Twice-Yearly HIV Prevention Injection Sparks Global Access Debate

A long-acting injectable medicine that requires dosing only twice a year is being described as the most significant advance in HIV prevention in a decade, yet its rollout is exposing deep fractures in how global health innovations reach the people who need them most.

Lenacapavir, developed by United States pharmaceutical giant Gilead Sciences, demonstrated extraordinary efficacy in a 2024 clinical trial involving more than 2,000 young women across South Africa and Uganda. Not a single participant who received the injection contracted HIV during the study, a result that has energized researchers and advocates alike.

The World Health Organization has endorsed the drug as an additional form of pre-exposure prophylaxis, commonly known as PrEP, a category of medicine designed to reduce the risk of HIV infection in people who are HIV-negative but face elevated exposure risks.

Carlota Baptista da Silva, who leads global HIV efforts at Doctors Without Borders, known internationally by its French acronym MSF, described lenacapavir in striking terms. She called it the most innovative tool to enter the HIV arena in the past decade, adding that it represents the closest thing the world currently has to an HIV vaccine.

Yet the enthusiasm surrounding this breakthrough is colliding with a difficult moment in the broader fight against the virus. International funding for HIV programs dropped by 18 percent in 2025, falling to $7.3bn, the lowest level recorded in nearly two decades, according to UNAIDS. The financial squeeze has already produced measurable consequences, with the number of people receiving preventive medicine declining from 1.4 million in 2024 to 1.1 million in 2025.

That retreat makes the arrival of a highly effective, twice-yearly prevention option especially consequential. It also makes the question of who will actually be able to obtain it more urgent than ever.

In the United States, lenacapavir carries a price tag of roughly $28,000 per person annually. Generic versions, by contrast, are expected to cost approximately $40 per year. A generic is a copy of the original medicine produced by a different manufacturer once the patent holder has licensed the technology, containing the same active ingredient but manufactured and sold at a fraction of the cost.

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

Gilead is currently supplying its own branded version of the drug at no profit to programs backed by the Global Fund and the US President's Emergency Plan for AIDS Relief, with rollouts underway in South Africa, Kenya, Zambia, Nigeria, and Eswatini. These are not the inexpensive generics expected to cost about $40 annually. The company has licensed six manufacturers to produce those lower-cost versions, with large-scale distribution projected for 2027.

MSF has identified a significant gap in this arrangement. At least 26 middle-income countries are excluded from Gilead's generics agreement, including nations experiencing rising HIV infection rates and several that participated in testing the drug. Brazil, Mexico, Argentina, and Peru are among those left out.

Da Silva argued that it is fundamentally unjust for countries that helped generate the scientific evidence behind a breakthrough medicine to then find themselves shut out of affordable generic access. According to MSF's analysis, the countries excluded from the licensing arrangement accounted for nearly 23 percent of new HIV infections worldwide in 2023.

Gilead has since announced a separate agreement with the Pan American Health Organization, establishing an access pathway for 14 Latin American and Caribbean nations outside its generic licensing territory, including Brazil, Mexico, Argentina, and Peru. MSF contends, however, that this arrangement leaves those countries dependent on Gilead rather than empowered to purchase the cheaper generics automatically.

A separate dispute has emerged over MSF's own attempts to obtain the drug. For more than a year, the humanitarian organization says it has sought permission to buy lenacapavir directly from Gilead for its medical programs, without requesting any discount. Da Silva said that despite these repeated requests, Gilead has refused to allow MSF to purchase the medicine directly.

She emphasized that this matters acutely in humanitarian emergencies. People displaced by conflict or natural disaster often struggle to take a daily prevention pill, while sexual violence and other vulnerabilities can heighten their risk of contracting HIV. Daily PrEP pills are already available as an alternative, but unlike lenacapavir, they must be taken consistently to provide protection. An injection that offers six months of coverage could prove especially valuable in crisis settings.

Da Silva insisted that people living through conflict and humanitarian crises cannot be relegated to the back of the line for medical innovation.

Gilead declined Al Jazeera's request for an interview, citing 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 the drug directly to MSF or why certain countries were excluded from its generics agreement.

The company has stated it 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 contends that this falls far short of the scale required, pointing to projections that close to 20 million people worldwide need access to PrEP in some form to substantially reduce new HIV infections.

Countries left outside Gilead's generic licensing deal may have another avenue. World Trade Organization rules permit governments, under certain circumstances, to bypass a drug company's patent so that cheaper versions can be manufactured or imported without the company's authorization.