FDA and international regulatory bodies' announcements

Gilead's Phase 3 Trial Led by Emory Shows Lenacapavir Reduces HIV Risk by 96%

Nov 27, 2024, 10:21 PM

Gilead Sciences has announced the publication of the full results of its Phase 3 PURPOSE-2 clinical trial in the New England Journal of Medicine. The trial, led by Emory University, evaluated the efficacy of twice-yearly lenacapavir injections for HIV prevention in men and gender-diverse individuals. Results showed that lenacapavir significantly reduced the risk of HIV infection by 96%, outperforming daily oral PrEP in adherence and effectiveness. The study demonstrated that lenacapavir had a lower incidence of HIV infection compared to both the background incidence and the incidence with emtricitabine–tenofovir disoproxil fumarate.