Access debate grows over twice-yearly HIV prevention injection

A twice-yearly injectable medicine that has shown strong results in preventing HIV is at the centre of an international debate over affordability and access.

Lenacapavir prevented HIV infections among more than 2,000 young women who took part in a 2024 clinical trial in South Africa and Uganda. None of the participants who received the medicine contracted HIV, according to the trial findings reported by the source.

The World Health Organization has recommended the long-acting injection as an additional form of pre-exposure prophylaxis, or PrEP. The United States Food and Drug Administration approved lenacapavir for HIV prevention in June 2025, allowing it to be administered twice a year.

Affordability remains a concern

Despite the medical progress, Doctors Without Borders, also known as MSF, says access could be restricted by the medicine’s price and by Gilead Sciences’ licensing arrangements.

Lenacapavir costs about $28,000 per person annually in the United States, while generic versions are expected to cost about $40 per person annually. Large-scale production of cheaper versions is expected to begin in 2027.

Gilead has licensed six manufacturers to produce generic lenacapavir. However, MSF says at least 26 middle-income countries are outside that agreement. The organisation says those countries accounted for close to 23 percent of new HIV infections worldwide in 2023.

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

Brazil, Mexico, Argentina and Peru are among the countries identified by MSF as excluded from the generic licensing arrangement.

Different access arrangements

Gilead is supplying its own version of lenacapavir at no profit for programmes supported by the Global Fund and the United States President’s Emergency Plan for AIDS Relief. Rollouts are under way in countries including South Africa, Kenya, Zambia, Nigeria and Eswatini.

The company has also announced an agreement with the Pan American Health Organization covering an access pathway for 14 countries in Latin America and the Caribbean that are outside its generic licensing territory.

MSF argues that the regional agreement leaves the countries covered dependent on Gilead rather than giving them automatic access to lower-cost generic products. Gilead says its broader access strategy combines no-profit supplies, royalty-free licensing and regional agreements.

Gilead declined an interview request and responded by email. The company says it plans to provide enough lenacapavir for up to three million people through 2028 while generic manufacturers expand production.

Humanitarian access

MSF says it sought permission for more than a year to buy lenacapavir directly from Gilead for its medical programmes, but the company did not allow those purchases.

“Despite those requests, Gilead has not allowed MSF to purchase this medicine directly,” da Silva said. She added that the twice-yearly injection could be particularly important for people affected by conflict, disasters, sexual violence and other humanitarian crises.

“People living through conflict [and] humanitarian crises cannot be the last in line for medical innovation,” she said.

MSF is urging governments excluded from Gilead’s licence to consider legal measures such as compulsory licensing, government-use authorisations and patent challenges. World Trade Organization rules and the 2001 Doha Declaration allow countries, in some circumstances, to use intellectual-property safeguards for public health.

The access dispute comes as international HIV funding fell to $7.3bn in 2025, an 18 percent decrease, according to UNAIDS figures reported by the source. The number of people receiving medicine to reduce HIV risk also fell from 1.4 million in 2024 to 1.1 million in 2025.

MSF says projections indicate that close to 20 million people may need access to PrEP to substantially reduce new HIV infections globally. It argues that Gilead’s planned supply for up to three million people through 2028 remains far below that potential need.