The U.S. Food and Drug Administration (FDA) has granted approval to Gilead Sciences’ groundbreaking HIV prevention injection, Yeztugo—a twice-yearly shot hailed as a significant step forward in the global battle against HIV.
Gilead’s new drug, lenacapavir (marketed as Yeztugo), is the first-ever biannual injectable PrEP (pre-exposure prophylaxis) treatment to be authorized, offering a much-needed alternative to daily oral pills. The approval, announced on June 18, 2025, comes after extensive clinical trials demonstrated unprecedented levels of HIV protection.
A NEW ERA IN HIV PREVENTION
“This is a historic day in the decades-long fight against HIV,” said Daniel O’Day, Chairman and CEO of Gilead Sciences. “Yeztugo offers hope and convenience to millions worldwide, especially for those who struggle with daily PrEP regimens.”
Traditional PrEP methods like Truvada have existed for over a decade, but require strict adherence to daily dosing, limiting their impact in many regions. With Yeztugo, users receive just two injections per year, making it a highly practical solution in both high- and low-resource settings.
CLINICAL TRIALS SHOW REMARKABLE RESULTS
Gilead’s success is backed by two pivotal clinical trials:
- Trial 1: Involved over 2,000 women across sub-Saharan Africa. Result? 100% prevention rate, outperforming Truvada.
- Trial 2: Included 2,000 men and gender-diverse individuals. Only two infections were reported—a 99.9% efficacy rate.
Both studies were published in The New England Journal of Medicine, and the drug earned the prestigious title of “Breakthrough of the Year” by the journal Science in 2024.
Common side effects were minimal, including mild reactions at the injection site, headaches, and nausea.
PRICING SPARKS DEBATE
Despite the excitement, the high cost of Yeztugo has sparked concern. Gilead confirmed that the U.S. list price will be $28,218 per year, though this is lower than its price as an HIV treatment ($39,000 annually).
“Even wealthy nations will struggle to afford lenacapavir at this price,” warned Dr. Andrew Hill of Liverpool University, who led research showing the drug could potentially be manufactured for as little as $25 per year.
Winnie Byanyima, UN Under-Secretary-General and Executive Director of UNAIDS, applauded the breakthrough but echoed the affordability concerns. “Lenacapavir could be the game-changer we need to finally control new infections. But that’s only possible if it’s affordable and accessible to all,” she stated.
GILEAD’S ACCESS STRATEGY: GENERICS & GLOBAL DEALS
Gilead has announced partnerships with six pharmaceutical manufacturers to produce generic versions of lenacapavir for 120 low- and middle-income countries, pending regulatory approval.
To bridge the gap, Gilead signed a deal with the Global Fund in December to supply two million doses—working in tandem with programs like the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). However, recent funding cuts to PEPFAR under former President Trump have cast doubt on future support.
Despite the uncertainty, Gilead insists on pushing forward with global access plans. “We’re committed to ensuring that anyone who needs or wants Yeztugo can get it,” said Blair Baumwell, Gilead spokesperson. “We anticipate widespread insurance coverage in the U.S. and are actively working to expand access worldwide.”
