Jean-Michel Molina1, Catherine Capitant, Bruno Spire, Gilles Pialoux, Laurent Cotte, Isabelle Charreau, Cecile Tremblay, Jean-Marie Le Gall, Eric Cua, Armelle Pasquet, François Raffi, Claire Pintado, Christian Chidiac, Julie Chas, Pierre Charbonneau, Constance Delaugerre, Marie Suzan-Monti, Benedicte Loze, Julien Fonsart, Gilles Peytavin, Antoine Cheret, Julie Timsit, Gabriel Girard, Nicolas Lorente, Marie Préau, James F Rooney, Mark A Wainberg, David Thompson, Willy Rozenbaum, Veronique Doré, Lucie Marchand, Marie-Christine Simon, Nicolas Etien, Jean-Pierre Aboulker, Laurence Meyer, Jean-François Delfraissy. 1. From the Departments of Infectious Diseases (J.-M.M., C.P., P.C., B.L., W.R.) and Sexually Transmitted Diseases (J.T.), and the Laboratories of Virology (C.D.) and Biochemistry (J.F.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris Diderot, Sorbonne Paris Cité, INSERM UMR 941, Department of Infectious Diseases, Hôpital Tenon (G.Pialoux, J.C.), Collège des Universitaires de Maladies Infectieuses et Tropicales (F.R.), Laboratoire de Toxicologie et Pharmacologie, Centre Hospitalier Bichat-Claude Bernard (G.Peytavin), Collège d'Etudes Mondiales (G.G.), France Recherche Nord et Sud Sida-HIV et Hépatites (V.D., L.Marchand, M.-C.S., N.E., J.-F.D.), Université de Paris Sud, Kremlin Bicêtre (L.Meyer), Paris, INSERM SC10 US19, Villejuif (C. Capitant, I.C., J.-P.A., L.Meyer), Department of Medicine, INSERM UMR 912 SESSTIM, Marseille (B.S., M.S.-M., N.L.), Department of Infectious Diseases, Hôpital de la Croix Rousse, Centre Hospitalier et Universitaire de Lyon (L.C., C. Chidiac), and Groupe de Recherche en Psychologie Sociale EA 4163, University of Lumière (M.P.), Lyon, Department of Infectious Diseases, Hôpital de l'Archet, Centre Hospitalier de Nice, Nice (E.C.), Department of Infectious Diseases, Hôpital G. Dron, Centre Hospitalier Universitaire de Tourcoing, Lille (A.P., A.C.), and Association AIDES, Pantin (J.-M.L.G.) - all in France; Centre Hospitalier de l'Université de Montréal (C.T.), Institut de Recherche en Santé Publique de l'Université de Montréal (G.G.), McGill University AIDS Centre, Jewish General Hospital (M.A.W.), and Association REZO (D.T.) - all in Montreal; and Gilead Sciences, Foster City, CA (J.F.R.).
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. METHODS: We 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. RESULTS: Of 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). CONCLUSIONS: The 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.).
RCT Entities:
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. METHODS: We 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. RESULTS: Of 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). CONCLUSIONS: The 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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