Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women

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dc.contributor.authorLandovitz, Raphael
dc.contributor.authorDonnell, Deborah J.
dc.contributor.authorClement, Meredith
dc.contributor.authorHanscom, Brett
dc.contributor.authorCottle, Leslie
dc.contributor.authorCoelho, Lara
dc.contributor.authorCabello, Robinson
dc.contributor.authorChariyalertsak, Suwat
dc.contributor.authorDunne, Eileen F.
dc.contributor.authorFrank, Ian
dc.contributor.authorGallardo-Cartagena, Jorge A.
dc.contributor.authorGaur, Aditya H.
dc.contributor.authorGonzales, Pedro
dc.contributor.authorTran, Ha V.
dc.contributor.authorHinojosa, Juan C.
dc.contributor.authorKallas, Esper
dc.contributor.authorKelley, Colleen F.
dc.contributor.authorLosso, Marcelo H.
dc.contributor.authorValdez Madruga, J.
dc.contributor.authorMiddelkoop, Keren
dc.contributor.authorPhanuphak, Nittaya
dc.contributor.authorSantos, Breno R.
dc.contributor.authorSued, Omar
dc.contributor.authorValencia Huamaní, Javier
dc.contributor.authorOverton, Edgar T.
dc.contributor.authorSwaminathan, Shobha
dc.contributor.authordel Rio, Carlos
dc.contributor.authorGulick, Roy M.
dc.contributor.authorRichardson, Paul
dc.contributor.authorSullivan, Philip
dc.contributor.authorPiwowar-Manning, Estelle M.
dc.contributor.authorMarzinke, Mark
dc.contributor.authorHendrix, Craig
dc.contributor.authorLi, Maoji
dc.contributor.authorWang, Zhe
dc.contributor.authorMarrazzo, Jeanne
dc.contributor.authorDaar, Eric
dc.contributor.authorAsmelash, Aida
dc.contributor.authorBrown, Todd T.
dc.contributor.authorAnderson, Peter
dc.contributor.authorEshleman, Susan H.
dc.contributor.authorBryan, Marcus
dc.contributor.authorBlanchette, Cheryl
dc.contributor.authorLucas, Jonathan
dc.contributor.authorPsaros, Christina
dc.contributor.authorSafren, Steven A.
dc.contributor.authorSugarman, Jeremy
dc.contributor.authorScott, Hyman
dc.contributor.authorEron, Joseph
dc.contributor.authorFields, Sheldon D.
dc.contributor.authorSista, Nirupama D.
dc.contributor.authorGomez, Kailazarid
dc.contributor.authorJennings, Andrea
dc.contributor.authorKofron, Ryan M.
dc.contributor.authorHoltz, Timothy H.
dc.contributor.authorShin, Katherine
dc.contributor.authorRooney, James F.
dc.contributor.authorSmith, Kimberly
dc.contributor.authorSpreen, William
dc.contributor.authorMargolis, David
dc.contributor.authorRinehart, Alex
dc.contributor.authorAdeyeye, Adeola
dc.contributor.authorCohen, Myron
dc.contributor.authorMcCauley, Marybeth
dc.contributor.authorGrinsztejn, Beatriz
dc.date.accessioned2024-05-21T13:37:38Z
dc.date.available2024-05-21T13:37:38Z
dc.date.issued2021-08
dc.description.abstractBACKGROUND Safe and effective long-acting injectable agents for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection are needed to increase the options for preventing HIV infection. METHODS We conducted a randomized, double-blind, double-dummy, noninferiority trial to compare long-acting injectable cabotegravir (CAB-LA, an integrase strand-transfer inhibitor [INSTI]) at a dose of 600 mg, given intramuscularly every 8 weeks, with daily oral tenofovir disoproxil fumarate–emtricitabine (TDF–FTC) for the prevention of HIV infection in at-risk cisgender men who have sex with men (MSM) and in at-risk transgender women who have sex with men. Participants were randomly assigned (1:1) to receive one of the two regimens and were followed for 153 weeks. HIV testing and safety evaluations were performed. The primary end point was incident HIV infection. RESULTS The intention-to-treat population included 4566 participants who underwent randomization; 570 (12.5%) identified as transgender women, and the median age was 26 years (interquartile range, 22 to 32). The trial was stopped early for efficacy on review of the results of the first preplanned interim end-point analysis. Among 1698 participants from the United States, 845 (49.8%) identified as Black. Incident HIV infection occurred in 52 participants: 13 in the cabotegravir group (incidence, 0.41 per 100 person-years) and 39 in the TDF–FTC group (incidence, 1.22 per 100 person-years) (hazard ratio, 0.34; 95% confidence interval, 0.18 to 0.62). The effect was consistent across prespecified subgroups. Injection-site reactions were reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF–FTC group. In the participants in whom HIV infection was diagnosed after exposure to CAB-LA, INSTI resistance and delays in the detection of HIV infection were noted. No safety concerns were identified. CONCLUSIONS CAB-LA was superior to daily oral TDF–FTC in preventing HIV infection among MSM and transgender women. Strategies are needed to prevent INSTI resistance in cases of CAB-LA PrEP failure. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 083 ClinicalTrials.gov number, NCT02720094.)
dc.identifier.citationN Engl J Med 2021;385:595-608
dc.identifier.other10.1056/NEJMoa2101016
dc.identifier.urihttps://repositorio.huesped.org.ar/handle/123456789/1000
dc.relation.ispartofseriesNew England Journal of Medicine; 385 (7)
dc.subjectCabotegravir
dc.subjectCisgender Men
dc.subjectTransgender Women
dc.titleCabotegravir for HIV Prevention in Cisgender Men and Transgender Women

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