will help educate people about global issues of hepatitis FDA APPROVES HARVONI (SOFOSBUVIR/LEDIPASVIR)

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1 16 October 2014 Vol. 17, Issue 10.5 Welcome to the first edition of the HCV Advocate: Mid-Month Edition. We decided to publish an additional mid-monthly edition because there is so much more news now and we wanted to make sure we are keeping our readership up to date on the latest information. The Mid-Month Edition will feature Jacques Alan Franciscus, Editor-in-Chief Chambers monthly benefits column, fact sheet updates and other critical updates. In this issue, we are happy to announce a new series of fact sheets titled HCV Around the World that will provide information about hepatitis C in various countries. We hope that this series will help educate people about global issues of hepatitis C and what the specific issues and consequences in these particular countries are. We also hope to raise the level of awareness worldwide and in the countries that we write about. This first fact sheet on Egypt is featured in this issue of the HCV Advocate: Mid-Month Edition. FDA APPROVES HARVONI (SOFOSBUVIR/LEDIPASVIR) IN THIS ISSUE On October 10, 2014 the Food and Drug Administration (FDA) approved the combination of sofosbuvir and ledipasvir brand name Harvoni one pill taken once a day. The majority of people will have a 12- week course of treatment. Some people people with low HCV RNA (viral load), minimal liver damage and treatment naïve (never been treated) will only need an 8-week course of treatment. The cure rates in Gilead s three pivotal Phase 3 trials were 94 to 99%. The price of sofosbuvir brand name Sovaldi has been a lightning rod, and this combination will continue to be so with the wholesale list price listed at $63,000 for an 8-week course of treatment and $94,500 for a 12-week course of treatment. It is unfortunate because Medicare and Medicaid are likely to continue to severely restrict access to this combination and other expensive HCV drugs. Hopefully, more providers will access Gilead s patient assistance programs. HEPATITIS C AROUND THE WORLD: Hepatitis C in Egypt 2 HCV GENOTYPE SUBTYPE 4 DISABILITY & BENEFITS: Open Enrollment for Obamacare and Medicare 6

2 Hepatitis C in Egypt Egypt has the highest prevalence of chronic HCV of any country worldwide estimated at a rate of up to 8.5% in 2008, but declining to 7.3% in The decline in the rate of chronic HCV was because of two factors deaths related to HCV or people with HCV who died of other causes, and because of the number of people successfully treated with HCV medications. The number of people in Egypt who have actually been diagnosed totals only 15% of the total HCVinfected population. Annually, there are 125,000 newly diagnosed chronic HCV cases. HCV genotype 4 is the most common strain in Egypt followed by HCV genotype 1 (90% and 10% respectively). Transmission Blood-to-blood contact transmits hepatitis C. In Egypt the most common transmission routes include: 2 Sharing needles and works for injection drug use (medical, traditional practices and recreational use), Receiving a blood transfusion or an organ transplant, Dental practices, Circumcision, Medical care from local informal health providers and centers. Some of the transmission is the result of a mass campaign in the 1960 s though the 1980 s to control schistosomiasis infection a parasitic disease transferred by snails to humans wading in water while working in rice fields. At that time, schistosomiasis was treated with injections of the drug tartar emetic using unsterilized and reused syringes. Today, as in the past, the majority of infections are the result of transmission from unsafe medical practices. Culturally, Egyptians have many needless injections Alan Franciscus, Editor-in-Chief and blood transfusions using unsafe blood, needles and tools. This includes: Unsterilized medical and dental instruments, Gloves used on multiple patients, Blood spills not cleaned up, One-use vials used on more than one patient, Used syringes Blood Safety Training Egypt has a national plan in place to train medical staff and the population (urban and rural) about blood safety. Egypt is a poor country that has many cultural practices that will Egypt has one of the oldest civilizations in the world and has survived thousands of years, so conquering HCV may just be a matter of a united will. CONTINUED ON PAGE 3

3 2014 Hepatitis C Support Project FROM PAGE 2 need to be addressed before blood safety practices can change. Deaths In 2013, there were 153,000 deaths recorded: 33,000 related to HCV; 120,000 deaths for allcause mortality. HCV can be a contributing factor for non-hcv related deaths so the actual number of deaths related to HCV might be higher. Treatment The Ministry of Health treats 50,000 patients a year; Health Insurance Organization treats 10,000; 5,000 patients paid cash for treatment. Note: The HCV protease inhibitors boceprevir and telaprevir only have antiviral activity against HCV genotype 1. The Ministry of Health has a national treatment program that provides free treatment for most patients. By 2013, the total number of patients with HCV treated reached 350,000. Until recently pegylated interferon plus ribavirin was the standard of care. The cure rate in the Egyptian population with HCV genotype 4 was 54-59%. Now there is Sovaldi (plus pegylated interferon and ribavirin) which has a cure rate for HCV genotype 4 of 96% (more than 9 out of 10 people). There are even more drugs that are being studied to treat hepatitis C genotype 4 that may be able to cure everyone, but these drugs are expensive. The drug company that makes Sovaldi, Gilead, has made a deal with the Egyptian government that will make the course of treatment much cheaper for Egyptians. Twelve weeks of Sovaldi will cost $300 per Egyptian patient compared to $84,000 per US patient. Treating millions of Egyptians and educating/ training 85 million people about prevention measures seems like an incredibly uphill battle for any country, especially a country that has a large urban and rural poor population that is recovering from a revolution. But Egypt has one of the oldest civilizations in the world and has survived thousands of years, so conquering HCV may just be a matter of a united national will. Resources: The Association of Liver Patients Care (ALPC) is a non governmental organization founded in 1997 in Dakahliah- Egypt eg/en/ Terous: org/ Check Out Our New Fact Sheet on Treatment for Genotype 4 HCSP VERSION 1 October a series of fact sheets written by experts in the field of liver disease HCSP FACT SHEET HCV TREATMENT: FDA-APPROVED MEDICATIONS Genotype 4: Sovaldi (Sofosbuvir) Triple Therapy Written by: Alan Franciscus, Editor-in-Chief Foreword In December 2013, the Food and Drug Administration (FDA) approved the combination of sofosbuvir brand name Sovaldi, plus pegylated interferon and ribavirin (PEG/RBV) to treat hepatitis C (HCV) genotype 4. This fact sheet will discuss the basics of the therapy for treatment of HCV genotype 4. For more detailed information please see the Sovaldi (sofosbuvir) Package Insert. The FDA approval was based on the NEUTRINO study except where otherwise noted. Note: The NEUTRINO study included mostly patients with HCV genotype 1 (see fact sheet Genotype 1: Sovaldi (Sofosbuvir) Triple Therapy). The FDA approval for the use of the triple therapy was based on treatment of 28 HCV genotype 4 patients. The FDA Sovaldi (sofosbuvir) Package Insert information did not separate out the information between the genotypes, so I am listing out the basic information. Medications and Dose: Sofosbuvir (brand name Sovaldi) a HCV polymerase inhibitor. Sovaldi is a 400 mg pill taken once-a-day. Pegylated interferon (PEG) is injected under the skin once-a-week. Ribavirin (pill) taken twice daily. The dose of ribavirin is based on body weight (<75kg = 1000mg; 1000kg = 1200mg). Dose Modification: Sovaldi should not be dose reduced. If pegylated interferon and ribavirin are discontinued, Sovaldi should be discontinued. HCSP FACT SHEET A publication of the Hepatitis C Support Project EXECUTIVE DIRECTOR, EDITOR-IN-CHIEF, HCSP PUBLICATIONS Alan Franciscus DESIGN Leslie Hoex, Blue Kangaroo Design PRODUCTION C.D. Mazoff, PhD CONTACT INFORMATION Hepatitis C Support Project PO Box Sacramento, CA alanfranciscus@hcvadvocate.org The information in this fact sheet is designed to help you understand and manage HCV and is not intended as medical advice. All persons with HCV should consult a medical practitioner for diagnosis and treatment of HCV. This information is provided by the Hepatitis C Support Project a nonprofit organization for HCV education, support and advocacy Reprint permission is granted and encouraged with credit to the Hepatitis C Support Project. hepatitis/factsheets_ pdf/sovaldi_gt4.pdf 1 3

4 HCV Genotype Subtype There are 185 million people worldwide (2.8%) infected with the hepatitis C virus. The virus has seven different strains called genotypes numbered 1 through 7. The variance (nucleotides) between each genotype is approximately 30-35%. There are also variances (nucleotides) of about 15% difference within each genotype these are called subtypes, further classified by alphabetic letters, i.e., genotype 1b. The test to find out the genotype and subtype is a blood test. Subtype information is necessary in regards to HCV antiviral treatment. Some medications work better with some of the HCV inhibitors than with others. This is one of the reasons that multiple HCV inhibitors (protease inhibitors, NS5A inhibitors, polymerase inhibitors) are being combined to treat hepatitis C. 4 Old vs. New Subtypes The different HCV subtypes can be thought of as old and new because of the prevalence worldwide and mode of transmission. The transmission route of the older subtypes was prior to the introduction of blood transfusions, blood products and injection drug use hundreds if not thousands of years ago. Most likely these strains were transmitted via blood rituals, older forms of tattooing, mother-to-child transmission and other more uncommon routes. These older forms developed over long periods of time and were isolated from other genotypes and subtypes. The newer subtypes were likely spread with the introduction of blood transfusions, blood products, injection drug use, and other modern modes of transmission in the 20th century. The more prevalent and recent subtypes are genotypes 1a, 1b, 2a, and 3a. Of the 53% of genotype 1 cases globally identified so far, 99% are attributed to Alan Franciscus, Editor-in-Chief What happens if the medication works against a particular genotype or subtype, but it turns out that it doesn t work against the other strain or subtype? 1a (31%) and 1b (68%). Subtype 3a is believed to have spread mostly via injection drug use, and in India and Pakistan by way of immigration. R e g a r d i n g G e n o t y p e s: Genotype 1 is the most common genotype (83 million worldwide) followed by genotype 3 (54 million), genotypes 2, 4, and 6 (about 23% of hepatitis C worldwide) and genotype 5 (less than 1% of the global population with hepatitis C). There has only been 1 case of genotype 7 that was identified in Canada from a Central African immigrant. CONTINUED ON PAGE 5

5 Subtype FROM PAGE 4 G e n o t y p e / S u b t y p e & Antiviral Treatment The medications that are used to treat hepatitis C have different cure rates based on the genotype and subtype. In fact, the first HCV protease inhibitors telaprevir and boceprevir had antiviral activity against HCV genotype 1 and very little or no antiviral activity against other HCV genotypes. Sofosbuvir, by itself, has more antiviral activity against HCV genotypes 1 and 2, but less against genotype 3. However, differences exist among subtypes: the cure rate for sofosbuvir plus pe gylated interferon and ribavirin with HCV genotype 1b is 10% lower than that treatment s cure rate with HCV genotype 1a. In the Phase 3 clinical trials of daclatasvir plus asunaprevir, the antiviral activity was much higher in HCV genotype 1b than in HCV genotype 1a. The differences in cure rates between genotypes and subtypes can be overcome by adding a different class of inhibitor (protease, NS5A or polymerase) to the mix. This difference in cure rates based on different medications does bring up an important treatment consideration of treating more than one genotype and/or subtype in one person. There has been some research regarding multiple genotypes and subtypes mostly in people who contracted hepatitis C by blood transfusions or blood products, and people who shared needles and drug preparation tools. These are groups that generally had multiple exposures to the hepatitis C virus and could have been infected with multiple genotypes and subtypes. What happens if the medication works against a particular genotype or subtype, but it turns out that it doesn t work against the other strain or subtype? This would mean that someone who did not achieve a cure would need to have a genotype test to make sure that the reason they didn t achieve a cure was that they had more than one genotype/subtype. This is an interesting question that needs to be explored. What do our readers think? Genetic Diversity of Hepatitis C - Genotypes & Subtypes 5

6 Open Enrollment for Obamacare and Medicare Jacques Chambers, CLU Medicare Open Enrollment starts October 15, 2014 and ends December 7, All changes made during this time are effective January 1, Obamacare has its second Open Enrollment this year. It runs from November 15, 2014 to February, Employer-Provided Benefits also frequently provide an Open Enrollment Period for employees, allowing them to make changes in their employee benefits choices. Although employers can select other times of the year, most employers have their Open Enrollment in November and/ or December for a January 1, 2015 effective date. Medicare Medicare beneficiaries have several choices: Original Fee For Service Medicare Many people elect to stay with original Fee-For-Service Medicare. It consists of Part A Hospital Coverage; Part B Medical Coverage; 6 and Part D Prescription Drug Coverage. Parts A and B of Original Medicare are the same for everyone; however, each beneficiary can choose from several prescription drug plans. The only way to do this is to compare plans using your own prescriptions, since your medications may have changed, and plan formularies and prices also change. There is a program on line at that allows you to enter your medications, which pharmacy your prefer, and where you live; it will then show you what each plan would cost you out of your pocket based on your medications. Click on Find Health and Drug Plans and follow from there. I recommend the General Search rather than the personal one; it is much quicker. Even if your current Drug Plan has been serving you well, it is advisable to run the program. The plans for 2015 are already up on the website. For persons who are not comfortable with computers, Medicare s toll-free number (800-MEDICARE) will do the same calculation. However, I recommend you find a friend or relative who will do it for you on a computer because the results are too long and involved for a telephone operator to spend much time reviewing all options. Medicare Supplement (also called Medigap) Plans These are the plans sold to people with Original Medicare to fill the coverage gaps left by Medicare Parts A & B. Because they are sold by private insurance companies, enrollment rules can be complicated. To find out when you can purchase them, go to and search for When Can I Buy a Medigap Policy. It will list the Open Enrollment opportunities for them. They may also be purchased at other times, but the insurance company may require proof of good health. CONTINUED ON PAGE 7

7 FROM PAGE 6 Medicare Advantage Plans These are plans offered by insurance companies and health service providers and are an alternative to Fee-for-Service Medicare. Many of these plans are run by Health Maintenance Organizations (HMOs), but there are also Preferred Provider Organization Plans (PPOs), Special Needs Programs, and Private Fee-For-Service plans, although not all types are available in all states. Under these plans, Medicare pays the insurance company to provide all of your medical care. Benefits under your red, white, and blue Medicare card are no longer covered directly, but the Medicare Advantage Plan must offer all of its benefits and may add more. Some plans may also charge an additional premium, usually relatively small. These plans usually include the prescription drug coverage in their plan so you don t have to work through finding a Part D coverage question. During this Open Enrollment Period, persons may switch from one Medicare Advantage Plan to another or move back to or away from Fee-For Service Medicare. There is also a Disenrollment Period from January 1 through February 14, 2015 when one can leave a Medicare Advantage Plan and move to Original Feefor-Service Medicare; there is also a Special Enrollment Period to add Prescription Drug Coverage during this time. Also, for persons who did not enroll in Medicare Part B when it was first available and who do not qualify for a Special Enrollment Period, there is a General Enrollment Period between January 1 and March 31 of each year with the Part B coverage taking effect the following July 1. There will usually be a surcharge to the premium of 10% for each year you could have been in Part B but were not. The exception to the surcharge is for persons who were covered under an employer-provided plan due to the active employment of the person or his/ her spouse. Obamacare Persons enrolled in coverage, as well as those who have not yet joined, have the opportunity to enroll in or change health plans under the Affordable Care Act (Obamacare). Many plans are making changes in coverage as well as cost, so I recommend you go to your state s health exchange or to www. healthcare.gov if you live in a state that does not opeate its own exchange, and search to see if there is better coverage for you. This is also your opportunity to confirm the accuracy of your estimated annual income for For those who qualify for premium subsidies from the government, remember that if you under-report your income and get a larger subsidy than you are eligible for, you may be asked to repay some at the end of the year. This is also a good time to confirm that your medical providers are still part of your plan s network, and that your prescriptions are still part of the plan s formulary. CONTINUED ON PAGE 8 7

8 FROM PAGE 7 E m p l o y e r - P r o v i d e d Benefit Plans Companies offering an Open Enrollment period will publish (or offer online) an Open Enrollment Guide that spells out each employee s current benefits plus the available options, opportunities, and costs that may be chosen during the period. For persons dealing with a serious medical condition like HCV, it can be an opportunity to alter benefits and, in some cases, actually increase benefits. Life Insurance. Persons dealing with HBV/ HCV are generally unable to purchase life insurance in the individual market. If your employer offers supplemental life insurance, you can purchase above what he or she offers; see if there is an amount you can purchase that will not require evidence of good health. An employer may give all employees a base benefit from $10,000 to $50,000. While some employers offer this option, many others will not. If it is available, it is an excellent way for an 8 otherwise uninsurable person to obtain additional life insurance. Long Term Disability. Less common, but still occasionally available, is the opportunity to increase the benefit of your LTD plan. Some employers will provide a basic benefit for LTD, such as 50% or 60% of your monthly earnings, and allow employees to purchase an additional 10% or 15% to raise the benefit they would receive in the event of disability. Some employers may allow you to add this benefit if you did not elect it originally. Again, it is important to read your Open Enrollment material to see if your employer offers this. Revising LTD Premium Payment. One additional possibility to explore is the payment of LTD premiums and its effect on the income taxability of the disability benefits should you ever need to collect them. Some employers will allow you to have the premium for the LTD coverage added to your W-2, making the premiums taxable rather than receiving it as a tax-free gift. If this is possible you may want to jump at the chance, the reason being taxes. If you pay for the LTD coverage with money that is taxed as income, then the benefits you receive if you become disabled will be income tax free, substantially increasing the spendable dollars you would receive as a disability benefit. The IRS will tax either the premium paying for the coverage or the disability benefits being paid, but not both. Health Related Benefits. Many employers, especially larger ones, offer a variety of health, dental, and vision plans from which employees can choose. At Open Enrollment, you have the opportunity to change your coverage from one plan to another regardless of your medical condition, and sometimes have the opportunity to make choices within your plan, such as to increase or decrease the size of the deductible. CONTINUED ON PAGE 9

9 FROM PAGE 8 For someone dealing with HCV, this can be an important choice, especially if this is the first Open Enrollment since diagnosis. There is no one type of health plan that is best for everyone. There are two main kinds of plans that employers offer most often: Preferred Provider Organization These plans provide some coverage for all physicians, but pay more if you choose a physician that has contracted with the insurance company, a Participating Provider. This plan will give you the greatest flexibility in medical providers; however, it will often cost you more out-of-pocket for both your portion of the monthly premium as well as the plan co-pays and co-insurance. Health Maintenance Organizations These plans usually offer the lowest out-of-pocket expenses, but limit your choice of physician. Coverage is only provided when using one of their contracting doctors and hospitals. Also, a Primary Care Physician (also called a Gatekeeper) oversees all your medical care and must refer you to a specialist before the HMO will cover the specialist s charge. Exclusive Provider Organization These plans are exactly like an HMO, except there is no Gatekeeper physician. You decide if you need to see a specialist and make the appointment directly. Which plan is better for you will depend on which doctors you wish to retain and what HMOs or PPO plans they are part of, as well as the cost to you. Check Out Our New Easy C Fact Sheet on harvoni for Genotype 1 by Alan Franciscus Genotype 1 Treatment: Harvoni (Sofosbuvir & Ledipasvir) Harvoni is the combination of two drugs (sofosbuvir and ledipasvir) to treat people with hepatitis C Remember Talk to your doctor or nurse about treatment for hepatitis C. St. John s wort should not be taken with Harvoni or any drug that contains an HIV or HCV inhibitor. Talk with your doctor or nurse about what drugs you should not take with Harvoni. The drugs are expensive if you need to, visit Gilead s patient support program at who have a certain strain of hepatitis C called genotype 1. There are a couple of important facts to know about Harvoni: The two drugs are combined into one pill, taken once a day. The period of time that people take the drugs is either 8 weeks or 12 weeks. The cure rates are over 90% (over 9 out of 10 people who take them are cured). All drugs have side effects or symptoms. The most common side effects of Harvoni were feeling tired, headaches, difficulty sleeping, diarrhea, and feeling sick to the stomach (nausea). HCV ADVOCATE org/hepatitis/easyfacts/ Harvoni_e.pdf 10/2014 Executive Director Editor-in-Chief, HCSP Publications Alan Franciscus alanfranciscus@hcvadvocate.org Managing Editor, Webmaster C.D. Mazoff, PhD cdmazoff@hcvadvocate.org Contributing Authors Jacques Chambers, CLU Design Leslie Hoex Blue Kangaroo Design blueroodesign@aol.com Contact information: Hepatitis C Support Project PO Box Sacramento, CA The HCV Advocate offers information about various forms of intervention in order to serve our community. By providing information about any form of medication, treatment, therapy or diet we are neither promoting nor recommending use, but simply offering information in the belief that the best decision is an educated one. Reprint permission is granted and encouraged with credit to the Hepatitis C Support Project Hepatitis C Support Project 9

10 HCSP P.O. Box Sacramento, CA Get Tested. Get Treated. Get Cured.