Results from the Phase 3 PURPOSE 2 clinical trial have confirmed the effectiveness of Lenacapavir, an injectable HIV-1 capsid inhibitor, in preventing HIV infection.
In the trial, involving over 2,180 participants, only 2 cases of HIV infection occurred in the Lenacapavir group, indicating that 99.9% of participants remained infection-free. Lenacapavir demonstrated superiority over the once-daily oral medication Truvada for pre-exposure prophylaxis (PrEP).
The trial’s independent Data Monitoring Committee recommended discontinuing the blinded phase and offering open-label Lenacapavir to all participants.
Lenacapavir’s success in PURPOSE 2 adds to the evidence supporting its potential as a transformative HIV prevention tool. It has consistently demonstrated superior efficacy in multiple population groups, and regulatory filings are expected to support its global availability if approved.
Gilead plans to initiate regulatory filings by the end of 2024, potentially leading to the launch of the first and only twice-yearly HIV prevention option in 2025. This will significantly expand the range of HIV prevention choices, particularly for populations facing a disproportionate burden of the epidemic.
Gilead remains committed to working with regulatory bodies, governments, and community partners to ensure equitable access to Lenacapavir for PrEP globally.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
