By most accounts, the HIV drug lenacapavir is so effective in preventing infection and treating HIV-positive patients that it could revolutionize the fight against AIDS.
“Lenacapavir could be transformative,” says Peter Maybarduk, director of the access to medicines program at the nonprofit organization Public Citizen, “if people can get it.”
What’s the main obstacle? It’s the drug company that developed and owns lenacapavir, Foster City, Cal.-based Gilead Sciences. Gilead has so tightly limited access to the drug that millions of people at risk from HIV might not get it, according to Public Citizen.
“We have a technology that could end AIDS, and collectively we’re wasting it,” Maybarduk told me.
Gilead’s action became public at the end of March, when the international health organization Médicins Sans Frontières, or MSF, published an open letterdetailing its fruitless yearlong effort to purchase a supply of lenacapavir from the company.
MSF, or Doctors Without Borders, says Gilead advised it to obtain the drug from the Global Fund to Fight AIDS, Tuberculosis and Malaria, which will acquire 2 million doses over three years.
That’s a small fraction of what’s needed, MSF said in its letter, given that “this allocation is capped, demand far exceeds supply, and every dose directed to MSF is a dose unavailable to another program.”
The last meeting between MSF and the company came on Feb. 18, when the company “made it clear that there was no prospect that they would sell directly to us,” says Melissa Barber, MSF’s global health advocacy and policy advisor. “We went through all the reasons why they would say ‘no,’ and they finally said that negotiating supply contracts is ‘a lot of work.’”
Gilead’s refusal to sell to MSF left the organization’s negotiators bewildered. “We weren’t asking them for a donation,” Barber said. MSF was willing to pay for the drug, but “we never even got to the question of price; it was a question of whether they would even sell to us at all.”
Gilead says it’s committed to “ensuring broad, sustainable access” to the drug via licenses it has issued to generics manufacturers taking effect next year, and through a deal with a U.S. agency and an international organization.
Lenacapavir, which Gilead markets in the U.S. as Yeztugo, has become widely sought because it requires only two injections twice a year for pre-exposure prophylaxis, or PrEP — that is, to protect against HIV before a person is exposed to the virus. That makes it relatively easy to administer to mobile populations in less-developed countries.
In the U.S., Gilead’s list price for the drug is more than $28,000 per person per year, and $42,000 for the post-exposure treatment version. Its price for the Global Fund is confidential, but experts believe it’s about $100 per person per year. Once manufacturing is fully ramped up, a year’s supply of the drug could be made for as little as $25, according to professional estimates. The mismatch among those prices and costs has prompted Gilead’s critics to accuse the company of placing profits before people.
This is not the first time that Gilead has been accused of profiteering. The same accusation arose a decade ago over its marketing of Sovaldi and Harvoni, its miracle cures for hepatitis C.
As the Senate Finance Committee documented in 2015, its executives concluded it could make a profit by charging $55,000 per 12-week treatment for Sovaldi. But the company decided to charge $84,000, making it so expensive that insurance carriers and government programs imposed severe restrictions on coverage. Gilead brought its follow-on drug Harvoni to market at nearly $100,000 for a full treatment.
Gilead has ranked low among major pharmaceutical companies for its resistance to providing maximum public access for livesaving therapies — it ranked 16th among 20 top companies in an index maintained by the nonprofit Access to Medicine Foundation measuring drugmakers’ “efforts to improve access to medicines, vaccines, and diagnostics in low- and middle-income countries.”
HIV is a major focus for Gilead, with its suite of HIV drugs accounting for $16.9 billion of its $20.9 billion in product sales last year, even without a major contribution from lenacapavir. Overall, Gilead reported a pretax profit of $9.8 billion on revenue of $29 billion in 2025.
Gilead’s position on access to lenacapavir comes at a fraught moment for the global fight against HIV.
The biggest problem is the Trump administration’s hostility to foreign aid generally, as evidenced by its dismantling of the U.S. Agency for International Development, which had been a major source of funding for anti-HIV programs around the world. On the day of his inauguration, Trump ordered a 90-day freeze on all U.S. foreign aid funding, including the U.S. State Department’s PEPFAR — the President’s Emergency Plan for AIDS Relief, which was launched by President George W. Bush in 2003 and has been credited as saving 26 million lives since then.
Secretary of State Marco Rubio issued a partial waiver allowing PEPFAR to continue, but the waiver was limited to PrEP for pregnant and breastfeeding women, Jennifer Kates and Kellie Moss of KFF have reported.
Congress has supported PEPFAR in the face of Trump’s opposition by maintaining its funding at $6 billion in 2026, the same level as last year. But people familiar with the program say the government has been slow-walking the funding, leaving many overseas programs uncertain how to operate.
“A lot of the programs and community services and networks that the world relied on to deliver HIV/AIDS treatment and PrEP have been dismantled or abandoned for lack of funding for a year,” Maybarduk says.
Gilead has cited some initiatives it says are aimed at making lenacapavir more accessible. The company in September touted a deal it reached with the Global Fund and PEPFAR to “accelerate access to lenacapavir and move us closer to ending the HIV epidemic,” Gilead Chief Executive Daniel O’Day said then, calling the drug “one of the most important scientific breakthroughs of our time.” He said it would be provided at a price that yielded no profit to the company. But since the deal was for a mere 2 million doses over three years, the HIV community was largely unimpressed.
Gilead also has cited licensing contracts it has reached with six makers of generic drugs in India, Pakistan and Egypt to begin manufacturing and distributing the generic version starting next year, after Gilead’s patent on the drug expires. The contract terms are unusually strict, however: The licensees can sell to 120 low- and middle-income countries, but are strictly forbidden to provision 26 middle-income countries in Latin America, Eastern Europe and the Middle East.
Gilead told me by email that the generics rollout would “enable rapid, affordable, long‑term supply across 120 high-incidence, resource-limited countries.” It said it had “significantly accelerated” approval of generics manufacturing, which it said would be “unprecedented in both speed and scale.”
Among the excluded markets are Argentina, Brazil, Mexico, and Peru, where the company held clinical trials that contributed to the drug’s development, in part because HIV incidence was high in those countries. Gilead has said it will provide the drug to trial participants in those countries, “but this alone is not a national access plan and it will do too little to help reduce the HIV incidence in these countries,” observed global health expert Gavin Yamey of Duke University in 2024.
Although Gilead has applied for or received patents for lenacapavir in 15 of the excluded countries, “it has made no promises that it will sell or license the drug in those countries,” says Brook Baker of Northeastern University Law School, who has followed the licensing issue closely.
There aren’t many tools for HIV patient advocates to persuade Gilead to allow broader international distribution of lenacapavir. The federal Bayh-Dole Act of 1980 allows the government to force drug companies to license products if they’ve been developed with federal funds, as are most drugs reaching the market today.
Although studies at the University of Utah provided some of the basic research that led to the development of lenacapavir, the federal support for that research was too remote from the drug’s ultimate development to provide for government “march-in rights.”
“This is wholly Gilead’s drug,” Maybarduk says. In any case, the government has never claimed march-in rights for any drug.
All that remains may be the power of public suasion, but Gilead hasn’t demonstrated much sensitivity to such pressure. The first clue to whether it will alter its position might come Tuesday, when O’Day joins a State Department official and Peter Sands, the Global Fund’s executive director, for a one-hour webcast about last September’s announced deal.
But the company hasn’t offered any clues to what O’Day might announce, if anything. Until then, HIV advocates will have to live on hope.
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