6/22/2016 Disclosures Updates in HIV Care I have no disclosures Susa Coffey, MD UCSF Division of HIV, Infectious Diseases and Global Medicine San Francisco General Hospital Objectives Intro To learn about recent developments in: � Why are we still talking about HIV? � Nearly 50,000 new infections/year in the U.S. � HIV epidemiology in the U.S. � Approx 1.1 million living with HIV � Prevention • About 13% are unaware of their infection � PrEP � If untreated, inevitably causes illness and death � Nonoccupational PEP � Disproportionately affects vulnerable populations � Treatment � When to start � But , it’s a preventable disease, and a � What to start treatable disease � ARV update (TAF; single-pill regimens) � Immediate ART initiation 1
6/22/2016 United States HIV Care Continuum, 2011 Question The goal of HIV treatment is suppression of HIV viremia. What percentage of the U.S. HIV population is on antiretroviral therapy (ART) with complete suppression of HIV viremia? 34% A. 82% 28% 25% B. 66% C. 45% D. 30% 9% 3% E. 25% National HIV Surveillance System,: Estimated number of persons aged ≥ 13 years living with diagnosed or undiagnosed HIV infection (prevalence) in the United States at the end of the specified year . The estimated number of persons with diagnosed HIV infection was calculated as part of the overall prevalence estimate. % % % % % 2 6 5 0 5 Medical Monitoring Project: Estimated number of persons aged ≥ 18 years who received HIV medical care during January to April of 8 6 4 3 2 the specified year, were prescribed ART, or whose most recent VL in the previous year was undetectable or <200 copies/mL—United States and Puerto Rico. HIV by Race/Ethnicity in the U.S. Incidence of HIV in MSM Rates of Diagnoses of HIV Infection among Adults and Adolescents, by Sex and Race/Ethnicity, 2014—U.S. Note. Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. All displayed data have been statistically adjusted to account for reporting delays, but not for incomplete reporting. a Hispanics/Latinos can be of any race. CDC, 2015 2
6/22/2016 Lifetime Risk of HIV Prevention PrEP (Pre-Exposure Prophylaxis) CDC, 2/16 PrEP: Pre-Exposure Prophylaxis Cases 1) 22 yo white MSM, 3 regular partners, 1 HIV+ and on ART, others on PrEP. Usually uses � A pill taken daily (or peri-coitally?) to condoms (always with HIV+ partner). prevent HIV infection � Should he be offered PrEP? � Tenofovir + emtricitabine (TDF/FTC, Truvada), 1 pill once daily 2) 16 yo AA young man, reports sex with girls. � Approved by FDA, recommended by the Gonorrhea 4 months ago. CDC and WHO � Should he be offered PrEP? • No other medications approved for PrEP* 3) 34 yo Latina, former IDU, now clean. Delivers 3 rd child in hospital; rapid HIV Ab and HIV RNA are neg at delivery. � Should she be offered PrEP? * Do not use TAF/FTC (Descovy) for PrEP (no clinical data) 3
6/22/2016 PrEP: Pre-Exposure Prophylaxis USPHS and CDC PrEP Recs � What do we know about efficacy and safety? Consider PrEP for individuals who are at Substantial risk includes: � Highly effective if taken as directed substantial risk of HIV (preferably daily ) - >90% acquisition, including: • iPrEx study in MSM (and TG women), 2 • Using condoms inconsistently studies in heterosexual men and • Sexually active MSM • High number of sex partners women • Heterosexually active • HIV+ sex partner � Does NOT work if not taken regularly* women and men • Recent STD • eg, VOICE and Fem-PrEP studies in women • IDUs (PWIDs) • HIV+ injecting partner � Efficacy strongly tied to adherence • Sharing injection or drug � AEs: mild “start-up syndrome” (GI); rare • (Transgender women and serious AEs. Small decreases in Cr and men)* preparation equipment bone density. • Commercial sex work * # of doses/week required for efficacy is not well defined; may be higher for women than for men. *Not a specific GL recommendation USPHS, CDC et al. PrEP GL 2014. Clinical trials: Efficacy of TDF/FTC-based PrEP – “Real World” PrEP Trial Population, Location Reduction in HIV infections (95% CI) � PROUD study Men, Cisgender transwomen women � 554 high-risk HIV-neg MSM iPrEx 1 MSM, transgender women - 44% (15-63) � STD clinics in England Americas, RSA, Thailand 92% if detectable drug � Randomized immediate vs deferred PrEP Partners Mutually disclosed serodifferent 84% 66% (TDF/FTC [Truvada]) PrEP 2 heterosexual couples (54-94) (28-84) Kenya, Uganda � New HIV infections: 3 vs 19; incidence 1.3 vs TDF2 3 Heterosexual men, women 80% 49% 8.9 per 100 py Botswana (25-97) (-21-81) � 86% reduction in HIV infection (p=0.0002) Fem- Women - 6% Kenya, RSA, Tanzania PrEP 4 (-52-41) � NN to prevent: 13 VOICE 5 Women - -4% � Study stopped early Uganda, RSA, Zimbabwe (-49-27) PROUD 6 MSM (open-label) - 86% UK (58-96) IPERGAY 7 MSM (intermittent PrEP) - 86% France, Canada (40-98) McCormack, Lancet. 2016 1. Grant et al. NEJM 2010. 2. Baeten et al . NEJM 2012 . 3. Thigpen et al. NEJM 2012. 4. Van Damme et al. NEJM 2012. 5. Marazzo et al. NEJM 2015. 6. McCormack et al. Lancet 2015. 7. Molina et al. NEJM 2015. 4
6/22/2016 PrEP – “Event-Based” PrEP – Kaiser SF � IPERGAY study � Kaiser SF � Event-based PrEP � 400 high-risk MSM (≥2 partners in previous � N=657 initiators + 20 restarters, 99% MSM 6 mos), randomized TDF/FTC vs placebo � 30% with HIV+ partner � 2 tabs before sex, 1 tab 24 hrs after, 1 tab � NO new HIV infections (July 2012-Feb 2015) 48 hrs after � Update: >1000 on PrEP by July 2015, NO � New HIV infections: 2 (PrEP) vs 14 HIV infections (placebo); incidence 0.94 vs 6.6 per 100 py � 86% reduction in incidence, p=0.002 � NN to prevent: 18 � Median 16 pills/month NEJM Volk, CID, 2015 Volk JE. Clin Infect Dis. 2015. Marcus JL. Curr HIV/AIDS Rep. 2016. Molina, NEJM, 2015 Question CDC indications for PrEP Which of the following is true about the number of people in the U.S. with Number of U.S. adults with an indication for PrEP? indication for PrEP % of U.S. adults with 78% indication for PrEP More MSM than women A. 17% The number of women and B. 4% MSM is about the same More IDUs than MSM C. M n e . . S m . n M o e w m n a n o h w a t h f s t o U M D r e I S M b e m r o e u M r n o M e h T MMWR 2015 5
6/22/2016 PrEP Cascade for U.S. Women PrEP Uptake by Sex (2015) 468,000 ? ? ? ~1,000 ? Bush, S. et al; IAPAC Prevention Bush, S. et al; IAPAC Prevention 2015; #74 Slide courtesy of D. Seidman 2015; #74 Return to Cases PrEP – it’s not rocket science! 1) 22 yo white MSM, 3 regular partners, 1 HIV+ and on ART, others on PrEP. Usually uses condoms (always with HIV+ partner). � 1 medication (Truvada) � Should he be offered PrEP? � 1 pill 2) 16 yo AA young man, reports sex with girls. � 1 time per day Gonorrhea 4 months ago. � Should he be offered PrEP? 3) 34 yo Latina, former IDU, now clean. Delivers 3 rd child in the hospital. Rapid HIV Ab and HIV RNA are neg there. � Should she be offered PrEP? 6
6/22/2016 PrEP PrEP Core Summary At baseline and at least every 3 months: � PrEP works if people take it • Assess HIV risk (sex, drugs) � Need more data in U.S. women • Assess for ssx acute HIV � Close adherence required, ideally 7 days • Test HIV, HBV (baseline only), Cr, per week pregnancy, STIs � Some data in MSM suggest 4 doses/week • Assess and reinforce adherence, and risk may be adequate (fewer is not protective) � In women, daily dosing may be very reduction • Assess pregnancy intentions important • Prescription for ≤90 days at a time � No data support less frequent dosing � Tissue drug levels may be very low � May take 2+ weeks to achieve adequate drug levels � Have a referral source for HIV+ patients TFV concentrations up to 100-fold higher PrEP in rectal than in cervicovaginal tissues Summary (2) � Only Truvada (TDF/FTC) should be used � TAF/FTC (Descovy): no clinical data as PrEP; should not be used Tenovovir tissue concentrations � PrEP failure can result in HIV infection with ARV resistance � Women (cis- and transgender), AA, Latino, IDU, other risk groups are underserved re PrEP and may need focused PrEP outreach and education efforts Days after TDF/FTC dose Patterson et al. Sci Transl Med 2011, Garrett KL, CROI 2016, Abs 102LB. 7
6/22/2016 nPEP Prevention nPEP Nonoccupational Post- Exposure Prophylaxis CDC MMWR 2016 2016 nPEP Guidelines Update nPEP PrEP nPEP Recommendations: � For high risk individuals (ongoing risks; 3 drugs for all � use of PEP ≥ once in past year) � Preferred PEP regimen: � Offer PrEP at the end of 28-day nPEP, • TDF/FTC (Truvada) + raltegravir (twice daily) or dolutegravir (once daily) after documenting HIV-negative status � Alternative regimen: TDF/FTC + darunavir + ritonavir � No interruption between nPEP and PrEP Start PEP ASAP after exposure, w/in 72 hrs � � nPEP can be an entry point into PrEP Treat 28 days � HIV testing at baseline, 4-6 weeks, and 3 months � � HIV Ag/Ab test preferred; consider HIV RNA in high-risk patients nPEP and oPEP recommendations now largely the � same CDC MMWR 2016 CDC MMWR 2016 8
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