Millions of people at risk of HIV in low- and middle-income countries (LMICs) such as Malawi will have access to a new prevention option, a low-cost, generic version of lenacapavir, the world’s first twice-yearly injectable pre-exposure prophylaxis (PrEP).
A new partnership between the Gates Foundation and Indian manufacturer Hetero Labs (Hetero) will enable the company to manufacture generic lenacapavir at roughly $40 per patient per year, 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,” Dr Vamsi Krishna, managing director of Hetero Group of Companies, said.
He added that the collaboration aims to ensure access to innovative HIV medicines for patients in India and other low- and middle-income countries.
Lenacapavir in LMICs, is expected to reach countries as early as the end of 2025.
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The PreP, approved by the United States Food and Drug Administration and the European Commission, offers six months of protection with a single injection.
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.
Modelling suggests that the introduction of lenacapavir has the potential to prevent significant numbers of HIV infections.
One study showed that scaling up access to affordable lenacapavir to just four percent of the population in high-burden countries could prevent up to 20 percent of new infections.
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“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,” Trevor Mundel, president of global health at the Gates Foundation, said.
“We are committed to ensuring that those at highest risk, who can least afford it, aren’t left behind.”
Following regulatory approvals, generic lenacapavir is expected to flow through national HIV programmes and public procurement channels such as the Global Fund.
Despite global progress driving down HIV rates and Aids-related deaths since 2000, 1.3 million people acquired HIV in 2024, and only 18 percent of people who could benefit from PrEP currently have access.
