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

Open access
Molina, Jean-Michel, Capitant, Catherine, Spire, Bruno, Pialoux, Gilles, Cotte, Laurent, Charreau, Isabelle, Tremblay, Cecile, Le Gall, Jean-Marie, Cua, Eric, Pasquet, Armelle, Raffi, François, Pintado, Claire, Chidiac, Christian, Chas, Julie, Charbonneau, Pierre, Delaugerre, Constance, Suzan-Monti, Marie, Loze, Benedicte, Fonsart, Julien, Peytavin, Gilles, Cheret, Antoine, Timsit, Julie, Girard, Gabriel, Lorente, Nicolas, Préau, Marie, Rooney, James F., Wainberg, Mark A., Thompson, David, Rozenbaum, Willy, Doré, Veronique, Marchand, Lucie, Simon, Marie-Christine, Etien, Nicolas, Aboulker, Jean-Pierre, Meyer, Laurence, Delfraissy, Jean-François·2015·New England Journal of Medicine

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.).

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Metadata

Authors
Molina, J.-M., Capitant, C., Spire, B., Pialoux, G., Cotte, L., Charreau, I., Tremblay, C., Le Gall, J.-M., Cua, E., Pasquet, A., Raffi, F., Pintado, C., Chidiac, C., Chas, J., Charbonneau, P., Delaugerre, C., Suzan-Monti, M., Loze, B., Fonsart, J., Peytavin, G., Cheret, A., Timsit, J., Girard, G., Lorente, N., Préau, M., Rooney, J. F., Wainberg, M. A., Thompson, D., Rozenbaum, W., Doré, V., Marchand, L., Simon, M.-C., Etien, N., Aboulker, J.-P., Meyer, L., & Delfraissy, J.-F.
Venue
New England Journal of Medicine
Published
2015-12-03
Volume
373
Issue
23
Pages
2237-2246
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2319917590
Cited by
1,633
References
20
FWCI
118.53
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. https://app.cochat.ai/papers/10.1056/nejmoa1506273
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Molina, J.-M., Capitant, C., Spire, B., Pialoux, G., Cotte, L., Charreau, I., Tremblay, C., Le Gall, J.-M., Cua, E., Pasquet, A., Raffi, F., Pintado, C., Chidiac, C., Chas, J., Charbonneau, P., Delaugerre, C., Suzan-Monti, M., Loze, B., Fonsart, J., . . . Delfraissy, J.-F. (2015). On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1506273

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.