Gilead's Twice-yearly Injection Offers 100% Protection Against HIV In Women: Study

(RTTNews) - In a recent study conducted by Gilead Sciences, Inc. (GILD) and published in the New England Journal of Medicine, it was revealed that a biannual injection of lenacapavir, a pre-exposure prophylaxis or PrEP drug, has been shown to provide complete protection against HIV infections in women, demonstrating 100% effectiveness.

The study, known as the PURPOSE 1 trial, involved 5,338 HIV-negative adolescent girls and young women from South Africa and Uganda. These participants were divided into three groups: one group received lenacapavir injections every 26 weeks, another group received the daily oral tablet Descovy (F/TAF), and the third group received Truvada (F/TDF). The results showed a total of 55 infections, with none occurring in the lenacapavir group, 39 in the Descovy group, and 16 in the Truvada group.

Linda-Gail Bekker, the Director of the Desmond Tutu HIV Centre said, "These stellar results show that twice-yearly lenacapavir for PrEP, if approved, could offer a highly effective, tolerable and discreet choice that could potentially improve PrEP uptake and persistence, helping us to reduce HIV in cisgender women globally."

Gilead anticipates the results from another trial, PURPOSE 2, which is expected to be released later this year and in early 2025. This trial will focus on examining the efficacy of biannual lenacapavir in preventing HIV among men, transgender women, and gender nonbinary individuals in several countries.

The company plans to submit lenacapavir for regulatory approval as a PrEP option based on the positive outcomes of both PURPOSE 1 and PURPOSE 2 trials. This submission aims to facilitate approval for various populations in need of additional HIV prevention alternatives. While lenacapavir is already FDA-approved for HIV treatment in adults, its current cost is estimated to be over $40,000 annually based on the manufacturer's list price, or around $39,000 as the average wholesale price.

However, based on research presented at the AIDS Conference in Munich, lenacapavir could potentially be mass-produced for approximately $40 per person annually, considering the drug's current ingredients and production and cost models.