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On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection

Jean-Michel Molina 1 Catherine Capitant Bruno Spire 2 Gilles Pialoux 3 Laurent Cotte 4 Isabelle Charreau 5 Cecile Tremblay 6, 7 Jean-Marie Le Gall 8 Cua Eric Pasquet Armelle Francois Raffi 9 Claire Pintado 1 Christian Chidiac 10 Julie Chas 3 Pierre Charbonneau 1 Constance Delaugerre 11 Marie Suzan-Monti 2 Benedicte Loze 1 Julien Fonsart 12 Gilles Peytavin 13 Antoine Chéret 14 Julie Timsit 12 Gabriel Girard 15 Nicolas Lorente 2 Marie Préau 2 James F. Rooney Mark Wainberg 16 David Thompson Willy Rozenbaum 1 Veronique Doré 17 Lucie Marchand 17 Marie-Christine Simon 17 Nicolas Etien 17 Jean-Pierre Aboulker 5 Laurence Meyer 18 Jean Francois Delfraissy 19
Abstract : Background Antiretroviral preexposure prophylaxis has been shown to reduce the risk of human immunodeficiency virus type 1 (HIV-1) infection in some studies, but conflicting results have been reported among studies, probably due to challenges of adherence to a daily regimen.MethodsWe conducted a double-blind, randomized trial of antiretroviral therapy for preexposure HIV-1 prophylaxis among men who have unprotected anal sex with men. Participants were randomly assigned to take a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or placebo before and after sexual activity. All participants received risk-reduction counseling and condoms and were regularly tested for HIV-1 and HIV-2 and other sexually transmitted infections.ResultsOf the 414 participants who underwent randomization, 400 who did not have HIV infection were enrolled (199 in the TDF-FTC group and 201 in the placebo group). All participants were followed for a median of 9.3 months (interquartile range, 4.9 to 20.6). A total of 16 HIV-1 infections occurred during follow-up, 2 in the TDF-FTC group (incidence, 0.91 per 100 person-years) and 14 in the placebo group (incidence, 6.60 per 100 person-years), a relative reduction in the TDF-FTC group of 86% (95% confidence interval, 40 to 98; P=0.002). Participants took a median of 15 pills of TDF-FTC or placebo per month (P=0.57). The rates of serious adverse events were similar in the two study groups. In the TDF-FTC group, as compared with the placebo group, there were higher rates of gastrointestinal adverse events (14% vs. 5%, P=0.002) and renal adverse events (18% vs. 10%, P=0.03).ConclusionsThe use of TDF-FTC before and after sexual activity provided protection against HIV-1 infection in men who have sex with men. The treatment was associated with increased rates of gastrointestinal and renal adverse events. (Funded by the National Agency of Research on AIDS and Viral Hepatitis [ANRS] and others; ClinicalTrials.gov number, NCT01473472.)
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https://halshs.archives-ouvertes.fr/halshs-01429281
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Submitted on : Saturday, January 7, 2017 - 3:42:37 PM
Last modification on : Monday, June 14, 2021 - 1:58:07 PM

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Jean-Michel Molina, Catherine Capitant, Bruno Spire, Gilles Pialoux, Laurent Cotte, et al.. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. New England Journal of Medicine, Massachusetts Medical Society, 2015, 373 (23), pp.2237-2246. ⟨10.1056/NEJMoa1506273⟩. ⟨halshs-01429281⟩

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