Access Concerns Cloud Promise of Twice-Yearly HIV Prevention Injection

A twice-yearly injection that can prevent HIV is facing questions over its price, licensing arrangements and availability in countries that may need it most.

Lenacapavir showed high effectiveness in a 2024 clinical trial involving more than 2,000 young women in South Africa and Uganda. None of the participants who received the medicine contracted HIV, according to the report on the trial.

The World Health Organization has recommended long-acting injectable lenacapavir as an additional form of HIV pre-exposure prophylaxis, or PrEP. The United States Food and Drug Administration approved it for HIV prevention in June 2025.

The injection is administered twice a year and is intended to provide six months of protection. Daily PrEP pills remain an alternative, but they must be taken consistently to provide protection. Doctors Without Borders, also known as MSF, says a long-acting option could be particularly valuable for people affected by conflict, displacement or humanitarian emergencies, where taking a pill every day can be difficult.

Concerns over generic access

MSF says at least 26 middle-income countries are excluded from Gilead Sciences’ generic licensing agreement for lenacapavir. The organisation identified Brazil, Mexico, Argentina and Peru among the countries outside the agreement and said those countries represented close to 23 percent of new HIV infections globally in 2023.

Generic medicines are versions of original drugs made by other manufacturers after the patent holder licenses the technology. Gilead has licensed six manufacturers to produce generic lenacapavir, with large-scale production expected in 2027.

MSF has called on Gilead to ensure that its licensing arrangements do not prevent supply to countries where governments have removed patent barriers through legal measures.

“People should not really help generate the evidence for breakthrough medicine and then find that their country is excluded from affordable generic access,” Carlota Baptista da Silva of MSF said.

The expected price difference is substantial. The source report puts the approximate United States cost of lenacapavir at $28,000 per person annually, while generic versions are expected to cost about $40 per person annually. The final price and availability of generic supplies have not been established for each country.

Gilead outlines supply plans

Gilead said its access strategy includes no-profit supplies, royalty-free licensing and regional agreements. The company has committed to providing its own version of lenacapavir at no profit to programmes supported by the Global Fund and the US President’s Emergency Plan for AIDS Relief.

It has also announced a separate agreement with the Pan American Health Organization covering 14 countries in Latin America and the Caribbean. Gilead said it plans to provide enough medicine for up to three million people through 2028 while generic manufacturing expands.

MSF says that planned supply is well below the projected need. The organisation estimates that close to 20 million people worldwide need access to PrEP to substantially reduce new HIV infections.

MSF also says Gilead has not permitted it to purchase lenacapavir directly for its medical programmes, despite requests made over more than a year. The reasons for that decision were not provided, and Gilead did not respond to questions on the issue in the source report.

“For a humanitarian medical organisation, we should not have to spend more than a year trying to find a way to buy a WHO-recommended medicine,” da Silva said.

Public-health safeguards

The debate has revived discussion of public-health measures that allow governments, in some circumstances, to bypass drug patents and make or import lower-cost versions without the patent holder’s permission.

The 2001 Doha Declaration affirmed the right of World Trade Organization members to use such safeguards. Brazil previously issued a compulsory licence for the HIV drug efavirenz in 2007 after price negotiations with Merck failed.

MSF says access to lenacapavir should not depend solely on commercial licensing decisions. Da Silva said, “People living through conflict [and] humanitarian crises cannot be the last in line for medical innovation.”

While the medicine’s clinical results have generated optimism, the timing and scale of its rollout will vary by country. It also remains unclear whether all countries excluded from Gilead’s generic agreement will gain access through the Pan American Health Organization arrangement.