PrEP for Women: HIV Prevention in Family Planning Settings

Transcription

1 National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention PrEP for Women: HIV Prevention in Family Planning Settings Dawn K. Smith, MD, MS, MPH Division of HIV/AIDS Prevention The findings and conclusions in this presentation have not been formally disseminated by the CDC and should not be construed to represent any agency determination or policy

2 Disclosures Nothing to disclose

3 Objectives Define PrEP and report the efficacy of PrEP in women Describe how to identify women eligible for PrEP Outline implementation strategies for how to integrate PrEP into family planning care List clinical pearls in providing PrEP to women.

4 Diagnoses of HIV Infection among Adult and Adolescent Females, by Race/Ethnicity, Source:

5 Rates of Diagnoses of HIV Infection among Adult and Adolescent Females, 2014, US VT 1.5 NH 1.3 MA 6.2 RI 4.5 CT 5.0 NJ 10.0 DE 11.3 MD 15.0 DC 25.2 Rates per 100,000 population 1.8 < Source:

6 Diagnoses of HIV Infection among Adult and Adolescent Females, by Age at Diagnosis, 2014, US yrs yrs yrs yrs >45 yrs Number Source:

7 What Is PrEP? Daily use of an antiretroviral pill for preexposure prophylaxis (PrEP) Taken for months to years to reduce the risk of HIV infection in persons with frequent, ongoing exposures FDA approved a once-daily pill containing a fixed-dose combination of two antiretrovirals: Tenofovir disoproxil fumarate (TDF) 300 mg Emtricitabine (FTC) 200 mg Brand name is Truvada (sole source) Not like postexposure prophylaxis (PEP), antiretrovirals taken for only 28 days after a single exposure event

8 Daily Oral PrEP Effectiveness by Adherence in Initial Randomized Trials % HIV Prevention Effectiveness MSM Heterosexuals PWID Entire Cohort Drug Level Present Sources: Grant RM, et al. N Engl J Med. 2010;363: ; Baeten JM, et al. N Engl J Med. 2012;367: ; Choopanya K, et al. Lancet. 2013;381:

9 PrEP Protection and Route of Exposure For rectal exposures, strong data suggests that high levels of protection: are achieved after 7 days of daily dosing can be maintained with 4 or more doses per week ( forgiveness for missed doses) For vaginal exposures, modest data suggests that high levels of protection: are achieved after 20 days of daily dosing can be maintained with 6 or 7 doses per week (less forgiveness ) When discontinuing, PrEP should continue for 28 days after the most recent exposure no protection should be expected for exposures occurring 7 or more days after the last dose of PrEP Sources: Seifert SM, et al. Clin Infect Dis. 2015;60(5): Grant RM., et al. Lancet Infect Dis. 2014;14(9): Anderson PL, et al. J Antimicrob Chemother. 2011;66(2): Hendrix CW, et al. AIDS Res Hum Retrovir. 2015, 32(1):

10 Safety in Women (Partners PrEP) Few, mild, time-limited side effects No clinically significant effect on renal health 431 pregnancies No differences between placebo to TDF and TDF/FTC groups in: Pregnancy rates Pregnancy loss rates Preterm births Birth defects 12-month infant growth Weight Length Head circumference Sources: Mugo NR, et al. JAMA. 2014;312(4):362-71; Mugwanya KK, et al. JAMA internal medicine. 2015;175(2):246-54; Mugwanya KK, et al. JAIDS. 2016;71(4):

11 Guidelines: PrEP Indications for Women HIV-uninfected adult Sexually active in past 6 months with men AND Has an ongoing sexual relationship with a man known to have HIV infection Infrequently uses condoms during sex with 1 male partners of unknown HIV status who are known to be at substantial risk of HIV infection Men who inject drugs Bisexual male partner Had a recent bacterial STI HIV per 100,000 py Rates of HIV diagnosis, , among women ages years, with/without preceding STI, Florida STI reported No STI GC Syphilis Source: Peterman TA, et al. Int J STD AIDS. 2015;26(2):113-9.

12 PrEP Use by Women An estimated 468,000 (1 in 167) women years of age have indications for PrEP use An unknown number of uninfected women in HIV discordant couples become pregnant each year New PrEP Starts by Sex These data represent 43.7% (n=21,463) of unique individuals who have started FTC/TDF for PrEP from Q2015 Sources: Smith, D. K., et al. (2015). Morbidity and Mortality Weekly Report 64(46): ; Bush S, et al. ASM/ICAAC 2016; Boston, MA. #2651