Gilead Sciences has announced that Lenacapavir, a twice-yearly injectable form of PrEP, achieved a 96% reduction in HIV infections in a recent clinical trial, outperforming the traditional daily pill regimen. This development is crucial for HIV prevention as it provides a user-friendly alternative that does not require daily adherence. The FDA is expected to review Lenacapavir for approval later this year, with hopes for market availability by mid-2025. This injectable option joins other products like ViiV Healthcare’s Apretude, which is administered every two months but has faced challenges due to its cost and insurance coverage limitations. The U.

S. Preventive Services Task Force recently rated injectable PrEP with an "A" rating, which could lead to broader insurance coverage under the Affordable Care Act by 2025. Previous trials have indicated Lenacapavir's efficacy in preventing HIV among various demographics, including young women and diverse gender identities across multiple countries. Gilead’s CEO emphasized the transformative potential of this treatment in combating the HIV epidemic, highlighting the urgency of regulatory collaboration for its approval. With a comprehensive dataset backing its effectiveness, Lenacapavir stands poised to be a pivotal tool in HIV prevention efforts.