Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection

Summary

The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing HIV infection, in adolescent girls and young women (AGYW). The primary objective of this study is to evaluate the efficacy of LEN and F/TAF for HIV-1 PrEP in AGYW at risk of HIV-1 infection.

Timeline

Start

2021-08-30

Primary completion

2024-05-27

Completion

2028-01

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry Lenacapavir vs Incidence Phase: All Screened Participants With Non-missing HIV-1 Diagnosis; p <0.0001; Rate Ratio 0.000 (95% CI 0.000 to 0.042) reads as mixed primary results NCT04994509 ↗

registry F/TAF vs Incidence Phase: All Screened Participants With Non-missing HIV-1 Diagnosis; p = 0.20697; Rate Ratio 0.839 (95% CI 0.550 to 1.279) reads as mixed primary results NCT04994509 ↗

release “PURPOSE 1 met its key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada” reads as met primary endpoint gilead.com ↗

release “PURPOSE 1 trial ( NCT04994509 ), studying lenacapavir for PrEP among cisgender women in sub-Saharan Africa, was also unblinded early because it met its key efficacy endpoints” reads as met primary endpoint gilead.com ↗

release “In both trials, twice-yearly lenacapavir also demonstrated superiority of prevention of HIV infections when compared with once-daily oral Truvada®” reads as met primary endpoint gilead.com ↗

release “100% reduction in HIV infections and superiority of prevention of HIV infections” reads as met primary endpoint gilead.com ↗

Publications

• Background Bekker LG, Das M, Abdool Karim Q, Ahmed K, Batting J, Brumskine W, Gill K, Harkoo I, Jaggernath M, Kigozi G, Kiwanuka N, Kotze P, Lebina L, Louw CE, Malahleha M, Manentsa M, Mansoor LE, Moodley D, Naicker V, Naidoo L, Naidoo M, Nair G, Ndlovu N, Palanee-Phillips T, Panchia R, Pillay S, Potloane D, Selepe P, Singh N, Singh Y, Spooner E, Ward AM, Zwane Z, Ebrahimi R, Zhao Y, Kintu A, Deaton C, Carter CC, Baeten JM, Matovu Kiweewa F; PURPOSE 1 Study Team. Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women. N Engl J Med. 2024 Oct 3;391(13):1179-1192. doi: 10.1056/NEJMoa2407001. Epub 2024 Jul 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenacapavir	Small molecule	927 mg	Oral
Subject	Tenofovir disoproxil fumarate	Small molecule	—	Oral
Subject	emtricitabine	Other / unclassified	—	Oral
Subject	tenofovir alafenamide	Small molecule	—	Oral

Indications

No indication recorded.