result, he wrote Be Prepared: The Complete Financial, Legal and Practical Guide For Living With HIV/AIDS, Cancer and other Life-Challenging Conditions, published in 1998 by St. Martin s Press. (Both Mr. Landay s parents died of cancer). His education at Harvard and Wharton in law and insurance, with more than 20 years experience working with people with life-changing conditions, forms the basis of SurvivorshipAtoZ.org, with all its practical information for the new normal inherent in life after a diagnosis. The comprehensive website was launched on June 11 with a segment on ABC s Good Morning America with cancer survivor and co-host Robin Roberts. (The interview can be viewed on the site s home page under In The News ). The non-profit site, with initial funding from Johns Hopkins and the City of New York, provides people with the financial, legal, and practical information that answers the questions that come charging after a diagnosis, as well as those which come up 5, 10 or 20 years later, in unprecedented breadth and depth including form letters and how to complete government forms. The site also offers a free computer-generated report (including videos) personalized to the user s health, economic, and social situation. The site also explains why, in spite of 14

15 standard advice, High Deductible Health Plans are good for people with cancer and other life changing conditions. According to SurvivorshipAtoZ.org, published reports note that more than 30,000 sites provide medical information. SurvivorshipAtoZ, however, aims to avoid all the time and stress of making mistakes and using trial-and-error by integrating information from a practical, legal, and financial standpoint, including personalized information from visitors to the site who need help. The website would like people to know that Over 50% of bankruptcies are due to medical bills including people with health insurance and that there are steps people can take to minimize the financial pain. Survivors can still get health insurance and life insurance in spite of a health history. Only one third of the people who apply for Social Security Disability Insurance get it, but chances can be increased by legally working the system. When it comes to work: People no longer have to be afraid of not being hired or unable to change jobs because of a pre-existing medical condition. Visit us on the web at to view additional online news briefs, and subscribe to our PA Update newsletter. While there don t forget to check out our newly added community forums and blogs where you can interact with the growing online community! Special 20th Anniversary Issue in January/February celebrates its 20th anniversary, going back to its origin as TPA News, with a special issue in January/February The annual drug guide will be published in March/ April instead. If you have any reminiscences or updates about your experiences at TPAN or with that you d like to share, especially from the early days, please submit them to publications@tpan.com or to our mailing address by November 24. There are techniques for negotiating accommodations needed because of a health condition (such as time off to go for treatment). There are easy steps to take while people are working to make life on disability better if a condition becomes disabling. Up to 70% of doctors ignore end-of-life requests, but proper planning can help avoid the situation. Pain and depression do not have to be part of an illness. In a community-focused section, user participation is encouraged to provide practical tips, local information, and resources. Message boards are set up by category (insurance, employment, etc.) with specific boards for business owners and for people who are self-employed. Users will be asked to donate to help keep the site advertising free to avoid any potential conflict-of-interest. e (Editor s note: The above was taken from a press release from SurvivorshipAtoZ.org.) We really would love to hear from you as we expand our blog and community forum section at our newly redesigned website, So, if you haven t done so already, please register (it only takes a minute) and join in on the dialogue. Lots of interesting stuff going on and lots more interesting stuff to come! 15

16 Ask the This issue s Specialists Daniel Pearce, D. O., AAHIVS and Ellen Tedaldi, M. D., AAHIVS Daniel Pearce, D.O., AAHIVS Ellen Tedaldi, M.D., AAHIVS Dear HIV Specialist: I was infected about a year and a half ago and diagnosed about 11 months ago. Upon diagnosis I had positive ELISA and then indeterminate Western Blot. Then, I had a positive ELISA and Western Blot on blood draw. In August, October, January, and April I had an undetectable viral load with a CD4 count above 800 each time. Last week, I visited my doctor again for my final hepatitis vaccinations and my normal three-month check up. My CD4 count was above 1,100 and my viral load came back at 100. Naturally, I have not taken any HIV medications yet. I have read some about long-term non-progressors and am obviously hoping to be in this category as time marches forward. What is the current medical opinion on LTNP and what can I expect? Signed, Hoping Dear Hoping: I am happy for you. I have had many patients I have followed over the last 20 years with similar numbers and some have been in the same category as you ever since we ve had the HIV test in the mid-1980s the viral load is undetectable or very low, less than 1,000 occasionally or always undetectable, and their CD4 is above 500. We keep following these patients and making sure that there isn t a decline in CD4s or a rise in viral load. I sometimes let them come in every six months when their body vs. virus war has shown that the body is winning based on the last three blood tests. We think the ability for the immune system to stay so healthy is due to the inheritance of a protective mutation, making it difficult for the virus to enter the cell. This has been estimated to be in around 7% of Europeans. I have worked mainly with non- European patients so I have seen it mainly in African descendents who must have had a European ancestor in the mix. How did this happen? A great many Europeans died from three major plagues: the flu, smallpox, and the bubonic plague; some of the survivors of these plagues survived because they had a genetic mutation that was protective, and one of these mutations may be the one helping you. For example, Africans had malaria and those with the sickle cell mutation seem to not get as sick from malaria. Another example of evolution in action: If I spray a field of 1 million mosquitoes with DDT, then maybe only 1 in 10,000 will survive due to not getting any or enough spray, or having a protective mutation, leaving 100 alive and 999,900 dead. These very few survivors will have many offspring over the next few generations reaching 1 million again with a much larger percentage having the protective mutation. My recommendations for you are to monitor your numbers, have periodic exams like HIV-negative people, and practice the healthy habits you know you should! Daniel Pearce, D.O., AAHIVS Associate Professor of Internal Medicine Chief, Division of Hospital and General Internal Medicine Medical Director of HIV Services Western University of Health Sciences College of Osteopathic Medicine of the Pacific Dear HIV Specialist: How many different types of tests are there to detect HIV viral load? My doctor told me there is only one available, but reading online it seems like there are more. Photo provided by Daniel Pearce, D.O., AAHIVS and Ellen Tedaldi, M.D., AAHIVS 16

17 SUBMIT YOUR QUESTIONS FOR ASK THE HIV SPECIALIST TO My viral load has been checked twice since being diagnosed as being HIV-positive, but my viral load has come back twice as being undetectable (less than 48 copies). From my sexual history it was concluded that I was infected almost two years ago. My CD4 count is in the high 400s. Is this a normal situation, after two years of infection to have a high CD4 [count] and an undetectable viral load without being on any medication? Signed, Testing Dear Testing: You are correct that there are different tests to measure the HIV-1 viral load. Viral load refers to the number of copies of free virus in the blood and is used as a guide for when to start antiretroviral treatment and as a monitor of your response to therapy. There are three different assays (or tests) from three different categories available for viral load, also called quantitative HIV-1 RNA, tests: 1. RT-PCR or reverse transcriptase polymerase chain reaction (PCR) 2. bdna or branched chain DNA 3. Nucleic acid sequence based amplification assay (NASBA) The HIV-1 RT-PCR (Amplicor HIV-1 Monitor, version 1.5) test works by using short portions of the genetic material of the virus and making additional copies that can be increased or amplified and measured. The first generation of viral load tests measured from 400 to 750,000 copies. The current version of the test, the ultrasensitive or extended range available in commercial labs, measures to less than 50 copies/ml. The bdna assay (Versant v.3.0) uses a different technique of viral probes that are linked to another molecule resulting in a chemical light reaction. This assay measures from 75 to 500,000 copies/ml. The last assay, NASBA (NucliSens HIV-1 QT), measures from copies/ml and can be used to measure virus in other body fluids. When measuring your viral load, it is important to use the same type of assay from one measurement to the next to be able to compare results. The goal of HIV therapy is to control the replication, or growth, of virus and get the viral load in your blood to levels that are undetectable. When the viral load is undetectable or below the lowest number of a particular test, you can still have HIV stored in other parts of your body, however. Your situation, where the viral load is undetectable after two years without treatment, is fortunate but not that common. Most persons infected with HIV-1 will have some level of virus in their blood. There are individuals who seem to control their HIV virus without therapy. There are research studies to examine what factors, genetic or immune-related, enable the virus to be held in check by these elite controllers. As for the CD4 count, individuals can lose a different amount of cells every year depending on the level of immune activation. The CD4 count on any given test can be influenced by many factors, from an intercurrent illness to time of day. Ellen Tedaldi, M.D., AAHIVS Temple University Hospital Philadelphia, PA e Is your provider an AAHIVMcredentialed HIV Specialist? If you are living with HIV, you have a lot of choices to make when seeking care and treatment. One of your most important choices is your health care practitioner so why not choose someone who is knowledgeable about HIV and experienced in its treatment? The American Academy of HIV Medicine (AAHIVM) s HIV Specialist credentialing program is the first and only clinical credentialing program offered domestically and internationally to physicians, nurse practioners, and physician assistants specializing in HIV care. HIV care providers become designated HIV Specialists after meeting experience and education requirements, and successfully completing a rigorous exam on HIVspecialized care. Look for the letters AAHIVS after their name. Locate an HIV Specialist Your search for an HIV Specialist is easy with AAHIVM s online Find-A- Provider directory at Just click on the Find-A-Provider window on the homepage, key in your location, and click on the search button for a list of HIV Specialists near you. Due to space limitations, not all submitted questions can be answered in this column, but every effort is made to ensure you receive the information you have requested. For more information about AAHIVM, call or visit www. aahivm.org. 17

18 More Than Just Another Brick In The Wall Want a piece of TPAN? TPAN is growing and we need your help! Not only are we expanding our variety of programs to include the new POWER (Positive Outcomes for Wellness, Education and Recovery) Program, as well as thinking ahead towards future growth, but we re also expanding our physical space into 5541 N. Broadway. There, we will have room for new staff members, a meeting room large enough for 75 people, modern equipment and facilities that will serve us well for years to come. But, as you can imagine, all of that costs money. True to our long history of being peer-led, we are creating a grassroots campaign to support this growth. One of the large walls in the new space is made of bricks we are inviting everyone to buy a brick in the wall at whatever level is right for them. In order to show our gratitude and acknowledge your ownership of TPAN s future, the bricks will bear the names of every contributor who wants their name, or the name of someone they donate in honor or memory of, to appear there. We believe that even the smallest donation deserves to be recognized for helping to make this exciting growth possible. If you would like to donate, you can do so in several ways: By mail: Use the form below and send a check or money order to TPAN at 5537 N. Broadway, Chicago, IL Online: By credit card, go to and click on The Wall In person: forms and donation envelopes are available at reception There are four levels of giving: Bronze: $5 $99; Silver: $100 $249; Gold: $250 $499; Platinum: $500 and above. And, yes, your donation is tax deductible! Additionally, there are other opportunities to become a conference or counseling room sponsor starting at $1,500. Contact Ron Schnorbus, Director of Development, at , ext. 229, for more information. If you ve ever felt that TPAN has helped you or someone you know to live a healthier, more informed, more empowered life, now is your chance to help us to continue to do that for all who enter here. Thanks for being part of TPAN s continued success! Yes! I want my piece of TPAN! Name Address Phone Is your donation in honor or in memory of someone? How would you like your donation to appear on the The Wall? (please print legibly): I prefer to donate anonymously. Bronze: $5 to $99 Silver: $100 to $249 Gold: $250 to $499 Platinum: $500 and above Donation Amount: $ Payment method: Cash Check/MO Credit Card Credit card # Expiration Code

19 AS PART OF HIV COMBINATION THERAPY: SUSTIVA ONCE-DAILY SUSTIVA IN HIV COMBINATION THERAPY: Can help keep viral loads undetectable* for a long time Helps improve your body s immune system by raising your T-cell count *Undetectable is defined as a viral load of less than 400 copies/ml or less than 50 copies/ml (depending on the test used). Up to 168 weeks. SUSTIVA does not cure HIV and has not been shown to prevent passing HIV to others. & ME... We re in this together. Individual results may vary. Ask your doctor if SUSTIVA is right for you. Visit IMPORTANT INFORMATION ABOUT SUSTIVA (efavirenz) INDICATION: SUSTIVA is a prescription medicine used in combination with other medicines to treat people who are infected with the human immunodeficiency virus type 1 (HIV-1). SUSTIVA does not cure HIV and has not been shown to prevent passing HIV to others. See your healthcare provider regularly. IMPORTANT SAFETY INFORMATION: Do not take SUSTIVA if you are taking the following medicines because serious and life-threatening side effects may occur when taken together: Hismanal (astemizole), Vascor (bepridil), Propulsid (cisapride), Versed (midazolam), Orap (pimozide), Halcion (triazolam), or ergot medicines (for example, Wigraine and Cafergot ). In addition, SUSTIVA should not be taken with: Vfend (voriconazole) since it may lose its effect or may increase the chance of having side effects from SUSTIVA. Some doses of voriconazole can be taken at the same time as a lower dose of SUSTIVA, but you must check with your doctor first. SUSTIVA should not be taken with ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) because it contains efavirenz, the active ingredient of SUSTIVA. Fortovase, Invirase (saquinavir mesylate) should not be used as the only protease inhibitor in combination with SUSTIVA. Taking SUSTIVA with St. John s wort (Hypericum perforatum) is not recommended as it may cause decreased levels of SUSTIVA, increased viral load, and possible resistance to SUSTIVA (efavirenz) or cross-resistance to other anti-hiv drugs. This list of medicines is not complete. Discuss with your healthcare provider all prescription and non-prescription medicines, vitamins, and herbal supplements you are taking or plan to take. Tell your healthcare provider right away if you have any side effects or conditions, including the following: Severe depression, strange thoughts, or angry behavior have been reported by a small number of patients taking SUSTIVA. Some patients have had thoughts of suicide and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness. Dizziness, trouble sleeping or concentrating, drowsiness, unusual dreams, and/or hallucinations are common, and tend to go away after taking SUSTIVA for a few weeks. Symptoms were severe in a few patients and some patients discontinued therapy. These symptoms may become more severe with the use of alcohol and/or mood-altering (street) drugs. If you are dizzy, have trouble concentrating, and/or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery. If you have ever had mental illness or are using drugs or alcohol. Pregnancy: Women should not become pregnant while taking SUSTIVA and for 12 weeks after stopping SUSTIVA. Serious birth defects have been seen in children of women treated with SUSTIVA (efavirenz) during pregnancy. Therefore, women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control. Breast-Feeding: Women with HIV should not breast-feed because they can pass HIV through their milk to the baby. Also, SUSTIVA may pass through breast milk and cause serious harm to the baby. Rash is a common side effect that usually goes away without any change in your medicines, but may be serious in a small number of patients. Rash may be a serious problem in some children. If you have liver disease, your healthcare provider may want to do tests to check your liver. Seizures have occurred in patients taking SUSTIVA, usually in those with a history of seizures. If you have ever had seizures, or take medicines for seizures, your healthcare provider may want to switch you to another medicine or monitor you. Changes in body fat have been seen in some patients taking anti-hiv medicines. The cause and long-term health effects are not known. Other common side effects of SUSTIVA taken with other anti-hiv medicines include: tiredness, upset stomach, vomiting, and diarrhea. You should take SUSTIVA on an empty stomach, preferably at bedtime, which may make some side effects less bothersome. SUSTIVA is one of several treatment options your doctor may consider. SUSTIVA and the SUNRISE logo are registered trademarks of Bristol-Myers Squibb Pharma Company. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks are owned by third parties Bristol-Myers Squibb Company, Princeton, NJ U.S.A. 692US08AB /08 Please see Patient Information about SUSTIVA on the next page. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA-1088.

20 PATIENT INFORMATION SUSTIVA (sus-tee-vah) [efavirenz (eh-fah-vih-rehnz)] capsules and tablets ALERT: Find out about medicines that should NOT be taken with SUSTIVA (efavirenz). Please also read the section MEDICINES YOU SHOULD NOT TAKE WITH SUSTIVA. Read this information before you start taking SUSTIVA. Read it again each time you refill your prescription, in case there is any new information. This leaflet provides a summary about SUSTIVA and does not include everything there is to know about your medicine. This information is not meant to take the place of talking with your doctor. What is SUSTIVA? SUSTIVA is a medicine used in combination with other medicines to help treat infection with Human Immunodeficiency Virus type 1 (HIV-1), the virus that causes AIDS (acquired immune deficiency syndrome). SUSTIVA is a type of anti-hiv drug called a non-nucleoside reverse transcriptase inhibitor (NNRTI). NNRTIs are not used in the treatment of Human Immunodeficiency Virus type 2 (HIV-2) infection. SUSTIVA works by lowering the amount of HIV-1 in the blood (viral load). SUSTIVA must be taken with other anti-hiv medicines. When taken with other anti-hiv medicines, SUSTIVA has been shown to reduce viral load and increase the number of CD4+ cells, a type of immune cell in blood. SUSTIVA may not have these effects in every patient. SUSTIVA does not cure HIV or AIDS. People taking SUSTIVA may still develop other infections and complications. Therefore, it is very important that you stay under the care of your doctor. SUSTIVA has not been shown to reduce the risk of passing HIV to others. Therefore, continue to practice safe sex, and do not use or share dirty needles. What are the possible side effects of SUSTIVA? Serious psychiatric problems. A small number of patients experience severe depression, strange thoughts, or angry behavior while taking SUSTIVA. Some patients have thoughts of suicide and a few have actually committed suicide. These problems tend to occur more often in patients who have had mental illness. Contact your doctor right away if you think you are having these psychiatric symptoms, so your doctor can decide if you should continue to take SUSTIVA. Common side effects. Many patients have dizziness, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams during treatment with SUSTIVA. These side effects may be reduced if you take SUSTIVA at bedtime on an empty stomach. They also tend to go away after you have taken the medicine for a few weeks. If you have these common side effects, such as dizziness, it does not mean that you will also have serious psychiatric problems, such as severe depression, strange thoughts, or angry behavior. Tell your doctor right away if any of these side effects continue or if they bother you. It is possible that these symptoms may be more severe if SUSTIVA is used with alcohol or mood altering (street) drugs. If you are dizzy, have trouble concentrating, or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery. Rash is common. Rashes usually go away without any change in treatment. In a small number of patients, rash may be serious. If you develop a rash, call your doctor right away. Rash may be a serious problem in some children. Tell your child s doctor right away if you notice rash or any other side effects while your child is taking SUSTIVA. Other common side effects include tiredness, upset stomach, vomiting, and diarrhea. Changes in body fat. Changes in body fat develop in some patients taking anti-hiv medicine. These changes may include an increased amount of fat in the upper back and neck ( buffalo hump ), in the breasts, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these fat changes are not known. Tell your doctor or healthcare provider if you notice any side effects while taking SUSTIVA. Contact your doctor before stopping SUSTIVA because of side effects or for any other reason. This is not a complete list of side effects possible with SUSTIVA. Ask your doctor or pharmacist for a more complete list of side effects of SUSTIVA and all the medicines you will take. How should I take SUSTIVA? General Information You should take SUSTIVA on an empty stomach, preferably at bedtime. Swallow SUSTIVA with water. Taking SUSTIVA with food increases the amount of medicine in your body, which may increase the frequency of side effects. Taking SUSTIVA at bedtime may make some side effects less bothersome. SUSTIVA must be taken in combination with other anti-hiv medicines. If you take only SUSTIVA, the medicine may stop working. Do not miss a dose of SUSTIVA. If you forget to take SUSTIVA, take the missed dose right away, unless it is almost time for your next dose. Do not double the next dose. Carry on with your regular dosing schedule. If you need help in planning the best times to take your medicine, ask your doctor or pharmacist. Take the exact amount of SUSTIVA your doctor prescribes. Never change the dose on your own. Do not stop this medicine unless your doctor tells you to stop. If you believe you took more than the prescribed amount of SUSTIVA, contact your local Poison Control Center or emergency room right away. Tell your doctor if you start any new medicine or change how you take old ones. Your doses may need adjustment. When your SUSTIVA supply starts to run low, get more from your doctor or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to SUSTIVA and become harder to treat. Your doctor may want to do blood tests to check for certain side effects while you take SUSTIVA. Capsules The dose of SUSTIVA capsules for adults is 600 mg (three 200-mg capsules, taken together) once a day by mouth. The dose of SUSTIVA for children may be lower (see Can children take SUSTIVA?). Tablets The dose of SUSTIVA tablets for adults is 600 mg (one tablet) once a day by mouth. Can children take SUSTIVA? Yes, children who are able to swallow capsules can take SUSTIVA. Rash may be a serious problem in some children. Tell your child s doctor right away if you notice rash or any other side effects while your child is taking SUSTIVA. The dose of SUSTIVA for children may be lower than the dose for adults. Capsules containing lower doses of SUSTIVA are available. Your child s doctor will determine the right dose based on your child s weight. Who should not take SUSTIVA? Do not take SUSTIVA if you are allergic to the active ingredient, efavirenz, or to any of the inactive ingredients. Your doctor and pharmacist have a list of the inactive ingredients. What should I avoid while taking SUSTIVA? Women should not become pregnant while taking SUSTIVA and for 12 weeks after stopping it. Serious birth defects have been seen in the offspring of animals and women treated with SUSTIVA during pregnancy. It is not known whether SUSTIVA caused these defects. Tell your doctor right away if you are pregnant. Also talk with your doctor if you want to become pregnant. Women should not rely only on hormone-based birth control, such as pills, injections, or implants, because SUSTIVA (efavirenz) may make these contraceptives ineffective. Women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control. SUSTIVA may remain in your blood for a time after therapy is stopped. Therefore, you should continue to use contraceptive measures for 12 weeks after you stop taking SUSTIVA. Do not breast-feed if you are taking SUSTIVA. The Centers for Disease Control and Prevention recommend that mothers with HIV not breast-feed because they can pass the HIV through their milk to the baby. Also, SUSTIVA may pass through breast milk and cause serious harm to the baby. Talk with your doctor if you are breast-feeding. You may need to stop breast-feeding or use a different medicine. Taking SUSTIVA with alcohol or other medicines causing similar side effects as SUSTIVA, such as drowsiness, may increase those side effects. Do not take any other medicines without checking with your doctor. These medicines include prescription and nonprescription medicines and herbal products, especially St. John s wort. Before using SUSTIVA, tell your doctor if you have problems with your liver or have hepatitis. Your doctor may want to do tests to check your liver while you take SUSTIVA. have ever had mental illness or are using drugs or alcohol. have ever had seizures or are taking medicine for seizures [for example, Dilantin (phenytoin), Tegretol (carbamazepine), or phenobarbital]. Your doctor may want to switch you to another medicine or check drug levels in your blood from time to time. What important information should I know about taking other medicines with SUSTIVA? SUSTIVA may change the effect of other medicines, including ones for HIV, and cause serious side effects. Your doctor may change your other medicines or change their doses. Other medicines, including herbal products, may affect SUSTIVA. For this reason, it is very important to: let all your doctors and pharmacists know that you take SUSTIVA. tell your doctors and pharmacists about all medicines you take. This includes those you buy over-the-counter and herbal or natural remedies. Bring all your prescription and nonprescription medicines as well as any herbal remedies that you are taking when you see a doctor, or make a list of their names, how much you take, and how often you take them. This will give your doctor a complete picture of the medicines you use. Then he or she can decide the best approach for your situation. Taking SUSTIVA with St. John s wort (Hypericum perforatum), an herbal product sold as a dietary supplement, or products containing St. John s wort is not recommended. Talk with your doctor if you are taking or are planning to take St. John s wort. Taking St. John s wort may decrease SUSTIVA levels and lead to increased viral load and possible resistance to SUSTIVA or cross-resistance to other anti-hiv drugs. MEDICINES YOU SHOULD NOT TAKE WITH SUSTIVA The following medicines may cause serious and life-threatening side effects when taken with SUSTIVA. You should not take any of these medicines while taking SUSTIVA: Hismanal (astemizole) Vascor (bepridil) Propulsid (cisapride) Versed (midazolam) Orap (pimozide) Halcion (triazolam) Ergot medications (for example, Wigraine and Cafergot ) The following medicine should not be taken with SUSTIVA since it may lose its effect or may increase the chance of having side effects from SUSTIVA: Vfend (voriconazole). Some doses of voriconazole can be taken at the same time as a lower dose of SUSTIVA, but you must check with your doctor first. The following medicine should not be taken with SUSTIVA since it contains efavirenz, the active ingredient in SUSTIVA: ATRIPLA (efavirenz, emtricitabine, tenofovir disoproxil fumarate) The following medicines may need to be replaced with another medicine when taken with SUSTIVA: Fortovase, Invirase (saquinavir) Biaxin (clarithromycin) Carbatrol, Tegretol (carbamazepine) Sporanox (itraconazole) The following medicines may require a change in the dose of either SUSTIVA or the other medicine: Calcium channel blockers such as Cardizem or Tiazac (diltiazem), Covera HS or Isoptin SR (verapamil), and others. The cholesterol-lowering medicines Lipitor (atorvastatin), PRAVACHOL (pravastatin sodium), and Zocor (simvastatin). Crixivan (indinavir) Kaletra (lopinavir/ritonavir) Methadone Mycobutin (rifabutin) REYATAZ (atazanavir sulfate). If you are taking SUSTIVA and REYATAZ, you should also be taking Norvir (ritonavir). Rifadin (rifampin) or the rifampin-containing medicines Rifamate and Rifater. Zoloft (sertraline) These are not all the medicines that may cause problems if you take SUSTIVA. Be sure to tell your doctor about all medicines that you take. General advice about SUSTIVA: Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use SUSTIVA for a condition for which it was not prescribed. Do not give SUSTIVA to other people, even if they have the same symptoms you have. It may harm them. Keep SUSTIVA at room temperature (77 F) in the bottle given to you by your pharmacist. The temperature can range from 59 to 86 F. Keep SUSTIVA out of the reach of children. This leaflet summarizes the most important information about SUSTIVA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for the full prescribing information about SUSTIVA, or you can visit the SUSTIVA website at or call SUSTIVA is a registered trademark of Bristol-Myers Squibb Pharma Company, ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC, PRAVACHOL is a registered trademark of ER Squibb & Sons, LLC, and REYATAZ is a registered trademark of Bristol-Myers Squibb Company. Other brands listed are the trademarks of their respective owners. Distributed by: A2 T4-B0001B Rev March 2008

21 Ambassador of Healing Photos courtesy of Seane Corn Seane Corn YouthAIDS ambassador Seane Corn circles the globe teaching the healing power of yoga by Jeff Berry The journey of yoga instructor and YouthAIDS ambassador Seane Corn begins in the most improbable of all places Heaven and carries her to corners of the world that may appear to some to be closer to hell. But the journey has ultimately led her to a life filled with joy and meaning. When I was young and living in New York City, I worked in a nightclub called Heaven, which was an all-male, gay sex club, says Corn. Stationed behind the bar, she was at the time the only woman who worked there, when the prevalence of HIV and AIDS was increasing among the gay community. And yet, she says, there was still a lot of denial. Volunteers from Gay Men s Health Crisis would come into the gay clubs with a big vat of condoms, which would be gone by the end of the night, which was always great, recalls Corn. But there was still a lot of unsafe and casual behavior, so unfortunately a lot of the men I met and became friends with were becoming sick and subsequently dying. Around 1987 Corn got involved with ACT UP New York, and says she was so young and angry that she was the worst kind of activist. I had a megaphone in one hand and a middle finger up at the world, telling everyone how they should live their life, what they should think, and what they should believe, says Corn. She soon got out of the whole activism world because, she says, she was really ineffectual and had some of her own issues she needed to deal with. That s where yoga came in. Yoga taught me how to deal with my anger. It taught me especially around AIDS that I did have fear, 21

22 and I did have confusion and sadness. But I didn t have the ability to process those emotions, so I kept acting out through my rage. When a person doesn t have the tools to deal with their emo- tions, says Corn, its shadow comes out in other ways, such as drugs, alcohol, sleeping around, or food. There are a variety of ways we use to anesthetize or numb ourselves, and that s essentially what I was doing. She says that yoga helped open her up and connect with her bigger emo- tions, and process them more appropriately and become more effective in the way in which she expressed herself, so that she wasn t coming from anger or fear, but more from compassion and love. It s always interesting to me, says Corn, the very thing that I was judging the people I was trying to educate was basically the same thing I had inside myself, it was just coming out in a different way. It s probably why I couldn t stand the people who were in judgment about my friends I couldn t stand them and their ignorance and fear because I couldn t stand the ignorance and fear in myself. Working through yoga really helped me to have more respect for the human experience to understand that fear, anger, and rage are a part of the human dilemma, and the more that I can understand it in myself, the more I m going to be able to recognize it in another being, and hopefully act more patiently and compassionately, rather than react from anger or fear. Yoga helped to put all that into perspective for me. In 1999 Corn became involved with Children of the Night, an orga- nization which houses and provides informa- tion for adolescent sex workers both young boys and girls between the ages of 11 and 17. I went there because I thought that yoga would be a really good feel- ing tool for them to use, as they get back into their bodies and try to re-adapt to the world after such levels of abuse and exploitation, Corn explains. While working at the shelter she learned that a good percentage of the boys and girls had HIV/AIDS. She also came to understand that while many here in the U.S. have access to resources and information, most of those who live in resource-poor countries aren t entitled to the same privilege. During that same period, a friend, actress Ashley Judd, reached out to Corn. Judd had just returned from Southeast Asia and was upset not only by the high incidence of HIV/AIDS among the children and sex workers, but also by the sex trafficking that she saw happening there. While working at the shelter she learned that a good percentage of the boys and girls had HIV/AIDS. She called me because she just wanted to talk about how I deal emotionally when working with sexually abused children, and if I had any suggestions or tools for her, because a lot was coming up for her, as you can imagine. Corn says that Judd proceeded to open her eyes to what was happening internationally. These young girls and boys were being exploited, not just because their parents didn t love them, but more often because of poverty, and because they needed food for their families. Not to say that a lot of the children aren t just getting sold or abandoned, says Corn, but there s a variety of reasons why this particular population was being turned out. They were having sex for I think the statistic is $1 for sex with a condom, $2 for sex without. And it s not just a health issue, it s a political issue, it s an educational issue, it s an environmental issue it s an issue across the board. Photos courtesy of Seane Corn 22

23 Yoga has very little to do with your strength and flexibility, and everything to do with your attitude and perception, says Corn. Judd s involvement with YouthAIDS intrigued Corn, not only because of its extended, international reach, but also due to the fact that around 97 cents out of every dollar went to providing direct services and information not a bad return. Out of curiosity, Corn began working with various grassroots businesses within the yoga community, creating products and tithing a portion of the proceeds to YouthAIDS. In just a few short years we ve been able to raise hundreds of thousands of dollars, raise an enormous amount of awareness, and really get the word out and get people much more actively interested and involved. YouthAIDS eventually named Corn their national yoga ambas- sador, and invited her to travel with them to teach yoga to prosti- tuted children and sex workers, and to better understand how their programs run. That was just life changing, says Corn. To be able to go and to meet the populations who are really at risk, to really put a face to AIDS. It also furthered her own understanding of the impact HIV/AIDS was having on thosecommunities,aswell as the effectiveness of the programming itself. Yet despite all the good work that is being done, it became clear to her how much prejudice and stigma still exists, even to this day, and how much needs to change before health and wellness can ever be fully achieved. The type of yoga that Corn currently practices is something called Vinyasa Flow, which simply means linking movement with breath. Corn, who s now 41, has been practicing a variety of styles of yoga for the last 22 years. She says that as she s gotten older, her yoga has evolved and changed over time. That s the thing I love about yoga is that it s a real creative experience. It s more like an art it evolves and grows as you evolve and grow, so it s never fixed or absolute. It certainly has matured as I have matured. Corn was fortunate enough to have been turned on to yoga as a kind of alternative high, she says, as it provided different lifestyle opportunities for her. I learned how to get back into my body, and the healthier I got, the more responsibility I was able to take for my life, and I was able to stop drinking, smoking, and doing drugs. It just opened my mind up to an alternative way to live my life. These days Corn divides her time between overseas excursions as ambassador for YouthAIDS, spending time at home with her two cats Daisy and Grace, and her boyfriend of eight years, actor Al Corley (who played the original Steven on the TV series Dynasty), as well as teaching yoga at various workshops around the country. While she hasn t taught any workshops specifically geared towards HIV-positive people, she s worked one-on-one with a number of HIV-positive clients, and has many HIV-positive individuals who attend her workshops. She says that one of the most important things for people to realize, regardless of their HIV status, is that the practice of yoga has a very specific influence on the nervous system. It helps you stay calm and grounded no matter what conflict or crisis is in your life, says Corn. One of the things in working with people with HIV is that it s very important to help give them the tools to deal with stress. 23

24 There s one other very positive gain derived from yoga that she s seen in the lives of people with HIV/AIDS. Acceptance, says Corn, just acceptance. You can live with HIV/AIDS angry, resentful, and bitter, or you can live with HIV/AIDS with acceptance, ance, openness, and a willingness to take your experience and help to serve the world in which you live. Those are two very different attitudes. It doesn t guarantee a longer life as a result, but the person who can come to a sense of greater self-acceptance and peace can certainly live a life that has so many additional gifts as a result. And I m not just talking about HIV, I m talking about any struggle, gle, any conflict, any challenge that one has in life, you can either use it as a way to become disempowered, or you can use it as a way to become empowered. For example, the reason I work with sexually abused children is because that s my own personal history, and I ve watched other people who have been sexually abused choose to live as a victim as a result. My quest has always been, This has happened, it s a part of my journey, but it s not going to define who I am. How can I take this experience and actually help it make sense? And so for me it s all about service. That s the most important thing for me you can t change what has happened, that s just life. It s a bummer, I wish it hadn t happened, but that s not the reality, it did. So now what? It s the same philosophy I have with someone with HIV/AIDS now what? What are you going to do with this disease? How are you going to live your life? My hope is that we can all choose to break shame and live completely authentically, and tell the truth, share our stories, reach out to another human being, dignify the human experience no matter how difficult or challenging or scary it is, and come from such a sincere place of love that it empowers someone else to be able to live their truth. That s the one thing I always want to offer, whether it s someone who has HIV, or they have cancer, or a drug addict, or someone who has been sexually abused, that you don t have to take something that you might perceive as negative and allow it to impact every aspect of your life in a way that s disempowering. There s a way that we can turn it around. So for me, service is everything. And that s what I encourage anyone I have worked with who has HIV who does heal and come full circle with it, to get back out there into the world and to reach out to their community, because What are you going to do with this disease? How are you going to live your life? who better than them knows the struggle that another human being is going through? Corn has some simple advice for anyone thinking about starting yoga. On a practical level and this is not just for people with HIV, it s for anyone if you can create a three-day-a-week practice, an hour to an hour and a half a day, three days a week, something that is going to increase your circulation and help to provide more elasticity in the muscles and in the joints, increase your heart rate any kind of exercise program that s going to help strengthen and tone all of the various systems of your body is going to help make you feel better. The two just go together instantly. So three days a week at an hour to an hour and a half is what I would recommend, depending on their status. If I had five people in the room, I m going to recommend five different kinds of yoga, not based on whether or not they re HIVpositive, but on their age, their health level, their weight that s going to determine what the proper yoga is for them. So there s not one style of yoga that s going to be recommended for someone with HIV/AIDS. It s really going to be who they are, their personality, and what they are attracted to. If your status is more accelerated, then she recommends the restorative classes on a daily basis, as well as in the evening time before you go to bed. Photos courtesy of Seane Corn 24

25 Corn adds that it s not just about exercise, but it s about mind, coming, never. My dad is the perfect example of someone who was body, and spirit. You also have to look into your diet, and look at older, and he was curious, then all of a sudden it took his life over the emotions that you might be repressing, and deal with any feel- and he s doing remarkably well. ings of anger, fear, or rage that are coming up. Yoga has very little to do with your strength and flexibility, Create a medication practice, a practice of forgiveness, a prac- and everything to do with your attitude and perception, says Corn. tice of self-acceptance. And none of this is not yoga all of this Yoga really holds a mirror to who you are and gives you the opportunity to heal it. If I m snorting and pushing and being all aggres- is yoga. And, of course, a connection with God, the god within themselves, the god of their own understanding. It s a very holistic sive and egotistical in my yoga practice, there s a good chance that practice. My recommendation is to allow the disease to become anytime I m up against a conflict or a crisis that I m going to be an opportunity where they have to look at the whole of their own reactive. Whereas the person who can learn to really breathe in the lives, to see that even holding onto bitterness or resentment, that s face of a challenge, when they go out into the world and they re con- a poison one takes hoping that someone else will die, and that s just fronted by an injustice, they re going to think to themselves, I m in as dysfunctional as a poor diet, as drugs, as inertia. So it s really a very challenging yoga pose right now, and I m going to breathe, looking at the whole of their lives, using, perhaps, the disease as an stay in my body, stay focused and present. And so, that s really opportunity to clean up other places that might be dysfunctional or what yoga is about. You know, great if you can get your legs behind repressed, and hopefully this healing class as mind, body, and soul your head, but it s not really going to change your life or make you will help to create a life that s whole, that s complete, that s integra- any happier. tive, that s loving for themselves and for others. If you get into a practice, Corn advises to go slow at first. Corn recommends either checking with a local health club or Learn as much as you can about the technique, but be willing to searching online for programs throughout the country, many of have an incredible sense of humor about it. Yoga can be challenging, which offer free classes to people with HIV. Unfortunately this but it can also be incredibly humbling. You just have to be willing is the part that makes me crazy yoga is a business, and it is expensive. a practice. And have fun with it. Enjoy being back in your body. to laugh at yourself, commit to the practice it s not a perfect, it s For those who may think that you can t teach an old guru new Whether you re old, thin, fat, it doesn t matter. It always feels good tricks, Corn says it s never too late to take up the practice. My dad when it s done. And that s the most important thing. e got into yoga in his 50s, and he s now in his 60s. He has kidney cancer, and he s a yoga teacher. And I would never have seen that For more information visit seanecorn.com and youthaids.org. 25

26 USE OF TRUVADA: TRUVADA is a type of medicine called an HIV-1 (human immunodeficiency virus) nucleoside analog reverse transcriptase inhibitor and combines EMTRIVA (emtricitabine) and VIREAD (tenofovir disoproxil fumarate [DF]) in one pill. TRUVADA is always used with other anti-hiv-1 medicines to treat adults with HIV-1 infection. TRUVADA should not be used with ATRIPLA (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir DF 300 mg), VIREAD, EMTRIVA, Combivir (lamivudine/zidovudine), Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), or Trizivir (abacavir sulfate/ lamivudine/zidovudine). IMPORTANT SAFETY INFORMATION: Contact your healthcare provider right away if you experience any of the following side effects or conditions while taking TRUVADA: Nausea, vomiting, unusual muscle pain, and/or weakness. These may be signs of a buildup of acid in the blood (lactic acidosis), which is a serious medical condition Light colored stools, dark colored urine, and/or if your skin or the whites of your eyes turn yellow. These may be signs of serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly), and fat in the liver (steatosis) If you have HIV-1 and hepatitis B virus (HBV) and stop taking TRUVADA, your liver disease may suddenly get worse. Your healthcare provider will monitor your condition for several months If you have had kidney problems or take other medicines that can cause kidney problems, your healthcare provider should do regular blood tests to check your kidneys It is not known whether long-term use of TRUVADA causes damage to your bones. If you have had bone problems in the past, talk to your healthcare provider before taking TRUVADA Changes in body fat have been seen in some people taking TRUVADA and other anti-hiv-1 medicines. The most common side effects of the medicines in TRUVADA when taken with other anti-hiv-1 medicines are diarrhea, nausea, fatigue, sinusitis, upper respiratory tract infections, nasopharyngitis, headache, dizziness, depression, insomnia, abnormal dreams, and rash. Skin discoloration (spots and freckles) may also happen with TRUVADA. Discuss all medicines you take with your healthcare provider and be aware: Your healthcare provider may need to follow you more closely or adjust your therapy if you are taking Videx or Videx EC (didanosine), Reyataz (atazanavir sulfate), or Kaletra (lopinavir/ritonavir) with TRUVADA Please see Patient Information on next page, including What is the most important information I should know about TRUVADA? in the Patient Information section. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA I feel positive Charles My HIV meds include TRUVADA In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults References: 1. Based on data from PHAST retail monthly data; September 2005-January 2008; Wolters Kluwer Health. 2. Truvada [prescribing information]. Foster City, CA: Gilead Sciences, Inc.; May TRUVADA, EMTRIVA, and VIREAD are trademarks of Gilead Sciences, Inc. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks are the property of their respective owners Gilead Sciences, Inc. All rights reserved. PT0450 7/08

27 prescribed HIV med by doctors 1 about my future. TRUVADA helps make it possible. Individual results may vary. With once a day TRUVADA for my HIV, I can plan for long-term success. Proven over the long term to reduce viral load to undetectable (<400 copies/ml) and increase CD4 cell count in 3 years of a clinical study* 2 Established long-term safety and tolerability* 2 TRUVADA does not cure HIV-1 infection or prevent passing HIV-1 to others. Ask your doctor about TRUVADA and go to Think long term.* Starting now. *Through 3 years in Gilead Study

28 Patient Information TRUVADA (tru-vah-dah) tablets Generic name: emtricitabine and tenofovir disoproxil fumarate (em tri SIT uh bean and te NOE fo veer dye soe PROX il FYOU mar ate) Read the Patient Information that comes with TRUVADA before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. You should stay under a healthcare provider s care when taking TRUVADA. Do not change or stop your medicine without first talking with your healthcare provider. Talk to your healthcare provider or pharmacist if you have any questions about TRUVADA. What is the most important information I should know about TRUVADA? Some people who have taken medicine like TRUVADA (nucleoside analogs) have developed a serious condition called lactic acidosis (build up of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your healthcare provider right away if you get the following signs or symptoms of lactic acidosis. You feel very weak or tired. You have unusual (not normal) muscle pain. You have trouble breathing. You have stomach pain with nausea and vomiting. You feel cold, especially in your arms and legs. You feel dizzy or lightheaded. You have a fast or irregular heartbeat. Some people who have taken medicines like TRUVADA have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get the following signs or symptoms of liver problems. Your skin or the white part of your eyes turns yellow (jaundice). Your urine turns dark. Your bowel movements (stools) turn light in color. You don t feel like eating food for several days or longer. You feel sick to your stomach (nausea). You have lower stomach area (abdominal) pain. You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog medicines, like TRUVADA, for a long time. If you are also infected with the Hepatitis B Virus (HBV), you need close medical follow-up for several months after stopping treatment with TRUVADA. Follow-up includes medical exams and blood tests to check for HBV that could be getting worse. Patients with Hepatitis B Virus infection, who take TRUVADA and then stop it, may get flare-ups of their hepatitis. A flare-up is when the disease suddenly returns in a worse way than before. What is TRUVADA? TRUVADA is a type of medicine called an HIV-1 (human immunodeficiency virus) nucleoside analog reverse transcriptase inhibitor (NRTI). TRUVADA contains 2 medicines, EMTRIVA (emtricitabine) and VIREAD (tenofovir disoproxil fumarate, or tenofovir DF) combined in one pill. TRUVADA is always used with other anti-hiv-1 medicines to treat people with HIV-1 infection. TRUVADA is for adults age 18 and older. TRUVADA has not been studied in children under age 18 or adults over age 65. HIV infection destroys CD4 + T cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops. TRUVADA helps block HIV-1 reverse transcriptase, a chemical in your body (enzyme) that is needed for HIV-1 to multiply. TRUVADA lowers the amount of HIV-1 in the blood (viral load). TRUVADA may also help to increase the number of T cells (CD4 + cells). Lowering the amount of HIV-1 in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections). TRUVADA does not cure HIV-1 infection or AIDS. The longterm effects of TRUVADA are not known at this time. People taking TRUVADA may still get opportunistic infections or other conditions that happen with HIV-1 infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infection. It is very important that you see your healthcare provider regularly while taking TRUVADA. TRUVADA does not lower your chance of passing HIV-1 to other people through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom or other barrier to lower the chance of sexual contact with semen, vaginal secretions, or blood. Never use or share dirty needles. Who should not take TRUVADA? Do not take TRUVADA if you are allergic to TRUVADA or any of its ingredients. The active ingredients of TRUVADA are emtricitabine and tenofovir DF. See the end of this leaflet for a complete list of ingredients. Do not take TRUVADA if you are already taking ATRIPLA, Combivir (lamivudine/zidovudine), EMTRIVA, Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/ lamivudine), Trizivir (abacavir sulfate/lamivudine/ zidovudine), or VIREAD because these medicines contain the same or similar active ingredients. What should I tell my healthcare provider before taking TRUVADA? Tell your healthcare provider if you: are pregnant or planning to become pregnant. We do not know if TRUVADA can harm your unborn child. You and your healthcare provider will need to decide if TRUVADA is right for you. If you use TRUVADA while you are pregnant, talk to your healthcare provider about how you can be on the TRUVADA Antiviral Pregnancy Registry.

29 are breast-feeding. You should not breast feed if you are HIV-positive because of the chance of passing the HIV virus to your baby. Also, it is not known if TRUVADA can pass into your breast milk and if it can harm your baby. If you are a woman who has or will have a baby, talk with your healthcare provider about the best way to feed your baby. have kidney problems or are undergoing kidney dialysis treatment. have bone problems. have liver problems including Hepatitis B Virus infection. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: Videx, Videx EC (didanosine). Tenofovir DF (a component of TRUVADA) may increase the amount of Videx in your blood. You may need to be followed more carefully if you are taking TRUVADA and Videx together. Also, the dose of didanosine may need to be reduced. Reyataz (atazanavir sulfate) or Kaletra (lopinavir/ritonavir). These medicines may increase the amount of tenofovir DF (a component of TRUVADA) in your blood, which could result in more side effects. You may need to be followed more carefully if you are taking TRUVADA and Reyataz or Kaletra together. TRUVADA may decrease the amount of Reyataz in your blood. If you are taking TRUVADA and Reyataz together, you should also be taking Norvir (ritonavir). Keep a complete list of all the medicines that you take. Make a new list when medicines are added or stopped. Give copies of this list to all of your healthcare providers and pharmacist every time you visit your healthcare provider or fill a prescription. How should I take TRUVADA? Take TRUVADA exactly as your healthcare provider prescribed it. Follow the directions from your healthcare provider, exactly as written on the label. The usual dose of TRUVADA is 1 tablet once a day. TRUVADA is always used with other anti-hiv-1 medicines. If you have kidney problems, you may need to take TRUVADA less often. TRUVADA may be taken with or without a meal. Food does not affect how TRUVADA works. Take TRUVADA at the same time each day. If you forget to take TRUVADA, take it as soon as you remember that day. Do not take more than 1 dose of TRUVADA in a day. Do not take 2 doses at the same time. Call your healthcare provider or pharmacist if you are not sure what to do. It is important that you do not miss any doses of TRUVADA or your anti-hiv-1 medicines. When your TRUVADA supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to TRUVADA and become harder to treat. Do not change your dose or stop taking TRUVADA without first talking with your healthcare provider. Stay under a healthcare provider s care when taking TRUVADA. If you take too much TRUVADA, call your local poison control center or emergency room right away. What should I avoid while taking TRUVADA? Do not breast-feed. See What should I tell my healthcare provider before taking TRUVADA? Avoid doing things that can spread HIV infection since TRUVADA does not stop you from passing the HIV infection to others. Do not share needles or other injection equipment. Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades. Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom or other barrier to reduce the chance of sexual contact with semen, vaginal secretions, or blood. ATRIPLA, Combivir (lamivudine/zidovudine), EMTRIVA, Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), Trizivir (abacavir sulfate/lamivudine/ zidovudine), or VIREAD. TRUVADA should not be used with these medicines. What are the possible side effects of TRUVADA? TRUVADA may cause the following serious side effects (see What is the most important information I should know about TRUVADA? ): Lactic acidosis (buildup of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your doctor right away if you get signs of lactic acidosis. (See What is the most important information I should know about TRUVADA? ) Serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get any signs of liver problems. (See What is the most important information I should know about TRUVADA? ) Flare-ups of Hepatitis B Virus infection, in which the disease suddenly returns in a worse way than before, can occur if you stop taking TRUVADA. Your healthcare provider will monitor your condition for several months after stopping TRUVADA if you have both HIV-1 and HBV infection. TRUVADA is not approved for the treatment of Hepatitis B Virus infection. Kidney problems. If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider should do regular blood tests to check your kidneys. Changes in bone mineral density (thinning bones). It is not known whether long-term use of TRUVADA will cause damage to your bones. If you have had bone problems in the past, your healthcare provider may need to do tests to check your bone mineral density or may prescribe medicines to help your bone mineral density.

30 Other side effects with TRUVADA when used with other anti-hiv-1 medicines include: Changes in body fat have been seen in some patients taking TRUVADA and other anti-hiv-1 medicines. These changes may include increased amount of fat in the upper back and neck ( buffalo hump ), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long term health effect of these conditions are not known at this time. The most common side effects of EMTRIVA or VIREAD when used with other anti HIV-1 medicines are: diarrhea, nausea, vomiting, dizziness and headache. Additional side effects are stomach pain, indigestion, gas, inflammation of the pancreas, increased amylase, sleeping problems, abnormal dreams, weakness, pain, low blood phosphate, shortness of breath, increase liver enzymes, inflammation of the liver, allergic reaction, muscle problems and rash. Skin discoloration (small spots or freckles) may also happen with TRUVADA. These are not all the side effects of TRUVADA. This list of side effects with TRUVADA is not complete at this time because TRUVADA is still being studied. If you have questions about side effects, ask your healthcare provider. Report any new or continuing symptoms to your healthcare provider right away. Your healthcare provider may be able to help you manage these side effects. How do I store TRUVADA? Keep TRUVADA and all other medicines out of reach of children. Store TRUVADA at room temperature 77 F (25 C). Keep TRUVADA in its original container and keep the container tightly closed. Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away make sure that children will not find them. General information about TRUVADA: Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use TRUVADA for a condition for which it was not prescribed. Do not give TRUVADA to other people, even if they have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about TRUVADA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about TRUVADA that is written for health professionals. For more information, you may also call GILEAD-5 or access the TRUVADA website at Do not use TRUVADA if seal over bottle opening is broken or missing. What are the ingredients of TRUVADA? Active Ingredients: emtricitabine and tenofovir disoproxil fumarate Inactive Ingredients: Croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (gluten free). The tablets are coated with Opadry II Blue Y containing FD&C Blue #2 aluminum lake, hydroxypropyl methylcellulose 2910, lactose monohydrate, titanium dioxide, and triacetin. Rx Only May 2008 TRUVADA, EMTRIVA, and VIREAD are registered trademarks of Gilead Sciences, Inc. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks referenced herein are the property of their respective owners Gilead Sciences, Inc. All rights reserved GS MAY08

31 The Beating of Your Heart Special conference looks at what s known and not known about cardiovascular disease in HIV by Enid Vázquez Joyce Turner Keller stumbled onto a meeting on heart disease in HIV while attending the Ryan White conference in Washington, D.C. in August. As a woman in her 50 s living with HIV for more than 10 years, and taking HAART (highly active antiretroviral therapy), it made her wonder what should she know about protecting herself from heart disease? Turner Keller stood up in the audience and asked the panel of experts at the roundtable that question. Given her age, given her virus, given her HIV therapy history what should she discuss with her doctor and what advice do they have for her? HIV specialists Dr. Steven K. Grinspoon of Boston and Dr. Julian M. Falutz of Montreal along with cardiologist Dr. Ann Bolger of San Francisco were in agreement make sure your doctor is thinking about your risks for heart disease. The last thing a doctor thought of was a patient s glucose and insulin when they were fighting to save your life from PCP, said Falutz, an assistant professor of Medicine at Montreal General Hospital and McGill University. Now that these drugs are available we need to think in a different way. Obviously at that time we were completely focused on measuring and treating opportunistic infections. We ve come a long way and it s a different world now. Grinspoon added, HIV is very important, but it s important to focus on risk factors for atherosclorosis. Doctors see HIV on the [patient s] chart and everything else drops off that chart. Now that s not acceptable. A new world Thanks to HIV therapy, people with the virus are much less likely to die of AIDSrelated causes. Instead, they are dying in greater proportion of common conditions that strike the general population, such as cancer, diabetes, and heart disease. Part of this has to do with simple aging the longer you live, the greater your risk of these and other diseases. For example, death from coronary heart disease (CHD) in particular may not be surprising considering that it s the leading cause of death in this country (as well as Europe). Last year, the American Heart Association (AHA) and the American Academy of HIV Medicine (the Academy) collaborated on a State of the Science conference to look at what s known and what s not known about cardiovascular disease (disease of the heart and its blood vessels) in people with HIV. Earlier this year, the collaboration 31

32 simultaneously published its findings in the association s journal Circulation (June 20) and in the Journal of Acquired Immune Deficiency Syndrome (JAIDS). Note: The conference was funded (and the report was funded in part) by an unrestricted educational grant from Bristol- Myers Squibb, a pharmaceutical company whose products include HIV medications. The AHA, the Academy, and the resulting Initiative stress that the funding did not influence their work in any way. Key points The risk for heart attack is 70 to 80% higher among people with HIV compared to those who do not have HIV, but the actual (absolute) risk is still low for younger patients. The virus itself is associated with two important risk factors for heart disease: low levels of HDL (the good cholesterol) and increased levels of triglycerides (a type of blood fat). (There are other HIV effects as well.) Large studies suggest that the increase in cardiovascular disease being seen is also associated with HIV therapy, including metabolic abnormalities such as diabetes and increased triglycerides, among others. Research also shows that even children are affected. There is a large variation in risk, however, seen among the medications within the HIV drug classes. Both HIV and its therapy are also associated with heart disease that is not atherosclerotic (narrowing of the arteries), such as pulmonary hypertension (high blood pressure in the lungs) and pericardial disease (inflammation of the membranous sac surrounding the heart). All in all, there are several ways in which HIV and its therapy are thought to have a negative effect on the heart. At the same time, one large international study (SMART) found that having people delay or go on and off their HIV therapy was actually associated with a higher risk of heart disease and other serious illnesses compared to those who went on meds and took them continuously. New HIV treatments may be associated with fewer metabolic effects. HIV-positive people on therapy who experienced heart trouble often tend to be those who also had traditional risk factors such as smoking, high blood pressure (hypertension), and family history of cardiovascular disease. Whether the greater risk of heart disease comes from HIV therapy, traditional risk factors, or from a combination of the two is not yet known. Doctors can use current tools to determine risks that were developed in an HIV-negative population, such as the risk assessment from the Framingham Heart Study, which measures the probability of having a heart attack or death from coronary disease over the following 10 years. Framingham, however, may underpredict the risk of heart attacks in HIV-positive people who smoke. Also, although the tools seem to work well in people with HIV, the testing of these measurements need to include HIV-positive individuals in order to be validated for this population. (Take the Framingham risk assessment for yourself, available at about/framingham/index.html. The conference report points out that Framingham looks at risk, and people can still experience a heart attack even if their score finds them at low risk.) The members of the initiative [to decrease cardiovascular risk and increase quality of care for patients living with HIV/ AIDS] recommend that strategies to prevent cardiovascular disease in HIV-[positive] patients should focus on reducing traditional risk factors, as well as HIV and ART [drug]-specific risk factors, said Grinspoon, co-chair of the conference, in a press release. Grinspoon is professor of medicine at Harvard Medical School and Massachusetts General Hospital in Boston. In essence, it means practicing good preventive medicine with all patients, including those who have HIV. What role does HIV therapy play in heart disease? The effect of the virus and of traditional risk factors is one thing, the effect of HIV therapy is another. People with HIV are especially concerned with the effects of antiviral therapy, some of which have been associated with an increased risk for heart disease. One of the five working groups created at the conference was dedicated to this concern. Grinspoon said that three studies in particular were thought by the conference 32

33 to answer this question. Each of these studies looked at thousands of individuals. There s a twist, however. As usual, the studies are now outdated. Newer HIV drugs that are kinder on the heart are used more today. Still, the HIV specialists at the conference, along with patients also participating, say that more needs to be known. The first of the three studies reported 127 cardiovascular events in 7,542 individuals with HIV. Dr. Iloeje and colleagues, reporting in 2005, found that having a protease inhibitor in your HIV regimen increased the risk of cardiovascular disease by 71% (see s Annual HIV Drug Guide, January/February issue, for the different classes of medications and their components). The other two reports came from the DAD Study. The research team for DAD I last year reported that there s a 16% increase in heart attack for each year of taking a protease inhibitor. The study found 345 heart attacks in 23,437 individuals. DAD II reported, also in 2007, that there is a 24% increase in heart attack for each year of being on HIV therapy period. It found 40 heart attacks in 10,002 individuals. Grinspoon pointed out that many of the cardiac events were in young patients, which is of special concern because it s unusual for this age group. It takes years, however, for researchers to publish their findings. In this case, that means that the results are at least in part outdated. To some extent, they looked at drugs that were being used before, but are rare today. Partial funder Bristol-Myers Squibb, for example, has the newer protease inhibitor Reyataz that s known for not increasing lipid levels, unlike most of the other drugs in its class. Still, doctors are cautious about assuming that higher lipid levels caused by HIV therapy increase the risk of heart disease. They want solid evidence from studies that may never be conducted. As usual, the researchers point to a depressing fact: you would need to do a study with a whole lot of people over a very long time in order to get definitive answers. That s just not easy to do. They would also need a control group people without HIV but with similar characteristics in order to compare the two populations. That would be difficult too. What else is known about the HIV medications? According to the report summary, Numerous effects of HAART, both class-specific and non-class specific, have been reported with respect to lipids, glucose [blood sugar], and body composition [increased belly fat is co-related with heart disease]. Among protease inhibitors, Norvir (ritonavir) most significantly increases triglycerides. Increased triglyceride levels may also occur with the nucleoside reverse transcriptase inhibitor (NRTI) Zerit (stavudine) and the non-nucleoside reverse transcriptase inhibitor (NNRTI) Sustiva (efavirenz). LDL cholesterol increases modestly with initiation of most forms of HAART; this increase is not due to direct effects of specific antiretroviral drugs, but whether it relates to immune effects or restoration of health remains unclear. Significant increases in LDL cholesterol among HIV-[positive] patients are more likely to be due to genetic and dietary causes. Although [NNRTIs] increase HDL cholesterol, most other antiretroviral therapies do not, and low HDL cholesterol levels may contribute to coronary heart disease in HIV- [positive] patients. Insulin resistance may be caused by specific drugs, including indinavir [Crixivan] and other PIs, but is less likely to occur with newer PIs. Changes in renal [kidney] function due to HIV may contribute to increased cardiovascular dis- Recommendations and Guidelines for Screening for Cardiovascular Risk Factors in HIV-Infected Individuals, from the Infectious Diseases Society of America, HIV Medicine Association Fasting lipid levels should be monitored before and within 4 6 weeks after starting HAART. Fasting glucose levels should be measured before and during HAART; currently, routine monitoring of insulin levels and/or oral glucose tolerance testing are not recommended. Routine measurements of body weight and patient self-report of body shape changes are sufficient for clinical practice. Note: recommendations from two other authorities are given in the AHA report. 33

34 ease. Microalbuminuria is five times more common among HIV- [positive] patients than among non- HIV infected subjects in the current era of HAART and is associated with black race and other cardiovascular disease risk factors. Importantly, smoking rates are higher in HIV-infected patients and also contribute significantly to increased risk. Other traditional risk factors such as male sex and [older] age, as well as diabetes mellitus [the technical term for diabetes] and dyslipidemia, also contribute to CHD to a degree similar to that seen in non-hiv infected patients; however, rates of dyslipidemia and diabetes appear to be higher among HIV-[positive] patients. Because HIV-[positive] patients live longer owing to the success of HAART, these factors may become even more important. Rates of non-traditional risk factors such as inflammation have not been well evaluated in terms of cardiovascular disease risk in the HIV-infected population. Future research needs to determine whether increased risk is related to HIV or its therapy, or whether the presence of HIV infection is an indication (a marker ) of populations at greater risk. For example, several reports have found a much higher rate of smoking in HIV-positive people. Measurement of fasting glucose and lipids at least yearly in HIVinfected patients and with changes in antiretroviral therapy is critical. More recently, after the conference was held in August 2007, controversy has risen in regard to heart disease associated with Ziagen (abacavir, an HIV medication also contained in the drugs Epzicom and Trizivir). See page 43 for a report on this topic. Whatever the risks, there s comforting news as well. The prevention working group of the conference noted that, continuous use of antiretroviral therapy for viral suppression is associated with reduced mortality and less cardiovascular disease than intermittent antiretroviral therapy, which suggest that these agents may also be protective by unknown mechanisms potentially related to reduced inflammation or effects on lipids if used continuously. Nonetheless, it is important to consider the known metabolic effects of individual drugs in choosing an antiretroviral regimen, particularly in those patients with preexisting CHD risk factors. The prevention working group reported that Cigarette smoking is highly prevalent among patients with HIV (41 Recommendations and Guidelines for Screening for Cardiovascular Risk Factors in the General Population, from the U.S. Preventive Services Task Force Strongly recommends that clinicians routinely screen men ages 35 and over and women ages 45 and over for lipid disorders. Clinicians should routinely screen younger adults (men 20 to 35 and women 20 to 45) for lipid disorders if they have other risk factors for CAD (coronary artery disease). Screening for lipid disorders should include measurement of total cholesterol and HDL-C (HDL cholesterol). Evidence is insufficient to recommend for or against triglyceride measurement as a part of routine screening for lipid disorders. Evidence is insufficient to recommend for or against routinely screening asymptomatic adults for type 2 diabetes, impaired glucose tolerance, or impaired fasting glucose. Adults with hypertension [high blood pressure] or hyperlipidemia [high cholesterol or triglycerides] should be screened for type 2 diabetes. Strongly recommends that clinicians screen adults 18 or older for high blood pressure. Evidence is insufficient to recommend for or against routine screening for high blood pressure in children and adolescents to reduce the risk of CVD (cardiovascular disease). Note: The report also gives the recommendations of the National Cholesterol Education Program all adults over 20 should obtain a fasting lipoprotein profile (total cholesterol, LDL-C, HDL-C, and triglycerides) once every five years. 34

35 71% [depending on the study being cited]) and is more prevalent than in the general population. Aside from having a history of CVD, current cigarette smoking is the most powerful predictor of CVD events among patients with HIV. Smokers with HIV have higher total mortality and are more likely to develop pneumonia, chronic obstructive pulmonary disease, cancers, and decreased quality of life than non-smokers. The best evidence suggests that ART may be associated with a modest increase in blood pressure and the prevalence of hypertension; however, these relationships may be confounded by increases in body mass index and other risk factors for the development of hypertension, so the effect of ART on hypertension is unclear. The prevalence of hypertension is expected to increase as the age of patients with HIV infection increases and the prevalence of HIV increases among patients in ethnic subgroups at increased risk of developing hypertension. Adverse dietary habits are common in patients with HIV and contribute to dyslipidemia; therefore, a trial of dietary modification may be appropriate before initiation of drug therapy. Pharmacotherapy [treatment] for dyslipidemia powerfully reduces CVD risk in non-hiv infected patients. Guidelines for the effective diagnosis and management of dyslipidemia have been widely adopted and are the basis of the general approach to the patient with HIV; however, current pharmacological strategies for treating dyslipidemia in patients undergoing ART are limited by drug interactions, relative lack of efficacy, and, potentially, pill burden, as well as consideration of comorbidities [other illnesses]. In addition to ART exposure, risk factors for insulin resistance and type 2 [adult] diabetes mellitus in patients with HIV include male sex, increasing age, increasing body weight, and increasing waist circumference, as well as ethnicity and hepatitis C co-infection. Impaired fasting glucose and impaired glucose tolerance are best treated non-pharmacologically with lifestyle interventions such as dietary changes and exercise, although medications can be considered. Metformin and thiazolidinediones tend to improve insulin resistance in patients with HIV; however, the long-term effectiveness of these [drugs] for the prevention and treatment of diabetes mellitus in patients with HIV is not known. Some studies also suggest insulin resistance is increased among children undergoing ART. Patients initiating ART should be screened for impaired fasting glu- Mechanisms by Which HIV Infection and Antiretroviral Therapy (ART) May Adversely Affect the Vasculature HIV infection Endothelial dysfunction Lipid disorders associated with HIV infection Viral protein-related endothelial cell activation Systemic inflammatory cytokine-chemokine dysregulation Direct HIV infection of endothelium and vascular smooth muscle cells Enhanced atheroma formation by activated macrophages Prothrombotic state ART Endothelial dysfunction Increased endothelial permeability Increased oxidative stress Increased mononuclear cell adhesion Insulin resistance Accelerated lipid accumulation in vessel wall Persistent inflammation and immune activation Impaired response to vascular injury ART-associated lipodystrophy leading to metabolic disorders, increased systemic inflammation, and reduced circulating adiponectin 35

36 cose and diabetes mellitus by measurement of fasting glucose levels at baseline, annually, and after changes are made to ART regimens. Measurement of insulin and hemoglobin A1C as screening tests are not recommended by current guidelines. Oral glucose tolerance testing may help to identify and distinguish between patients with impaired glucose tolerance and those with diabetes mellitus. [While HIV therapy may increase risk of heart disease], there are compelling data to support an increase in total mortality and possibly CVD risk when HIV is inadequately suppressed or ART is withdrawn. Indeed, one study demonstrated that use of ART was associated with short-term decreases in CVD risk and overall mortality. Treatment of HIV may improve some CVD risk factors while exacerbating others. The working group concluded that, As the population of HIV-[positive] patients ages and accumulates CVD risk that is, at least in part, related to ART, efforts to appropriately recognize and manage CVD risk will be necessary. Lifestyle medication, including smoking cessation, increased physical activity, weight reduction for those who are overweight or obese, and education on healthy dietary practices are the cornerstones of CVD risk reduction. These strategies, combined with appropriate management of dyslipidemia, disordered glucose metabolism, and hypertension, will help maximize the long-term health of persons living with HIV. Ironically, the conference report notes that the success of various smoking cessation drugs and programs in people with HIV is not known and needs to be investigated, along with the best strategies to use given their age, sex, ethnicity, and socioeconomic status. The report also notes that clinicians may mistakenly attribute signs of cardiovascular abnormalities to pulmonary [lung] or infectious causes, an error that can delay appropriate treatment. The conference working group on the effects of HIV and its therapy on the heart concluded that, A high degree of suspicion and early screening may allow appropriate intervention and improved quality of life in those affected. e Details for Calculating the Pretest Probability in Patients Suspected of Having Coronary Heart Disease Variable Choose Response Sum Age (male/female) Under 40/under / or older/65 or older 9 Estrogen status Positive = -3 Women only Negative = 3 Angina (heart pain) history Typical = 5 Diamond method Atypical = 3 Nonanginal = 1 Diabetes? 2 Hyperlipidemia? 1 Hypertension (high blood pressure)? 1 Smoking (any)? 1 Family history of CAD (first degree*) 1 Obesity (BMI greater than 27**) 1 Total Score The pretest probability associated with a score of 0 to 8 is low, 9 to 15 points is intermediate, and greater than 15 is high. The data here were published in 2003 and do not reflect the more recent findings of estrogen replacement and cardiovascular risk. Cardiac risk may worsen with use of estrogen. Reproduced from Morise A.P., Jalise F., Journal of the American1 College of Cardiology, 2003; 42: * First-degree family history of coronary artery disease indicates an immediate family member, such as mother or father, brother or sister. ** Body mass index is easy to calculate using your current height and weight; many websites provide online BMI calculators. 36

37 XVII International AIDS Conference Mexico City, August 3 8, 2008 Treatment Round-up from the International AIDS Conference New and improved drug information by Jeff Berry Photo Keith R. Green At this year s International AIDS conference in Mexico City some useful, longer-term data was presented on FDA-approved antiretroviral drugs and strategies on how to use them, as well as research on drugs currently in the pipeline. While we re not, at least for the near future, as likely to see as many new blockbuster treatments or novel classes of drugs come to market such as what we ve seen over the past couple of years, there is still much research being done in both treatment naïve and experienced populations. Following are some of the highlights. Visit aids2008 for webcasts, podcasts, and transcripts from the conference; view the abstracts at Treatment-naïve individuals Sustiva vs. Kaletra A 48-week non-inferiority study by Madero JS, et al. (abstract TUAB0104) looked at 189 HIV-positive individuals in Mexico with CD4+ cell counts less than 200 who were starting treatment for the first time. The NNRTI Sustiva (efavirenz) went head to head against the PI Kaletra (lopinavir/ritonavir), and once-daily Sustiva was found to be superior to twice-daily Kaletra. Both groups in the study also received Combivir (3TC/AZT), and the soft-gel formulation of Kaletra was used; study participants were allowed to substitute Ziagen for AZT (zidovudine). At week 48, 70.5% of those in the Sustiva group vs. 53.2% in the Kaletra group achieved a viral load of less than 50. CD4 counts increased in both groups, and those with more advanced disease tended to fare better in the Sustiva group. Incidence of grade 2-4 adverse events were comparable in both groups, as were increases in total cholesterol, HDL and LDL, but significantly higher triglycerides were seen in those taking Kaletra. Two new non-nukes, RDEA806 and IDX899 In several small phase 1 studies in HIV-negative individuals (used in early research before medication is given to people with the virus), data was presented on two secondgeneration NNRTIs which have demonstrated a potential for high barrier to resistance in vitro. During an 8-day dose ranging of Ardea BioSciences RDEA806, a median reduction of viral load from -1.3 to -1.8 log was seen at day 8, and no serious grade 3-4 adverse events were reported. RDEA806 is currently enrolling a phase 2a dose-ranging monotherapy study in HIV-positive individuals using several different doses taken both once and twice daily. Idenix Pharmaceuticals conducted a 7-day dose ranging study of its NNTRI IDX899, with a mean reduction of baseline viral load of around 1.8 log observed. Mild adverse events were reported in those taking IDX899, similar to placebo. IDX899 was studied using oncedaily doses ranging from mg; planning for a phase 2b study is currently underway. Visit for more information. PEARLS A large, phase 4 study of 1,575 treatment-naïve HIV-positive individuals found a significantly greater risk of treatment failure in those taking 400 mg ddi (didanosine-ec, brand name Videx- EC) in combination with 200 mg Emtriva (emtricitabine) and 400 mg Reyataz (atazanavir), all once-daily, compared to those taking Combivir (zidovudine/lamivudine) twice-daily plus Sustiva (efavirenz) once-daily. The Videx-EC/Emtriva/Reyataz treatment group was discontinued due to inferiority back in May 2008 after a planned, interim analysis by its Data Safety Monitoring Board (DSMB). The study, known as ACTG 5175, or PEARLS (Prospective Evaluation of Antiretrovirals in Resource-Limited Settings), also contained a third group receiving Sustiva plus Truvada (Emtriva/ Viread), both once daily. The two Sustiva-containing arms of the study will continue, following a comparison of the two groups which was inconclusive. Norvir film-coated vs. soft-gel A small, single-dose PK study of 93 HIV-negative individuals compared the newer film-coated, heat-stable Norvir (ritonavir) tablet to the currently available soft-gel capsule and found both formu- 37

38 XVII International AIDS Conference Mexico City, August 3 8, 2008 lations to be generally well tolerated and no differences in adverse events, with both achieving similar blood concentrations, meeting the criteria of bio-equivalence. Boosting 2.0 PK enhancers Almost all protease inhibitors (PIs) are taken with a Norvir booster, especially in treatment-experienced individuals. The booster allows more of the PI into the bloodstream, resulting in smaller doses and fewer side effects. Many pharmaceutical companies are racing to become the next to bring a boosting compound, or PK enhancer, to market, but it is most likely still several years away. Only time will tell if these PK enhancers will be released first as a stand-alone booster to compete with Norvir, which is currently the only boosting compound available, or in a co-formulation with another compound(s) in an effort to compete with the appeal of Abbott s Kaletra. One would hope that they would both occur simultaneously. Gilead s GS9350, a PK enhancer currently in development, has no antiviral activity (unlike Norvir) which is good news (in that it should not have any potential for contributing to HIV resistance). Nor does it seem to have the dreaded gastrointestinal side effects of Norvir. All of this is ultimately good news as the next phase of HIV treatment unfolds. Advocates continue to push for companies to find ways to work together, such as with the groundbreaking partnership of Gilead and Bristol-Myers Squibb in the development of the blockbuster co-formulation of Truvada and Sustiva, found together in the once-a-day pill Atripla. All of this is ultimately good news as the next phase of HIV treatment unfolds. Rilpivirine (TMC278) at 96 weeks A 96-week phase 2 dose-ranging study in antiretroviral-naïve individuals of the next-generation NNRTI rilpivirine (TMC278) found it to be effective and well tolerated. Rilpivirine (TMC278) taken once daily in combination with two NRTIs was associated with a high sustained response rate, comparable to Sustiva plus two NRTIs. More rash (21% vs. 9%), nervous system disorders (48% vs. 31%), and neuropsychiatric adverse events (21% vs. 16%) were seen in those taking Sustiva compared to rilpivirine, and fewer lipid abnormalities were seen with rilpivirine versus Sustiva. QTc interval (a measure of time in the heart s electrical cycle) increased (or was prolonged) in all study arms (both rilpivirine and Sustiva) through week 48, and then plateaued. QTc prolongation was lowest with the 25 mg per day dose, and phase 3 trials of rilpivirine with the 25 mg once-daily dose are ongoing. Isentress at 96 weeks 96-week data from a head-to-head study comparing the integrase inhibitor (INI) Isentress (raltegravir) to the NNRTI Sustiva (efavirenz), both in combination with OBT (optimized background therapy) in those taking therapy for the first time, showed those in the Isentress group had sustained viral suppression comparable to those in the Sustiva group. Adverse events were comparable between groups, with drug-related adverse events more common in the Sustiva group. Continued forthcoming data from treatment naïve studies of Isentress as well as other newer agents in combination will become even more important as they each battle for their positions in the strategy of first-line treatment of HIV. Ten years from now it may be an entirely different ballgame instead of two nukes plus a boosted PI or NNRTI, we may be looking at an INI plus a PI or other possible nuke-sparing regimens for first-line treatment of HIV. Treatment experienced Prezista plus Intelence A 48-week pooled, sub-analysis of DUET 1 & 2, which are two identical, parallel studies looking at boosted Prezista (darunavir/ritonavir) in combination with an optimized background regimen (OBT) plus either Intelence (etravirine) or placebo found that those in the Intelence group had a significantly higher rate of viral suppression than those in the placebo group (61% vs. 40%). The planned analysis of this 96-week study also demonstrated that virologic response was not significantly predicted by gender, race, or previous use of Viramune (nevirapine). However, the number of previous NNRTIs used did predict response to Intelence, with 67% of those on Intelence who had used one NNRTI reaching undetectable (viral load less than 50), compared to 58% of those who had used two or more NNRTIs. Another DUET 1 & 2 sub-analysis found that those who had favorable combined resistance profiles for both Prezista and Intelence were predicted to have a higher virologic response rate at 24 weeks. These were multiclass-experienced patients receiving Intelence and Prezista/ritonavir plus optimized NRTIs who were not first-time users of Fuzeon. This sub-analysis used a weighted resistance score, which basically assigns a numeric value based on the resistance-associated mutation (RAM). While this is a more complicated method, it reduces the discrepancy between genotypic and phenotypic (two types of resistance test) scores. Photo Keith R. Green 38

39 XVII International AIDS Conference Mexico City, August 3 8, 2008 Switching from Fuzeon to Isentress In several studies of heavily treatment experienced individuals on stable Fuzeon-based therapy who replaced Fuzeon with Isentress, 94-96% maintained undetectable viral load (less than 50) and immunologic control. Patients reported greater satisfaction in treatment, and there were few adverse events, with three case reports of hepatic cytolysis (breakdown of liver cells) after switching from Fuzeon to Isentress in men receiving Aptivus/r (tipranavir/ritonavir) plus Isentress. Intelence in EAP; updated safety on Intelence A sub-analysis of an open-label early access program (EAP) in the U.S. and other countries found that in the U.S.-based EAP, Intelence-containing regimens were associated with virologic response rates greater than 60% in treatment-experienced patients with limited treatment options at 24 weeks. When use of Intelence was combined with multiple agents, including Isentress and combinations of Prezista/ritonavir and Isentress, there were few discontinuations due to adverse events, and similar efficacy was observed across groups, including those receiving Prezista/ritonavir and/or Isentress. Also in the DUET studies, rates of neuropsychiatric adverse events were similar in those taking Intelence compared to placebo, regardless of an individual s previous psychiatric history, and no effects from Intelence were seen on the development of fetuses in rats and rabbits. In related news, one case of hemarthrosis (bleeding into the knee) was recently reported by the U.S. Food and Drug Administration (FDA) in an individual using Intelence, as the agency began reporting of new drug safety evaluations this past summer. However, a drug s inclusion in the report does not mean the FDA has concluded that there is a risk (see News Briefs). Prezista/r + Intelence + Isentress A phase 2 study (TRIO) of 103 HIV-positive treatment-experienced individuals with advanced HIV infection and multi-drug resistance found the combination of boosted Prezista (darunavir/ ritonavir), Intelence (etravirine), and Isentress (raltegravir) to be highly active at 24 weeks (90% achieved viral load less than 50). There was a median CD4 increase of 99, and the regimen was generally well tolerated. There was an overall low rate of serious adverse events reported, although there were two possibly drug-related clinical grade 4 adverse events, one of which was rash/fever and led to discontinuation of treatment. Physicians continue to report seeing patients achieve undetectable viral loads for the first time ever when combining many of these recently approved newer agents. In several studies of heavily treatment experienced individuals on stable Fuzeon-based therapy who replaced Fuzeon with Isentress, 94-96% maintained undetectable viral load (less than 50) and immunologic control. Selzentry entry inhibitor In sub-analyses of MOTIVATE 1 & 2, two double-blind, phase 3 studies of 1,076 individuals using entry inhibitor Selzentry (maraviroc) plus OBT, superior outcomes were seen at 48 weeks compared to those using placebo plus OBT in patients with R5-tropic virus. In both TCR (triple-class resistant) and non-tcr subgroups, significantly better virologic and immunologic outcomes were seen in the Selzentry groups versus placebo, as well as early and greater increases in CD4+ cell and CD8+ cell counts. Apricitabine 24-week data from a phase 2 study of apricitabine, a novel nucleoside (NRTI), showed it to be safe and very well tolerated in combination with other ART, and if approved should be a good second-line choice for treatment-experienced individuals. Thanks to Dan Berger, M.D. for his review of this article. 39

40 XVII International AIDS Conference Mexico City, August 3 8, 2008 Race, Sex, and Pregnancy A round-up of news in special populations by Enid Vázquez Men, women, and race The GRACE study is the first pharmaceutical company trial to focus on enrolling women so that differences from men can be seen. Early 24-week results (halfway through the study) were reported in this study which compares gender differences in the efficacy, safety, and tolerability of Prezista (darunavir) in combination with other HIV medications. Of the 203 women reaching 24 weeks, about half (51%) had less than 50 viral load. (People in the study were treatment experienced, and could therefore be expected to have less of a treatment response.) Almost one out of four women dropped out of the study before 24 weeks, but few of them did so because of virological failure (inadequate suppression of viral load). Less than one percent of the women experienced virological failure. Adverse events led to study discontinuation in 7.8% of the women. About 1 in 3 of the women experienced an adverse event grades 2 4 (considered problematic) that was potentially related to the medications they were taking. Side effects occurring in more than five percent of the women included nausea (6%), diarrhea (6%), elevated AST (a type of liver enzyme, 6%), elevated total cholesterol (12%), elevated LDL cholesterol (6%), and hyperglycemia (elevated levels of blood sugar, 16%). Almost 17% of the women experienced a serious adverse event, the most common being pneumonia (4.4%). The CASTLE study comparing Reyataz/ Norvir to Kaletra (which contains Norvir in it) reported that women on Kaletra experienced more nausea than men did (14% vs. 5%), but less diarrhea (9% vs. 12%). Increases in triglyceride levels were higher in the men on Kaletra than the women who were taking it, 64 vs. 34 mg/dl. In another study, women also experienced less diarrhea than men. In the ARTEMIS study of darunavir/norvir, 26% of the women had diarrhea compared to 37% of the men. The women, however, had more vomiting 11% of them had this side effect compared to 4% of the men. A third study also found a greater increase in triglyceride in men than in women 58.7 vs in the M study of Kaletra once a day vs. twice a day. There was a non-significant trend toward greater diarrhea in men than in women, 17.1% vs. 11.1%. The study also found that diarrhea was higher in whites than in non-whites (17.8% vs. 9.7%, the difference was statistically significant). The CASTLE study found that diarrhea while taking Kaletra was highest in whites (14%) and lowest in blacks (5%), and that blacks had zero increase in cholesterol levels. ARTEMIS found that rash was greater in Latinos (14%) than in other groups (5 7%). Pregnancy A look at drug levels found that the entry inhibitor vicriviroc, currently in development, does not lower blood concentration of birth control pills, but did if it was taken with Norvir, and this suggests the need for additional or alternate contraception. Reyataz when taken with Norvir once a day causes a drop in blood levels in the third trimester of pregnancy, and this suggests a need for a change in dosing. The Women s Interagency HIV Study (WIHS, pronounced wise ) reported that the use of progestin-only hormonal birth control was by itself associated with increased insulin resistance and decreased HDL cholesterol in both HIV-positive and HIV-negative women at risk for infection. Insulin resistance is associated with diabetes and lower levels of HDL cholesterol and is associated with heart disease. Kaletra was shown to have no evidence of birth defects risk compared to women without HIV. There was a non-significant trend between Kaletra used during the first trimester of pregnancy and premature delivery and low birth rate. The results were based on the international Antiretroviral Pregnancy Registry. One study looked at the development of drug resistance in 135 women taking HIV medications for the first time during their pregnancy who stopped taking their therapy immediately after delivery. Most (57.3%) used Viracept with Combivir, more than a fourth (26.7%) used Viramune with Combivir, and the rest (16%) used Kaletra with Combivir. Ten percent of the women (13 of the 135) had developed drug resistance. Five of these women (38.4% of the 13) had drug resistant mutations in their virus before going on medications and developed new mutations during therapy. Of the rest, four developed resistance to the Viramune class of drugs (non-nukes), two had resistance only to the nucleoside analog class of drugs (Combivir and others), one had both nuke and protease inhibitor mutations, and one had resistance only to the protease inhibitor drug class. There was also news about women s desire for children. One study found that HIV-positive women knew little about the risk of mother-to-child transmission of the virus and overestimated their risk of passing on the infection. Another study found that positive women feel a strong difference between their attitudes and that of society in regard to pregnancy and childbearing. Nearly six out of 10 said they felt pressured to avoid pregnancy. Research led by Dawn Averitt Bridge of the U.S., herself a positive woman with two HIV-negative children (visit reported communication problems between women and their doctors. The research found that nearly half of the HIVpositive women who had thought about having a baby or had been previously pregnant were not asked about their current or future pregnancy plans. e 40

41 XVII International AIDS Conference Mexico City, August 3 8, 2008 Metabolic Complications and Hepatitis Co-infection News from the International AIDS Conference by Liz Highleyman Photo Keith R. Green The XVII International AIDS Conference took place August 3-8 in Mexico City. This large bi-annual meeting which this year drew more than 22,000 participants emphasizes the social and policy aspects of the HIV/ AIDS epidemic along with recent medical findings. CD4 cell count and cardiovascular risk In a cardiovascular presentation, researchers with the HIV Outpatient Study (HOPS) looked at the relationship between heart disease and CD4 cell count (Abstract THPE0236). The investigators evaluated 1,697 cohort participants followed from December 2001 through June Patients were categorized into four cardiovascular risk groups based on traditional risk factors according to National Cholesterol Education Program (NCEP) guidelines, and the researchers calculated rates of new cardiovascular events including heart attacks, or myocardial infarction (MI), angina, and surgery for coronary artery disease. About one-third were low risk (0-1 risk factors), 28% were moderate risk, 19% were borderline high risk, and 21% were high risk, meaning they had a greater than 20% chance of having a heart attack within 10 years. The incidence of cardiovascular disease ranged from 0.4 per 100 person-years in the low-risk group to 3.7 in the high-risk group. As expected, traditional risk factors were strongly linked to cardiovascular disease, but there was no apparent effect with duration of use of any HAART, all NRTIs, abacavir (Ziagen, also in Epzicom and Trizivir), d-drugs (ddi and d4t), non-nucleoside reverse transcriptase inhibitors (NRTIs), and protease inhibitors (PIs). (See the Annual HIV Drug Guide in January/February for classes of medications.) However, having a pre-treatment CD4 cell count below 350 was independently associated with a higher risk of cardiovascular disease after adjusting for traditional risk factors (almost double the odds with a hazard ratio of 1.83). Reyataz and lipodystrophy Reyataz (atazanavir) is less likely to cause blood lipid abnormalities than other protease inhibitors, and researchers have explored whether it might also lower the risk of body fat changes, or lipodystrophy. Graeme Moyle from London presented results from the REAL study (Abstract MOPDB103), in which 200 participants with suppressed viral load and abdominal fat accumulation were randomly assigned to either switch from their twice-daily Norvir (ritonavir)- boosted PI to once-daily boosted Reyataz, or else stay on their current regimen. After 48 weeks, total cholesterol, LDL bad cholesterol, and triglyceride levels decreased significantly in the Reyataz arm. However, changes in visceral fat, subcutaneous fat, and trunk-to-limb fat ratio were similar in both groups, leading the researchers to conclude that switching to Reyataz resulted in no significant change in body composition. Very early response in HIV/HCV co-infection Rapid virological response (RVR) four weeks after starting interferon-based therapy for chronic hepatitis C predicts sustained response in both people with HCV alone and HIV/HCV co-infected individuals. But it may be possible to predict long-term response even sooner. Natalia Laufer and colleagues from Argentina analyzed HCV viral decay during the first 24 hours of therapy in 11 co-infected patients including eight with hard-to-treat genotype 1 treated with pegylated interferon plus weight-based ribavirin (Abstract WEPDB204). Three patients achieved RVR at week four, while eight achieved early virological response (EVR) at week 12. During the first 24 hours, HCV viral load declined by an average of 99% among patients who achieved RVR and 85% among those who achieved EVR. But among patients who did not achieve either rapid or early response, HCV levels only dropped by 51%. The researchers concluded that very early assessment of viral decline could be of clinical relevance in evaluating whether to continue treatment, especially for people with severe side effects or in resource-poor settings where drug availability is limited. 41

42 XVII International AIDS Conference Mexico City, August 3 8, 2008 Relapse in HIV/HCV co-infected patients HIV-positive people do not respond as well as HIV-negative individuals to interferon-based therapy, but post-treatment relapse has been less extensively studied. Spanish researchers tested the hypothesis that HIV/HCV co-infected patients might be more likely to experience HCV relapse after completing treatment, but might do so more slowly (Abstract THAB0202). An analysis of 119 HIV/HCV co-infected and 134 HCV mono-infected patients who achieved undetectable HCV viral load after 48 weeks of pegylated interferon plus weight-based ribavirin revealed that 30% and 26%, respectively, experienced HCV relapse, a non-significant difference. About half of the relapsers in each group experienced HCV recurrence between the end of treatment and post-treatment week 12. Among the remainder, mono-infected patients were more likely than co-infected patients to relapse between post-treatment weeks 12 and 24, but the co-infected patients were about three times more likely to do so after 24 weeks post-treatment that is, after they had achieved sustained virological response (SVR), which is usually considered a cure. Patients with HCV genotype 1 or 4 were more likely to relapse, and all but one of the very late relapsers had genotype 1. HCV recurrence was detected as late as 105 weeks posttreatment, but the researchers concluded that very late relapse was rare, and suggested that 24 weeks of follow-up is still warranted to confirm SVR. HIV/HCV co-infection and cardiovascular disease Coming back to cardiovascular disease, Roger Bedimo presented data from a study assessing the influence of HCV co-infection on the risk of acute MI and cerebrovascular disease (stroke) in the pre- HAART and HAART eras (Abstract THAB0205). The investigators analyzed data from more than 20,000 HIV-positive patients in the Veterans Administration Clinical Case Registry, about one-third of whom also had hepatitis C. In accordance with previous findings, patients with HCV were less likely to have abnormally high blood lipid levels (18% vs. 27% with high total cholesterol; 55% vs. 60% with high triglycerides) or to be taking lipid-lowering medications. And while HIV monoinfected individuals had an increased likelihood of having high cholesterol in the HAART era ( ) compared with the pre-haart years ( ), there was no change in the co-infected group. In the pre-haart era, co-infection patients had about a 40% greater risk of both MI and stroke. After the advent of HAART, co-infected patients were about 25% more likely to experience an MI (4.19 vs per 1,000 person-years), but the difference did not reach statistical significance. For strokes, however, co-infected patients had a 20% higher risk (12.47 vs per 1,000 person-years), which in this case was a significant difference. Based on these findings, the researchers concluded that adjustment for HCV status is indicated when assessing cardiovascular disease risk in people with HIV. HIV/HBV co-infection HIV-positive people exposed to hepatitis B virus (HBV) are more likely than HIV-negative individuals to develop chronic infection, but response to hepatitis B treatment in HIV/HBV coinfected patients has not been well studied. As reported in a poster at the conference (Abstract WEPDB207), researchers retrospectively reviewed the medical records of more than 5,000 patients at St. Luke s-roosevelt Hospital HIV clinic. They identified 355 with hepatitis B, 283 of whom received antiretroviral drugs with dual activity against both HIV and HBV, including Epivir (lamivudine), Viread (tenofovir), Hepsera (adefovir), and Baraclude (entecavir). Patients who received these drugs and those who did not were equally likely (about 10%) to experience HBV surface antigen (HBsAg) loss, a measure of treatment success. However, people with higher baseline CD4 cell counts, and those who gained more CD4 cells after starting HAART, were more likely to clear HBsAg. The researchers concluded that High CD4 counts at the time of HBV infection and immune restoration through [antiretroviral therapy] are the most important predictors in successful treatment of HBV in HIV infected patients. e Liz Highleyman (liz@black-rose.com) is a freelance medical writer based in San Francisco. 42

43 XVII International AIDS Conference Mexico City, August 3 8, 2008 Can Ziagen Hurt Your Heart? Research presented at the International AIDS Conference weighs in on the controversy by Liz Highleyman Photo Keith R. Green In one of the most widely discussed sessions held at the International AIDS Conference in Mexico City, researchers presented data on the link between cardiovascular disease and specific nucleoside/nucleotide reverse transcriptase inhibitor (NRTIs). Cardiovascular disease is a growing concern as HIV-positive people live longer, but the relationships between heart disease, antiretroviral therapy, and HIV infection itself are not yet fully understood. (See story on page 31.) Earlier this year, researchers studying the large multi-national D:A:D cohort reported that patients who took abacavir (Ziagen, also in the Epzicom and Trizivir combination pills) or ddi (Videx) within the past six months had a significantly greater risk of heart attacks, or myocardial infarction (MI), than people taking other NRTIs. These unexpected results led researchers with the SMART treatment interruption trial to look for a similar pattern in their data (Abstract THAB0305). SMART included more than 5,000 participants randomly assigned to either stay on continuous HAART or interrupt treatment when their CD4 cell count was above 350. Patients in the treatment interruption arm not only had a higher risk of AIDSrelated opportunistic illnesses and death, but also had more serious cardiovascular, liver, and kidney disease. The researchers went back and analyzed data on cardiovascular events and several blood biomarkers associated with inflammation, blood vessel damage, and coagulation. Current abacavir users had about a four-fold greater risk of MI, nearly twice the risk of major cardiovascular events (including MI, stroke, surgery for coronary artery disease, and cardiovascular-related death), and nearly three times the risk of minor cardiovascular events. Furthermore, levels of high sensitivity C reactive protein (hscrp) and interleukin-6 (IL-6) were significantly higher among patients taking abacavir (by 27% and 17%, respectively). The researchers concluded that abacavir was associated with an increased risk of cardiovascular disease, but they added that this risk only appeared to be clinically relevant for people with traditional cardiovascular risk factors such as older age and smoking. Abacavir manufacturer GlaxoSmithKline also re-analyzed data from prior clinical trials to look for an association between the drug and cardiovascular disease (Abstract THAB0305). Investigators performed a pooled analysis of more than 14,000 participants in 54 company-sponsored studies, including 12 adult randomized clinical trials. They found that rates of cardiovascular events both MI and an expanded definition that included atherosclerosis and angina were similar in patients who took abacavir and those who did not. The overall rates were lower than those observed in D:A:D, and closer to those seen in studies of the general HIV-negative population. Since these studies were not originally designed to look at cardiovascular outcomes, they did not collect data on traditional risk factors or blood biomarker levels. However, in the company s HEAT study (Abstract LBPE1138), which compared the fixed-dose Epzicom (abacavir/3tc) and Truvada (tenofovir/emtricitabine) combination pills plus Kaletra (lopinavir/ritonavir), hscrp and IL-6 levels did not differ significantly in the two arms. These conflicting results and uncertainty about what mechanisms might explain an association between abacavir and heart disease underline the need for further study, including careful analysis of cardiovascular outcomes and biomarkers in future 43

44 XVII International AIDS Conference Mexico City, August 3 8, 2008 clinical trials. In the meantime, it is important to consider individual cardiovascular risk factors when weighing the benefits and risks of specific antiretroviral drugs. Chicago HIV specialist Renslow Sherer, M.D. said the SMART analysis indicates that there is a real effect of Ziagen on the heart, but the drug is still very useful for people who don t have the traditional risk factors and are unable to take alternative medications. (Editor s note: Ziagen s principle competitor, Viread, is associated with kidney dysfunction in certain susceptible people; see page 13.) Epzicom versus Truvada Another pair of conflicting presentations focused on the effectiveness of the Epzicom and Truvada NRTI backbones. Earlier this year, ACTG study A5202 was modified after preliminary data showed that when used with Sustiva (efavirenz) or Norvir-boosted Reyataz (atazanavir), Epzicom did not suppress HIV as well as Truvada in people who started treatment with a high viral load (greater than 100,000). Paul Sax presented un-blinded data from the high viral load patients in Mexico City (Abstract THAB0303); the study is still continuing with the low viral load patients. A5202 enrolled 1,858 treatment-naïve participants, of whom 797 had a viral load of at least 100,000 copies. About twice as many patients in the Epzicom arm experienced virological failure, which the researchers defined as either a viral load of 1,000 copies or more between 16 and 24 weeks, or else 200 copies or more after 24 weeks (trials usually do not report response before 24 weeks). The time to virological failure was significantly shorter in the Epzicom arm compared with the Truvada arm, but similar proportions in both groups achieved a viral load below 50 copies at 48 weeks (75% vs. 80%, respectively) and CD4 cell gains were comparable. People taking Epzicom were quicker to experience serious adverse events and were more likely to modify their regimen. The most common side effects were general body aches and blood lipid increases. In both arms, about 7% reported symptoms that might indicate an abacavir hypersensitivity reaction (participants were not screened for genetic susceptibility to hypersensitivity). No heart attacks occurred in either arm, and there were two cases of kidney failure a potential side effect of Viread (the tenofovir component of Truvada) in both groups. Here again, GlaxoSmithKline researchers analyzed data from past studies to search for similar findings (Abstract THAB0304). They looked at 48-week efficacy outcomes from six clinical trials that included a total of 2,940 antiretroviral-naïve patients who took either Epzicom or a comparator NRTI backbone. At 48 weeks, 87% to 95% of participants in both groups maintained a viral load below 50 copies, and there were no significant differences in people with high or low viral load. Safety outcomes were also similar. Taken together, these studies indicate that despite possible minor differences in speed of response and side effects, both Epzicom and Truvada are highly effective as part of a first-line treatment regimen. e Liz Highleyman (liz@black-rose.com) is a freelance medical writer based in San Francisco. 44

45 XVII International AIDS Conference Mexico City, August 3 8, 2008 The Epidemic at Home Takes Center Stage Reflections on the XVII International AIDS Conference by Keith R. Green Photo Keith R. Green I feel obligated to preface this piece with a little bit of context. If you have never attended an International AIDS Conference, it is important for you to understand just how overwhelming these things can be. There were over 22,000 people from all over the world who attended the conference this year in Mexico City (a city with a population which easily surpasses the 20 million mark), and more sessions, workshops, and posters than one could probably attend to in a lifetime. I generally like to approach situations like this with a preset agenda. Typically, I glance through the Conference Program to see what captures my attention, and plan to attend those particular sessions or events. Not surprisingly, there were a great number of things that were of significant interest to me presentations on everything from the worldwide criminalization of people living with HIV to sex work rights to a Cambodian hip-hop group performing in the Global Village section of the conference. As you can probably imagine though, with so much stimulus in one place at one time, it s almost a given that things will not go as planned. My time spent at this year s IAC was no exception. The major distraction home is where the heart is Upon my arrival in Mexico City, news had already begun to circulate that the most recent and long-awaited HIV incidence data from the U.S. Centers for Disease Control and Prevention (CDC) had leaked, reflecting a 40% increase over the previous estimate (approximately 56,300 new infections annually versus 40,000). Of particular interest to me was the data which suggests that African Americans, who make up approximately 13% of the U.S. population, accounted for 45% of new infections in Equally alarming was that gay and bisexual men of all races and ethnicities accounted for 53% of all new infections. I thought it almost selfish, initially, to walk onto a stage set for discourse regarding the impact of the HIV epidemic globally, with my mind completely preoccupied with the havoc that it is wreaking in the land that I call home. And, considering that the nature of my travels was business rather than pleasure, I felt even more of an obligation to have a much broader perspective in my approach to this conference. As an African American man who also identifies as bisexual, however, digesting these new data made such ideals much easier to sort out in my head than to actually act upon. These statistics were not just numbers showing how HIV affects people in some faraway land. Instead, they represented people who look and identify as I do. It didn t help much either, that the conference center itself was all abuzz with talks about the U.S. epidemic, and the lack of political will to do anything about it. Advocates call for national AIDS strategy The more effort I put into expanding my focus beyond the U.S., the more I realized why such a focus was indeed necessary. I learned that one of the many conditions placed on the support that several foreign countries receive from the U.S. by way of the President s Emergency Plan for AIDS Relief (PEP- FAR), is that they have a national strategy in place for addressing the epidemic within their borders. The U.S. itself, however, does not have such a plan. I also learned that the prevalence rate among African Americans is greater than that of seven of the 15 countries receiving assistance from this program, yet there exists no U.S. strategy for even this severely impacted population. I was reminded of a certain incident which followed the devastation of Hurricane Katrina and the impact that it had on the thousands of Americans living in the gulf region Americans who were initially referred to by the news media as refugees. During a live televised relief effort, hip-hop superstar Kanye West stunned the nation by verbalizing a thought that many would not have the audacity to say aloud George Bush doesn t care about Black people. To be fair, many of the countries that receive aid from PEP- FAR have high concentrations of people of color living within them. 45

46 XVII International AIDS Conference Mexico City, August 3 8, 2008 However, due to the historical nature of what it means to be Black in America, African Americans are unquestionably in a class all by ourselves. With respect to the epidemic on the home front, though, I would take Kanye s statement a tad bit further. I would argue that perhaps it s not just that George W. Bush doesn t care about Black people; rather, it appears from his administration s response to our national AIDS crisis that he doesn t care about anyone who doesn t fit the apparently homogenous pure Caucasian, heterosexual, and deeply invested in democratic capitalism American ideal. Thankfully though, there are many Americans (and a host of allies) who do care. And, in the midst of an International AIDS Conference, several distinguished advocates and advocacy groups came together to bring global attention to the outright neglectful response of the U.S. government to the growing catastrophe among its own citizens, and to push for the development and implementation of a national AIDS strategy. Ideally, according to such a plan should: Improve prevention and treatment outcomes through reliance on evidence-based programming Set ambitious and credible prevention and treatment targets and require annual reporting on progress towards goals Identify clear priorities for action across federal agencies and assign responsibilities and timelines for followthrough Include, as a primary focus, the prevention and treatment needs of African Americans, other communities of color, gay men of all races, and other groups at elevated risk Address social factors that increase vulnerability to infection Promote a strengthened HIV prevention and treatment research effort Involve many sectors in developing the national strategy: government, business, community, civil rights organizations, faith-based groups, researchers, and people living with HIV/AIDS I am anxious to see how this will play out, particularly in light of the U.S. presidential election. Presidential candidates from both of the major political parties issued statements shortly after the release of the CDC incidence data. Senator Barack Obama specifically declared his commitment to the development of a national AIDS strategy, while Senator John McCain vowed to work closely with non-profit, government, and private sector stakeholders to continue the fight against HIV/AIDS. The proof, as they say, will be in the pudding, but I guess neither could do any worse than what the current administration is doing, or could they? On being left behind The Black AIDS Institute hosted a press conference in response to the CDC data, and in support of the BAI s recently published report entitled Left Behind Black America: A Neglected Priority in the Global AIDS Epidemic. Speakers on the panel included Phill Wilson, CEO of BAI; Dr. Helene Gayle, president and CEO of CARE; Congresswoman Barbara Lee (D-Calif.); Jacob Gayle, deputy vice president of the Ford Foundation; Pernessa C. Seele, founder and CEO of the Balm in Gilead, Inc; and the beautifully talented Sheryl Lee Ralph, actress and activist. The report breaks down the epidemic among Blacks in America by establishing a proverbial Black America, and discussing the impact of the virus on this population from the perspective of it being an independent nation, separate and apart from the United States. My thoughts on this idea are enough for an entire dissertation; however, the point is well made that African Americans have contributed and continue to contribute significantly to this sovereign state, and that the neglectful response of the U.S. government to the HIV/AIDS crisis among this population is nothing short of criminal. Sheryl Lee Ralph, forever the diva and activist extraordinaire, was most profound on this issue. She challenged the journalists in the room to do something different as it relates to communicating the issue of HIV/AIDS, particularly among Black America. Photo Keith R. Green 46

47 XVII International AIDS Conference Mexico City, August 3 8, 2008 She stressed that we must sincerely confront the isms that exist within America, if we are to ever really make a difference. I couldn t agree with her more. For it is, without question, the isms classism, racism, sexism and heterosexism that are fueling the epidemic in Black America. Ralph referenced an event where Senator Hilary Clinton recently commented that if AIDS were affecting the general population the way that it is devastating Black America, there would be a national health emergency. And then, with the level of conviction that the world has come to know and love her for, she posed a rhetorical question that I have been asking myself and others around me for some time now. She asked, When is somebody gonna value black people? She said, I am looking to be valued as a full, complete human being. I am black. I am in the world. Look at me and stop looking past me. I need a seat at the table. I watched her as the room transitioned from total silence, with folks hanging on to her every word, to a thunderous applause of approval. She sat back in her seat fighting off tears, her passion and sincerity most evident. But the Black AIDS Institute leaves black gay men behind, some say Following this press conference there was much talk among many black gay men (and others) that the Black AIDS Institute itself, headed by a black gay man living with HIV, has consistently neglected their issues over the years. The Left Behind report, for example, is 55 pages long but contains only a page and a half dedicated specifically to black gay men a population with an infection rate that rivals some of the hardest hit regions in Africa. Because I have worked with Phill Wilson on several occasions, and sincerely believe in what he attempts to do through BAI, I pulled him aside following one of the organization s breakfast updates to ask him about this claim. We have a variety of programming that addresses Black gay men, he said. I think that it just depends on the point at which you intersect with us. It is a challenge though, he admits. Our core mission is to address HIV/AIDS health disparities in Black America regardless of gender, sexual orientation, or what have you. So it is a challenge to craft messages that will resonate with the larger Black population. Therefore, we have to be strategic with both our message as well as our messengers. That, in my opinion, makes perfect sense considering the enormous amount of homophobia that exists within Black America. Unfortunately, if a document such as the Left Behind report were presented with heavy content relating to black MSM, it would more than likely be dismissed by the larger black community as somebody else s problem. In spite of this, Phill insists, both the Left Behind report and BAI s Call to Action do make strong recommendations for addressing the HIV epidemic among Black MSM. He also says that BAI is preparing a special report that specifically speaks to the issues facing this population, which will be released in December of this year. Shortly after I returned home from Mexico City, I received an from Phill s assistant, inviting me to take part in an advisory committee of black gay men that is being strategically developed to assist with constructing this document. I happily obliged. Unfortunately, if a document such as the Left Behind report were presented with heavy content relating to black MSM, it would more than likely be dismissed by the larger black community as somebody else s problem. The take-home message We cannot be leaders in the global fight against HIV if we are not addressing our own crises at home. Addressing this crisis, however, will require us to take a really good (and truthful) look at ourselves. I question whether or not that is something this prideful nation is really ready to do. e 47

48 XVII International AIDS Conference Mexico City, August 3 8, 2008 Oh, the Humanity Homophobia multiplied nineteen times by Jim Pickett So, as it turns out, efforts (and the lack thereof) to eradicate HIV across the globe are systematically ignoring, denying, under-serving, and failing gay men and other men who have sex with men (MSM). While this was not exactly a surprise on a planet where 86 countries continue to criminalize LGBTs in any number of human rights-crushing ways, to fully comprehend the broad, wide-reaching neglect of gay/msm in the global AIDS pandemic is nevertheless a shock and awe to the soul. I was delighted that this issue emerged as a key, defining theme of the XVII International AIDS Conference (AIDS 2008), held in Mexico City August 3 8. The AIDS 2006 conference in Toronto had frustrated me with the paucity of discussion and energy around gay/msm topics. While AIDS 2008 featured gay/msm issues prominently, my emotions were yet again set to frustration, and rage, as the extent of the neglect was revealed in countless plenaries, sessions, symposia, and press conferences. Structural homophobia is not only as American as apple pie it has the flavors and spices from every corner of the developed and developing world. Gay men and other men who have sex with men who identify in all sorts of marvelous ways are routinely dehumanized and disempowered all over. Now here is something almost every nation on the planet can agree on. On the second day of the conference, amfar, The Foundation for AIDS Research, released a report titled MSM, HIV, and the Road to Universal Access How Far Have We Come? MSM continue to have little or no access to HIV services of any kind and as a result are plagued by high rates of infection, the report begins. In an unfolding tragedy of epic proportions, the numbers tell the story. Globally, MSM are 19 times more likely to be infected with HIV than the general population. Based on data from 128 countries submitted to UNAIDS, the report found that 44% of countries failed to provide any data on MSM and despite a unanimous commitment from all United Nations member countries to monitor HIV among high-risk Fifty-six countries pretend as if they have no gay men or MSM. groups, 71% of countries said they did not have any information on the percentage of MSM contacted by HIV prevention groups. Although data were scarce, the study found MSM were 33 times more likely to be living with HIV than the general population in Latin America, 18 times more likely in Asia, and at least four times more likely in Africa. The report also stated that Benin, Ghana, Jamaica, Kenya, and Thailand are the countries with the highest reported HIV prevalence rates among MSM. So, gay men/msm are at enormously high risk and are bearing the brunt of the epidemic in places all over the world from North to South and is it turns out, less than 1% of the $669 million reported in global prevention spending from 2006 targeted men who have sex with men, according to UNAIDS. One. Percent. Nineteen times. So, there are tons of countries who report that theirs is a heterosexual epidemic but don t reports stats for gay/msm. Forty-four percent of 128 (see above) is 56, by the way. Fifty-six countries pretend as if they have no gay men or MSM. And as long as we are doing the math here, 91 countries don t have any idea if any gay men or MSM are even contacted by prevention groups. While I was delighted to see the conference giving so much attention to the epidemic among gay/msm finally I was concurrently horrified to fully comprehend the depth and the breadth of just how negligent governments and foundations and service providers and advocates are, and the extent of their/our complicity in the Photo Keith R. Green 48

49 XVII International AIDS Conference Mexico City, August 3 8, 2008 unnecessary suffering and deaths of so many human beings. For me, one of the highlights of the conference was actually a pre-conference titled, The Invisible Men: Gay Men and Other MSM [Men Who Have Sex With Men] in the Global HIV/AIDS Epidemic. Something like 80 countries were represented, and it was an honor and a privilege for me to present on behalf of the International Rectal Microbicide Advocates (IRMA) with other IRMA members from Nigeria, Malaysia, and Peru. Unfortunately, due to a travel fiasco, I missed one of the most important sessions of the pre-conference the one in which outgoing UNAIDS Executive Director Peter Piot talked about gay men, MSM, and rampant homophobia. With thanks to TheBody.com, I was able to read his whole speech. I excerpt it here. There s a terrible underfunding of programs for MSM, and yet this is the population where the epidemic is in most countries, Piot stated. There s something that, as a straight man, I really have a hard time understanding, and that is this obsessive homophobia that I find, and which tells me that there s something going on in the heads of people that must mean that they are having a major problem with their own sexuality. There may be other explanations, but this is my opinion, and I have been everywhere in the world and have met people like that, including in the UN system. But it is totally absurd, and it s also cruel. I think that the title of this meeting is only too apt. I m really more and more convinced that homophobia is one of the top five obstacles to really stopping this epidemic. That s where I think we need to probably have a more We must envision a day when we are reflexively empathetic to gay men. scientific, businesslike approach to how we tackle this. There are some really fantastic programs, and here, I would really like to pay tribute to Jorge Saavedra (who came out at the conference, incidentally) and the Mexican government for supporting him with its anti-homophobia campaign, and the whole of the activist groups. But there are not too many countries where this is happening, and yet there are so many places where these programs are needed. In a growing number of countries, Piot continued, we may be reaching a tipping point where working with MSM becomes really possible, and where we can see results. That didn t happen by coincidence. It s proof that some of our joint advocacy and insistence are bearing fruit. So, while things are indeed really bad for our brothers around the world who are gay and or have sex with men, perhaps Piot is right in that we have reached a global tipping point and we can begin to do what is required for gay men, MSM, and all humans beyond the safe focus on politically palatable populations, the folks for whom we are reflexively empathetic. We must envision a day when we are reflexively empathetic to gay men. We must envision a day when we care about gay men on their own terms, as human beings in their own right. We must envision a day when we seek resources on behalf of gay men, upfront, unapologetic, and transparent. It will take all of us to hold the feet of every single stakeholder and leader to the fire. It will take all of us to dismantle the laws that criminalize the existence LGBTs. It will take all of us to ensure that the programs and the dollars follow the science, and not some warped, hateful ideology. Now let s get to work. e 49

50 2007 Bristol-Myers Squibb Company, Princeton, NJ U.S.A. VIUS07AB /07 Living with HIV doesn t

51 mean you have to live here. Ask your doctor if there are HIV medications with a low risk of diarrhea.

52 World AIDS Day Some thoughts on leadership S 2008 On December 1 every year, the world comes together to commemorate World AIDS Day. Leadership has been chosen by the World AIDS Campaign as the theme for World AIDS Day 2007 and This theme will continue to be promoted with the slogan Stop AIDS. Keep the Promise. The theme for World AIDS Day has been determined by the World AIDS Campaign since For this issue we asked a few, select individuals, What does leadership mean to you? Here is what they said, but we d also like to hear from our readers, so please visit us at and take the PA online poll, and tell us what leadership means to you. Julie Davids Julie Davids, Senior Consultant and founding executive director of Community HIV/AIDS Mobilization Project (CHAMP); Although it s easy enough to be a self-appointed leader, I believe the HIV/AIDS movement needs leaders who are effective in two ways: by their actions, and by their commitment to bringing out the leadership in others. We must not fall sway to political or community leaders who talk the talk or who bring out a tasty spread at a meeting or reception. What are these leaders actually doing, and is it in our interest? In order to evaluate if it s in our interest, it s the collective responsibility of all of us as leaders to understand the issues and have the ability to read between the lines... and that happens best by coming together as groups to set our priorities and consider the contexts that will affect decisions made in or against our interests. An ethical and valuable leader will be part of creating a shared understanding of what we need to get, what we have to get it with, and how we are going to get there, valuing and nurturing the leadership of others rather than just showcasing themselves. To make this possible, all of us who seek change in the fight against HIV/AIDS should know our own strengths and weaknesses, our skills and our resources, so we can come together effectively. And it s way past time to expand our notion of leadership the skills that people with HIV and their allies develop as parents, as neighbors, as the members of faith communities, and even those that you may have developed out there surviving on the streets are every bit as needed and valuable as being able to stand up and make a rousing speech. True leaders bring out the leadership of others so we can become powerful enough to win the change we need. Experienced leaders must work alongside and share experiences with a new generation of leaders, respecting (and learning from) their insights and making room for them to take on positions of power. Photos courtesy of Julie Davids and Heidi Nass 52

53 Heidi Nass Heidi Nass, treatment advocate and woman living with HIV We should be winning this thing. HIV and AIDS are completely preventable. The means exist to do enough and tragic experience has taught us the extreme cost of doing too little. What we lack is a culture of brave leadership unified in its adherence to the science of prevention and treatment. Certainly there are individual leaders among us people, organizations, even governments but each swims in a sea of indifference, denial and greed. In 2004 leaders in Brazil turned away $40 million from PEP- FAR rather than publicly denounce prostitution, saying of sex workers, They are our partners. How could we ask prostitutes to take a position against themselves? Meanwhile, organizations in the U.S. claiming to serve people with HIV scooped up abstinenceonly money from the government, with hands open and eyes closed to the damning evidence of the method s failure. More than a dozen years ago, Peter Piot of UNAIDS told the world of the inevitable intersection of women s rights and HIV prevention. Today, as women and girls continue to comprise half of all global infections and more in some regions, the U.S. has altogether rejected family planning services as a necessity of women s health in PEPFAR. Voices raised for the rights of women to control our bodies and protect our health beyond the prevention of HIV from mothers to babies are lonely ones. Members of my community of people living openly with HIV/ AIDS have arguably done the most with the least to move forward rational and humane approaches to prevention and treatment. The best inhabit a radical honesty, a commitment to steadfastly articulate the truth as it is, however unwelcome, rather than what is polite and acceptable. It is a bravery that stands in bold relief against a landscape of too many who think showing up is enough. The many examples of leadership in this epidemic, of bravely showing the way by going the way, remain outnumbered by those of disregard and complacency. Without more decision-makers in all corners claiming HIV/AIDS as the enemy to beat, our best shot at winning this thing will be lost. 53

54 Stephen Lewis Stephen Lewis, Co-Director, AIDS-Free World ( It is said, authoritatively, that Ban-Ki Moon, Secretary General of the United Nations, is increasingly frustrated by his inability to make progress on key international issues from Darfur to the Millennium Development Goals. An AFP news report alleged that uncharacteristically the Secretary General recently lashed out at his staff at a meeting in Turin: Our job is to change the UN and through it the world. This is the big picture. I am frustrated by our failure, so often, to see it. I would argue that the problem lies within it s the failure of the Secretary General to do his job as the world s first citizen that has compromised so many of the issues that might otherwise be addressed. The United Nations has before it a recommendation to create a new international agency for women. It s a recommendation that has attracted the support of a majority of nation states. But it s moving forward at a snail s pace. The Secretary General, in obligatory and ritual speeches, has endorsed the idea, but he s never shown the energy to dramatically hasten its implementation. He s never instructed the agencies over which he has control, to advocate for the new entity at every opportunity. He s never summoned the leading country actors into his office and laid down the law. He s never called a press conference to admit, on the one hand, that the UN record on women is abysmal, and on the other that the world s neglect of women is catastrophic. He talks about a big picture; he works in miniature. But that s just one example. A burning crisis, again acknowledged with pro forma rhetorical vigor, is the terrible contagion of sexual violence that afflicts the world, especially in countries in conflict. Whether it s Darfur or Zimbabwe or the DRC, everyone knows that there s a war on women taking place. In fact, things are so out of control that on June 19th last, the Security Council passed a resolution declaring sexual violence to be a matter of international peace and security. It was unprecedented. The carnage never ends. Yet, the United Nations has responded with almost criminal passivity. The voice of the Secretary General should ring with anger, indignation, dismay and accusation, day in and day out, relentlessly, indefatigably, until the world and the Security Council come to their collective senses and are galvanized into action. That s called leadership. Anything less simply reveals that indifference at best and misogyny at worst have stifled the tongues of truth. That s what leadership is all about: uncompromising principle. What has happened to the leadership of the United Nations is a tragedy: the nuance of diplomatic illusion trumps the passion of conviction and human rights. It s not just Ban-Ki Moon. He s simply part of the legacy. Everyone myself included has time for the former Secretary General, Kofi Annan. But stop and think for a moment; think about the AIDS pandemic and South Africa. Now that Thabo Mbeki and his lunatic Minister of Health are gone, all of the media in South Africa comment on the dreadful AIDS denialism pursued by Mbeki during the days of his Presidency and the awful human costs as a result. Leading members of the Treatment Action Campaign estimate that at least three hundred thousand people perished at the hands of Mbeki s intellectual barbarism. But we knew what was happening all along. And what kind of leadership was it that no one in a senior UN position said a word as the corpses filled the gravesites for the last 10 years? Not the Executive Director of UNAIDS. Not the Director General of the World Health Organization. Not the Executive Director of UNI- CEF. And not the Secretary General of the United Nations. They simply watched the chapters of death unfold. What meaning leadership? e Photo Nick Wiebe 54

55 Statistics 101 A basic guide to the numbers game behind research by Amy G. Cutrell Have you ever stood around a cocktail party discussing statistics? I didn t think so. But we hear about them all the time, especially when we re absorbing clinical trial results or election year polls. Understanding the basics of statistics is not that hard to do, despite how it seemed in school! There are a handful of concepts that serve as the building blocks for learning statistics. I m jumping ahead of mean, median, mode; those will not be covered here (see sidebar). We will look first at standard deviation, standard error, and confidence interval, and how they all tie in to p-value. Building Block #1: Standard Deviation The standard deviation is simply a measure of the amount of variability in your particular sample. Because we can t practically measure everyone in a population that we are interested in studying, we have to take a sample of the population. The standard deviation describes the variation in measurements from individual to individual data point within the sample. Below is a picture of what the standard deviation (SD) tells us. The mean, μ, which is the average, is the highest point in the center of the bell-shaped curve. The area between plus or minus (±) 1 standard deviation (1σ) of the mean captures 68% of all measurements in your sample; the area between ± 2 standard deviations (2σ) captures 95% of all measurements in your sample. In other words, not very many data points approximately 5% will lie more than 2 standard deviations from the mean. Building Block #2: Standard Error The standard error (SE) is important in describing how well the sample mean represents the true population mean. Remember, because we can t practically measure everyone in the population, we take a random sample. Every random sample will give a slightly different estimation of the whole population. The standard error gives you a measure of how precise your sample mean is compared to the true population mean. It is calculated by the standard deviation divided by the square root of the mean. So it depends on the size of your sample. As the sample size gets larger, then variability gets smaller and we get a more precise measurement of the truth. If we measure every member of the population, then it is no longer a sample. There is only one value that can be computed by measuring every member of the population, thus there is no variability and the truth is known. Building Block #3: Confidence Interval Since every random sample will give a slightly different estimation of the whole population, it makes sense to try to describe what the true population looks like with more than a single number. The confidence interval (CI) estimates a range of values within which we are pretty sure the truth lies. The confidence interval depends on the standard error. It is calculated by the sample mean you have measured in your sample plus or minus approximately 2 times the standard error. For example, the 55

56 95% CI gives us the range of values within which we are confident that the true population mean falls 95% of the time. Every point outside of the confidence interval is very unlikely to occur by chance alone. If we have a 95% CI, then it means that there is a 5% chance that the true mean of the population is outside of that interval. In other words, we re pretty confident of the value of our confidence interval! This area outside the confidence area corresponds to a parameter called alpha, α. And usually we split α so that half is in the upper tail (2.5%) and half is in the lower tail (2.5%). This is what we mean by a two-tailed confidence interval. The CI tells us a lot about our sample. We can draw conclusions about statistical significance based on the location of the CI. For example, suppose we have a CI that estimates the difference between two groups: a value of zero corresponds to no difference (that is, the null value). Therefore a CI that excludes zero denotes a statistically significant finding. Beware, though, that the null value is not always zero! It depends upon your null hypothesis, which will be described below. Combining Building Blocks 1, 2, & 3: Describing a Sample Before moving on to new concepts, let s put the three summary statistics of standard deviation, standard error, and confidence interval together by considering an example from blood pressure measurements on 50 individuals. The scatter plot in the picture below shows each of the 50 individual measurements from this hypothetical sample. Our sample mean is represented by the large dot in the center of the 4 vertical lines beside the scatter plot. In the first green line, we can see that about 2/3 of our sample results are contained within +/- 1 standard deviation. In the second green line, 95% of our data points are covered by +/- 2 standard deviations. Once we know the standard error, we can construct the confidence interval. The 95% CI, depicted by the second blue line, gives us the range within which we are 95% confident that the true population mean lies. Four Steps in Conducting an Experiment or Study Step 1 The first step of the experiment is to state your hypothesis. The null hypothesis, H 0, is pre-defined and represents a statement which is the reverse of what we hope the experiment will show. It is named the null hypothesis because it is the statement that we want the data to reject. The alternative hypothesis, H a, is also predefined and represents a statement of what we hope the experiment will show. H a is the hypothesis that there is a real effect. Suppose we design a study to test if Optimized Background Treatment (OBT) + New Drug are better than just OBT alone. Our null hypothesis is that there is no difference between the groups. Our alternative hypothesis is that the two groups are not the same. (We hope that OBT + New Drug is better!) Depending on the data gathered from the study, we will either reject the null hypothesis or not. Step 2 The next step is to design your experiment and select the test statistic. The test statistic defines the method that will be used to compare the two groups and help interpret the outcome at the end of the study. Sometimes the comparison may be based on the differences in means, and use continuous data analysis methods. Sometimes the comparison may be based on proportions, and use categorical data analysis methods. There are many possibilities. For our example from Step 1, the test statistic will be based on the comparison of the proportion of patients with HIV viral load (VL) less than (<) 50 copies/ml in each treatment group of our study sample. Many other important decisions go into designing the experiment besides selecting the test statistic. We also calculate the sample size, agree on the power of the study, and establish parameters like α and β (described below). Step 3 56

57 The Median, the Mean, and the Mode After we generate a random study sample, we conduct the study and collect the data. The third step is to investigate the hypotheses stated in Step 1 and compare the groups. In our hypothetical example, we find that 75% of subjects in the OBT + New Drug group achieve VL <50 copies/ml compared to 35% of patients in the control group. This produces a p-value < The p-value (the p stands for probability ) helps us decide whether the data from the random study sample supports the null hypothesis or the alternative hypothesis. P-value is the probability that these results would occur if there was truly no difference between the groups that is, how likely the results would have been observed purely by chance. The closer the p-value is to 0, the greater the likelihood that the observed difference in viral load is real and not due to chance, thus the more reason we have to reject the null hypothesis in favor of the alternative hypothesis. We look for a p-value of 0.05 or smaller. This represents a 5-in-100 probability a very small chance indeed! Step 4 The last step is to compare the p-value with α and interpret the finding. Alpha is called the significance level. As described above in the section on CI, it is the area outside of the confidence area. It is most commonly defined as α=0.05. If the p-value is less than or equal to α, then the null hypothesis is rejected and we declare a statistically significant finding has been observed. If the p-value is greater than α, then the null hypothesis is not rejected. Remember, our hypothetical example produced a p-value < This is well below α=0.05, so we reject the null hypothesis and conclude that OBT + New Drug and OBT alone are different. We can even take it one step further and conclude that OBT + New Drug are better than OBT. The results of a study are often described by both the p-value and the 95% CI. The p-value is a single number that guides whether or not to reject the null Before you can begin to understand statistics, there are four terms you will need to fully understand. The first term, average, is something we have been familiar with from a very early age when we start analyzing our marks on report cards. We add together all of our test results and then divide it by the sum of the total number of marks there are. We often call it the average. However, statistically it s the mean! The Mean Example: Four tests results: 15, 18, 22, 20 The sum is: 75 Divide 75 by 4: The mean (average) is (Often rounded to 19) The Median The median is the middle value in your list. When the totals of the list are odd, the median is the middle entry in the list after sorting the list into increasing order. When the totals of the list are even, the median is equal to the sum of the two middle (after sorting the list into increasing order) numbers divided by two. Thus, remember to line up your values, the middle number is the median! Be sure to remember the odd and even rule. Examples: Find the median of: 9, 3, 44, 17, 15 (odd amount of numbers) Line up your numbers: 3, 9, 15, 17, 44 (smallest to largest) The median is: 15 (the number in the middle) Find the median of: 8, 3, 44, 17, 12, 6 (even amount of numbers) Line up your numbers: 3, 6, 8, 12, 17, 44 Add the two middle numbers and divide by 2: 8 12 = 20 2 = 10 The median is 10. The Mode The mode in a list of numbers refers to the list of numbers that occur most frequently. A trick to remembering this one is to remember that mode starts with the same first two letters that most does. Most frequently mode. You ll never forget that one! Examples: Find the mode of: 9, 3, 3, 44, 17, 17, 44, 15, 15, 15, 27, 40, 8 Put the numbers is order for ease: 3, 3, 8, 9, 15, 15, 15, 17, 17, 27, 40, 44, 44 The mode is 15 (15 occurs the most at three times) It is important to note that there can be more than one mode. If no number occurs more than once in the set, then there is no mode for that set of numbers. Occasionally in statistics you ll be asked for the range in a set of numbers. The range is simply the smallest number subtracted from the largest number in your set. Thus, if your set is 9, 3, 44, 15, and 6, the range would be 44-3=41. Your range is 41. A natural progression once the three terms in statistics are understood is the concept of probability. Probability is the chance of an event happening and is usually expressed as a fraction. But that s another topic! Source: 57

58 True State H o : no fire Accept H o : no alarm No error Type II Reject H o : alarm Type I No error hypothesis. The 95% CI provides a range of plausible values for describing the underlying population. Concepts in Designing a Study: Type I error, Type II error, and power Three more terms that we often hear or read about are called Type I error, Type II error, and power. They are inter-related and are important in the design stage and in the interpretation stage as well. One way to think about them is to consider the relationship between a smoke detector and a house fire. (Reference: Larry Gonick & Woollcott Smith; The Cartoon Guide to Statistics; 1993; pp ). The purpose of the smoke detector, of course, is to warn us in case of a fire. However, it is possible to have a fire without an alarm, as well as an alarm without a fire. Those are situations or errors that we do not ideally want, but they are possible events nevertheless. So the true state can be either no fire (H o ) or house fire (H a ). Ideally, we want the alarm to alert us if there is a fire and we want the alarm to remain silent when there is no fire. If we have an alarm without a fire, then a Type I error has been committed. This corresponds to α, which is the probability of claiming a difference/rejecting H o. Alpha is normally pre-set to In other words, we accept a 5% chance of a false alarm. If we have a fire but it does not cause an alarm, then a Type II error has been committed. This corresponds to beta, β, which is the probability of missing a difference when one truly exists/not rejecting H o. Beta is normally pre-set to 10% or 20%. In other words, we H a : fire accept a 10% or 20% chance of a failed alarm. Power is defined by 1-β, which is the probability of a real fire when there is an alarm. It is normally preset to 80% or 90%. It controls the probability of observing a true difference, or a true alarm. In other words, with power=80%, we accept that eight trials out of 10 will correctly declare a true difference and that two trials out of 10 will incorrectly miss a true difference. β is a risk that we would want to minimize; and it is a risk to minimize as much as possible but it comes with a price: a larger study, plus more time to recruit subjects, measure, and report. A p-value greater than α=0.05 could be non-significant because there is truly no difference between the groups. Or it could be non-significant because the study is not large enough to detect a true underlying difference. Determining the optimal sample size for a study requires a great deal of thought in the beginning at the planning stage. A sample size that is unnecessarily large is a waste of resources. But a sample size that is too small has a higher likelihood of not representing the underlying population and consequently missing a true alarm. The small study has a wider confidence interval because the standard error is large, or less precise. As we said above in Building Block #2, when the sample size gets larger, the variability gets smaller and we get a more precise measurement of the truth. The optimal sample size depends on all of the various assumptions that go into its calculation. For instance, to plan a superiority study as in Step 2 above, we need to make decisions/assumptions on the following parameters: α (generally 0.05), whether the hypothesis is one-sided or two-sided (generally two-sided), power (generally 80-90%), the response rate in the test arm, and the response rate in the control arm. These assumptions are directly tied to the study being designed so different types of studies require different sets of information for the sample size calculation. Changing any one of the decisions/assumptions will change the sample size calculation. Basic Requirements of Clinical Research Study Understanding the basics of statistics is helpful in evaluating the messages that arise out of research. Good research follows clearly articulated steps and serious planning. The goal of research is to answer a question. In order to do so, it comes down to establishing: Clearly stated primary objective Clearly defined primary endpoint Well-defined study population Study design characteristics that support the objectives Adequate sample size Analysis plan that addresses objective and all important analysis issues In conclusion, study designs are chosen depending on the questions that are being studied. Study endpoints are selected according to the hypothesis under investigation and the study population being enrolled. And study interpretations depend on the hypotheses being tested. Statistics can help weigh the evidence and draw conclusions from the data. e Amy Cutrell resides in Chapel Hill, NC, and has worked at GlaxoSmithKline for twenty years. She received a MS in biostatistics from the UNC School of Public Health. 58

59 The Buzz Sexual Encounters with Undetectable HIV-Positive Men A controversy about HIV transmission by Daniel S. Berger, M.D. Many HIV experts have recently become embroiled in a new controversy: Does an undetectable viral load translate to significant reduction in HIV transmission during sex? If so, are condoms necessary? What message should be imparted by physicians to their patients who confront this situation in their daily lives? In January 2008, an important and prestigious panel of experts from the Swiss Federal Commission for HIV/AIDS boldly produced the first-ever consensus statement saying that HIV-positive individuals on effective antiretroviral therapy and without sexually transmitted infections (STIs) are sexually non-infectious. This opinion was also published in the Bulletin of Swiss Medicine (Bulletin des médecins suisses). Hotly discussed at the International AIDS conference in Mexico City this summer, it was soon followed by a rejection statement by a joint Australasian group of experts. The members and authors of the Swiss Federal Commission for HIV/AIDS are made up of the most reputable Swiss HIV experts, including professor Pietro Vernazza, of the Cantonal Hospital in St. Gallen, and President of the Swiss Federal Commission for HIV/AIDS, and professor Bernard Hirschel from Geneva University. Their opinion was based on a review of the medical literature and extensive discussion. They concluded with this statement: An HIV-infected person on antiretroviral therapy with completely suppressed viremia ( effective ART ) is not sexually infectious, i.e. cannot transmit HIV through sexual contact. The Swiss also considered study data from Rakai, Uganda, where no transmission event occurred in individuals who had viral loads lower than 1,500 copies/ml, although this was a relatively small study. In laymen s terms, this means that barebacking among HIVinfected persons who are on the cocktail who have undetectable viral load, would not transmit HIV to their partners. However, the Australasian group soon rejected the Swiss expert consensus and responded that condom use and effective treatment of STIs is the only way to prevent HIV spread. They went further to suggest that there could be a fourfold rise in transmission if condom use is left awry. They based this on a mathematical model that utilized published data estimating relationships between viral load and HIV transmission risks; they also assumed that transmission does occur at all viral load levels, regardless of how low they may be. Without true data, many question the utility of using mathematical models to form factual declarations. One doesn t forget the mathematical model that was used by Dr. David Ho to regrettably forecast HIV eradication in patients who were at undetectable levels of HIV on treatment. HIV latency was not well understood at that time. With these two differing opinions at hand, a more balanced editorial commentary which was more practical emerged from the UK. Drs. Geoffrey P. Garnett and Brian Gazzard state that ignoring the effect of undetectable viral load would be dishonest. They welcomed the Swiss statement for having opened up the discussion to where we can further suggest to patients to consider HIV treatment and urge better adherence. This may promote a reduction in the risks for HIV transmissions and other infections. Past and present Sexual behavior has been an evolution throughout the AIDS epidemic. During the first years of the HIV epidemic, without the knowledge of how HIV transmission occurred, most gay men continued to have unprotected sex. Without a clear dissemination of information, there was little caution during sex. Places such as bathhouses were a booming business. Eventually, as the AIDS epidemic progressed, individuals were in fear of contracting the virus and practiced safe or safer sex. Safe sex became a household term. HIV was at that time an incurable, progressive disease. Thus bathhouses were closed in various cities such as New York and San Francisco, and clientele dropped sharply since bathhouses were felt to be a reservoir for HIV transmission. In laymen s terms, this means that barebacking among HIV-infected persons who are on the cocktail who have undetectable viral load, would not transmit HIV to their partners. Real progress finally occurred in the field of HIV treatment with the arrival of the cocktail and soon coincided with many patients achieving undetectable levels of virus. The practice of safe sex was still heavily promoted. But this eventually led to a safe sex fatigue, especially since HIV infection was no longer viewed as a death sentence. Not safe sex but safe sex fatigue (which I am coining here) has become the pervasive attitude. In the real world, 59

60 The Buzz continued many patients admit that condoms hamper spontaneity during sex and have become too much of an inconvenience, not to mention the resulting reduction or loss in pleasurable sensations during anal intercourse, for some individuals. Not uncommonly, condoms are also a turn off and cause some individuals to lose their erections. Not confronting safe sex, too many HIV-positive individuals avoid having the conversation about their HIV status. They ve grown tired of feeling the need to re-assure their negative partners about reduced transmission. There s already been the consensus in the men-having-sex-with-men (MSM) community that undetectable patients only remotely pose risk for HIV seroconversion. Also, oral sex has never been considered to be of significant HIV risk nor has it ever been adequately proven to cause HIV seroconversion. However, a common solution for HIV-positive men had been to act as the receptor of anal intercourse or bottom for someone HIVnegative, thereby further limiting exposure to their partner. It is unfortunate that MSMs avoid discussing HIV status during first sexual encounters. It is unfortunate that MSMs avoid discussing HIV status during first sexual encounters. One would expect that encountering HIV-positive men within the gay community is not uncommon. It should be a positive experience for a partner to disclose their status and have a reasonable discussion. In particular situations, it s usually a relief to both partners when discovering what they re each dealing with. If it is revealed that both partners are HIV-positive, it s a tremendous relief and stress reducer for both. Alternatively, if only one partner is positive, it opens a conversation about harm reduction during sex. The absolute worst that can happen is that a negative person does not want to proceed with the situation and thus neither need waste the other s time. HIV status is a personal issue, but individuals should all act responsibly without being inhibited about disclosure from the start. Undetectable viral loads and transmission The Swiss expert statement had been originally downplayed in the media for fear of encouraging more unsafe sex. One applauds the Swiss for encouraging individuals to get tested and begin effective treatment, thereby slowing the transmission of the virus within the community. The Swiss statement and referenced studies, however, were also criticized due to being heterosexually based and debated as to its application to the MSM population or gay community. But it also generated irrational fear that HIV transmission would get out of control. Hence the Australasian rejection and conclusion of only the strict use of condoms plus early treatment of STIs being the only means to reduce transmission of HIV. However this continues to beg for further debate. It is fruitless to ignore that effective antiretroviral therapy eliminates HIV from genital secretions, and that HIV RNA, measured in sperm, declines below the limits of detection on antiretroviral therapy. HIV RNA also falls below the detection limits in female genital secretions during effective antiretroviral therapy. Moreover, usually sperm cell viral particles rise only after an increase in viral load from the blood. The cell-associated viral gene particles, present in genital secretions during effective antiretroviral therapy, are actually non-infectious virions; HIV-containing cells in sperm lack markers of viral proliferations such as circular LTR-DNA. Thus it s logical to abstract that less virus (undetectable) translates to less ability to transmit HIV to others. There can never be a prospectively conducted ethical study since one can t ask HIV-negative individuals to participate in having unprotected sex with undetectable positives. However, patients infected with hep C are usually not undetectable and can also transmit hepatitis C sexually. Thus, unsafe sex, although protective for HIV if the partners are undetectable, does not protect against hepatitis C or syphilis. Harm reduction Let us reconcile ourselves to the widespread existence of safe sex fatigue. While many HIV-positive men abandon safe sex, some do this while engaging themselves primarily with other HIV-positive men. Incomprehensibly, many HIV-negative gay men have accepted the idea that they ll eventually seroconvert to HIV and thus avoid safe sex. Addiction has also had a major impact on behavior. Methamphetamine addiction often results in irrational and relentless 60

61 search for lust and sex with multiple partners by means of higher risk behavior. It is also associated with HIV seroconversions; other STIs while using is also associated with non-adherence to antiviral treatment. As a physician engaged in the research and treatment of HIV infection within the MSM community, I have observed a burgeoning epidemic of increasing HIV, hepatitis C, syphilis, and MRSA (resistant staphylococcal) infections. Individuals who take extra precautions are always better off. Once becoming HIV and/or hepatitis C infected, there are tough consequences to face. Sexually active men should be responsible and have frequent HIV, hepatitis, and STI testing. Anal warts should be treated quickly to discourage the transmission of HPV. Anal Pap smears should be done when indicated. Finally, vaccination for HPV in gay men as a preventative step against development of anal cancer should be studied. At Northstar Healthcare in Chicago, Gardasil, the HPV vaccine, is currently offered to patients for this reason but is pending further study. HPV is the cause of anal cancer (and anal warts) and is a quickly rising problem among HIV-infected individuals. Conclusion Sexually active HIV-positive individuals are better off knowing their status and undergoing effective treatment and therefore reducing HIV transmission. Although HIV transmission has been curtailed among individuals who are undetectable and barebacking may be considered safe in some situations, there is still the prevalence of hepatitis C, syphilis, and resistant staph infection. On the other hand, HIV-positive persons in stable relationships with HIV-negatives, or individuals who understand the importance of adherence to HIV treatment while getting frequent STD (sexually transmitted disease) screening may provide effective harm reduction. Still, condoms should always be considered when sexually interacting with unknown partners. e Dr. Daniel Berger is a leading HIV specialist in the U.S. and is Clinical Associate Professor of Medicine at the University of Illinois at Chicago. He is the founder and medical director of Northstar Medical Center, the largest private HIV treatment and research center in the Greater Chicago area. Dr. Berger has published extensively in such prestigious journals as The Lancet and the New England Journal of Medicine and serves on the Medical Issues Committee for the Illinois AIDS Drug Assistance Program and the AIDS Foundation of Chicago. Dr. Berger has been honored by Test Positive Aware Network with the Charles E Clifton Leadership Award. Dr. Berger can be reached at DSBergerMD@aol.com. Get Positively Aware! Subscribe: 1 year of for $30.* Subscription renewal: My payment of $30 is enclosed. Back issues: Please send me the following back issue(s) at $3 per copy: Jan/Feb 2008 Qty. Mar/Apr 2008 Qty. May/Jun 2008 Qty. Jul/Aug 2008 Qty. Sep/Oct 2008 Qty. Nov/Dec 2007 Qty. *Subscriptions are mailed free of charge to those who are HIV-positive. Donation: * $25 $50 $100 $250 $500 $ Thank you for your donation. Your contribution helps to provide subscriptions to people who cannot afford them. All donations are tax-deductible to the full extent allowed by law. N/D 2008 Mail to: 5537 N. Broadway Chicago, IL NAME: ADDRESS: CITY: STATE: ZIP: PHONE: CHARGE MY: VISA MASTERCARD AMERICAN EXPRESS TOTAL $ CARD NUMBER: EXPIRES: NAME ON CARD: SIGNATURE (REQUIRED): Charges will appear on your credit card bill as TPA Network Please send us bulk copies of at no charge (donation requested - U.S. and Canada only) Number of copies of each issue via U.P.S. (No P.O. Box) Test Positive Aware Network (TPAN) is a not-for-profit organization dedicated to providing support and information to all people impacted by HIV. 61

62 Wholistic Picture A World Together? Health care, not just insurance by Sue Saltmarsh These days we hear a lot about people coming together to create positive change. This when many of us individually are feeling, more urgently than ever, alone, abandoned, overwhelmed, desperate. Even though conventional wisdom tells us that money can t buy happiness, most of the people I know, myself included, would be a helluva lot happier if we had some. This became even more crystal clear to me on August 15th when my body gave me a lesson I could not ignore or deny. After a trip to the emergency room and four days in the hospital without the benefit of health insurance, I now have a $30,000 bill to pay more than I bring home in a year. And yet, they tell me I make too much to qualify for assistance. I ve sent pages of forms in to the hospital committee that decides who is going to get a break on their bill and am waiting for their verdict. Though I ve worked in the HIV/AIDS community for almost 20 years, I have myself been blessed with fairly good health, so when the company insurance raised the deductible to $1,000 and our contribution to $50 twice monthly, neither of which was affordable for me, I cancelled it. So much for the $3,600 I d paid into the system over the last three years. Pocket change for the AIG guys, but a significant, and sorely missed, chunk of my earnings down the drain. As I contemplate a future during which the fibroids in my uterus may necessitate a hysterectomy and my Type II diabetes may slide from the current managed state into some sort of crisis, I find myself in what I imagine to be a similar trap to the one After a trip to the emergency room and four days in the hospital without the benefit of health insurance, I now have a $30,000 bill to pay more than I bring home in a year. HIV-positive folks deal with either we pay dearly for insurance and then have co-pays and deductibles on top of the premium as well as insurance companies refusing to pay for treatment, we rely on other sources for our meds and on the charity of doctors and hospitals, or we just give up and let Nature take its course. Especially for people like me who make up what was formerly the middle class, there is no such thing as a free clinic and the so-called sliding scale is no more affordable than insurance premiums. Mr. Bush, who is going to bail us out? Where is our golden parachute? Where is any kind of parachute for us? Hearing reports of the International AIDS Conference in Mexico City, I was inspired to think, What if all the people who came to that conference, all the people of the world, HIV-positive or not, cancer patients, diabetics, heart disease sufferers, arthritics, and all who carry within them some sort of health problem were to get together and say, No more! What if we could create a world in which health care, not health insurance, was everyone s right? So many countries have done it already that it doesn t seem that impossible. But of course, such a monumental undertaking would require surgical removal of the idea that people should be able to profit from the illness and suffering of others. Let me make clear that I totally support doctors, nurses, paramedics, and all other kinds of medical practitioners in their right to make a better living than I do they have, after all, invested hundreds of thousands of dollars and years of their lives in their education and training. But what I would like to see is the end of those who are in it for the money, who will never be true healers. I would also like to see medical science and pharmaceutical research supported and encouraged, but what s wrong with a motive like altruism both from the folks doing the research and the governments that should give them abundant support? I don t know about you, but I would much rather pay the $100 I m now paying every month for insurance to the IRS than my $3,000 share (yes, folks, that s what it s going to cost each and every taxpayer to save Wall Street) of the current financial bail out plan if I knew that I could go to my internist any time without worrying about how I m going to pay for it. Is this possible? I don t know, but if anyone out there wants to give it a try, I m in. Breathe deep, live long (or at least until you get your insurance s worth!) e Photo Russell McGonagle 62

63 2008 Reader Survey Hey, it s been a little while since our last survey! Please take a few minutes to fill out the survey below it would really help us out. Then just mail or fax it back. If you like you can visit us on our website at positivelyaware.com and take the survey online. All responses are completely anonymous. Thank you for your help! Age Under and over Ethnicity African American Caucasian Latino / a Asian / Pacific Islander Native American (American Indian) More than one race Other I identify as Male Transgender I identify as Female Gay / queer / lesbian / homosexual Straight / heterosexual Other / do not wish to disclose Bisexual What was the last level of education you received? Did not graduate from high school High-school diploma / GED Associates degree College degree Graduate / Professional degree Post-graduate degree / Doctorate What is your annual income? Less than $10,000 $10,000 24,999 $25,000 54,999 $55,000 69,999 $70,000 84,999 $85,000 99,999 $100,000 or more My current job is: Physician Pharmacist Other healthcare professional Case Manager/Social Worker Other Non-profit Media Pharmaceutical company Other (please specify) What is your HIV status? HIV-positive Unknown HIV-negative Do not wish to disclose Are you currently taking HIV medications? Yes No What assists you in getting your medications? (Please check all that apply) Medicare Medicaid ADAP (AIDS Drug Assistance Program) Private insurance Other: Where / how did you get your issue of Positively Aware? (Please check all that apply) I m a subscriber A household member / friend / relative is a subscriber Doctor s / healthcare provider s office Case manager / AIDS service organization s office Online / Internet Bar / restaurant / club Other: How many people do you share with? None or more How long have you been a reader? First time reader 1 2 years 3 4 years Less than a year 2 3 years 4 years or more I have used to help me make decisions regarding my HIV treatment Frequently Sometimes Never Often Rarely I get most of my information about HIV/AIDS from Magazines/printed material Local AIDS service organization Online My doctor Friends Other (please specify) Please list any comments or suggestions you have for Mail to TPAN, c/o 2008 Reader Survey, 5537 N. Broadway, Chicago, IL, 60640; or fax to Take the survey online at 63

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