Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
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Kelley Colleen F, Acevedo-Quiñones Maribel, Agwu Allison L, Avihingsanon Anchalee, Benson Paul, Blumenthal Jill, Brinson Cynthia, Brites Carlos, Cahn Pedro, Cantos Valeria D, Clark Jesse, Clement Meredith, Creticos Cathy, Crofoot Gordon, Diaz Ricardo S, Doblecki-Lewis Susanne, Gallardo-Cartagena Jorge A, Gaur Aditya, Grinsztejn Beatriz, Hassler Shawn, Hinojosa Juan Carlos, Hodge Theo, Kaplan Richard, Lacerda Marcus, LaMarca Anthony, Losso Marcelo H, Valdez Madruga José, Mayer Kenneth H, Mills Anthony, Mounzer Karam, Ndlovu Nkosiphile, Novak Richard M, Perez Rios Alma, Phanuphak Nittaya, Ramgopal Moti, Ruane Peter J, Sánchez Jorge, Santos Breno, Schine Patric, Schreibman Tanya, Spencer LaShonda Y, Van Gerwen Olivia T, Vasconcelos Ricardo, Vasquez Jose Gabriel, Zwane Zwelethu, Cox Stephanie, Deaton Chris, Ebrahimi Ramin, Wong Pamela, Singh Renu, Brown Lillian B, Carter Christoph C, Das Moupali, Baeten Jared M, Ogbuagu Onyema, PURPOSE 2 Study Team
Аннотация
METHODS: In this phase 3, double-blind, randomized, active-controlled trial, we randomly assigned participants in a 2:1 ratio to receive subcutaneous lenacapavir every 26 weeks or daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF). The primary efficacy analysis compared the incidence of HIV infection in the lenacapavir group with the background HIV incidence in the screened population. The secondary efficacy analysis compared the incidence of HIV infection in the lenacapavir group with that in the F/TDF group.
RESULTS: Among 3265 participants who were included in the modified intention-to-treat analysis, HIV infections occurred in 2 participants in the lenacapavir group (0.10 per 100 person-years; 95% confidence interval [CI], 0.01 to 0.37) and in 9 participants in the F/TDF group (0.93 per 100 person-years; 95% CI, 0.43 to 1.77). The background HIV incidence in the screened population (4634 participants) was 2.37 per 100 person-years (95% CI, 1.65 to 3.42). The incidence of HIV infection in the lenacapavir group was significantly lower than both the background incidence (incidence rate ratio, 0.04; 95% CI, 0.01 to 0.18; P<0.001) and the incidence in the F/TDF group (incidence rate ratio, 0.11; 95% CI, 0.02 to 0.51; P = 0.002). No safety concerns were identified. A total of 26 of 2183 participants (1.2%) in the lenacapavir group and 3 of 1088 (0.3%) in the F/TDF group discontinued the trial regimen because of injection-site reactions.
CONCLUSIONS: The HIV incidence with twice-yearly lenacapavir was significantly lower than the background incidence and the incidence with F/TDF. (Funded by Gilead Sciences; PURPOSE 2 ClinicalTrials.gov number, NCT04925752.).