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

The FDA has approved Gilead's groundbreaking twice-yearly injection to prevent HIV, offering a powerful new tool in the fight against the virus with over 99.9% efficacy demonstrated in clinical trials.
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
Stay Updated with Mia's Feed
Get the latest health & wellness insights delivered straight to your inbox.
Related Articles
Revolutionary Gene Therapy Shows Promise in Inducing HIV Dormancy
A groundbreaking study reveals that gene therapy targeting HIV's antisense transcript (AST) may permanently induce viral dormancy, paving the way for potential cures beyond lifelong medication.
Stem Cell Transplant as a Promising Cure for Pediatric Monogenic Inflammatory Bowel Disease
Research shows hematopoietic stem cell transplantation as a promising, potentially curative therapy for children with severe monogenic inflammatory bowel disease, offering new hope for early intervention.
Promising Results from Antibody-Drug Conjugate in Treating Rare Blood Cancer
A novel antibody-drug conjugate shows high response rates and safety in treating the rare and aggressive blood cancer BPDCN, potentially offering a new standard of care.