Many millions more people at risk of HIV in low- and middle-income countries will have access to a powerful new prevention option thanks to the Gates Foundation and Indian drug manufacturer Hetero Labs.
The two organisations have partnered to produce a low-cost, generic version of lenacapavir, the world’s first twice-yearly injectable pre-exposure prophylaxis (PrEP), at roughly $40 per patient per year (after a short pre-treatment oral regimen) – a price point designed to make the breakthrough treatment 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,” says Dr Vamsi Krishna, MD of Hetero Group. “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 move, Unitaid, the Clinton Health Access Initiative (CHAI), and Wits RHI have announced new commitments with Dr Reddy’s Laboratories, another Indian manufacturer, reinforcing efforts to build a competitive generics ecosystem. The accelerated development of a large-scale generic supply of lenacapavir, which is anticipated as early as 2027 pending regulatory approval, will reduce the time between initial doses and provide wider access to the drug. This move could potentially transform the fight against HIV and help end the epidemic faster and more equitably.
Lenacapavir for PrEP offers six months of protection with a single injection, adding a powerful new prevention option for communities underserved by existing methods. Public health experts see it as a transformative option for people who face barriers to daily oral PrEP including stigma, adherence challenges, and inconsistent access to medication.
Despite global progress driving down HIV rates and AIDS-related deaths since 2000, 1,3-million people acquired HIV in 2024 – and only 18% of people who could benefit from PrEP currently have access.
Modeling suggests that the introduction of lenacapavir has the potential to prevent significant numbers of HIV infections. In fact, one study showed that scaling up access to affordable lenacapavir to just 4% of the population in high-burden countries could prevent up to 20% of new infections.
That potential drives the urgency of this investment.
“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,” says 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.”