Pharma giant Gilead Sciences has unveiled promising results from its Phase 1 trial of a once-a-year PrEP injection. The company presented these findings this week at the Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, and they were also published in The Lancet. Gilead already offers a twice-yearly PrEP injection using the drug lenacapavir, which is also used to treat HIV in many countries. The FDA is expected to decide on its approval as PrEP this summer.
But Gilead isn’t stopping there; they are now testing a new, once-a-year version of the injection. Early results from this Phase 1 trial, which included 40 participants, show that a 5000 mg once-a-year injection of lenacapavir maintains higher drug levels in the body than two lower-dose six-month injections. The drug’s concentration remained above the 95% effective level for 56 weeks, surpassing the 52-week protection from biannual doses. While injection-site pain was a common side effect, it was mild to moderate and resolved quickly.
Gilead plans to start a Phase 3 trial later this year. Dr. Jared Baeten of Gilead believes this could be a game-changer for HIV prevention, addressing adherence challenges and ultimately reducing global HIV transmissions.
