Gilead Sciences Announces Lenacapavir Demonstrates 100% Efficacy in HIV Prevention Trial PURPOSE 1

Gilead Sciences today announced results from the Phase 3 PURPOSE 1 trial showing that twice-yearly subcutaneous injections of lenacapavir demonstrated 100% efficacy in preventing HIV infection in cisgender women in sub-Saharan Africa. The trial enrolled 5,338 cisgender women aged 16-25 years in South Africa and Uganda. Zero HIV infections were observed in the lenacapavir arm compared to 16 infections in the background incidence rate arm. These unprecedented results position lenacapavir as a potential game-changer in HIV prevention. Gilead plans to submit regulatory applications for lenacapavir as pre-exposure prophylaxis (PrEP) based on these results and is committed to ensuring broad access in high-burden countries.