The Gates Foundation has announced a new partnership with Indian manufacturer Hetero Labs to drive down the cost and expand access to a groundbreaking HIV prevention drug and accelerate access for millions of people in low- and middle-income countries.
The agreement, announced in New York on Wednesday, will allow Hetero Labs to produce a generic version of lenacapavir, the world’s first twice-yearly injectable pre-exposure prophylaxis (PrEP), to be sold at about $40 per patient annually.
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This will come after a short oral pre-treatment regimen.
“Hetero is pleased to partner with the Gates Foundation to create a pathway for the sustainable and affordable supply of lenacapavir,” said Vamsi Krishna, managing director of the Hetero Group of Companies.
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“This collaboration reflects our commitment to ensuring access to innovative HIV medicines for patients in India and other low- and middle-income countries.”
The announcement comes at a troubling time for global health, particularly in the fight against HIV/AIDS, as US foreign aid faces sharp cuts under the Trump administration.
According to UNAIDS, more than 40 million people are living with HIV worldwide.
Despite progress since 2000, an estimated 1.3 million people contracted HIV in 2024, while over 600,000 died from AIDS-related illnesses.
New prevention option
According to a statement from the foundation, lenacapavir was approved by the United States Food and Drug Administration in June and by the European Commission in August.
It noted that the injection provides six months of protection in a single dose, offering a practical option for people unable to use daily oral PrEP because of stigma, adherence difficulties, or unreliable access to medicines.
Public health experts describe the drug as a transformative addition to the HIV prevention toolkit. The foundation noted that only 18 per cent of those who could benefit from PrEP currently have access.
The foundation cited a modelling study published in The Lancet this year, which found that scaling up lenacapavir to just four per cent of the population in high-burden countries could prevent up to 20 per cent of new infections.
Partnerships for scale
Alongside the Hetero deal, Unitaid, the Clinton Health Access Initiative, and Wits RHI announced commitments with another Indian manufacturer, Dr Reddy’s Laboratories, to further expand generic production.
The foundation noted that large-scale supply is expected as early as 2027, pending regulatory approvals.
The collaborations complement agreements between the Global Fund to Fight AIDS, Tuberculosis and Malaria; Gilead Sciences; and the US State Department through PEPFAR, supported by the Children’s Investment Fund Foundation (CIFF).
According to the statement, these efforts could enable the initial roll-out of lenacapavir in LMICs, with supplies potentially reaching countries by the end of 2025.
“The deals announced today on generics are a major step forward in ending the HIV epidemic,” said Kate Hampton, CEO of the Children’s Investment Fund Foundation.
Addressing affordability
The Gates Foundation further noted that it has already invested more than $80 million to speed up market readiness and shorten the timeline for generic entry of lenacapavir.
Trevor Mundel, president of global health at the foundation, said affordability and equitable access are central to the partnership.
“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,” Mr Mundel said.
“We are committed to ensuring that those at highest risk, who can least afford it, aren’t left behind.”
The Hetero agreement also includes provisions for an affordable supply of the active pharmaceutical ingredient, allowing other manufacturers to expand production quickly and support a competitive generics market.
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Global Fund
The announcement comes days after Gates pledged $912 million to the Global Fund’s 2026–2028 replenishment campaign, which aims to save 23 million lives from HIV, tuberculosis and malaria between 2027 and 2029.
The Global Fund has credited its work with helping reduce HIV infection rates by 82 per cent in supported countries since 2000. The addition of low-cost lenacapavir is expected to bolster these gains.
Earlier this year, Bill Gates, Chair of the Gates Foundation also announced that he would give away most of his wealth to accelerate progress in global health.
Mr Gates said the foundation would spend $200 billion over the next two decades on ending preventable deaths of mothers and babies, tackling infectious diseases, and lifting millions out of poverty, before winding down its operations.
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