Gilead Sciences Inc. (NASDAQ: GILD), a U.S. biopharmaceutical company, has announced topline results from the Phase III PURPOSE 1 study. The study indicates that lenacapvir has successfully demonstrated its potential as a twice-yearly pre-exposure prophylaxis (PrEP) drug to prevent HIV infection.
The trial involved 5,300 cisgender women and adolescent girls aged 16-25 across 25 sites in South Africa and three sites in Uganda. It assessed the safety and efficacy of twice-yearly, subcutaneous lenacapavir for PrEP, compared to once-daily oral Descovy (emtricitabine 200mg and tenofovir alafenamide 25mg; F/TAF). The study also included a third group taking once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF). Participants were randomized in a 2:2:1 ratio to receive lenacapavir, Descovy, or Truvada, respectively.
The independent data committee recommended stopping the study early after twice-yearly lenacapavir showed 100% efficacy with zero infections, surpassing its key efficacy endpoints of superiority over once-daily oral Truvada and background HIV incidence (bHIV).
Gilead is advancing lenacapavir in several studies, including the PURPOSE 2 trial, which focuses on men who have sex with men, transgender men, transgender women, and gender non-binary individuals who have sex with partners assigned male at birth. The trial is being conducted in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States. Results from PURPOSE 2 are expected in late 2024 or early 2025 and, together with the PURPOSE 1 trial, will support the first New Drug Application (NDA) filings for the drug.- Flcube.com
