Despite a new supply commitment from Gilead Sciences, Doctors Without Borders/Médecins Sans Frontières (MSF) is poking holes in the company’s plan to support global access to its twice-yearly injectable HIV pre-exposure prophylaxis (PrEP) medicine Yeztugo.
Gilead announced Tuesday that it is expanding its Yeztugo supply program to reach an additional 1 million people in high-incidence, resource-limited countries, bringing the total to 3 million people through 2028. The access plan is in collaboration with the U.S. State Department, the United States President’s Emergency Plan for AIDS Relief (PEPFAR) and The Global Fund, all of which are “experts in country delivery and distribution,” the company said.
However, international humanitarian aid program MSF says that this commitment is “not nearly enough” to make a dent in the global HIV epidemic.
"The number of doses announced today—spread over multiple years, split between countries, and then divided among health facilities—is insufficient,” director of MSF’s Southern Africa Medical Unit Tom Ellman said in a Tuesday MSF release. “If Gilead has the capacity to produce more, it’s indefensible and inhumane that they’re choosing not to.”
According to Ellman, the country with the highest rates of new HIV infections in the world, Eswatini, has only received 70 doses of Gilead’s long-acting PrEP, “which were depleted in weeks.” A clinic MSF is working with in Kenya, meanwhile, is operating on “a paltry 39 doses,” Ellman said.
So far, initial deliveries of Gilead’s HIV prevention have reached nine African countries through the Global Fund, which said in its own Tuesday announcement. Some of those countries, including Eswatini and Kenya, have already started distributing Yeztugo, also known as lenacapavir, with early uptake “particularly strong among priority populations,” the Global Fund said.
“As one of the countries preparing for early introduction, Eswatini is committed to ensuring that this innovation reaches those who need it most,” the country’s Minister of Health, Mduduzi Matsebula, commented in the Global Fund’s release. “We value the Global Fund and United States partnership in helping us move quickly and effectively.”
As part of its expansion to another 1 million people, the Global Fund arrangement has now also extended to 12 additional countries, including Haiti, Indonesia, Morocco, Rwanda and Thailand.
“Our focus now is on supporting rapid, responsible introduction—ensuring that programs are ready to deliver and communities can benefit as quickly as possible,” head of grant management Mark Edington commented, describing the level of country demand for the drug as “both encouraging and urgent.”
MSF has been looking to get involved in Gilead’s Yeztugo access plan for the last year, but the company has refused its repeated requests to directly purchase doses, the organization said in a March 31 open letter to Gilead.
In the letter, Ellman and MSF USA’s CEO Tirana Hassan laid out Gilead’s rationale for denying MSF’s requests, as relayed during a February meeting with the company.
Gilead’s defense, according to the letter, leans heavily on its plan to support affordable generics in certain countries in 2027, which is a key spoke in the company’s wider access plan. However, MSF argues that “deflecting responsibility to future generics, while having no plan to supply much of the world during the first two years of launch, is unacceptable,” Ellman and Hassan wrote.
The company acknowleges that it has “engaged with MSF over an extended period through multiple discussions focused on access pathways, supply planning, and how best to maximize public health impact during the early rollout phase,” a company spokesperson told Fierce Pharma over email.
“The consistent message has been that, during this phase, lenacapavir supply is being managed through a single, coordinated pathway with the Global Fund and PEPFAR—an approach designed to enable equitable allocation, avoid fragmentation, and ensure efficient use of early supply. Direct bilateral contracting outside that model would undermine the coordinated systems needed to deliver access at scale,” the spokesperson continued. “We continue to value dialogue with MSF and have engaged constructively on both near term access and the transition to large scale generic supply.”
Gilead's broader access plan
Gilead got the ball rolling on its global Yeztugo supply strategy months before the med’s world-first approval from the FDA in June, inking voluntary license agreements back in October 2024 with six generic manufacturers that will make and sell the drug in 120 high-incidence, resource-limited countries. As this large-scale generic rollout won’t begin until 2027, the company worked up its procurement model with the Global Fund and PEPFAR as a “bridging strategy,” supplying the injections at no profit to Gilead and letting its partners head up country prioritization and implementation through their existing systems.
In its dedicated access strategy webpage, Gilead makes it clear that it has “always encouraged countries and organizations with an interest in procuring lenacapavir to contact the Global Fund.”
Although MSF is “making use” of the doses it has access to through the Global Fund, it explains in the open letter that “demand far exceeds supply,” and that allowing MSF to directly purchase a supply of its own would help scale up access. The organization’s latest announcement also notes that Gilead’s generic supply plan excludes many countries that also have a high HIV rate, such as Brazil and Mexico.
MSF has seen support from other advocate groups such as Public Citizen, whose director, Peter Maybarduk, called Gilead’s reported refusal to sell its PrEP to MSF “hard to understand and impossible to justify, apart from Gilead’s wish to sell more to rich countries at high prices,” he said in a March statement.
Meanwhile, Gilead’s executive vice president of pharmaceutical development and manufacturing Stacey Ma, Ph.D., told Fierce Pharma in a recent interview that she is “extremely proud” of her team’s work to get lenacapavir’s access plan in place early, noting that the company managed to deliver doses to two countries in sub-Saharan Africa last year within an “unprecedented” time frame of roughly six months.
The company remains “very much on track” to deliver the remaining doses it’s pledged at no profit, she said at the time.
Editor's Note: The story has been updated at 5:40 p.m. ET with a statement from Gilead.