A Twice-Yearly HIV Prevention Shot Could Be a Game-Changer — If People Can Actually Get It

A new injectable drug that requires only two doses a year is being described as the most significant advance in HIV prevention in a decade, offering protection so effective that researchers recorded zero infections among recipients in a major clinical trial. Yet as the medicine moves toward wider use, the debate is shifting from whether it works to who will be allowed to have it.

The drug, lenacapavir, was developed by the American pharmaceutical giant Gilead Sciences. In a 2024 study involving more than 2,000 young women in South Africa and Uganda, not a single participant who received the injection contracted HIV. The World Health Organization has since recommended the long-acting injectable as an additional form of pre-exposure prophylaxis, or PrEP — medication taken to lower the risk of contracting the virus.

Carlota Baptista da Silva, who leads global HIV work at Doctors Without Borders, known by its French initials MSF, called it "the closest we have to a vaccine." She described lenacapavir as the most innovative tool to reach the HIV field in roughly ten years, a sentiment echoed across the global health community.

The enthusiasm, however, is colliding with a stark funding reality. International financing for HIV efforts dropped 18 percent in 2025, falling to $7.3bn — the lowest figure in nearly two decades, according to UNAIDS. The consequences are already visible: the number of people receiving preventive medicine fell from 1.4 million in 2024 to 1.1 million in 2025. In that context, a highly effective option requiring just two injections per year carries enormous promise — and enormous questions about distribution.

Cost is at the center of the access problem. In the United States, lenacapavir is priced at roughly $28,000 per patient annually. Generic alternatives, once available, are expected to cost around $40 per year. A generic is a copy of the original drug produced by another manufacturer after the patent holder licenses the technology; it uses the same active ingredient but can be made and sold far more cheaply.

The US Food and Drug Administration approved lenacapavir for HIV prevention in June 2025, giving Americans the option of a twice-yearly shot. But in many low- and middle-income countries, widespread access to the cheaper generic form is not anticipated until 2027. Gilead is currently supplying its own version at no profit to programs backed by the Global Fund and the US President's Emergency Plan for AIDS Relief, known as PEPFAR, with rollouts under way in South Africa, Kenya, Zambia, Nigeria and Eswatini.

Those supplies are not the low-cost generics. Gilead has licensed six manufacturers to produce generic versions, with large-scale distribution expected in 2027. But MSF says at least 26 middle-income countries have been left out of that licensing agreement, including nations seeing rising HIV infection rates and several that helped test the drug. Brazil, Mexico, Argentina and Peru are among those excluded.

"People should not really help generate the evidence for breakthrough medicine and then find that their country is excluded from affordable generic access," da Silva said. According to MSF, the excluded countries accounted for nearly 23 percent of new HIV infections worldwide in 2023.

Gilead later announced a separate arrangement with the Pan American Health Organization, establishing an access route for 14 Latin American and Caribbean nations outside its generic licensing territory, among them Brazil, Mexico, Argentina and Peru. MSF contends that this approach leaves those countries reliant on Gilead's goodwill rather than empowered to purchase cheaper generics on their own terms.

A second grievance concerns MSF's own inability to obtain the drug. For more than a year, the organization says it has asked Gilead for permission to buy lenacapavir directly for its medical programs — without requesting any discount. "Despite those requests, Gilead has not allowed MSF to purchase this medicine directly," da Silva said.

She argues this matters most in humanitarian emergencies. People uprooted by conflict or natural disaster often cannot maintain a daily pill regimen, while sexual violence and other heightened vulnerabilities increase their risk of infection. Daily PrEP pills already exist as an alternative to the injection, but unlike lenacapavir, they only work if taken consistently. A shot that provides six months of protection could be uniquely valuable in such settings.

"People living through conflict [and] humanitarian crises cannot be the last in line for medical innovation," da Silva said. Gilead declined an interview request from Al Jazeera, citing scheduling constraints. In an emailed statement, the company said its access strategy combines no-profit supplies, royalty-free licensing and regional agreements, but it did not answer questions about why it will not sell the drug to MSF or why certain countries were excluded from the generics deal.

Gilead has said it plans to supply enough lenacapavir for up to three million people through 2028 as generic manufacturers ramp up production. MSF calls that scale inadequate, citing projections that close to 20 million people globally need access to PrEP — in all its forms, not just lenacapavir — to meaningfully reduce new infections.

Countries outside Gilead's licensing arrangements may still have another avenue. World Trade Organization rules, in certain circumstances, permit governments to override a drug company's patent so that cheaper versions can be manufactured or imported without the company's consent. Governments can also authorize public use of a patented medicine. Whether such measures will be invoked — and how quickly — remains one of the open questions determining whether a scientific breakthrough becomes a global health triumph or another example of unequal access.