Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
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Grant Robert M, Lama Javier R, Anderson Peter L, McMahan Vanessa, Liu Albert Y, Vargas Lorena, Goicochea Pedro, Casapía Martín, Guanira-Carranza Juan Vicente, Ramirez-Cardich Maria E, Montoya-Herrera Orlando, Fernández Telmo, Veloso Valdilea G, Buchbinder Susan P, Chariyalertsak Suwat, Schechter Mauro, Bekker Linda-Gail, Mayer Kenneth H, Kallás Esper Georges, Amico K Rivet, Mulligan Kathleen, Bushman Lane R, Hance Robert J, Ganoza Carmela, Defechereux Patricia, Postle Brian, Wang Furong, McConnell J Jeff, Zheng Jia-Hua, Lee Jeanny, Rooney James F, Jaffe Howard S, Martinez Ana I, Burns David N, Glidden David V, iPrEx Study Team
Аннотация
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.).