Contributors: Centre de recherche en épidémiologie et santé des populations (CESP); Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay; Essais Thérapeutiques et Maladies Infectieuses; Université Paris-Sud - Paris 11 (UP11)-Institut National de la Santé et de la Recherche Médicale (INSERM); Centre de Recherche du Centre Hospitalier de l’Université de Montréal (CR CHUM); Centre Hospitalier de l'Université de Montréal (CHUM); Université de Montréal (UdeM)-Université de Montréal (UdeM); Génomes, biologie cellulaire et thérapeutiques (GenCellDis (U944 / UMR7212)); Collège de France (CdF (institution))-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité); Hôpital Archet 2 Nice (CHU); Coalition PLUS Pantin, France (Community Research Laboratory Pantin); Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD); Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM); Observatoire régional de la santé Provence-Alpes-Côte d'Azur Marseille (ORS PACA); Centre d’Investigation Clinique de Nantes (CIC Nantes); Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de Nantes = Nantes University Hospital (CHU Nantes); CHU Tenon AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU); Centre Hospitalier Gustave Dron Tourcoing; Hôpital de la Croix-Rousse CHU - HCL; Hospices Civils de Lyon (HCL); ANRS (France Recherche Nord and Sud Sida-HIV Hépatites), the Canadian HIV Trials Network, Fonds Pierre Bergé (Sidaction), Gilead Sciences, and the Bill & Melinda Gates Foundation.; ANRS IPERGAY study group: Jean-Pierre Aboulker, Nathalie Bajos, Jean-Guy Baril, Michel Besnier, Johan Binesse, Diane Carette, Grégoire Cattin, Antoine Chéret, Christian Chidiac, Elias Choucair, Jean-François Delfraissy, Baptiste Demoulin, Alpha Diallo, Isabelle Durant-Zaleski, Véronique Doré, Nicolas Etien, Françoise Euphrasie, Julien Fonsart, Valérie Foubert, Séverine Gibowski, Gabriel Girard, Brigitte Guillon, Soizic Le Mestre, France Lert, Nicolas Leturque, Nicolas Lorente, Anaïs Mennecier, Michel Morin, Emmanuelle Netzer, Joanne Otis, Armelle Pasquet, Gilles Peytavin, Gilles Pialoux, Marie Préau, Cécile Rabian, Willy Rozenbaum, Luis Sagaon-Teyssier, Yacine Saïdi, Marine Saouzanet, Marie-Christine Simon, Marie Suzan-Monti, David Thompson, Julie Timsit, Benoît Trottier, Mark Wainberg
نبذة مختصرة : International audience ; Background: ANRS IPERGAY found that on-demand pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate plus emtricitabine was associated with an 86% relative reduction of HIV-1 incidence compared with placebo among men who have sex with men at high risk of HIV. We aimed to investigate whether on-demand PrEP was similarly effective among individuals with lower exposure to HIV risk.Methods: Participants in the ANRS IPERGAY trial were randomly assigned to receive PrEP (fixed-dose combination of 300 mg tenofovir disoproxil fumarate and 200 mg emtricitabine per pill) or placebo. The primary endpoint was the diagnosis of HIV-1 infection. Pill uptake was assessed by counting returned pills at each follow-up and by estimating tenofovir concentration from frozen plasma samples. Participants were interviewed at each visit to assess the pattern of PrEP use. All participants enrolled in the modified intention-to-treat population of the double-blind phase of the ANRS IPERGAY trial were eligible for this post-hoc analysis. We calculated the total follow-up time for periods of less frequent sexual intercourse with high PrEP adherence (15 pills or fewer per month taken systematically or often during sexual intercourse). To estimate the time of HIV acquisition, fourth-generation HIV-1/2 ELISA assays, plasma HIV-1 RNA assays, and western blot analyses were done with use of frozen samples, and the stage of HIV infection was defined according to Fiebig staging. HIV incidence was compared between the two treatment groups among individuals who had less frequent sexual intercourse with high PrEP adherence. The ANRS IPERGAY trial is registered with ClinicalTrials.gov, NCT01473472.Findings: 400 participants who were randomly assigned to receive PrEP (n=199) or placebo (n=201) between Feb 22, 2012, and Oct 17, 2014, were included in this analysis. 270 participants had at least one period of less frequent sexual intercourse with high PrEP adherence during the study, representing 134 person-years of ...
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