Despite new supply commitments from Gilead Sciences, Médecins Sans Frontières/Médecins Sans Frontières (MSF) is poking holes in the company’s plans to support global access to the twice-yearly HIV pre-exposure prophylaxis (PrEP) drug Eztugo.
Gilead announced on Tuesday that it would expand its Eztugo Supply program to reach an additional 1 million people in countries with high incidence and limited resources, reaching a total of 3 million people by 2028. The access plan is in collaboration with the U.S. Department of State, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund, all of which are “experts in domestic delivery and distribution,” the company said.
However, the international humanitarian aid program MSF says these efforts alone are “not enough” to stem the global HIV epidemic.
“The number of vaccinations announced today, divided across countries over several years and then distributed to health facilities, is insufficient,” Tom Elman, head of MSF’s Southern Africa medical unit, said in an MSF statement on Tuesday. “Given Gilead’s ability to produce more, it is indefensible and inhumane for them to choose not to produce.”
Ellman said Eswatini, a country with the highest rate of new HIV infections in the world, had only received 70 doses of Gilead’s long-acting PrEP and “used them up in a matter of weeks.” Meanwhile, a clinic MSF works with in Kenya is operating with “only 39 doses,” Elman said.
So far, the first deliveries of Gilead’s HIV prevention products have reached nine African countries through the Global Fund, according to Tuesday’s announcement. Some of these countries, including Eswatini and Kenya, have already begun distributing Eztugo, also known as lenacapavir, with early uptake “particularly among priority populations,” the Global Fund said.
“As one of the countries preparing to be an early adopter, Eswatini is committed to ensuring this innovation reaches those who need it most,” the country’s Health Minister Mduduzi Mathebula said in a Global Fund release. “We value the partnership between the Global Fund and the United States, which will help us act quickly and effectively.”
As part of its expansion to one million more people, the Global Fund arrangement is now being extended to 12 additional countries, including Haiti, Indonesia, Morocco, Rwanda and Thailand.
Mark Eddington, Head of Grants Management, commented: “Our focus is now on supporting a rapid and responsible roll-out, ensuring we are ready to deliver the program and getting the benefits to communities as quickly as possible,” calling the level of demand in each country for the drug “encouraging and urgent.”
Gilead did not immediately respond to Fierce Pharma’s request for comment.
MSF has been seeking involvement in Gilead’s Eztugo access plan for the past year, but the company has refused repeated requests to purchase doses directly, MSF said in an open letter to Gilead on March 31.
In a letter, Mr. Elman and MSF USA CEO Tirana Hassan explained Gilead’s rationale for denying MSF’s request, which was communicated in a February meeting with Gilead.
According to the letter, Gilead’s defense relies heavily on its plan to support affordable generic drugs for certain countries in 2027, a key component of the company’s broader access plan. But MSF argues that it is “unacceptable to avoid liability for future generic products when there are no plans to supply them globally during the first two years of their release,” Elman and Hassan wrote.
Gilead’s extensive access plan
Months before the drug became the first in the world to be approved by the FDA in June, Gilead embarked on a global Eztugo supply strategy, entering into voluntary licensing agreements with six generic manufacturers in October 2024 to manufacture and sell the drug in 120 high-incidence, resource-constrained countries. Because this large-scale generic rollout won’t begin until 2027, the company developed a procurement model with the Global Fund and PEPFAR as a “bridge strategy,” providing the shots to Gilead at no cost and allowing partners to lead country prioritization and implementation through existing systems.
Gilead states on its dedicated access strategy webpage that it has “always encouraged countries and organizations interested in procuring lenacapavir to contact the Global Fund.”
MSF is “leveraging” doses available through the Global Fund, but in an open letter it explains that “demand far outstrips supply” and that allowing MSF to directly purchase open supplies would expand access. The group’s latest announcement also notes that Gilead’s generic supply plan does not include many countries with similarly high HIV rates, such as Brazil and Mexico.
MSF has also seen support from other advocacy groups, including Public Citizen, whose president Peter Maberdach said in a statement in March that Gilead’s reported refusal to sell PrEP to MSF is “difficult to understand and impossible to justify,” other than Gilead’s desire to sell more at a higher price to wealthy countries.
Meanwhile, Dr. Stacey Marr, Gilead’s executive vice president of drug development and manufacturing, told Fierce Pharma in a recent interview that she is “very proud” of her team’s efforts to quickly put an access plan in place for lenacapavir, noting that the company was able to successfully deliver the vaccine to two countries in sub-Saharan Africa in an “unprecedented” time frame of approximately six months last year.
She said at the time that the company was “very on track” to deliver the remaining doses promised without making a profit.
