CROI 2019 Abstract eBook

Abstract eBook

Poster Abstracts

1 Hôpitaux Universitaires de Strasbourg, Strasbourg, France, 2 CHU Hôtel-Dieu, Nantes, France, 3 Necker Hospital, Paris, France, 4 CHU Fort de France, Fort de France, Martinique, 5 CHU de Montpellier, Montpellier, France, 6 Assistance Publique– Hopitaux Marseille, Marseille, France, 7 Hospices Civils de Lyon, Lyon, France Background: The care of individuals exposed to HIV remains a challenge regarding postexposure prophylaxis (PEP) completion and is a unique occasion of sexual counseling. Identifying risks of not fulfilling PEP course and concomitant condom use among individuals demanding PEP may improve clinical practice. Methods: Retrospective analysis from the French National Dat’AIDS cohort (NCT02898987) of individuals evaluated for PEP between 2004 and 2017. We assessed clinically relevant predictors (Odd-ratios [OR] and 95% Credibility Interval) and their probabilities (Pr) of both non-condom use and PEP premature interruption (< 20 days) by Bayesian modeling. Results: Overall, 48947 potential exposures to HIV were evaluated for PEP, 19887 for occupational and 29060 for sexual risks. Participants were primarily male (54%) with a median age of 30 years (IQR, 24-39). The source had an unknown HIV serostatus in 38743 exposures. Among the 29060 sexual exposures (36%MSM versus 64% heterosexual), 48% reported non-condom use during the exposure. Non-condom use increased (Pr > 99%) with the year of exposure (OR per 10-years increment, 1.22 [1.14-1.29]), MSM (OR, 1.33 [1.16-1.53]) and rape (OR, 12.3 [10.6-14.3]). Non-condom use decreased (Pr > 99%) with age (OR per 10-years increment, 0.90 [0.88-0.93]), in the case of an intercourse with a sex worker (OR, 0.33 [0.29-0.36]), or a woman partner (OR, 0.83 [0.72-0.95]), and knowledge of the serological status of the partner, whether positive (OR, 0.79 [0.73-0.86]); or negative (OR, 0.84 [0.73-0.95]). Overall, 22 402 individuals (46%) effectively received PEP (14% occupational and 86% sexual exposures). PEP regimens varied among time (Figure). Overall, 20% of individuals discontinued their PEP regimen within 20 days. Age (OR, 0.87 per 10-years increment [0.83-0.92]), MSM (OR, 0.59 [0.47-0.73]), intercourse with a sex worker (OR, 0.41 [0.31-0.51]), rape (OR, 0.41 [0.32-0.53]), moderate depth of occupational accident (OR, 0.76 [0.58-0.98]) versus deep and superficial), and known HIV-infected source patient (OR, 0.50 [0.42-0.59]), were factors associated with reduced risks of PEP early discontinuation (Pr > 98%). Neither PEP regimen nor reported condom use were associated with a premature PEP stop. Conclusion: Our study provides new insights for targeting groups of individuals with specific interventions, for improving both condom use and PEP completion. Especially Youth and MSM need more targeted interventions in risk behavior prevention and adherence.

1 Hôpitaux Universitaires de Strasbourg, Strasbourg, France, 2 CHU de Bordeaux, Bordeaux, France, 3 CHU de Rennes, Rennes, France, 4 Saint-Antoine Hospital, Paris, France, 5 Pitié-Salpêtrière Hospital, Paris, France, 6 Centre Hospitalier de Tourcoing, Tourcoing, France, 7 Bichat–Claude Bernard Hospital, Paris, France, 8 Assistance Publique – Hôpitaux de Paris, Paris, France, 9 Hospices Civils de Lyon, Lyon, France, 10 CHU de Reims, Reims, France, 11 CHU de Besançon, Besançon, France, 12 Tenon Hospital, Paris, France Background: HIV Postexposure prophylaxis (PEP) completion rates are often low. Newer antiretroviral combinations, such as the recently approved elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide coformulation (E/C/F/TAF), may improve PEP adherence. Methods: Prospective, open-label, single-arm trial conducted in 15 French centers (NCT02998320). Individuals with recent HIV exposure who met criteria for PEP initiation received once-daily E/C/F/TAF for 28 days. Follow-up visits were scheduled at days 14, 28, 60 and 120. The primary endpoint was PEP completion at day 28. Secondary endpoints were adherence, quality of life, adverse events and efficacy. Results: Ninety-eight individuals exposed to HIV received at least one dose of E/C/F/TAF (8 occupational and 90 sexual exposures, of which 64%were MSM). Participants were primarily male (77%) with a median age of 33 years (IQR, 25-39). Seventy-eight individuals (80%) completed PEP course till day 28 visit. Completion failure (n=20, 20%) was due to lost to follow-up (n=16), sexual partner or source-patient tested HIV-negative (n=2), individual’s own choice (n=1) and withdrawal of consent (n=1). No PEP interruption due to adverse events was documented. Fifteen additional participants (15%) were also lost to follow-up from day 28 to day 120. Self-reported adherence was 100%, between 90 and 99%, and <90% for 63 (76%), 18 (22%) and 2 (2%) individuals at day 14; and for 58 (75%), 13 (17%), 6 (8%) individuals at day 28, respectively. Median elvitegravir trough concentration at day 14 was 628 ng/mL (IQR, 471-934), therefore above 190 ng/mL for 96% of participants. Mean quality of life SF-12 measures of physical and mental health were of 50 and 47 on day 1, 52 and 48 on day 14, and 51 and 49 on day 28, respectively (p>0.05). Overall, 226 adverse events were reported in 58 (68%) and 43 (59%) participants, at day 14 and 28 respectively. At day 14; 93, 24 and 8 grade 1, 2 and 3 adverse events were observed, and 73, 21 and 7 on day 28, respectively. The most frequent reported adverse events were asthenia (19%), abdominal pain (16%), diarrhea (15%) and headache (14%). No renal or liver abnormalities occurred. Neither HIV seroconversion, nor acute hepatitis B infection were observed. Conclusion: PEP E/C/F/TAF was well tolerated and demonstrated good completion rates. Self-reported and drug levels indicated good adherence, confirming that E/C/F/TAF could be a regimen of choice for PEP. 986 HIV INFECTION AND FTC/TDF IN DRIED BLOOD SPOT: A POOLED ANALYSIS OF GLOBAL STUDIES Li Tao , Scott McCallister, Lindsey Smith, Robertino Mera Giler, David Magnuson Gilead Sciences, Inc, Foster City, CA, USA Background: Use of daily FTC/TDF for HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV-1 acquisition for individuals at high sexual risk. Dried blood spot (DBS) analyses of tenofovir-diphosphate (TFV-DP) in red blood cells measure chronic TDF drug use and provide an objective evaluation of adherence for individuals who may develop HIV infection. Methods: In 8 open-label HIV prevention studies, 3,058 participants were given FTC/TDF PrEP. Demographics, efficacy, and DBS measures of TFV-DP were collected at baseline and follow-up visits up to 3.4 years. We used logistic regression to estimate odds ratios (OR) for adherence, and Poisson regression to calculate incidence rates (IR) and incidence rate ratios (IRR) of new HIV cases. Results: Of the 3,058 participants, 99%were men who have sex with men (MSM), 68%were in the USA, 29% in South America, 2% in Asia, and 1% in Africa; the median age at PrEP initiation was 30 years (interquartile range, IQR, 25−38). DBS analyses suggested 26%, 14%, 34%, and 27% individuals were taking ≤2 (below lower limit of quantitation−349 fmol/punch of TFV-DP), 2−3 (350−699 fmol/punch), 4−6 (700−1,249 fmol/punch), and ≥7 (≥1,250 fmol/punch) tablets of FTC/TDF PrEP per week, respectively. Forty-one of the 3,058 individuals tested HIV positive (IR=1.13/100 person-years exposure, 95% confidence interval, CI, 0.82−1.54), with 38 of the 41 cases (93%) had TFV-DP consistent with taking ≤3 FTC/TDF tablets/week. With a median PrEP exposure of 0.96 years (IQR, 0.90−1.39), the IR (95% CI) of HIV infection were 3.41 (2.37−4.90), 1.59 (0.76−3.33), and 0.14 (0.04−0.43) per 100 person-years for individuals who took ≤2, 2−3, and ≥4 tablets/week. Compared to individuals

Poster Abstracts

985 E/C/F/TAF SINGLE TABLET REGIMEN FOR HIV POSTEXPOSURE PROPHYLAXIS

Pierre Gantner 1 , Mojgan Hessamfar 2 , Faouzi Souala 3 , Nadia Valin 4 , Anne Simon 5 , Faiza Ajana 6 , Emmanuelle Bouvet 7 , Elisabeth Rouveix 8 , Laurent Cotte 9 , Firouze Bani-Sadr 10 , Laurent Hustache-Mathieu 11 , Marie-Gisele Lebrette 12 , Patrice Muret 11 , David Rey 1 , for the E/C/F/TAF PEP Study Group

CROI 2019 386