FDA Approves Gilead's Biannual Injection for HIV Prevention in the US

On June 18, 2025, the U.S. Food and Drug Administration (FDA) approved Gilead Sciences' innovative twice-yearly injection designed to prevent HIV transmission. This landmark approval marks a significant advancement in HIV prevention strategies, providing a long-lasting alternative to daily oral medications. The injectable treatment, marketed as Yeztugo and containing the drug lenacapavir, has demonstrated in clinical trials the ability to reduce the risk of HIV infection by over 99.9% in adults and adolescents, effectively functioning like a powerful vaccine.

Pre-exposure prophylaxis (PrEP) medications have been available for over ten years, mainly in pill form requiring daily intake. However, adherence challenges have limited their impact on reducing global infection rates. This new injectable offers a promising solution by minimizing the need for frequent dosing, which could enhance compliance and broadening prevention efforts.

Despite the excitement surrounding this development, concerns about accessibility remain. Although Gilead has not announced official pricing, analysts estimate the US launch price could reach up to $25,000 annually. HIV activists are calling for the price to be significantly lowered—around $25 per year—to ensure widespread access and help end the HIV pandemic.

The approval comes at a time when U.S. funding for HIV treatment and prevention programs has been cut by the current administration, both domestically and internationally, raising questions about equitable access to this promising new tool. Still, health experts believe that this innovation could transform HIV prevention, reducing new infections and saving lives.

Source: https://medicalxpress.com/news/2025-06-gilead-yearly-hiv.html