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Clinical Trial
. 2024 Oct 3;391(13):1179-1192.
doi: 10.1056/NEJMoa2407001. Epub 2024 Jul 24.

Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women

Linda-Gail Bekker  1 , Moupali Das  1 , Quarraisha Abdool Karim  1 , Khatija Ahmed  1 , Joanne Batting  1 , William Brumskine  1 , Katherine Gill  1 , Ishana Harkoo  1 , Manjeetha Jaggernath  1 , Godfrey Kigozi  1 , Noah Kiwanuka  1 , Philip Kotze  1 , Limakatso Lebina  1 , Cheryl E Louw  1 , Moelo Malahleha  1 , Mmatsie Manentsa  1 , Leila E Mansoor  1 , Dhayendre Moodley  1 , Vimla Naicker  1 , Logashvari Naidoo  1 , Megeshinee Naidoo  1 , Gonasagrie Nair  1 , Nkosiphile Ndlovu  1 , Thesla Palanee-Phillips  1 , Ravindre Panchia  1 , Saresha Pillay  1 , Disebo Potloane  1 , Pearl Selepe  1 , Nishanta Singh  1 , Yashna Singh  1 , Elizabeth Spooner  1 , Amy M Ward  1 , Zwelethu Zwane  1 , Ramin Ebrahimi  1 , Yang Zhao  1 , Alexander Kintu  1 , Chris Deaton  1 , Christoph C Carter  1 , Jared M Baeten  1 , Flavia Matovu Kiweewa  1 ; PURPOSE 1 Study Team
Collaborators, Affiliations
Clinical Trial

Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women

Linda-Gail Bekker et al. N Engl J Med. .

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. (Funded by Gilead Sciences; PURPOSE 1 ClinicalTrials.gov number, NCT04994509.).

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