CROI 2016 Abstract eBook

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Poster Abstracts

Methods: High risk adult MSM who were followed or being screened in the ANRS IPERGAY trial at the time of the discontinuation of the placebo arm (November 2014) were offered to continue follow-up every two months with open-label TDF/FTC. The primary study objectives of this open-label phase were to assess study retention, HIV incidence, safety and changes in sexual behaviour. Results: In November 2014, among the 400 pts initially enrolled in the study, 336 (84%) were eligible and all but 3 (99%) were enrolled in the open-label phase. Twenty-nine new pts were also enrolled in this open-label study. Overall, 362 pts were enrolled for a cumulative follow-up time of 248 py until September 14, 2015. Study retention was good with only 13 pts discontinuing follow-up (3.6%). During follow-up, only a single individual who had discontinued PrEP acquired HIV-1 infection. The incidence of HIV-1 infection in this open-label phase was 0.40 per 100 py (95%CI: 0.01-2.25). Pts used a mean of 18 pills/month (SD:8.7). Overall, 33% of pts acquired a new STI. There was no significant changes between the double-blinded phase and the open-label phase in the median number of sexual intercourses or sexual partners, but there was a significant decrease in condom use for receptive anal intercourse (p=0.01). Safety was good with a low rate of serious adverse events (4%). One pt discontinued TDF-FTC because of an increase in serum creatinine level. Drug-related gastrointestinal adverse events (nausea, diarrhea, abdominal pain) were reported in 10% of pts. Conclusions: Open-label on demand PrEP with oral TDF-FTC remains highly effective to prevent HIV-infection in high risk MSM and has a good safety profile. 887 PrEP and CondomUse in High Risk MSM in the ANRS IPERGAY Trial Luis Sagaon Teyssier 1 ; Marie Suzan-Monti 1 ; Daniela Rojas Castro 2 ; Nolween Hall 3 ; Catherine Capitant 4 ; Christian Chidiac 5 ; CécileTremblay 6 ; Bruno Spire 7 ; Jean-Michel Molina 8 ; for the ANRS IPERGAY Study Group 1 UMR912 SESSTIM, Marseille, France; 2 AIDES, Mission Recherche Innovation Évaluation, Pantin, France; 3 CISIH, Nantes, France; 4 INSERM SC10-US19, Villejuif, France; 5 Hosp de la Croix-Rousse, Lyon, France; 6 CRCHUM, Montreal, QC, Canada; 7 INSERM UMR 912, Marseille, France; 8 Hopital Saint-Louis, Paris, France Background: Men who have sex with men (MSM) constitute a high-risk group in France’s HIV epidemic. In the setting of the follow-up in the ANRS IPERGAY PrEP trial, we aimed to identify behavioural trajectories over time for PrEP and condom use and to investigate links between these trajectories, using a tailored methodological framework. Methods: ANRS IPERGAY was a randomized double-blind trial of sexual activity-based PrEP in high-risk MSM, assigned to TDF-FTC or placebo. Online questionnaires collecting sexual behaviour and PrEP adherence data during the most recent episode of sexual intercourse were completed every 2 months. Only MSM reporting anal sex were included in this analysis. A longitudinal multi-trajectory model was constructed for two outcomes: PrEP use (correct/sub-optimal versus no PrEP), and condom use for anal sex (yes/no). Multivariate analyses were performed on identified trajectories using sociodemographic, socioeconomic, and behavioural data. Results: 332 participants (47.9% placebo; 52.1% PrEP) who had anal sex at least once during follow-up provided information on PrEP ( 1115 questionnaires ) and/or condom ( 1935 questionnaires ) use during the most recent episode of sexual intercourse. Four trajectories of PrEP use over time were identified among participants: “systematic users (PrEP-SU)” (39.5%), “high-level progressive users (PrEP-HLU)” (31.1%), “declining users (PrEP-DU)” (13.3%), and “low-level users (PrEP-LLU)” (16.1%). For condom use, common behaviour patterns identified two groups: “high-level users (C-HLU)” (29.9%) and “low-level users (C-LLU)” (70.1%). Joint trajectory modelling identified four groups: among C-HLU, 78%were PrEP-SU/PrEP-HLU, while 22%were PrEP-DU/PrEP-LLU. Among C-LLU, 68%were PrEP-SU/PrEP-HLU, whereas 32%were PrEP-DU/PrEP-LLU. The latter group (most-at-risk group), compared most protected group (C-HLU/PrEP-SU) included more frequently older participants (OR=1.05 per each additional year, p<0.001) with low-education levels (OR=1.91, p=0.02, ref. ≥ high school), participants with unknown partners (OR=2.82, p<0.001), those sexually dissatisfied (OR=2.09, p<0.001), and a trend appears for those practicing active anal sex (vs. receptive, p=0.08). Conclusions: In the ANRS IPERGAY trial, most high-risk MSM used either PrEP and/or condoms during the most recent anal intercourse. Special attention must be paid to MSM with low condom use who do not compensate by using PrEP, representing 22% among the 332 participants included in this analysis. 888 Increasing PrEP Use Among MenWho Have Sex With Men, New York City, 2013-2015 Kathleen K. Scanlin 1 ; Paul M. Salcuni 2 ; Zoe R. Edelstein 3 ; Demetre C. Daskalakis 3 ; Nana P. Mensah 2 ; BenjaminTsoi 2 ; Julie Myers 4 1 New York City DHMH, Brooklyn, NY, USA; 2 New York City DHMH, Long Island City, NY, USA; 3 New York City DHMH, Queens, NY, USA; 4 New York City DHMH, Long Island City, NY, USA Background: Pre-exposure prophylaxis (PrEP) is effective for HIV prevention, yet has been underutilized. Since 2012, the New York City (NYC) Department of Health and its partners have launched programs to support PrEP uptake. Using data from routine behavioral surveillance among men who have sex with men (MSM), we examined recent trends and associations with PrEP use. Methods: Data were derived from annual surveys conducted in-person and online, 2013-2015. Eligible respondents were NYC residents, who were born male, aged 18-40, and reported anal sex with a man (past 6 months). This analysis excluded those who reported being diagnosed with HIV. PrEP use was defined as use in the past 6 months. Demographic factors examined included age (18-29/30-40 years), race/ethnicity (black/Hispanic/white/other), education (college degree) and insurance status. Behavioral factors were condomless sex or known HIV-positive partner at last sexual encounter and number of condomless partners (3 or more) and/or post-exposure prophylaxis (PEP) use in the past 6 months. Using logistic regression, we assessed associations between PrEP use and year, factors, and year-factor interaction terms. Those associated bivariately (p<0.05) were added to a multivariate model with age, race/ethnicity, insurance, survey type (in-person/online) and year. Results: Among 1595 respondents, the majority were aged 18-29 (63%), black (24%) or Hispanic (32%), educated (60% had a college degree or higher) and insured (83%). Report of PrEP use was 2.1%, 3.2% and 14.8% in 2013, 2014 and 2015; this increase was significant in the multivariate model (p<0.001). Among demographic factors examined, only being insured was bivariately associated with PrEP use (OR 2.5, CI 1.1-5.5); it was not significant in the multivariate model. PrEP use was associated with condomless sex (adjusted odds ratio (aOR) 3.8, 95% confidence interval (CI) 2.4-6.1) and sex with a known HIV-positive partner (aOR 3.0, CI 1.3-6.8) at the last encounter; and ≥3 condomless partners (aOR 2.8, CI 1.8-4.4) and PEP use (aOR 26.9, CI 12.8-56.3) in the past 6 months. None of the associations with PrEP differed by year (interaction term p>0.05). Conclusions: Findings suggest PrEP use is increasing among MSM in NYC. Use appears to be greater among those with higher behavioral risk, consistent with recommendations. The association of use with insurance status underscores the importance of addressing financial barriers. Monitoring for disparities will be critical as PrEP use increases. 889 Background: There has been increasing traditional and social media coverage of pre-exposure prophylaxis using combination emtricitabine/tenofovir (FTC/TDF) to prevent HIV infection (PrEP). We sought to describe changes in awareness of PrEP, willingness to use PrEP, and use of PrEP among internet-using men who have sex with men (MSM) from the time before FDA-approval of FTC/TDF for PrEP in July 2012 through March 2015. Methods: Data were from 3 nationwide cross-sectional internet surveys of MSM living in the United States. The analysis sample included men who reported sex with a man in the past 12 months and did not report being HIV-positive. Because the percentage reporting awareness of PrEP changed non-linearly over time within survey cycle, we aggregated data into groups of months that spanned cycles to perform a segmented regression assessing the time trend for percentages of participants reporting awareness of, willingness to use, and actual use of PrEP. Multivariate models controlled for source of recruitment (a geo-location based sexual networking site versus other websites), race, educational attainment, income and risk behaviors included as indicators for PrEP in CDC guidelines (≥10 partners vs. ≤9, and bacterial STI diagnosis in the prior 12 months.) For awareness and use of PrEP we used a Poisson risk model with 3 indicator variables for time (See Table). We used a log-binomial model of percentage willing to use PrEP because the Poisson model gave estimates of > 100%willingness for some subgroups. Results: The total sample included 10,097 MSM. Awareness, willingness to use and actual use increased significantly over time, with the significant increases in awareness over time and in use in the most recent time period, November 2014-March 2015, compared to May 2012-April 2014 (See Table). The percentage of MSM willing to use PrEP increased Awareness and Use of PrEP Appear to Be Increasing Among Internet Samples of US MSM Kevin P. Delaney 1 ;Travis Sanchez 2 ; Kristina Bowles 1 ; Emeka Oraka 3 ; Elizabeth DiNenno 1 ; Patrick Sullivan 2 1 CDC, Atlanta, GA, USA; 2 Emory Univ, Atlanta, GA, USA; 3 ICF Intl, Atlanta, GA, USA

Poster Abstracts

373

CROI 2016