Twice-yearly Lenacapavir or daily F/TAF for HIV prevention in cisgender women

dc.contributor.authorBekker, Linda-Gail
dc.contributor.authorDas, Moupali
dc.contributor.authorKarim, Quarraisha Abdool
dc.contributor.authorAhmed, Khatija
dc.contributor.authorBatting, Joanne
dc.contributor.authorBrumskine, William
dc.contributor.authorGill, Katherine
dc.contributor.authorHarkoo, Ishana
dc.contributor.authorJaggernath, Manjeetha
dc.contributor.authorKigozi, Godfrey
dc.contributor.authorKiwanuka, Noah
dc.contributor.authorKotze, Philip
dc.contributor.authorLebina, Limakatso
dc.contributor.authorLouw, Cheryl E.
dc.contributor.authorMalahleha, Moelo
dc.contributor.authorManentsa, Mmatsie
dc.contributor.authorMansoor, Leila E.
dc.contributor.authorMoodley, Dhayendre
dc.contributor.authorNaicker, Vimla
dc.contributor.authorNaidoo, Logashvari
dc.contributor.authorNaidoo, Megeshinee
dc.contributor.authorNair, Gonasagrie
dc.contributor.authorNdlovu, Nkosiphile
dc.contributor.authorPalanee-Phillips, Thesla
dc.contributor.authorPanchia, Ravindre
dc.contributor.authorPillay, Saresha
dc.contributor.authorPotloane, Disebo
dc.contributor.authorSelepe, Pearl
dc.contributor.authorSingh, Nishanta
dc.contributor.authorSingh, Yashna
dc.contributor.authorSpooner, Elizabeth
dc.contributor.authorWard, Amy M.
dc.contributor.authorZwane, Zwelethu
dc.contributor.authorEbrahimi, Ramin
dc.contributor.authorZhao, Yang
dc.contributor.authorKintu, Alexander
dc.contributor.authorDeaton, Chris
dc.contributor.authorCarter, Christoph C.
dc.contributor.authorBaeten, Jared M.
dc.contributor.authorKiweewa, Flavia Matovu
dc.date.accessioned2025-05-30T13:03:08Z
dc.date.available2025-05-30T13:03:08Z
dc.date.issued2024-10
dc.description.abstractBACKGROUND : There are gaps in uptake of, adherence to, and persistence in the use of preexposure prophylaxis for human immunodeficiency virus (HIV) prevention among cisgender women. METHODS : We conducted a phase 3, double-blind, randomized, controlled trial involving adolescent girls and young women in South Africa and Uganda. Participants were assigned in a 2:2:1 ratio to receive subcutaneous lenacapavir every 26 weeks, daily oral emtricitabine–tenofovir alafenamide (F/TAF), or daily oral emtricitabine–tenofovir disoproxil fumarate (F/TDF; active control); all participants also received the alternate subcutaneous or oral placebo. We assessed the efficacy of lenacapavir and F/TAF by comparing the incidence of HIV infection with the estimated background incidence in the screened population and evaluated relative efficacy as compared with F/TDF. RESULTS : Among 5338 participants who were initially HIV-negative, 55 incident HIV infections were observed: 0 infections among 2134 participants in the lenacapavir group (0 per 100 person-years; 95% confidence interval [CI], 0.00 to 0.19), 39 infections among 2136 participants in the F/TAF group (2.02 per 100 person-years; 95% CI, 1.44 to 2.76), and 16 infections among 1068 participants in the F/TDF group (1.69 per 100 person-years; 95% CI, 0.96 to 2.74). Background HIV incidence in the screened population (8094 participants) was 2.41 per 100 person-years (95% CI, 1.82 to 3.19). HIV incidence with lenacapavir was significantly lower than background HIV incidence (incidence rate ratio, 0.00; 95% CI, 0.00 to 0.04; P<0.001) and than HIV incidence with F/TDF (incidence rate ratio, 0.00; 95% CI, 0.00 to 0.10; P<0.001). HIV incidence with F/TAF did not differ significantly from background HIV incidence (incidence rate ratio, 0.84; 95% CI, 0.55 to 1.28; P=0.21), and no evidence of a meaningful difference in HIV incidence was observed between F/TAF and F/TDF (incidence rate ratio, 1.20; 95% CI, 0.67 to 2.14). Adherence to F/TAF and F/TDF was low. No safety concerns were found. Injection-site reactions were more common in the lenacapavir group (68.8%) than in the placebo injection group (F/TAF and F/TDF combined) (34.9%); 4 participants in the lenacapavir group (0.2%) discontinued the trial regimen owing to injection-site reactions. CONCLUSIONS : No participants receiving twice-yearly lenacapavir acquired HIV infection. HIV incidence with lenacapavir was significantly lower than background HIV incidence and HIV incidence with F/TDF.
dc.description.departmentMedical Microbiology
dc.description.librarianhj2025
dc.description.sdgSDG-03: Good health and well-being
dc.description.sdgSDG-05: Gender equality
dc.description.sponsorshipGilead Sciences
dc.description.urihttps://www.nejm.org/
dc.identifier.citationBekker, L.G., Das, M. Karim, Q.A., Ahmed, K.,et al. 2024, 'Twice-yearly Lenacapavir or daily F/TAF for HIV prevention in cisgender women', New England Journal of Medicine, vol. 391, no. 13, pp. 1179-1192, doi : 10.1056/NEJMoa2407001.
dc.identifier.issn0028-4793 (print)
dc.identifier.issn1533-4406 (online)
dc.identifier.other10.1056/NEJMoa2407001
dc.identifier.urihttp://hdl.handle.net/2263/102590
dc.language.isoen
dc.publisherMassachusetts Medical Society
dc.rights© 2024 Massachusetts Medical Society. All rights reserved.
dc.subjectReexposure prophylaxis
dc.subjectHuman immunodeficiency virus (HIV)
dc.subjectCisgender women
dc.subjectHIV infection
dc.subjectLenacapavir
dc.titleTwice-yearly Lenacapavir or daily F/TAF for HIV prevention in cisgender women
dc.typePostprint Article

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