PrEP: Pre-Exposure Prophylaxis to Prevention HIV Infection Research and Implementation PPG/PCPG/FCPN Wednesday, May 13, 2015 5/19/15 1
Presentation Outline: Review PrEP science underpinning safety and efficacy Review PrEP-related continuing research Review AAHIVM provider survey: PrEP Review NHBS-MSM4 preliminary data related to PrEP/PEP PrEP/nPEP Statewide Consultation: planning highlights Community planning discussion: PrEP/nPEP 5/19/15 2
PrEP Evidence Summary Source: CDC/USPHS PrEP Guideline 2014 Study Design Agent Participants Control Limitations Evidence Quality Men Who Have Sex with Men iprex Phase 3 TDF/FTC (n = 1251) Placebo (n = 1248) Adherence High US MSM Safety Phase 2 TDF (n = 201) Placebo (n = 199) Minimal High Heterosexual Men and Women Partners PrEP Phase 3 TDF (n = 1589); TDF/FTC (n = 1583) Placebo (n = 1586) Minimal High TDF2 Phase 2 TDF/FTC (n = 611) Placebo (n = 608) High loss to follow-up; modest sample size Moderate Heterosexual Women Fem-PrEP Phase 3 TDF/FTC (n = 1062) Placebo (n = 1058) Stopped at interim analysis; limited follow-up time; very low adherence to drug regimen West African Phase 2 TDF (n = 469) Placebo (n = 467) Stopped early: operations concerns; small sample size; limited follow-up time VOICE Phase 2B TDF (n = 1007); TDF/FTC (n = 1003) Placebo (n = 1009) TDF arm stopped at interim, deemed futile; very low adherence to drug regimens Low Low Low People Who Inject Drugs Bangkok Thai Phase 3 TDF (n = 1204) Placebo (n = 1207) Minimal High 5/19/15 3
5/19/15 4
Clinical providers attitudes: PrEP/PEP AAHIVM Provider Survey Web-based survey to examine perceptions, attitudes and habits of U.S. front-line HIV care providers about PrEP 3,484 HIV care providers targeted; current AAHIVM members and/or AAHIVM-credentialed with authority to prescribe; analysis sample size n = 363 Survey launch: June 2014 Practice types: Infectious Disease, Internal Medicine, Family Medicine, and others 5/19/15 5
5/19/15 6
5/19/15 7
National HIV Behavioral Surveillance (NHBS) Miami-Dade MSM4 Cycle PrEP and PEP related questions Recruitment period: July thru December 2014 MSM-venues-based sample method e.g., bars, dance clubs, bookstores, etc. Eligibility criteria (basic): Miami-Dade resident; aged 18; male (not transgender); sex with male(s) (lifetime); English or Spanish language Total sample: 551 Analysis sample: xxx e.g., HIV-sero-negatives and HIVsero-unawares 5/19/15 8
National HIV Behavioral Surveillance (NHBS) Miami-Dade MSM4 Cycle Core Questionnaire PrEP/PEP Awareness Before today, have you ever heard of people who do not have HIV taking anti-hiv medicines, to keep from getting HIV? No Yes 59% 41% 5/19/15 9
National HIV Behavioral Surveillance (NHBS) Miami-Dade MSM4 Cycle Core questionnaire Recent PEP use In the past 12 months have you taken anti-hiv medicines after sex because you thought it would keep you from getting HIV? ** No Yes 93% 7% **Expressed prior PrEP/PEP knowledge/awareness; analysis restricted to HIV-sero-negatives and HIV-sero-unawares 5/19/15 10
National HIV Behavioral Surveillance (NHBS) Miami-Dade MSM4 Cycle Core questionnaire Recent PrEP use In the past 12 months have you taken anti-hiv medicines before sex because you thought it would keep you from getting HIV? ** No Yes 97% 3% **Expressed prior PrEP/PEP knowledge/awareness; analysis restricted to HIV-sero-negatives and HIV-sero-unawares; n = 184 5/19/15 11
National HIV Behavioral Surveillance (NHBS) Miami-Dade MSM4 Cycle Core questionnaire PrEP/PEP Access Please tell me if you got any of the anti-hiv medicines you took from the following people. Doctor/ Healthcare provider 73% 27% Some other place Answer choices: Dr./healthcare provider; sex partner/ friend/relative/acquaintance; internet; some other place 5/19/15 12
National HIV Behavioral Surveillance (NHBS) Miami-Dade MSM4 Cycle Core questionnaire PrEP: willingness to use question Would you be willing to take anti-hiv medicines every day to lower your chances of getting HIV? Yes No Don t know 63% 33% 4% 5/19/15 13
National HIV Behavioral Surveillance (NHBS) Miami-Dade MSM4 Cycle Local questionnaire PrEP: willingness to use question $ low/no-cost basis If a daily anti-hiv pill to prevent you from getting HIV was available for free or was covered by your health insurance, how likely would you be to take it? Very likely Somewhat likely Not at all likely Don t know 58% 22% 17% 3% N = 453 5/19/15 14
National HIV Behavioral Surveillance (NHBS) Miami-Dade MSM4 Cycle Local questionnaire PrEP: willingness to use question open-ended cost basis, by age What is the most you would pay monthly for a daily anti-hiv pill if it were proven to reduce your chances of getting HIV? Age $ maximum $ median $ mean 18 22 $150.00 $22.50 $31.56 23 29 $500.00 $25.00 $46.53 30 39 $500.00 $20.00 $47.09 40 49 $500.00 $30.00 $60.39 50 $500.00 $25.00 $51.32 N = 453 5/19/15 15
National HIV Behavioral Surveillance (NHBS) Miami-Dade MSM4 Cycle Local questionnaire PrEP: willingness to use question open-ended cost basis, by race/ ethnicity What is the most you would pay monthly for a daily anti-hiv pill if it were proven to reduce your chances of getting HIV? Race/ethnicity $ maximum $ median $ mean Black $500.00 $20.00 $45.21 Hispanic $500.00 $20.00 $44.24 White $500.00 $30.00 $81.97 Other $100.00 $37.50 $37.50 N = 453 5/19/15 16
National HIV Behavioral Surveillance (NHBS) Miami-Dade MSM4 Cycle Local questionnaire PrEP: risk compensation question I will no longer need to use condoms or practice safer sex if taking pills to prevent HIV infection. Strongly agree Agree Disagree Strongly disagree Don t know 3% 6% 33% 53% 2% 3% Answer refused N = 453 5/19/15 17
PrEP/nPEP Statewide Consultation Early June 2015 Approximately 30 attendees Diverse representation: public and private medical providers, public health administrators, PreP/nPEP program implementers, affected-communities members Develop a 2 3 year statewide strategic plan for implementing and supporting PrEP/nPEP programming 5/19/15 18
5/19/15 19