Twice-Yearly HIV Prevention Drug Declared Breakthrough, But Access Remains Unequal

A twice-yearly injection could revolutionize HIV prevention efforts.

A 2024 clinical trial involving over 2,000 young women in South Africa and Uganda found zero HIV infections among participants who received lenacapavir.

Developed by US pharmaceutical company Gilead Sciences, the injectable drug serves as pre-exposure prophylaxis (PrEP) to reduce HIV risk.

“It is the most innovative tool to reach the HIV landscape in a decade, representing the closest alternative we have to a vaccine,” said Carlota Baptista da Silva, global HIV lead at Doctors Without Borders (MSF), in an interview with Al Jazeera.

The World Health Organization (WHO) has endorsed the long-acting injectable as an additional PrEP option.

However, the drug’s introduction arrives at a difficult moment in the global HIV response. International HIV funding dropped 18 percent in 2025 to $7.3 billion, its lowest point in nearly two decades, according to UNAIDS. This funding squeeze has impacted prevention programs: the number of people receiving risk-reducing medication fell from 1.4 million in 2024 to 1.1 million in 2025.

This makes the arrival of a highly effective, twice-yearly preventive option particularly significant, raising the urgent question of who can access it.

For MSF, the scientific debate is largely settled: lenacapavir prevents HIV with remarkable efficacy.

The current battle centers on whether the rules governing manufacturing, pricing, and supply will allow this scientific breakthrough to reach those in need.

Why some countries are excluded

In the United States, lenacapavir costs approximately $28,000 per person annually, whereas generic versions are expected to cost around $40 per year.

A generic drug is a copy of the original produced by another manufacturer after the patent holder licenses the technology, containing the same active ingredients but sold at a significantly lower price.

The US Food and Drug Administration (FDA) approved lenacapavir for HIV prevention in June 2025, offering a twice-yearly injection option. Yet, in several low- and middle-income countries, access to cheaper versions is not anticipated at scale until 2027.

Gilead is supplying its own version of lenacapavir at no profit to programs supported by the Global Fund and PEPFAR, with rollouts underway in South Africa, Kenya, Zambia, Nigeria, and Eswatini.

These are not the cheaper generic versions expected to cost about $40 per person annually. Gilead has licensed six manufacturers to produce those generics, with large-scale rollout expected in 2027.

At least 26 middle-income countries are excluded from Gilead’s generic agreement, MSF says, including nations with rising HIV infections and some that participated in drug trials, such as Brazil, Mexico, Argentina, and Peru.

“People should not have to help generate evidence for a breakthrough medicine only to discover their country is excluded from affordable generic access,” da Silva stated.

According to MSF, countries excluded from the license accounted for nearly 23 percent of new HIV infections globally in 2023.

Gilead subsequently announced a separate agreement with the Pan American Health Organization, establishing an access pathway for 14 Latin American and Caribbean countries outside its generic licensing territory, including Brazil, Mexico, Argentina, and Peru.

MSF argues this leaves those countries dependent on Gilead rather than able to purchase cheaper generics automatically.

MSF says it still cannot buy the drug

For over a year, MSF says it has sought permission to purchase lenacapavir directly from Gilead for its medical programs, without demanding a discounted price.

“Despite those requests, Gilead has not allowed MSF to purchase this medicine directly,” da Silva said.

This is especially critical 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 increase HIV risk.

Daily PrEP pills are already available as an alternative to the injection. However, unlike lenacapavir, they require consistent daily use to provide protection. An injection offering six months of protection could be invaluable.

“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 due to scheduling constraints. In an emailed statement, it said its access strategy combines no-profit supplies, royalty-free licensing, and regional agreements. It did not respond to questions about why it refuses to sell the 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 this 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, including all forms of PrEP, not just lenacapavir.

However, countries left outside Gilead’s generic licensing deal may have another option.

Can governments bypass the patent barriers?

World Trade Organization (WTO) rules allow governments, in some cases, to bypass a drug company’s patent so cheaper versions can be manufactured or imported without the company’s permission.

They can also authorize government use of patents and challenge patents deemed weak or unjustified. The 2001 Doha Declaration affirmed WTO members’ right to use such safeguards to protect public health.

Brazil has used these powers before in the fight against HIV. In 2007, after negotiations with Merck over the price of efavirenz failed, Brazil issued a compulsory license to access cheaper generic versions.

Nearly two decades later, activists are urging Brazil to consider using those powers again for lenacapavir if patent barriers prevent affordable generic access.

MSF says governments excluded from Gilead’s license could consider those same legal safeguards for lenacapavir, including compulsory licensing, government-use authorizations, and patent challenges.

It also calls on Gilead to ensure its agreements with generic manufacturers do not prevent them from supplying countries where patent barriers have been removed through such measures.

For MSF, the stakes go beyond lenacapavir. The way the drug is made available could determine whether one of the greatest advances in HIV prevention in decades reaches people based on need, rather than where they live or what their health systems can afford.

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

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