Getting Prepped for PrEP. Ken Ho, MD, MPH World AIDS Day

Transcription

1 Getting Prepped for PrEP Ken Ho, MD, MPH World AIDS Day

2 Objectives HIV epidemiology What is PrEP? Does it Work? Who gets PrEP? How do I prescribe PrEP What to do at the first visit? What to do at follow up visits? Other issues

3 New HIV Diagnoses United States 2014

4 New HIV Infections

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8 Pre-exposure Prophylaxis Strategy of using HIV medications before a high risk exposure to prevent HIV in individuals who are HIV uninfected NRTI = Nucleoside/Nucleotide Reverse Transcriptase Inhibitor tenofovir/emtricitabine tenofovir emtricitabine Truvada was approved in July 2012 by the FDA for prevention of HIV in HIV negative individuals Side effects: nausea, headache, reduced kidney function (rarely seen)

9 Grant 2010 iprex Study (PrEP for MSM)

10 iprex: Adverse Events Adverse Event FTC/TDF (n = 1251) Placebo (n = 1248) % Events % Events P Value Any grade 3/4 event Death < 1 1 < Serious adverse event Elevated creatinine Creatinine elevation confirmed on next visit Grant R, et al. CROI Abstract 92.

11 PrEP Clinical Trial Data Study Location Population Drug Prevention iprex Partners PrEP International and Domestic Africa (Kenya, Uganda) 2,499 MSM FTC/TDF 44% 4,758 heterosexual Serodiscordant couples TDF2 Botswana 1,219 heterosexual men and women Bangkok Tenofovir Bangkok 2413 IVDU men and women FEM-PrEP, Africa 1,951 heterosexual women VOICE Africa 5,029 heterosexual women TDF FTC/TDF 62% 73% FTC/TDF 63% TDF 49% FTC/TDF FTC/TDF Unable to Evaluate Grant 2010, Baeten 2012, Thigpen 2011, Van Damme 2012, Marrazzo 2013

12 Case Presentation 30 year old graduate student presents to your clinic asking about PrEP PMH: None Medications: prn ibuprofen Social History: denies smoking, drinks on weekends,

13 CDC Guidelines: Who gets PrEP? HIGH RISK GROUPS Men who have sex with men Heterosexually active men and women Injection drug users RISK FOR HIV ACQUISITION Inconsistent condom use (anal sex) Bacterial STI High number of sex partners Serodiscordant relationship Transactional sex

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15 Summary of CDC guidelines

16 Getting Prepped for PrEP Assessment of Risk Assessing for Acute HIV Establishing Clinical Eligibility HIV testing (4 th generation testing ideal) Hepatitis B assessment GFR >= 60 STI testing (syphilis, GC/CT, HCV)

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18 Assessing for Acute HIV Assess for flu like illness in the setting of recent high risk exposure 2-4 weeks prior If acute HIV suspected, DO NOT PRESCRIBE PrEP Gold standard testing: viral load (however keep in mind that this takes 7 days to come back) Alternative: have patient return at a later point for repeat testing

19 Types of HIV testing Blood tests Rapid tests 4 th and 5 th generation tests HIV-RNA (viral load) If positive, reflex confirmation Oral swabs Usually 2 nd and 3 rd generation LONGER WINDOW PERIOD If positive, order blood test first

20 What tests to order first visit HIV: preferably 4 th or 5 th generation Creatinine or BMP Hepatitis B surface antigen, Hepatitis B surface antibody Syphilis serology or RPR NAAT for GC/CT (urine, rectal, pharyngeal) HCV IgG Pregnancy testing

21 Counseling Check List Adherence Discussion of HIV transmission risk Risk reduction counseling Risks versus benefits Accessibility

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24 Risks of PrEP Resistance in seroconvertors from the large phase 3 trials resistance rarely seen Risk Compensation No evidence of risk compensation in large phase 3 trials Report from Kaiser Permanente that in 45% of PrEP users condom use declined following initiation of PrEP Toxicity: Bone and Renal effects

25 Drug Resistance HIV antibody negative HIV infection occurs PrEP started Development of HIV drug resistance

26 What about condom use? Current guidelines support PrEP in conjunction with condom use and regular STI screening Risk compensation modification in behavior that occur based on perceived risk

27 Cost of PrEP Cost: ~ $ per month Insurance with prescription coverage Caution: high deductible programs patients may have signficant out of pocket expenses! Alternatives Demonstration projects and research studies Truvada assistance program (GILEAD) Patient Access Network (up to $4000 for coverage of copayments and out of pocket expenses)

28 Navigating the PrEP Access Maze IS THE PATIENT INSURED? UNDER-insured? High Deductible Plan/High copays Gilead Truvada as PrEP Assistance Program OPTIONS Gilead copay assistance program program $3600/year Patient Access Network Foundation Foundation Clinical trials Gilead copay assistance Patient Access Network ISSUES No overage of safety labs/physician visits Re-application every 3-6 months

29 Co-pay Assistance The Gilead Advancing Access co-pay coupon card may help eligible patients save on their TRUVADA Not available for patients who are enrolled in any state- or federally-funded prescription drug program, such as Medicare Part D and Medicaid

30 CDC: PrEP is Underused CDC analyzed representative data to estimate the percentages and numbers of persons in the US with indications for PrEP Individuals who had substantial risks for acquiring HIV consistent with PrEP indications ~24.7% of sexually active adult men who have sex with men (MSM) 18.5% of persons who inject drugs 0.4% of heterosexually active adults

31 PrEP Follow Up Guidelines recommend quarterly visits Prescribe 30 days supply of PrEP (with 2 refills) HIV testing quarterly Creatinine testing every 6 months Reassess HIV risk, desire to stay on PrEP

32 Real World PrEP CID Article PROUD Study

33 How long do I have to take PrEP for before I m considered protected No consensus Rectal tissue 7 days before maximum drug levels achieved Vaginal tissue/blood - ~20 days before maximum drug levels achieved Many providers suggest 1-2 weeks, some up to 1 month

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36 What about TAF based regimens? What is TAF? Tenofovir alafenamide fumarate NNRTI prodrug of tenofovir Improved renal and bone safety profile Coformulated with emtricitabine (Descovy) Can TAF be used as PrEP? Currently TAF is NOT recommended for use as PrEP Data from PK studies suggest that genital tract levels are low compared to TRUVADA Garrett KL, Cottrell ML, Prince HM, et al. 23 rd CROI; February 22-25, 2016; Boston. Abstract 102LB.

37 Summary Points Evidence shows that daily PrEP reduced the risk of HIV infection even in real world settings Adherence correlated with efficacy Prescribed with close monitoring that includes regular HIV testing, safety monitoring, STI screening, adherence, and risk reduction counseling Some early data to support on demand PrEP Challenges and concerns include access, stigma, risk compensation, potential for resistance, fear/mistrust of the medical community Future research to elucidate how PrEP can be further optimized