Twice-yearly Lenacapavir or daily F/TAF for HIV prevention in cisgender women
dc.contributor.author | Bekker, Linda-Gail | |
dc.contributor.author | Das, Moupali | |
dc.contributor.author | Karim, Quarraisha Abdool | |
dc.contributor.author | Ahmed, Khatija | |
dc.contributor.author | Batting, Joanne | |
dc.contributor.author | Brumskine, William | |
dc.contributor.author | Gill, Katherine | |
dc.contributor.author | Harkoo, Ishana | |
dc.contributor.author | Jaggernath, Manjeetha | |
dc.contributor.author | Kigozi, Godfrey | |
dc.contributor.author | Kiwanuka, Noah | |
dc.contributor.author | Kotze, Philip | |
dc.contributor.author | Lebina, Limakatso | |
dc.contributor.author | Louw, Cheryl E. | |
dc.contributor.author | Malahleha, Moelo | |
dc.contributor.author | Manentsa, Mmatsie | |
dc.contributor.author | Mansoor, Leila E. | |
dc.contributor.author | Moodley, Dhayendre | |
dc.contributor.author | Naicker, Vimla | |
dc.contributor.author | Naidoo, Logashvari | |
dc.contributor.author | Naidoo, Megeshinee | |
dc.contributor.author | Nair, Gonasagrie | |
dc.contributor.author | Ndlovu, Nkosiphile | |
dc.contributor.author | Palanee-Phillips, Thesla | |
dc.contributor.author | Panchia, Ravindre | |
dc.contributor.author | Pillay, Saresha | |
dc.contributor.author | Potloane, Disebo | |
dc.contributor.author | Selepe, Pearl | |
dc.contributor.author | Singh, Nishanta | |
dc.contributor.author | Singh, Yashna | |
dc.contributor.author | Spooner, Elizabeth | |
dc.contributor.author | Ward, Amy M. | |
dc.contributor.author | Zwane, Zwelethu | |
dc.contributor.author | Ebrahimi, Ramin | |
dc.contributor.author | Zhao, Yang | |
dc.contributor.author | Kintu, Alexander | |
dc.contributor.author | Deaton, Chris | |
dc.contributor.author | Carter, Christoph C. | |
dc.contributor.author | Baeten, Jared M. | |
dc.contributor.author | Kiweewa, Flavia Matovu | |
dc.date.accessioned | 2025-05-30T13:03:08Z | |
dc.date.available | 2025-05-30T13:03:08Z | |
dc.date.issued | 2024-10 | |
dc.description.abstract | BACKGROUND : 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.department | Medical Microbiology | |
dc.description.librarian | hj2025 | |
dc.description.sdg | SDG-03: Good health and well-being | |
dc.description.sdg | SDG-05: Gender equality | |
dc.description.sponsorship | Gilead Sciences | |
dc.description.uri | https://www.nejm.org/ | |
dc.identifier.citation | Bekker, 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.issn | 0028-4793 (print) | |
dc.identifier.issn | 1533-4406 (online) | |
dc.identifier.other | 10.1056/NEJMoa2407001 | |
dc.identifier.uri | http://hdl.handle.net/2263/102590 | |
dc.language.iso | en | |
dc.publisher | Massachusetts Medical Society | |
dc.rights | © 2024 Massachusetts Medical Society. All rights reserved. | |
dc.subject | Reexposure prophylaxis | |
dc.subject | Human immunodeficiency virus (HIV) | |
dc.subject | Cisgender women | |
dc.subject | HIV infection | |
dc.subject | Lenacapavir | |
dc.title | Twice-yearly Lenacapavir or daily F/TAF for HIV prevention in cisgender women | |
dc.type | Postprint Article |