Gilead's Biannual Shot 100% Effective in Phase III HIV Prevention Trial for Women

Gilead Sciences announced on Thursday that their antiviral drug, lenacapavir, achieved complete efficacy in preventing HIV in cisgender women during a Phase III clinical trial. The biannual injection outperformed Gilead’s existing oral HIV prevention medications, Truvada and Descovy.

The PURPOSE 1 trial comprised 2,134 women receiving lenacapavir, with none contracting HIV. In contrast, 16 cases were reported among 1,068 women taking Truvada, and 39 cases occurred among 2,136 women on Descovy. The long-acting injectable was well-tolerated, exhibiting no major safety issues, according to the company.

Joe Eron, the principal investigator at the HIV/AIDS Clinical Research Unit at the University of North Carolina-Chapel Hill, praised the results, highlighting the significance of zero infections in over 2,000 women. Although daily oral pre-exposure prophylaxis (PrEP) medications like Truvada and Descovy are effective when adhered to, prior clinical trials indicated challenges with consistent patient adherence. The primary goal of the PURPOSE 1 study was to demonstrate lenacapavir’s superiority over Descovy, with efficacy over Truvada as a secondary endpoint. Following these promising results, an independent data monitoring committee advised Gilead to unblind the trial and provide lenacapavir to all participants.

Linda-Gail Bekker, director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, noted that twice-yearly lenacapavir could help mitigate the stigma and discrimination associated with daily oral PrEP pills, potentially enhancing adherence and persistence due to its less frequent dosing schedule.

Lenacapavir is currently under development as a PrEP for individuals at risk of HIV infection. Ongoing trials are evaluating its effectiveness across a wider demographic, including cisgender men, transgender men and women, and non-binary individuals. Gilead plans to seek regulatory approval based on the results from both PURPOSE 1 and the forthcoming PURPOSE 2 trials to make lenacapavir available to communities in dire need of additional HIV prevention methods.

In 2023, HIV products contributed to a 6% increase in revenue for the California-based pharmaceutical company, reaching $18.2 billion. Descovy, which was approved in 2019, generated approximately $2 billion of that total. Each year, more than one million new HIV infections occur globally, with the virus causing over 480,000 deaths annually.

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