Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.
Open accessAbstract
BACKGROUND: Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition. METHODS: We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections. RESULTS: The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57). CONCLUSIONS: Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.).
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Daily oral antiretroviral PrEP with a fixed-dose combination of emtricitabine and either tenofovir disoproxil fumarate or tenofovir alafenamide has demonstrated safety and a substantial reduction in the rate of HIV acquisition for MSM.
“Daily oral antiretroviral PrEP with a fixed-dose combination of emtricitabine (FTC) and either tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) have demonstrated safety (74) and a substantial reduction in the rate of HIV acquisition for MSM (75).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [75]
The Results (page not provided) report a 44% reduction in HIV incidence with once-daily FTC–TDF versus placebo among men and transgender women who have sex with men. The cited paper studied FTC–TDF, not FTC–TAF, so it does not support the efficacy claim for both alternatives. The safety statement is attached to a different citation (74). (LLM, conf=0.90)
Experimental — accuracy not yet measuredStudies have demonstrated that a daily oral medication TDF/FTC is effective in preventing HIV acquisition, and specifically among MSM.
“Studies have demonstrated that a daily oral medication TDF/FTC is effective in preventing HIV acquisition, and specifically among MSM (74,75,201).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [75]
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- Authors
- Grant, R. M., Lama, J. R., Anderson, P. L., McMahan, V., Liu, A. Y., Vargas, L., Goicochea, P., Casapía, M., Guanira-Carranza, J. V., Ramirez-Cardich, M. E., Montoya-Herrera, O., Fernández, T., Veloso, V. G., Buchbinder, S. P., Chariyalertsak, S., Schechter, M., Bekker, L.-G., Mayer, K. H., Kallás, E. G., Amico, K. R., Mulligan, K., Bushman, L. R., Hance, R. J., Ganoza, C., Defechereux, P., Postle, B., Wang, F., McConnell, J. J., Zheng, J.-H., Lee, J., Rooney, J. F., Jaffe, H. S., Martinez, A. I., Burns, D. N., & Glidden, D. V.
- Affiliations
- Gladstone Institutes (US)
- Asociación Civil Impacta Salud y Educación (PE)
- University of Colorado Denver (US)
- University of California, San Francisco (US)
- Fundação Oswaldo Cruz (BR)
- Chiang Mai University (TH)
- Universidade Federal do Rio de Janeiro (BR)
- University of Cape Town (ZA)
- Brown University (US)
- University of Connecticut (US)
- Gilead Sciences (United States) (US)
- National Institutes of Health (US)
- ORCID
- Grant, Robert M.
- Lama, Javier R.
- Anderson, Peter L.
- McMahan, Vanessa
- Liu, Albert Y.
- Vargas, Lorena
- Casapía, Martín
- Veloso, Valdilea G.
- Buchbinder, Susan P.
- Chariyalertsak, Suwat
- Bekker, Linda-Gail
- Mayer, Kenneth H.
- Amico, K. Rivet
- Mulligan, Kathleen
- Bushman, Lane R.
- Ganoza, Carmela
- Wang, Furong
- Zheng, Jia-Hua
- Rooney, James F.
- Burns, David N.
- Glidden, David V.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2010-12-30
- Volume
- 363
- Issue
- 27
- Pages
- 2587-2599
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC3079639
- OpenAlex
- W2103920597
- Cited by
- 5,096
- References
- 48
- Citations by year
- 2026: 149 · 2025: 242 · 2024: 236 · 2023: 251 · 2022: 322 · 2021: 339 · 2020: 357 · 2019: 413 · 2018: 382 · 2017: 385 · 2016: 411 · 2015: 340 · 2014: 336 · 2013: 328 · 2012: 343
- FWCI
- 188.08
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (publishedVersion, other-oa)
- Scientific Electronic Library Online (São Paulo Research Foundation, Latin American and Caribbean Center on Health Sciences Information, Conselho Nacional de Desenvolvimento Científico e Tecnológico) (publishedVersion)
- PubMed Central (acceptedVersion)
- Americanae (AECID Library) (submittedVersion, other-oa)
- Arca - Repositório Institucional da Fiocruz (submittedVersion, other-oa)
- Funders
- Bill and Melinda Gates Foundation
- Gladstone Institutes
- National Institutes of Health (5u01ai064002-07)
- National Institute of Allergy and Infectious Diseases (U01-AI064002, U01AI64002, R01AI062333, R01AI118575, U01AI084735)
- National Center for Research Resources (UL1RR024131)
- Topics
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
- Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
- Keywords
- HIV pre-exposure prophylaxis, HIV prevention, men who have sex with men, transgender women, emtricitabine, tenofovir disoproxil fumarate, antiretroviral drugs, HIV incidence, nausea, adverse events
- MeSH terms
- Emtricitabine, Tenofovir, Adenine, Administration, Oral, Adolescent, Adult, Deoxycytidine, Drug Therapy, Combination, Follow-Up Studies, HIV, HIV Seropositivity, Humans, Male, Middle Aged, Nausea, Patient Compliance, RNA, Viral, Transsexualism, HIV Antibodies, HIV Infections, Incidence, Homosexuality, Male, Anti-HIV Agents, Drug Resistance, Viral, Kaplan-Meier Estimate, Young Adult, Organophosphonates
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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