I S H P S p r i n g C o n f e r e n c e Megan Koyle, PharmD Elaine Nguyen, PharmD, MPH, BCPS

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1 I S H P S p r i n g C o n f e r e n c e Megan Koyle, PharmD Elaine Nguyen, PharmD, MPH, BCPS

2 Objectives Increase foundational knowledge of HIV/AIDS through greater awareness of epidemiology, pathophysiology, and related disease background topics Describe how HIV is transmitted and apply this information to better understand safety precautions and prevention measures Recognize HIV/AIDS testing methods, treatment options, and the technician role in assisting patients with the disease

3 Outline Background Workplace Safety Testing Treatment Technician Opportunities

4

5 Epidemiology The CDC estimates that >1.1 million people over the age 13 are living with HIV infection in the U.S. Almost 16% of those are currently unaware of their infection Over the past decade, the number of new HIV infections in the U.S. has remained relatively stable at about 50,000 per year For patients in some rural communities easy access to physicians, hospitals and community health centers prevents testing and treatment Exploring and Defining the Community Pharmacists Role in HIV Prevention, Testing and Care [Internet]. Washington, DC: American Pharmacists Association; [cited 2015 March 7]. Available from:

6 HIV in the U.S.

7 HIV Incidence 1 case 7 cases 1 case 1 case 1 case

8 Origin of HIV Scientists identified a type of chimpanzee in West Africa as the source of HIV infection in humans Theory: Simian immunodeficiency virus (SIV) was transmitted to humans and mutated into HIV when humans hunted these chimpanzees for meat and came into contact with their infected blood Studies show that HIV may have jumped from apes to humans as far back as the late 1800s

9 Timeline of HIV/AIDS December 10: The CDC reports a case President Obama June 5: The CDC reports cases of a rare March 19: FDA approves FDA approves the first the first The protease CDC reports the first of AIDS in an infant antiretroviral who received drug, blood announces Newly elected accelerated President lung infection in five young, previously inhibitor. zidovudine This ushers substantial in a new decline June in AIDS 5: 25 deaths year anniversary Barack transfusions. The following (AZT) and week, FDA 22 efforts Obama to increase calls for the the healthy, gay men. These reports mark declares era of HAART. HIV By in the the end U.S. of Due largely since the to the first use AIDS cases of prevention unexplained availability development cases were of treatment of the first the first official reports of what will as a new the indication year, 500,000 for of cases HAART, of AIDS AIDS-related deaths reported. in National immunodeficiency and opportunistic to people HIV/AIDS living with Strategy become known as the AIDS epidemic. male condoms. have been reported the in U.S. the decline U.S. by 47% compared infections in infants were reported. HIV/AIDS for the in the U.S. with the previous year. U.S A time line of AIDS [Internet]. Washington, DC: US Department of Health and Human Services; [updated 2011; cited 2015 March 7]. Available from:

10 What is HIV? HIV stands for Human Immunodeficiency Virus H Human This particular virus can only infect human beings I Immunodeficiency HIV weakens your immune system by destroying cells that fight disease and infection V Virus A virus can only reproduce itself by taking over a cell in the body of its host WHAT IS HIV/AIDS? [Internet]. Washington, DC: US Department of Health and Human Services; [updated 2014 April 29; cited 2015 March 7]. Available from:

11 What is AIDS? AIDS stands for Acquired Immunodeficiency Syndrome A Acquired You acquire AIDS after birth, it is not inherited I Immuno Your body's immune system D Deficiency You get AIDS when your immune system is deficient S Syndrome A syndrome is a collection of symptoms and signs of disease WHAT IS HIV/AIDS? [Internet]. Washington, DC: US Department of Health and Human Services; [updated 2014 April 29; cited 2015 March 7]. Available from:

12 HIV Transmission How do you get HIV or AIDS? [Internet]. Washington, DC: US Department of Health and Human Services; [updated 2014 Jun 6; cited 2015 Feb 22]. Available from:

13 Pathophysiology of HIV The Pathophysiology of HIV[Internet]. [Updated 2011 Oct 25 ; cited 2015 March 7]. Available from:

14 Signs and Symptoms Signs and Symptoms [Internet]. Washington, DC: US Department of Health and Human Services; [updated 2014 April 29; cited 2015 March 7]. Available from:

15 Signs and Symptoms Initial symptoms Fever (this is the most common symptom) Swollen glands Sore throat Rash Fatigue Muscle and joint aches and pains Headache

16 Signs and Symptoms The clinical latency stage Virus is replicating without producing symptoms Also called asymptomatic HIV infection People in this symptom-free period are still able to transmit HIV to others

17 Trivia The clinical latency period can last

18 Signs and Symptoms Progression to AIDS Rapid weight loss Recurring fever or profuse night sweats Extreme and unexplained tiredness Prolonged swelling of the lymph glands in the armpits, groin, or neck Diarrhea that lasts for more than a week Sores of the mouth, anus, or genitals Pneumonia Red, brown, pink, or purplish blotches on or under the skin or inside the mouth, nose, or eyelids Memory loss, depression, and other neurologic disorders

19 Outline Background Workplace Safety Testing Treatment Technician Opportunities

20 HIV Transmission Body fluids Blood Semen (cum) Pre-seminal fluid (pre-cum) Rectal fluids Vaginal fluid Breast milk How do you get HIV or AIDS? [Internet]. Washington, DC: US Department of Health and Human Services; [updated 2014 Jun 6; cited 2015 Feb 22]. Available from:

21 HIV Transmission Occupational transmission is very rare How do you get HIV or AIDS? [Internet]. Washington, DC: US Department of Health and Human Services; [updated 2014 Jun 6; cited 2015 Feb 22]. Available from:

22 Trivia In what year was the last confirmed case of occupational HIV transmission in the United States? If exposed to HIV-infected blood at work, what is a health care workers risk of becoming infected? HIV/AIDS: Occupational HIV Transmission and Prevention Among Health Care Workers [Internet]. Atlanta (GA): Centers for Disease Control and Prevention; [updated 2014 Jan 7; cited 2015 Feb 22]. Available from:

23 Infection Control Precautions HIV/AIDS: Occupational HIV Transmission and Prevention Among Health Care Workers [Internet]. Atlanta (GA): Centers for Disease Control and Prevention; [updated 2014 Jan 7; cited 2015 Feb 22]. Available from:

24 Post-Exposure Prophylaxis Start post-exposure prophylaxis (PEP) as soon as possible! Source patient testing Three (or more) medications recommended Preferred PEP regimen: emtricitabine + tenofovir + raltegravir Consider side effects, drug interactions, etc. Source patient and drug-resistant HIV Complete 4 weeks of therapy Kuhar DT, Henderson DK, Struble KA, et al. for the US Public Health Service Working Group. Updated US Public Health Service Guidelines for the Management of Occupational Exposure to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis. Infect Contro Hosp Epidemiol. 2013;34:

25 Post-Exposure Prophylaxis Within 72 hours Counseling Post-exposure testing Medical evaluation Follow-up testing Initial 6 weeks 12 weeks 6 months Drug toxicity monitoring: blood count, renal function, liver function Baseline 2 weeks PEPline: Kuhar DT, Henderson DK, Struble KA, et al. for the US Public Health Service Working Group. Updated US Public Health Service Guidelines for the Management of Occupational Exposure to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis. Infect Contro Hosp Epidemiol. 2013;34:

26 Outline Background Workplace Safety Testing Treatment Technician Opportunities

27 Trivia at least HIV Testing Frequency[Internet]. Washington, DC: US Department of Health and Human Services; [updated 2014 Jun 6; cited 2015 Feb 22]. Available from:

28 Risky Behaviors Sharing needles, syringes, etc. History of sexual transmitted disorders Unprotected sex with multiple or anonymous partners Testing may be recommended more often HIV Testing Frequency[Internet]. Washington, DC: US Department of Health and Human Services; [updated 2014 Jun 6; cited 2015 Feb 22]. Available from:

29 Ways to Test for HIV Antibody test Enzyme immunoassay Blood, oral fluid, urine Results can take up to 2 weeks Rapid HIV antibody Blood, oral fluid, urine Results take minutes Require confirmatory test Types of HIV Tests [Internet]. Washington, DC: US Department of Health and Human Services; [updated 2014 Jun 6; cited 2015 Feb 27]. Available from:

30 Ways to Test for HIV Antigen test (p24) Blood Can detect HIV 1-3 weeks after infection Usually done in combination with antibody test Polymerase chain reaction (PCR) test Can detect HIV 2-3 weeks after infection Used to measure viral loads Types of HIV Tests [Internet]. Washington, DC: US Department of Health and Human Services; [updated 2014 Jun 6; cited 2015 Feb 27]. Available from:

31 Home Testing Home Access HIV-1 Test System OraQuick In-Home HIV Test

32

33

34 Home Access HIV-1 Test System 1. Register code number 2. Collect blood specimen 3. Ship blood specimen 4. Get results HIV-1 Test Demo [Internet]. Hoffman Estates (IL): Home Access Health; 2008 [cited 2015 Feb 27]. Available from:

35 OraQuick In-Home HIV Test

36 OraQuick In-Home HIV Test OraQuick : Before You Begin [Internet]. Bethleham (PA): OraSure Technologies, Inc.; 2014 [cited 2015 Feb 27]. Available from:

37 OraQuick : How Oral Testing Works [Internet]. Bethleham (PA): OraSure Technologies, Inc.; 2014 [cited 2015 Feb 27]. Available from:

38 Outline Background Workplace Safety Testing Treatment Technician Opportunities

39 Treatment Goals Reduce HIV-associated morbidity and mortality Restore and preserve immunologic function Suppress HIV viral load Prevent transmission Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents [Internet]. Washington, DC: Department of Health and Human Services; 2012 [updated 2012 Mar 27, cited 2015 Mar 1]. Available from:

40 Tests CD4 cell count and percentage Stage disease Determine opportunistic infection risk and when to begin prophylactic medications Urgency and response to therapy Plasma HIV RNA (viral load) Response to therapy and a lot more! Aberg JA, Gallant JE, Ghanem, K, et al. Primary Care Guidelines for the Management of Persons Infected with HIV: 2013 Update by the HIV Medicine of the Infectious Diseases Society of America. Clin Infect Disease. 2014;58:e1-34.

41 Initiating Therapy in Treatment-Naïve Patients Begin therapy to reduce the risk of disease progression: CD4 Count Panel Recommendation < 350 cells/mm 3 AI 350 to 500 cells/mm 3 AII > 500 cells/mm 3 BIII Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents [Internet]. Washington, DC: Department of Health and Human Services; 2014 [updated 2014 May 1, cited 2015 Mar 1]. Available from:

42 Initiating Therapy in Treatment-Naïve Patients Begin therapy when HIV positive and Pregnant Diagnosed with AIDS Have HIV-associated nephropathy Co-infected with hepatitis B or hepatitis C Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents [Internet]. Washington, DC: Department of Health and Human Services; 2014 [updated 2014 May 1, cited 2015 Mar 1]. Available from:

43 Initiating Therapy in Treatment-Naïve Patients Begin therapy to prevent transmission: Transmission Risk Perinatal Heterosexual Other Panel Recommendation AI AI AIII Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents [Internet]. Washington, DC: Department of Health and Human Services; 2014 [updated 2014 May 1, cited 2015 Mar 1]. Available from:

44 Initiating Therapy in Treatment-Naïve Patients Patients starting ART should be willing and able to commit to treatment and understand the benefits and risks of therapy and the importance of adherence (AIII). Patients may choose to postpone therapy, and providers, on a case-by-case basis, may elect to defer therapy on the basis of clinical and/or psychosocial factors. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents [Internet]. Washington, DC: Department of Health and Human Services; 2014 [updated 2014 May 1, cited 2015 Mar 1]. Available from:

45 HIV Web Study: Antiretrovial Rx, Discussion [Internet]. Seattle (WA): University of Washington; 2013 [cited 2015 Mar 1]. Available from:

46 Antiretroviral Therapy (ART) Medication Classes Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Protease inhibitors (PIs) Integrase inhibitors (InSTIs) Entry inhibitors Fusion inhibitors CCR5 antagonists

47 HIV Web Study: Antiretrovial Rx, Discussion [Internet]. Seattle (WA): University of Washington; 2013 [cited 2015 Mar 1]. Available from:

48 NRTIs Abacavir sulfate (ABC) Didanosine (ddi) Emtricitabine (FTC) Lamivudine (3TC) Stavudine (d4t) Tenofovir (TDF) Zidovudine (AZT or ZDV) Most are eliminated by the kidneys Adverse effects Peripheral neuropathy Pancreatitis Lipoatrophy Myopathy Anemia Life-threatening acidosis with fatty liver (rare) Resistance reported for all NRTIs Anderson PL, Kakuda TN, Fletcher CV. Chapter 103. Human Immunodeficiency Virus Infection. In: DiPiro JT, Talbert RL, Yee GC, et al. eds. Pharmacotherapy: A Pathophysiological Approach, 9e. New York (NY): McGraw-Hill; 2014 [cited 2015 Mar 1]. Available from:

49 NNRTIs Efavirenz (EFV) Etravirine (ETR) Delaviridine (DLV) Nevirapine (NVP) Rilpivirine (RPV) Mainly eliminated by the liver and/or gut metabolism through cytochrome P450 (CYP) enzyme system Adverse effects Rash Elevated liver function tests Low genetic barrier to resistance Anderson PL, Kakuda TN, Fletcher CV. Chapter 103. Human Immunodeficiency Virus Infection. In: DiPiro JT, Talbert RL, Yee GC, et al. eds. Pharmacotherapy: A Pathophysiological Approach, 9e. New York (NY): McGraw-Hill; 2014 [cited 2015 Mar 1]. Available from:

50 PIs Atazanavir (ATV) Darunavir (DRV) Fosamprenavir (FPV) Indinavir (IDV) Mainly eliminated by the liver and/or gut metabolism through cytochrome P450 (CYP) enzyme system CYP3A Often always boosted with ritonavir or cobicistat Lopinavir (LPV) Nelfinavir (NFV) Adverse effects Gastrointestinal distress Metabolic changes Ritonavir (RTV) High genetic barrier to resistance Saquinavir (SQV) Tipranavir (TPV) Anderson PL, Kakuda TN, Fletcher CV. Chapter 103. Human Immunodeficiency Virus Infection. In: DiPiro JT, Talbert RL, Yee GC, et al. eds. Pharmacotherapy: A Pathophysiological Approach, 9e. New York (NY): McGraw-Hill; 2014 [cited 2015 Mar 1]. Available from:

51 InSTIs Raltegravir (RAL) Elvitegravir (EVG) Dolutegravir (DTG) RAL and DTG No issues with CYP drug interactions EVG Metabolized by CYP3A Co-formulated with cobicistat Anderson PL, Kakuda TN, Fletcher CV. Chapter 103. Human Immunodeficiency Virus Infection. In: DiPiro JT, Talbert RL, Yee GC, et al. eds. Pharmacotherapy: A Pathophysiological Approach, 9e. New York (NY): McGraw-Hill; 2014 [cited 2015 Mar 1]. Available from:

52 Entry Inhibitors Enfuviritide (ENF) Fusion inhibitor Subcutaneous injection Adverse effects Injection-site reactions Maraviroc CCR5 antagonists Only effective against R5 virus, need to test for before use CYP3A and P-glycoprotein substrate, watch out for interactions Anderson PL, Kakuda TN, Fletcher CV. Chapter 103. Human Immunodeficiency Virus Infection. In: DiPiro JT, Talbert RL, Yee GC, et al. eds. Pharmacotherapy: A Pathophysiological Approach, 9e. New York (NY): McGraw-Hill; 2014 [cited 2015 Mar 1]. Available from:

53 Preferred Initial Regimens Regimens consist of two NRTIs + another ARV class NNRTI-based regimen EFV + TDF + FTC PI-based regimens ATV/r + TDF + FTC DRV/r + TDF + FTC InSTI-based regimens DTG + ABC + 3TC only if HLA-B*5701 negative DTG + TDF + FTC EVG + TDF + FTC EVG/cobi + TDF + FTC only if CrCl > 70mL/min RAL + TDF + FTC Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents [Internet]. Washington, DC: Department of Health and Human Services; 2014 [updated 2014 May 1, cited 2015 Mar 1]. Available from:

54 Opportunistic Infections Smith CL. HIV/Infectious Diseases. In: ACCP Updates in Therapeutics 2014: Pharmacotherapy Preparatory Review and Recertification Course. Lenexa (KS): ACCP; 2014.

55 Outline Background Workplace Safety Testing Treatment Technician Opportunities

56 Referring Patients Planned Parenthood 3668 North Harbor Lane Boise, ID The Community Center 305 E. 37th Street Garden City, ID A.L.P.H.A. of Boise 575 N. 8th St. Boise, ID Central District Health Dept. 707 N Armstrong Pl Boise, ID Testing Centers BSU Health Wellness Center Norco Building Boise, ID 83725

57 Donation Encouraging your pharmacy to donate test kits: Allies Linked for the Prevention of HIV and AIDS (A.L.P.H.A.) Tests costs approximately $15 A.L.P.H.A. is a 501(c)3 nonprofit corporation Donations or in-kind donations are taxdeductible

58 Professional Training A.L.P.H.A. Receive training on how to perform waived rapid HIV testing in the community Contact Judy Thorne at Idaho Department of Health and Welfare Passport to Partner Services - Date: May HIV and HCV Update: Corrections to Community - Date: May 27

59 Providing Resources The Idaho Ryan White Part B Program (RWPB) HIV diagnostic and monitoring labs to uninsured clients Emergency financial assistance Medical transportation Psychosocial support services Linguistic services and referral for health care services to all clients meeting eligibility criteria

60 Providing Resources Patient Assistance and Co-Pay Programs for HIV and Viral Hepatitis Drugs These programs offer assistance to people with private health insurance for the copayments required to obtain HIV drugs at the pharmacy

61

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