Gilead Sciences has reported promising data from its Phase 3 PURPOSE 2 trial, demonstrating the efficacy and safety of lenacapavir, an injectable HIV-1 capsid inhibitor for HIV prevention. The trial included a diverse population of cisgender men and gender-diverse individuals. Analysis revealed that twice-yearly lenacapavir significantly reduced HIV infections by 96% compared to background HIV incidence (bHIV), outperforming once-daily Truvada for HIV prevention.

Researchers found that lenacapavir was highly effective, with only 2 incident cases among 2,179 participants receiving the treatment. This translates to a 0.10/100 person-years HIV acquisition rate, demonstrating its superiority over bHIV. Additionally, lenacapavir was 89% more effective than Truvada (0.93/100 person-years), highlighting its potential impact on HIV prevention.

The PURPOSE 2 trial was designed to include a broad population, reflecting the diversity of individuals disproportionately affected by HIV. The study focused on gender, racial, ethnic, and geographic diversity, ensuring the results apply to various communities.

Gilead aims to begin regulatory filings for lenacapavir for PrEP by the end of 2024. Furthermore, the company has announced voluntary licensing partners to expand future access in high-incidence, resource-limited countries. These initiatives aim to make lenacapavir accessible to those who need it most, contributing to the fight against the HIV epidemic.

Source link: http://www.businesswire.com/news/home/20241006981896/en/Gilead-Presents-Additional-Efficacy-Safety-and-Demographic-Data-From-PURPOSE-2-Trial-at-5th-HIV-Research-for-Prevention-Conference

+ posts

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.