A phase 3 clinical trial known as PURPOSE 1 has yielded breakthrough results in HIV prevention. The trial studied the efficacy of lenacapavir, an injectable HIV-1 capsid inhibitor.
Among cisgender women, twice-yearly lenacapavir demonstrated 100% efficacy in preventing HIV infections. This result is superior to the currently approved once-daily oral PrEP (pre-exposure prophylaxis) regimen, Truvada.
Based on the interim analysis, an independent Data Monitoring Committee recommended discontinuing the blinded phase of the trial and offering open-label lenacapavir to all participants.
Lenacapavir was generally well-tolerated, with no significant safety concerns identified. The trial included over 5,300 cisgender women and adolescent girls across 25 sites in South Africa and Uganda.
The PURPOSE program, of which PURPOSE 1 is a part, represents the most comprehensive and diverse HIV prevention trial program to date. It aims to advance scientific innovation, improve trial design, engage communities, and promote health equity in the fight against HIV.
The results of PURPOSE 1 underscore the potential of lenacapavir as a transformative tool in HIV prevention. As the trial continues, researchers hope to gather additional data to support the development and implementation of new strategies to end the HIV epidemic.
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.
