New England Journal of Medicine publication of PURPOSE 2 results- Gilead Sciences
As previously indicated Gilead Sciences Inc announced The New England Journal of Medicine (NEJM ) published the full results from the company’s pivotal Phase III PURPOSE 2 trial evaluating twice-yearly lenacapavir for the investigational use of HIV prevention among a broad and geographically diverse range of gender-diverse people ( (see 2nd citation) .
The study found that twice-yearly lenacapavir for pre-exposure prophylaxis (PrEP) was highly efficacious at reducing HIV infections, reducing them by 96% compared to background HIV incidence. There were two incident cases among 2,179 participants, corresponding to 99.9% of participants not acquiring HIV infection in the lenacapavir group. Twice-yearly lenacapavir for PrEP also demonstrated superiority to once-daily Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; F/TDF) for PrEP and was generally well-tolerated, with no significant or new safety concerns identified. The strong efficacy and tolerability of lenacapavir are consistent with previous results from the PURPOSE 1 trial, which demonstrated zero infections and 100% efficacy for the investigational use of lenacapavir for PrEP in cisgender women in sub-Saharan Africa.
The NEJM publication of the full PURPOSE 2 results follows a data presentation during an oral abstract session at the International Congress on Drug Therapy in HIV Infection in Glasgow, Scotland (HIV Glasgow) earlier this month, the unblinding of the trial at interim analysis in September, and a presentation of additional efficacy and safety data in October at the HIV Research for Prevention Conference in Lima, Peru. PURPOSE 1 data were also published by NEJM (see 1st citation) in conjunction with the full data presentation at the 25 th International AIDS Conference in Munich, Germany (AIDS 2024).
Citation:Bekker LG, Das M et al." Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women". N Engl J Med 2024;391:1179 DOI: 10.1056/NEJMoa2407001
Citation: Kelley CF, Acevedo-Quiñones M et al. "Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons". N Engl J Med Published online November 27, 2024 https://www.nejm.org/ doi/full/10.1056/NEJMoa2411858 NB The citation is incompleted since no journal no. &/or volume & pages have been assigned
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