Gilead Refuses To Sell Lenacapavir To MSF

Melissa Barber, Ph.D., a health economist with Médecins Sans Frontières, told me that she was surprised that Gilead refused to sell lenacapavir to MSF, providing further details here. “While Gilead has licensed the drug to 120 countries, these generic drugs won’t be available until 2027, and it excludes dozens of countries,” she said.

Barber is highly critical of Gilead’s saying on its website, “We’re all in this together” and "Working to End the HIV Epidemic for Everyone" but then limiting access of low and middle-income countries to the Global Fund to Fight AIDS, Tuberculosis and Malaria. There, Gilead said it would offer doses for 2 million people over three years when 20 million might be eligible. Gilead had “announced its capacity to produce up to 10 million doses of lenacapavir by 2026, sufficient to fulfill the pledge made by the Global Fund and PEPFAR.”

I asked Gilead to verify MSF’s claim that it is refusing to sell Lenacapavir to the organization and to clarify why. I also asked why the company is only making 2 million (now 3) doses available through the Global Fund when they say they will have 10 million doses by 2026.

On Tuesday, Gilead announced it would provide another million doses to PEPFAR and the Global Fund. MSF’s director of the Southern Africa Medical Unit, Dr. Tom Ellman, responded, “Any expanded access to lenacapavir is a good thing, but reaching only one million more people in three years is a tiny fraction of what's needed to make a real dent in the HIV epidemic.”

Gilead’s response to the situation is this statement and a link: “Gilead is committed to ensuring broad, sustainable access to lenacapavir for HIV prevention in high‑incidence, resource‑limited countries. We are working closely with partners—including the Global Fund, the President’s Emergency Plan for AIDS Relief, and others—to accelerate delivery at unprecedented speed and at no profit to Gilead until generic manufacturers are able to meet demand.”

Note that MSF was not asking for a handout. It was looking to purchase doses outside the Global Fund’s capped allocation. Barber adds, “If you can afford it, there is no cap in the United States.”

Gilead has set the price of lenacapavir at $28,218 per person per year. It can be produced for as little as $25 per year if there are high enough volumes. Generic lenacapavir is expected to cost $40 per patient per year, according to the Gates Foundation, which is still profitable.

Global Health Needs

Public Citizen states, “sufficient US funding is available now to procure LEN-LA from Gilead, at their secret ‘access price’ of $100 per person per year. They add, however, that approximately $2.3 billion already appropriated for expenditure by PEPFAR in FY2026, are being illegally withheld by President Trump and Russell Vought, Director of the Office of Management and Budget.” Clinical trials funded by PEPFAR were all stopped abruptly, and Trump directed funding cuts on HIV research in particularly high-risk groups (e.g., sex workers and LGBTQ).

Peter Maybarduk, director of Public Citizen’s Access to Medicines program, is upset with Gilead’s allocation plan, noting, “there's a very serious need, both because of the value of the technology, but also because of the decimation of global health that we've witnessed over the past year. Very serious need for everyone to bring everything they can to the table.” He added, “Even if we can solve like the pricing and supply problems, you still have the challenges related to the cuts to community infrastructure and global health development that Trump made last year.”

Gregg Gonsalves, a Yale epidemiologist, long-time AIDS activist and co-founder of Defend Public Health, took a critical view of Gilead. “Yes,” he said, “Gilead has signed licensing agreements with six generic companies and a generic version should be available in 2027, but in the meantime, that means thousands of preventable HIV infections could have been avoided if these agreements were part of the initial launch package.”

“It is also playing games with countries like South Africa where PEPFAR has offered up a few thousand doses in a country with 8 million existing HIV infections,” Gonsalves added. “Gilead could have offered South Africa the ability to make its own version of the drug months and months ago. This drip-drop, slow-walking approach to lenacapavir access is again evident in Gilead’s refusal to sell lenacapavir to Doctors Without Borders, telling them to go ask the Global Fund for drug, when the supply availability through the Fund is limited and way below the need for it in low and middle income countries. The policy by Gilead is delay and deflect—it’s disingenuous, manipulative and will cost lives. People affected by HIV put their lives on the line to be part of clinical trials of this drug, Gates Foundation and others have put resources into its roll-out, but in the end Gilead sees one audience for what it is doing, its shareholders, and maximizing its share price is more important to them than the lives of people around the world.”

Profitability

Amesh Adalja, an infectious diseases physician, has a contrarian perspective on this. He dismisses arguments about government funding of research, as do some others, who note that the Bayh-Dole Act enables universities and businesses to patent inventions from such research.

Adalja continued via email, “Gilead has a moral right to charge what they want for their product and enter into whatever arrangements they choose. Lenacapavir is their property and it is just for them to produce and trade it in whatever manner they determine will yield the best return for their shareholders.”

Data from the Gates Foundation shows that while 1.3 million people acquired HIV in 2024, only 18% of people who could benefit from preexposure prophylaxis currently have access. It further notes that in a high-burden country, a small-scale expansion of access to 4% of the population would yield a disproportionate benefit — preventing up to 20% of new infections.

Research Ethics

While Gilead has a royalty-free voluntary licensing agreement to supply the generic drug to 120 low and lower-middle-income countries by 2028, thousands will die in the interim. This deal also leaves out middle-income and Latin American countries, a number of which participated in the PURPOSE trials that established the drug’s efficacy — “including Argentina, Brazil, Mexico, and Peru, countries where people participated in pivotal LEN-LA clinical trials that generated the data used by Gilead to secure US FDA approval.”

One of the basic “Belmont principles” of research ethics is distributive justice — the risks and benefits of research participation should be equitably distributed among different populations. Further international standards state that sponsors should give test volunteers access to the proven interventions they helped test. A study by researchers at Yale that was published in JAMA in November found that access to medicines after a trial was most limited in Africa and Latin America. For example, access to medicines in Africa wasn’t available for (median) “40 months after FDA approval—10 times longer than in Western Europe.”

That leads us to the question Ugandan HIV/AIDS researcher Peter Mugyenyi asked at the 2000 International AIDS Conference, “Where are the drugs? The drugs are where the disease is not. And where is the disease? The disease is where the drugs are not.”