At Riruta Health Centre in Nairobi, a clinician fills a syringe with lenacapavir, an HIV-prevention shot given just twice a year. Now a low-cost generic version has received tentative approval from the U.S. Food and Drug Administration, bringing the medicine closer to people in lower-income countries.
The approval was announced by Dr. Reddy's Laboratories, the Indian company making the generic, and Unitaid, a global health initiative. Under a pricing agreement announced in September 2025, the shot is expected to cost $40 per person per year in 120 countries. The agreement involved Unitaid, South Africa's Wits RHI health research institute, the Clinton Health Access Initiative, known as CHAI, and Dr. Reddy's.
Lenacapavir was developed by U.S. drugmaker Gilead Sciences and approved in June 2025. In large clinical trials, it was more than 99.9% effective at preventing HIV. It is not a vaccine: instead of training the immune system, the drug targets a protein shell that protects HIV's genetic material. But like a vaccine, its long-lasting effect means people need only two injections a year.
That schedule may make prevention easier than taking a pill every day. Daily HIV-prevention pills, called pre-exposure prophylaxis or PrEP, have been available in the United States since 2012, but they work only when taken consistently. Lenacapavir's price has been a major barrier: it costs roughly $28,000 per year in the United States, before accounting for insurance. The generic price of $40 a year is comparable to the cost of daily prevention pills, according to Carmen Perez-Casas, Unitaid's senior strategy lead for HIV and pandemic preparedness.
Perez-Casas called the FDA decision “an extraordinary milestone for global health.” She said access to new medicines in lower- and middle-income countries has often lagged a decade or more behind richer countries. With lenacapavir, she said, that wait has been reduced to little more than a year.
The FDA's decision is described as tentative approval. Under an accelerated pathway, a generic maker can rely on existing data. It moves the medicine closer to market, but the work of getting it to people is still ahead. More than 125,000 people in 10 early-adopter African countries have already started Gilead's version, Unitaid said. In late 2024, Gilead granted voluntary licenses to six generic manufacturers, including Dr. Reddy's.
The need remains urgent. An estimated 1.2 million people acquired HIV last year, even as a prevention medicine offering near-total protection became available. HIV has killed more than 40 million people over four decades. Unitaid says it is working with governments and partners to support rollouts led by each country, with communities involved in reaching those who need the shot. The generic approval is a major step toward wider access; whether it changes prevention on a large scale will depend on how quickly countries can bring it to clinics and communities.