Five months after a "breakthrough" HIV prevention drug got approval in the United States and became available in many wealthy countries, it's getting rolled out in two African countries hit especially hard by the disease.
On Wednesday, the U.S. State Department announced that Eswatini and Zambia have each received 500 doses of lenacapavir, a drug manufactured by Gilead Sciences that's been hailed as by Science as a "breakthrough." Just two injections a year provide near-complete protection against an HIV infection.
"This is somewhat unprecedented, to see an innovation in global health move this fast to low- and middle-income countries," says Mitchell Warren, the executive director of AIDS Vaccine Advocacy Coalition (AVAC), a global HIV prevention organization. "Obviously very small supplies, really just a down payment, but they're the first of what we think to be many doses in these two countries and in other countries."
The delivered doses mark the first small step toward providing at least 2 million doses to the highest burden countries, largely in Africa, by 2028. That's the goal of the Global Fund, a major donor to combating HIV, tuberculosis and malaria, along with Gilead Sciences and the State Department.
But the breakthrough drug arrives "just as we've seen some of the most dramatic political and economic challenges in the AIDS response," says Warren. In addition to likely increasing the overall HIV burden because of disrupted care, Warren says the Trump administration's foreign aid cuts have damaged some of the very systems and programs best positioned to deliver lenacapavir to the people most in need of protection. "We are starting from a deficit that we didn't have to, that was a making entirely of the U.S. government's own."
Rapid delivery
The State Department announced its investment in lenacapavir in September, pledging to provide up to 2 million doses by 2028.
"We think we're going to hit that target sometime in mid- to early 2027 [and] we're going to be procuring more than half a million doses collectively next year," said Jeremy Lewin, a senior official for Foreign Assistance, Humanitarian Affairs and Religious Freedom at the State Department, at a press briefing this week.
The 500 doses are being provided by Gilead at cost, with no profit going to the company, according to CEO Daniel O'Day. The company plans to cover up to 2 million doses total before licensed generic manufacturers get up and running, but it's not clear how many doses they currently have on hand. "We do have supply to send to markets when they have the appropriate regulatory approval, and replenishment for Eswatini and Zambia," he said in the briefing.
Since FDA gave lenacapavir the thumbs up in June (followed by World Health Organization and European Medicines Agency in July), Gilead has been applying for regulatory approvals across sub-Saharan Africa. So far, Zambia and South Africa have approved the drug (Lewin said the U.S. was not planning to fund doses of lenacapavir to South Africa, which would be encouraged "to fund doses for their own population." Eswatini's ministry of health issued a separate import authorization, their version of approval.
Where will the drug go next? The company has filed for approval in Botswana, Kenya, Malawi, Namibia, Rwanda, Tanzania, Uganda and Zimbabwe, with more in the works, said O'Day. "We continue to prioritize 18 high burden countries representing 70% of the HIV epidemic."
Of course, delivery is only the first step. To curb the epidemic, doses have to get into the arms of people who need them.
Health ministries will be primarily responsible for that. But in many cases, governments have relied on community organizations and non-governmental organizations for help. Lewin, of the State Department, said that's part of the U.S. America First Global Health Strategy's effort to boost national government's "self-reliance."
Still, many health systems have relied on outside organizations that have been defunded or diminished by the Trump administration's foreign aid cuts, says Warren. That includes one his organization, AVAC, helped implement. The program was aimed at boosting health systems capacity to deliver injectable HIV drugs, like lenacapavir, which can be trickier to distribute than pills. It was frozen in January, he says, and hasn't gotten back up to full speed.
"If you don't have the program that meets people where they are, then those doses aren't going to get used," says Warren. "There's a lot of history of global health products that everyone thinks are exciting, and then they sit in store rooms because we didn't build the program to deliver them."
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