A pharmacist holds a bottle of lenacapavir, called a “revolutionary” HIV prevention drug, at a research center in South Africa.
Nardus Engelbrecht/AP
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Nardus Engelbrecht/AP
Five months after a breakthrough HIV prevention drug won approval in the United States and became available in many rich countries, it has begun to roll out in two African countries particularly hard hit by the disease.
On Wednesday, the US State Department announced that Eswatini and Zambia had each received 500 doses of lenacapavir, a drug produced by Gilead Sciences. Science How “breakthroughJust two injections per year provide almost complete protection against HIV infection.
“It's somewhat unprecedented to see innovations in global health spreading so quickly to low- and middle-income countries,” says Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition (AVAC), a global HIV prevention organization. “Obviously this is a very small supply, it's really just a down payment, but it's the first of what we believe will be many doses in these two countries and in other countries.”
The doses delivered mark the first small step toward providing at least 2 million doses to countries with the highest disease burden, mostly in Africa, by 2028. That's the goal of the Global Fund, a major donor to the fight against HIV, tuberculosis and malaria, along with Gilead Sciences and the State Department.
But the revolutionary drug comes “just as we've seen some of the most dramatic political and economic challenges in the fight against AIDS,” Warren says. Warren says that in addition to likely increasing the overall burden of HIV due to treatment disruptions, the Trump administration's cuts to foreign aid have harmed some of the very systems and programs that are best suited to get lenacapavir to the people most in need of protection. “We're starting with a deficit that we didn't need, that was entirely created by the U.S. government.”
Fast delivery
State Department announced its investment in lenacapavir in September, promising to provide up to 2 million doses by 2028.
“We think we will reach this goal sometime in mid-to-early 2027. [and] we're on track to procure more than half a million doses next year,” Jeremy Levin, the State Department's senior foreign assistance, humanitarian affairs and religious liberty official, said at a press briefing this week.
Gilead is providing 500 doses at cost without making any profit, according to CEO Daniel O'Day. The company plans to cover up to 2 million doses in total before licensed generic manufacturers begin operations, but it is unclear how many doses they currently have on hand. “We have supplies to send to markets once they receive appropriate regulatory approval, as well as restocking for Eswatini and Zambia,” he told a briefing.
Since the FDA gave lenacapavir thumbs up in June (and then World Health Organization And European Medicines Agency in July), Gilead has applied for regulatory approvals in sub-Saharan Africa. The drug has now been approved by Zambia and South Africa (Levine said the U.S. has no plans to fund lenacapavir doses for South Africa, which will be asked to “fund doses for its own population.” Eswatini's Ministry of Health has issued a separate import authorization, its version of approval.
Where will the drug go next? The company has applied for approval in Botswana, Kenya, Malawi, Namibia, Rwanda, Tanzania, Uganda and Zimbabwe, with more countries in the works, O'Day said. “We continue to prioritize the 18 high HIV burden countries that account for 70% of the HIV epidemic.”
Of course, delivery is only the first step. To curb the epidemic, doses must get into the hands of the people who need them.
The ministries of health will be primarily responsible for this. But in many cases, governments relied on the help of public and non-governmental organizations. The State Department's Levin said it was part of the U.S. “America First” global health strategy efforts to make the nation's government more “self-reliant.”
However, many health systems rely on outside organizations that have been defunded or reduced by the Trump administration's cuts in foreign aid, Warren says. This includes one of his organizations, AVAC, which he helped implement. The program aimed to increase the capacity of health systems to deliver injectable HIV drugs such as lenacapavir, which are more difficult to distribute than the pill. It was frozen in January and never got up to full speed, he said.
“If you don't have a program that meets people where they are, then those doses won't be used,” Warren says. “There's a rich history of global health products that everyone thinks are interesting and then they sit in warehouses because we didn't build the program to deliver them.”
