HIV PREP THE NEWEST TOOL IN THE BOX

Transcription

1 HIV PREP THE NEWEST TOOL IN THE BOX Infectious Disease Update November 7, 2014 Andrew Petroll, MD, MS Department of Medicine, Division of Infectious Diseases Department of Psychiatry and Behavioral Medicine, Center for AIDS Intervention Research

2 Disclosures Gilead Sciences: Tibotec: Clinical Research Support Clinical Research Support

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4 HIV remains a sustained, global epidemic Prevalence Incidence Deaths Global 34 million 2.7 million ( ) 1.8 million ( ) US 1.1 million 48,000 (75, ) 21,000 (50, ) WHO Global HIV/AIDS response: epidemic update and health sector progress towards universal access: progress report CDC s HIV Surveillance Report: Diagnoses of HIV Infection and AIDS in the United States and Dependent Areas, 2010; Vol. 22. CDC: HIV Surveillance - United States,

5 US HIV remains highly concentrated within racial and sexual minority groups US Population Group Current HIV Prevalence White Males 0.4% Black Females 1.1% Black Males 2.4% White MSM 16% Hispanic MSM 18% Black MSM 28% Transgender women 30% CDC HIV Surveillance Report, March 2012; vol. 22. CDC: Prevalence and Awareness of HIV Infection Among Men Who Have Sex With Men - 21 Cities, United States, 2008

6 Predictive model of lifetime HIV prevalence for black MSM Used current estimates for HIV prevalence and current annual BMSM incidence of 4% Likelihood of HIV infection Age 25 25% Age 35 Age 40 Stall R. What s driving the U.S. epidemic in men who have sex with men? #53. Presented at: The 15th Conference on Retroviruses and Opportunistic Infections; Feb. 3-6, 2008; Boston.

7 Predictive model of lifetime HIV prevalence for black MSM Used current estimates for HIV prevalence and current annual BMSM incidence of 4% Likelihood of HIV infection Age 25 25% Age 35 50% Age 40 60% Stall R. What s driving the U.S. epidemic in men who have sex with men? #53. Presented at: The 15th Conference on Retroviruses and Opportunistic Infections; Feb. 3-6, 2008; Boston.

8 PREVENTING HIV

9 Holtgrave DR. Estimating the effectiveness and efficiency of US HIV prevention efforts using scenario and cost-effectiveness analysis. AIDS. 2002;16: Behavioral Interventions have prevented 1.5 million cases of HIV HIV testing Condom distribution Individual interventions Needle exchange Social network interventions HIV laws Risk reduction counseling Drug treatment Stable housing Serosorting Seropositioning Mental health care Contingency management Sex education Community norms Couple-based interventions

10 HOW DID WE GET TO PREP?

11 Biomedical HIV prevention may further decrease HIV cases Unexposed Precoital Postcoital Infected Male Circumcision Vaccines Behavioral Structural Oral PrEP Topical PrEP Other microbicides Oral PEP Treatment of HIV Behavioral Cohen MS et al. The spread, treatment, and prevention of HIV-1: evolution of a global pandemic. J Clin Invest. 2008; 118:

12 ART prevents perinatal infections

13 HPTN 052: randomized clinical trial of immediate vs. delayed ART in 1800 couples Total HIV-1 Transmission Events: 39 Linked Transmissions: 28 Unlinked or TBD Transmissions: 11 Immediate ART: 1 Delayed ART: 27 96% reduction in HIV transmission (95% CI 73-99%) p < 0.001

14 4 domains of biomedical HIV prevention Unexposed Precoital Postcoital Infected Male Circumcision Vaccines Behavioral Structural Oral PrEP Topical PrEP Other microbicides Oral PEP Treatment of HIV Behavioral Cohen MS et al. The spread, treatment, and prevention of HIV-1: evolution of a global pandemic. J Clin Invest. 2008; 118:

15 ARVs for Post-exposure prophylaxis (PEP) Started in health care settings (400,000 needlesticks/year) Initiate 3-drug therapy ASAP following exposure ( <72 hours) Case-control study: 80% reduction in HIV No healthcare-related transmissions since 2001 Applicable for sexual exposure to HIV (nonoccupational; npep) Feasible, especially in dedicated program Logistical challenges: timely access to ARVs; $$$$ Cardo et al. A case-control study of HIV seroconversion in health care workers after percutaneous exposure. NEJM, 1997 Kahn et al. Feasibility of Postexposure Prophylaxis (PEP) against Human Immunodeficiency Virus Infection after Sexual or Injection Drug Use Exposure: The San Francisco PEP Study. JID, 2001

16 4 domains of biomedical HIV prevention Unexposed Precoital Postcoital Infected Male Circumcision Vaccines Behavioral Structural Oral PrEP Topical PrEP Other microbicides Oral PEP Treatment of HIV Behavioral Cohen MS et al. The spread, treatment, and prevention of HIV-1: evolution of a global pandemic. J Clin Invest. 2008; 118:

17 Pre-exposure prophylaxis (PrEP): the hypothesis In PrEP, an HIV uninfected individual uses an antiretroviral medication ahead of an HIV exposure. By having the antiretroviral in blood/tissues, PrEP may make it so that HIV is unable to establish infection. Analogous to prophylaxis for malaria in travelers.

18 Why Truvada? Truvada contains 2 HIV medications Taken once per day Potent against HIV Low rates of side effects Successful in animal studies first

19 Grant et al N Engl J Med 2010 Baeten et al CROI 2012 Thigpen et al, IAS Trials of Truvada as Pre-exposure Prophylaxis Population Location iprex Partners PrEP TDF2 Men who have sex with men US, Brazil, Ecuador, Peru, South Africa, Thailand Heterosexual HIV serodiscordant couples Kenya, Uganda Male and Female y/o Botswana Sample size Intervention Daily oral FTC/TDF Daily oral FTC/TDF Daily oral FTC/TDF HIV protection due to PrEP 44% 75% 62%

20 Adherence and efficacy in PrEP trials Partners PrEP FTC/TDF arm % of blood samples with tenofovir detected HIV protection efficacy in randomized comparison 81% 75% TDF2 79% 62% iprex 51% 44% FEM-PrEP 26% 6% There is a clear dose-response between evidence of PrEP use & efficacy Donnell et al CROI 2012 Grant et al N Engl J Med 2010 Van Damme et al CROI 2012 Paxton et al FDA 2012

21 Tenofovir levels and HIV protection And when PrEP was taken (=detected in blood), protection was very high % with tenofovir detected HIV-1 relative risk reduction: detection versus no detection of tenofovir Protection p-value iprex 51% 92% <0.001 Partners PrEP FTC/TDF arm 81% 90% Donnell et al CROI 2012 Abstract 30 Grant et al N Engl J Med 2010

22 22 NEW research iprex Open Label Study 1,603 participants, 1,225 on PrEP Most from Peru/Ecuador, 18% USA 100% effectiveness associated with 4+ doses a week 84% effective in people who took 2-3 doses a week Adherence issues more pronounced among young people

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24 Released May 14, tinyurl.com/cdcprepguidelines (PDF) tinyurl.com/cdcprepguidelineswebinar (webinar audio/slides)

25 Who might be a good fit for PrEP? Sexual activity within high prevalence area or social network, and/or: Doesn t use male/female condoms consistently Has previously been prescribed PEP Diagnosed with STI(s) Exchanges sex for money, food, shelter, drugs, etc. Uses illicit drugs or depends on alcohol Is, has been incarcerated Doesn t know partner s HIV status Injects drugs one or more times daily Shares injection equipment Injects cocaine or meth 25

26 What PrEP does not do Truvada as PrEP does not Guarantee 100% protection from HIV (what does?) Protect a person against other STIs like chlamydia, syphilis, herpes, or gonorrhoea Prevent pregnancy Cure HIV Function as a treatment regimen for someone already living with HIV. 26

27 Taking PrEP what does it take? Taking the pill every day. HIV test before 1st dose, before each Rx renewal No sex for 2 weeks prior to test Take 7 days before enough drug is on board to provide protection. Honest, open, and ongoing discussions with medical provider about sex and HIV risk. 27

28 Prescribing PrEP what does it take? Baseline evaluation HIV testing at baseline Establish HIV-negative status Be certain of last sexual activity Hepatitis A, B & C testing Vaccinate for Hep A&B if not immune Further evaluation for HCV Kidney function testing STI screening Pregnancy testing Follow up visits every 3-6 months 28

29 Prescribing PrEP what does it take? Follow up evaluation HIV testing every 3 months Kidney function testing every 6 months STI screening every 3-6 months Follow up visits to assess PrEP Adherence PrEP appropriateness 29

30 Accessing PrEP Any medical provider who can write a script can write one for Truvada as PrEP Most HIV docs familiar with PrEP Though they are not as likely to have HIV-negative patients

31 31 Accessing PrEP insurance FDA approval of Truvada enables private ins to cover ADAP does not cover PrEP Truvada on Medicaid formulary Ins companies covering, so far

32 32 Accessing PrEP insurance Insurance Medicaid Devil in the details Prior auth Deductibles Co-pays Tiers Confusion

33 Accessing PrEP Gilead 1. Visit 2. Click on the link to access information about Truvada for a PrEP indication

34 34 Medication assistance Gilead will provide Truvada for PrEP at no cost for individuals who qualify for the assistance program Program Element Eligibility Criteria Drug Fulfillment Recertification Period Truvada PrEP Medication Assistance Program US resident, uninsured or no drug coverage, HIVnegative, low income (200% FPL) Product dispensed by Covance Specialty Pharmacy, labeled for individual patient use and shipped to prescriber (30 day supply); no card or voucher option 6 months, with 90 day status check

35 Co-pay card program Covers all Gilead HIV Products: Stribild, Complera, Atripla, Truvada, Viread, Emtriva Assists patients with commercial insurance who reside in the US, or US Territories Not valid for Rx that are eligible to be reimbursed by any federal or state funded healthcare benefit program Co-pay benefit provides assistance for co-pays above $0 Monthly benefit provided for 12 mos after activation of card $400/month for all STRs (Stribild, Complera, Atripla) $200/month for (Truvada, Viread, Emtriva) No maximum lifetime benefit but pts need to recertify after 12 months

36 RESPONSES TO PREP

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38 #Adherence2014

39 #Adherence2014

40 There is a constant message that condoms are the only way, and if you slip up or choose not to use them, you're dirty, toxic, unsafe, evil, and reckless. via facebook.com/groups/prepfacts

41 Taking the Truvada does not make me reckless in my decision to have unprotected sex, it makes me feel supported by a community of doctors and advocates who recognize the nuances of my situation, and are doing all they can to help me stay negative. Woman with HIV+ partner who started PrEP because they wanted to have a child

42 Different Strokes for Different Folks Prevention Paradigm 2013 and beyond Method Contraception HIV Prevention Behavior Barrier Methods Gels Rings Oral pill Injectables Implants Surgical procedures Treatment

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46 PrEP videos WhatisPrEP.org tinyurl.com/prepbyklb

47 iprex: Grant et al. NEJM, 2010 WOSCOPS: Shepherd et al. NEJM, 1995 PrEP: Why the controversy? A comparison of primary prevention tools Intervention Primary Outcome iprex PrEP Study FTC/TDF daily HIV infection Population Men aged Risk Factor Frequency of outcome in placebo arm MSM behavior 4% per year Relative risk reduction 44% WOSCOPS Pravastatin daily MI Men aged High cholesterol 1.6% per year 31%

48 THANK YOU Froedtert Infectious Diseases Clinic