A groundbreaking clinical trial conducted across South Africa and Uganda has revealed promising results for a new HIV prevention method targeting young women. The trial, known as Purpose 1 and sponsored by Gilead Sciences, tested the efficacy of lenacapavir—a novel fusion capsid inhibitor administered via a twice-yearly injection—against two existing daily oral PrEP drugs.
The study, involving 5,000 participants, aimed to determine if lenacapavir provided superior protection against HIV compared to Truvada (F/TDF) and Descovy (F/TAF). Remarkably, during the trial's randomized phase, not a single one of the 2,134 women who received lenacapavir contracted HIV—a 100% effectiveness rate. In contrast, 16 out of 1,068 women (1.5%) using Truvada and 39 out of 2,136 (1.8%) using Descovy became infected.
These compelling results prompted an independent data safety monitoring board to recommend halting the trial's blinded phase prematurely. Now, all participants are being offered a choice of PrEP options, marking a significant milestone in HIV prevention efforts.
Physician-scientist Linda-Gail Bekker, lead investigator in South Africa, emphasized the trial's significance in providing a highly effective prevention tool amidst ongoing challenges in reducing global HIV infections. With 1.3 million new infections annually, innovative solutions like lenacapavir offer hope in achieving UNAIDS targets to end AIDS by 2030.
Moving forward, the Purpose 1 trial will transition to an open-label phase, where participants will select their preferred PrEP regimen. Meanwhile, a companion trial, Purpose 2, is underway to assess lenacapavir's effectiveness among other high-risk groups.
Gilead Sciences plans to submit trial results to regulators in Uganda and South Africa in the coming months, with hopes of integrating lenacapavir into global and national HIV prevention guidelines. Affordable pricing and accessibility are critical considerations for widespread adoption, with Gilead offering generic licenses to facilitate cost-effective distribution.
As global health initiatives continue to evolve, the potential of lenacapavir represents a pivotal advancement in HIV prevention, aiming to empower individuals with more manageable and effective options against HIV transmission.