Partnerships with Hetero and Dr. Reddy’s set stage for $40-per-year generic lenacapavir, the world’s first twice-yearly injectable PrEP, with rollout in LMICs expected as early as 2025.
By Bunmi Yekini
Millions more people in low- and middle-income countries (LMICs) will soon gain access to a groundbreaking HIV prevention option following a new agreement to produce affordable, generic versions of lenacapavir, the world’s first twice-yearly injectable pre-exposure prophylaxis (PrEP).
The Bill & Melinda Gates Foundation announced on Tuesday that it is partnering with Indian manufacturer Hetero Labs to make the drug available at roughly $40 per patient per year, after a short pre-treatment oral regimen. The initiative, backed by upfront funding and volume guarantees, aims to make the breakthrough medication affordable for national health systems.
“Hetero is pleased to partner with the Gates Foundation to create a pathway for the sustainable and affordable supply of lenacapavir,” said Dr. Vamsi Krishna, managing director of Hetero Group of Companies. “This collaboration reflects our commitment to ensuring access to innovative HIV medicines for patients in India and other low- and middle-income countries.”
In a parallel development, Unitaid, the Clinton Health Access Initiative (CHAI), and Wits RHI announced new commitments with Dr. Reddy’s Laboratories Ltd. to strengthen the generics ecosystem. Large-scale supply of the drug is expected by 2027, pending regulatory approval.
Lenacapavir, approved by the U.S. FDA in June and the European Commission in August, offers six months of protection with a single injection. Public health experts view it as a transformative prevention tool, particularly for those facing barriers to daily oral PrEP due to stigma, adherence challenges, or limited access.
“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. “We are committed to ensuring that those at highest risk, who can least afford it, aren’t left behind.”
Modeling suggests that introducing affordable lenacapavir to just 4% of people in high-burden countries could prevent up to 20% of new infections. With 1.3 million new HIV cases reported in 2024 and only 18% of eligible individuals currently accessing PrEP, the urgency is high.
Kate Hampton, CEO of the Children’s Investment Fund Foundation, welcomed the move: “The deals announced today on generics are a major step forward in ending the HIV epidemic. They build on full value-chain investments by CIFF and others to foster a competitive market so that access to lenacapavir is affordable and reliable for all those who need it.”
The new collaborations complement ongoing agreements between the Global Fund, Gilead Sciences, PEPFAR, and CIFF, with initial supplies of lenacapavir expected to reach some LMICs by late 2025.
This development comes as the Gates Foundation deepens its commitment to fighting infectious diseases. Earlier this week, Chair Bill Gates announced a $912 million pledge to the Global Fund’s 2026–2028 campaign, aimed at saving 23 million lives from HIV, malaria, and tuberculosis.