Twice-Yearly HIV Shot Raises Hope—and Hard Questions About Who Will Get It

A long-acting injectable drug that requires only two doses a year is being described as the most promising advance in HIV prevention in a decade, but its rollout is unfolding against a backdrop of shrinking global funding and widening questions about equitable access.

The medicine, lenacapavir, is manufactured by the United States pharmaceutical company Gilead Sciences. In a 2024 clinical trial that enrolled more than 2,000 young women in South Africa and Uganda, not a single participant who received the injection contracted HIV—a result that has galvanized the prevention field.

Carlota Baptista da Silva, global HIV lead at Doctors Without Borders (known by its French initials, MSF), called it “the most innovative tool that has reached the HIV arena for the last decade, because it’s the closest we have [to] a vaccine.” The World Health Organization has recommended the long-acting injectable as an additional form of pre-exposure prophylaxis, or PrEP—medication taken to lower the risk of acquiring HIV.

Yet the drug’s arrival comes at a difficult moment. International funding for HIV fell 18 percent in 2025 to $7.3 billion, the lowest level in nearly two decades, according to the United Nations programme on HIV/AIDS, known as UNAIDS. The financial squeeze has already eroded prevention efforts: the number of people receiving medicine to reduce their risk dropped from 1.4 million in 2024 to 1.1 million in 2025.

That decline makes a highly effective, twice-yearly prevention option especially significant—and makes the question of who can obtain it more urgent than ever. For MSF, the scientific verdict is no longer in dispute. Lenacapavir prevents HIV with remarkable efficacy. The remaining battle concerns the rules governing manufacturing, pricing and supply, and whether those rules will let the breakthrough reach the people who need it most.

The price gap is stark. In the United States, lenacapavir costs roughly $28,000 per person annually. Generic versions—copies containing the same active ingredient, produced by other manufacturers after the patent holder licenses the technology—are expected to cost about $40 a year.

In June 2025, the US Food and Drug Administration approved lenacapavir for HIV prevention, giving Americans the option of an injection twice a year. But in numerous low- and middle-income countries, access to the cheaper versions is not expected at scale until 2027.

Gilead is supplying its own version of the drug at no profit for programmes backed by the Global Fund and the US President’s Emergency Plan for AIDS Relief, or PEPFAR, with rollouts under way in countries including South Africa, Kenya, Zambia, Nigeria and Eswatini. Those are not the generic versions expected to cost about $40 per person annually. Gilead has licensed six manufacturers to produce those, with large-scale generic distribution anticipated in 2027.

At least 26 middle-income countries are excluded from Gilead’s generics agreement, according to MSF. The list includes nations with rising HIV infections and some that helped test the drug, among them Brazil, Mexico, Argentina and Peru. “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.

MSF estimates that countries shut out of the licence accounted for close to 23 percent of new HIV infections globally in 2023. Gilead has since announced a separate agreement with the Pan American Health Organization, creating an access pathway for 14 Latin American and Caribbean countries outside its generic licensing territory, including Brazil, Mexico, Argentina and Peru. MSF contends that arrangement leaves those nations dependent on Gilead rather than able to automatically purchase the cheaper generics.

A further friction point involves humanitarian access. For more than a year, MSF says it has sought permission to buy lenacapavir directly from Gilead for its medical programmes, without asking for a discounted price. “Despite those requests, Gilead has not allowed MSF to purchase this medicine directly,” da Silva said.

That gap matters most in humanitarian emergencies, she argues. People displaced by conflict or disaster may struggle to take a daily prevention pill, while sexual violence and other vulnerabilities can heighten the risk of HIV. Daily PrEP pills are already available as an alternative to the injection, but unlike lenacapavir they must be taken consistently to provide protection. An injection conferring six months of protection could be especially 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 Al Jazeera’s request for an interview because of scheduling constraints. In an emailed statement, the company said its access strategy combines no-profit supplies, royalty-free licensing and regional agreements. It did not respond to questions about why it will not sell its drug to MSF, or why certain countries were excluded from its generics agreement. The company plans to provide enough lenacapavir for up to three million people through 2028 as generic manufacturers scale up production, with large-scale generic rollout expected in 2027.

MSF says that falls far short of what is required, pointing to projections that close to 20 million people worldwide need access to PrEP to substantially reduce new HIV infections—a figure covering all forms of PrEP, not just lenacapavir. About 1.3 million people were newly infected with HIV in 2023, according to UNAIDS, underlining the stakes.

Countries left outside Gilead’s generic licensing deal may have another route. World Trade Organization rules allow governments, in some circumstances, to bypass a drug company’s patent so that cheaper versions of a medicine can be made or imported without the company’s permission. Governments can also authorize government use of patented products. Such mechanisms have been invoked in past public health crises, though they often generate political friction and legal pushback.

For now, the debate over lenacapavir encapsulates a broader tension in global health: scientific breakthroughs increasingly outpace the financing and legal frameworks needed to deliver them equitably. As prevention funding retreats and the number of people on PrEP shrinks, the success of the twice-yearly injection may depend less on its science than on the negotiated terms of patents, prices and licensing—decisions being made far from the clinics and displacement camps where the need is greatest.