The study's primary endpoint, comparing lenacapavir to background HIV incidence (bHIV), and the secondary endpoint, comparing it to Truvada, both met with p-values less than 0.0001, indicating significant superiority.

The Independent Data Monitoring Committee (IDMC) has recommended ending the blinded phase of the trial and offering open-label lenacapavir to all participants immediately. This recommendation follows the trial's success in achieving its objectives with lenacapavir showing no new safety concerns.

Dr Nishanta Singh, a principal investigator at the Verulam site in KwaZulu-Natal, expressed optimism about the results, highlighting the potential impact on HIV prevention for young women.

The trial results represent the first data from Gilead’s extensive PURPOSE program, noted for its innovation in HIV prevention research. The findings underscore a significant step forward in the fight against HIV, particularly for populations who have struggled with adherence to daily oral PrEP options.

Further details about the PURPOSE program and individual trials can be accessed at www.purposestudies.com.