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)

1 Service de maladies infectieuses et tropicales [Saint-Louis]
2 SESSTIM - U912 INSERM - Aix Marseille Univ - IRD - Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale
3 CHU Tenon [AP-HP]
4 UNICANCER/CRCL - Centre de Recherche en Cancérologie de Lyon
5 Essais Therapeutiques et Infection Par Le Vih
6 Department of Medicine, University of Montreal
7 Centre de recherche
8 Methodology, Innovation, Research, Evaluation (MIRE)
9 CMIT - Collège des Universitaires des Maladies Infectieuses et Tropicales
10 Service de Maladies Infectieuses et Tropicales [Hôpital de la Croix-Rousse - HCL]
11 Laboratoire de virologie
12 AP-HP - Hopital Saint-Louis [AP-HP]
13 Laboratoire de Pharma-Toxicologie
14 Laboratoire de Virologie [CHU Necker]
15 Le Collège d'études mondiales/FMSH
16 McGill University = Université McGill [Montréal, Canada]
17 ANRS France Recherche Nord & sud Sida-hiv hépatites
18 CESP - Centre de recherche en épidémiologie et santé des populations
19 Service de médecine interne et maladies infectieuses

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.)

Mots clés: HIV; Preexposure Prophylaxis; prevention

Domaines: Psychologie

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, 2015, 373 (23), pp.2237-2246. ⟨10.1056/NEJMoa1506273⟩. ⟨halshs-01429281⟩