Millions of people across Africa and other low- and middle-income countries, including Kenya, are set to access a powerful new HIV prevention option following a groundbreaking deal that will drastically cut the cost of treatment.

The Bill & Melinda Gates Foundation has partnered with Indian pharmaceutical manufacturer Hetero Labs to produce a generic version of lenacapavir, the world’s first twice-yearly injectable pre-exposure prophylaxis (PrEP). Once approved, it will cost as little as $40 (Ksh5,100) per patient per year.

“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.

“This collaboration reflects our commitment to ensuring access to innovative HIV medicines for patients in India and other low- and middle-income countries.”

Lenacapavir, which was approved this year by the US Food and Drug Administration and the European Commission, provides six months of HIV protection with just one injection. Experts describe it as a transformative option for people who struggle with daily oral PrEP due to stigma, adherence challenges, or irregular access to medication.

According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), Kenya recorded over 22,000 new HIV infections in 2023, and young women remain disproportionately affected.

Public health experts say lenacapavir could be a game-changer in reducing new infections, particularly in high-burden counties such as Homa Bay, Kisumu, and Siaya.

“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.”

In parallel, Unitaid, the Clinton Health Access Initiative (CHAI), and Wits RHI announced a similar collaboration with another Indian manufacturer, Dr Reddy’s Laboratories Ltd. This move, they said, will “reinforce efforts to build a competitive generics ecosystem” and ensure a sustainable supply of the drug.

The generic supply of lenacapavir could be available as early as 2027, pending regulatory approval, while initial doses are expected to reach low- and middle-income countries by the end of 2025 under existing agreements between the Global Fund, PEPFAR, and Gilead Sciences.

Kate Hampton, CEO of the Children’s Investment Fund Foundation (CIFF), hailed the agreements as “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,” she added.

The Gates Foundation has invested more than $80 million to accelerate market readiness for lenacapavir and is also supporting delivery systems and regulatory approvals to fast-track access. Earlier this week, Bill Gates announced a $912 million pledge to the Global Fund’s 2026-2028 campaign, which aims to save 23 million lives from HIV, malaria, and tuberculosis.

Despite global progress, 1.3 million people were newly infected with HIV in 2024, and only 18% of people who could benefit from PrEP currently have access. Modeling studies suggest that scaling up lenacapavir to just 4% of the population in high-burden countries could prevent up to 20% of new infections.

For Kenya, where HIV/AIDS remains the leading cause of adult deaths and over 1.3 million people live with the virus, the new injection offers hope. If rolled out effectively through national health systems, it could ease the burden on families, especially in rural communities where access to healthcare and daily medication is a struggle.