The Gates Foundation teamed up with Indian drug maker Hetero Labs to produce a cheap generic version of lenacapavir, the world’s first twice-yearly HIV prevention shot, for about $40 per patient per year, according to the press release.
The partnership aims to get millions more people in low- and middle-income countries access to the breakthrough HIV prevention drug that only needs two injections per year. The generic version could be ready as early as 2027 pending regulatory approval. The move comes as 1.3 million people got HIV in 2024 and only 18% of people who could benefit from prevention drugs currently have access to them.
Lenacapavir offers six months of HIV protection with a single shot, making it much easier for people who struggle with daily pills. The U.S. FDA approved it in June and the European Commission followed in August. Public health experts see it as a game-changer for communities that face barriers like stigma, trouble sticking to daily medication, or poor access to healthcare. Current HIV prevention requires daily pills that many people find hard to take consistently.
“Scientific advances like lenacapavir can help us end the HIV epidemic—if they are made accessible to people who can benefit from them the most,” said Trevor Mundel, president of global health at the Gates Foundation. Dr. Vamsi Krishna from Hetero said the company is “pleased to partner with the Gates Foundation to create a pathway for the sustainable and affordable supply of lenacapavir.” Studies show that getting affordable lenacapavir to just 4% of people in high-burden countries could prevent up to 20% of new infections.
The Gates Foundation has put over $80 million into speeding up market readiness and cutting the timeline for generic versions of the drug. Unitaid and other groups also announced deals with Dr. Reddy’s Laboratories, another Indian manufacturer, to build competition in the generic market. Gilead Sciences, which makes the original drug, granted royalty-free licenses to six generic manufacturers for 120 low- and middle-income countries in 2024.
The partnership builds on existing agreements with the Global Fund, PEPFAR, and other programs to roll out lenacapavir in poor countries, potentially reaching some places by the end of 2025.
