Is a game-changing HIV prevention drug meeting global demand?

On a mid-June afternoon in the northwest part of Lusaka, Zambia—a country where about 11% of adults are living with HIV—the local group Ascend Futures Foundation had set up a tent along a dusty road in partnership with the U.S.-based HIV prevention group AVAC. Inside the tent, Ascend staffers were offering to passersby not only contraception, condoms and polio vaccines for children but initial doses of lenacapavir (LEN), the powerful game-changing HIV prevention (PrEP) drug from Gilead Sciences.

Administered as a pair of injections every six months, lenacapavir was found to be 96% effective in large global clinical trials, providing near-complete protection from acquiring HIV through sexual contact when taken as prescribed. In the wake of the results, the drug was hailed as the closest thing science has created yet to an HIV vaccine. 

Last year, the drug was approved in the U.S. under the brand name Yeztugo. By the end of 2025, global aid programs including the Global Fund and the U.S.-run PEPFAR, with on-the-ground partners like Ascend, were rolling out the drug at a fraction of its U.S. price in low-income nations including Eswatini, Zimbabwe and Zambia.

Among the tent staffers was a woman named Chilufya Kasanda Hampongo, an AVAC staffer in her native Zambia. She says the opportunity to not only educate passersby about LEN but to offer them that first dose on the spot was invaluable. 

“When you’re just educating, you have to trust that people will go later to a health facility, and sometimes you lose them along the way,” she says. “But when you bring services to where people are, they can receive them with ease. Yesterday, we gave LEN to a woman who said that she didn’t want to end up living with HIV like her mother is.”

The scene in the tent might have surprised some people who have been following the Trump 2.0 administration’s drastic cutback of the President’s Emergency Plan for AIDS Relief (PEPFAR), a U.S. government program started by then-President George W. Bush in 2003. (Providing HIV prevention, treatment and care in more than 50 countries, PEPFAR is credited with saving more than 26 million lives since its inception.) The Trump administration has all but destroyed USAID, the long-standing U.S. program that worked in tandem with PEPFAR.

Many elements that made PEPFAR successful are no longer. These include the program’s insistence that PEPFAR-recipient countries serve their most HIV-vulnerable populations—including men who have sex with men, transgender people, sex workers and injection-drug users—as well as its USAID-driven funding of special clinics so people from those so-called key populations could get care outside the hostility of mainstream government clinics. 

Last year, the U.S. government said that it wanted PEPFAR-funded prevention tools, such as any form of medical pre-exposure prophylaxis (PrEP) including LEN, going only to pregnant or breastfeeding women. That prompted a backlash from global advocates who said that PEPFAR was abandoning its commitment to key populations, leaving them to the mercy of their own governments’ tolerance, which varies widely among countries. (Later, in a semi-reversal, the U.S. said that PEPFAR recipient countries were free to prioritize lenacapavir for whomever they thought needed it most.)

But despite these U.S. restrictions, LEN is getting to people who need it in several poor nations worldwide, including not only those mentioned above but Kenya, Lesotho, Mozambique, Nigeria, South Africa and Uganda—with more to come. This has happened largely because Gilead has made the drug available via large funders, including the Global Fund and PEPFAR, for $100 per person per year—a sliver of the drug’s more than $25,000 yearly cost per person in the U.S. The goal of this rollout is to administer about 3 million doses over three years.

Advocates say it’s the fastest global rollout ever of a U.S.-made drug post-Food and Drug Administration (FDA) approval. But they also say 3 million doses over three years is only a fraction of the potential global demand—or the current supply. 

They also say that, since the Trump administration made PEPFAR abandon what had been its detailed and transparent data about which HIV interventions were serving exactly which populations from country to country, it’s hard to know if key populations are being targeted and served across recipient countries.

“The introduction of LEN is faster than we’ve ever seen a new product get to market,” says Mitchell Warren, the longtime executive director of AVAC. “But it’s still not fast enough to deliver the impact that’s needed.”

He is echoed by Ascend’s Hampongo, who says, “I know that with community engagement, we’ll soon see a lot of people asking for LEN, which is why we need to see more volume [of supply] beyond the current funder commitments.” 

Recently, the Global Fund—the second-largest provider of global HIV assistance after PEPFAR, which remains the leader despite Trump cutbacks—failed to meet goals from donor countries for its latest funds replenishment cycle, forcing it to scale back some plans. 

Still, says Hampongo, “It’s important that we really put pressure on the Global Fund to meet the demand.” Grassroots groups in many other recipient countries were engaging in the kind of on-the-ground LEN engagement efforts that Ascend is doing in Zambia, she says.

Nurturing demand and supply in balance

But Warren adds that as important as it is not to nurture demand for LEN out of pace with supply, the opposite is crucial, too. “You have to find the sweet spot,” he says. 

Not only do advocates need to pressure the Global Fund (and other large donors like the Gates Foundation) to put up more money and the U.S. to release the money that Congress has already allocated for PEPFAR, he says, but “we have to show those donors and LEN manufacturers that the demand is there.” (Next year, several global manufacturers of generic drugs will start making LEN for as low as $40 per person per year.)

One group that feels shut out by Gilead from access to LEN is the international medical humanitarian group Médecins Sans Frontières (MSF), known in the U.S. as Doctors Without Borders. MSF leaders say that, despite repeated requests last year, Gilead refused to sell LEN to them. Instead, the company reportedly told MSF to obtain the drug from the Global Fund. However, the Global Fund only received a limited number of doses from Gilead, which are already running short in countries like Eswatini and Kenya. Some of the countries and communities MSF is trying to reach are not eligible to receive LEN. 

In refusing to sell the drug to MSF, Gilead has reportedly said that once generic versions of LEN become available next year, MSF’s request to the company will be moot. 

“We should be rolling out 7 million doses of LEN in the next three years, not just 3 million,” he says, adding that research shows that more than half of people globally would choose injectable over oral PrEP. “And no one entity like Gilead can do that alone.”

He adds, “MSF could play a real role in delivering LEN in humanitarian settings. They reach populations that governments can’t.”

Meanwhile, MSF, which gets a very small amount of LEN from the Global Fund, relaunched its pressure campaign on Gilead in June, demanding that the company sell LEN for $40 per person per year to every country in the world that needed it. 

Carlota Baptista da Silva, MSF’s HIV and hepatitis C access advocacy manager, says MSF needs Gilead to sell LEN to the group because it often works in middle-income countries, such as in Latin America, the Middle East and the Balkans, where the Global Fund and PEPFAR are not currently providing LEN. 

“LEN is the closest thing we have to an HIV vaccine so far,” she says. “And we work with a lot of migrants and displaced people who face a variety of obstacles to taking daily oral PrEP”—such as having to carry it around everywhere and maybe hide it from people—“so a twice-yearly injection like LEN is highly attractive.”

But Warren says that, when it comes to LEN expansion, pressure should not be on Gilead alone but on big funders like the Global Fund and PEPFAR to step up their orders, especially once generic versions become available next year. 

“We should be rolling out 7 million doses of LEN in the next three years, not just 3 million,” he says, adding that research shows that more than half of people globally would choose injectable over oral PrEP. “And no one entity like Gilead can do that alone.”

He adds, “MSF could play a real role in delivering LEN in humanitarian settings. They reach populations that governments can’t.”

Are key populations being served?

Since the U.S. said last year that prevention tools could only go to pregnant and breastfeeding women—an order that many took a sign of a conservative administration’s hostility toward marginalized groups like men who have sex with men and sex workers—it has backtracked somewhat amid its new commitment to LEN, saying that individual governments can decide who is prioritized for LEN. 

“That’s good news,” Warren says. But he notes that countries like Uganda, which has one of the harshest anti-LGBTQ+ laws in the world, are not prioritizing LEN for key populations. 

He adds that since many special “safe” clinics for key populations in various countries have shut down in the wake of USAID’s closure, that further hampers people from those groups accessing not only LEN and prevention tools—but HIV treatment as well. 

And under Trump 2.0, PEPFAR no longer runs the comprehensive and detailed public dashboard it once did, showing exactly what populations in what countries were getting HIV tools, and at what levels. This has created an information gap for advocates who want to ensure that key populations are served.

Micheal Ighodaro, a queer, D.C.-based advocate originally from Nigeria, cofounded Global Black Gay Men Connect. He says he sees evidence that LEN is not sufficiently getting to men who have sex with men in target countries served by the Global Fund and the World Health Organization (WHO). 

Ighodaro says projections his group did with AVAC showed that 11 million doses of LEN are needed “to have any kind of significant impact on key populations. All the LEN and cabotegravir [another HIV prevention medication, which requires a shot every other month] we have right now is not even close.” 

Says Hampongo in Zambia: “We have organizations in all these countries working really hard to create demand for LEN. It’ll be really important that we keep this momentum going, and that we then make sure that the volume meets the demand.”