The U.S. announced Thursday that it will make an investment in the new HIV prevention drug called lenacapavir that's been hailed as a "breakthrough" and a "game changer" by the medical community.
The Department of State says the aim is to reach up to 2 million people by 2028 with the antiretroviral medication that has the potential to save hundreds of thousands of lives. Over the coming months, the U.S. will be working with countries with the largest HIV/AIDS epidemics to develop rollout strategies with a focus on preventing mother-to-child transmission.
This announcement has been welcomed by researchers and specialists who focus on HIV/AIDS. This news comes after the Trump administration's foreign cuts have severely impacted clinics and programs in lower resource countries that focus on prevention and treatment of the virus.
Clinical trial results for the drug, lenacapavir, showed last year that twice-yearly injections can provide almost complete protection against contracting HIV for individuals at risk in their intimate relationships and for preventing mother-to-child transmission. The medication is also used to treat HIV. The original discoveries that made this medicine possible were funded by the National Institutes of Health (NIH).
Scientists believe that the drug could help end the HIV epidemic. "It's really the only way to bring this epidemic under control," says Dr. Linda-Gail Bekker, director of the Desmond Tutu HIV Centre in the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town. "We have 31 million people on treatment around the world, but if we don't address protecting people who are susceptible to acquire HIV, we aren't going to bring the epidemic under control."
The U.S. financial commitment is a partnership with the Global Fund, a major donor to combating HIV, tuberculosis and malaria, and Gilead Science, the California-based biopharma company that makes the drug. Jeremy Lewin, a senior official for Foreign Assistance, Humanitarian Affairs, and Religious Freedom at the State Department, decline to put a dollar figure on how much the U.S. is spending on this effort.
The financial support will help ensure the medication is available in select low- and middle-income countries where the virus takes a big toll. Lewin declined to specify which countries will be receiving the doses but said more information would be available in the coming weeks.
"Many of us were in a great deal of dismay and despair," says Bekker, reflecting on the massive aid cuts that hobbled many HIV programs. "This announcement brings hope. It's huge." She helped conduct the lenacapavir trials in South Africa.
"PEPFAR and the U.S. government are back"
For decades, the U.S. had been the global leader in combating the HIV/AIDS epidemic. PEPFAR — the President's Emergency Plan for AIDS Relief — has received strong bipartisan support. With over $120 billion in funding since its founding in 2003, PEPFAR represents the largest commitment by any nation in history to fight a single disease.
In the past, PEPFAR has spearheaded efforts to introduce HIV prevention drugs — called pre-exposure prophylaxis or PrEP. A daily pill that prevents HIV infections is the most common form of PrEP and PEPFAR accounts for more than 90% of PrEP initiations globally.
However, President Trump's stop work order in January halted existing foreign aid projects and had a severe impact on the clinics and systems that supported PrEP, forcing many to cut back services or shut down entirely. A week later, Secretary of State Marco Rubio issued waivers to enable funds to continue flowing to PEPFAR but the terms were limited: Prevention work was only allowed to stop mother-to-child transmission.
"Prevention programs were absolutely gutted," says Mitchell Warren, the executive director of AIDS Vaccine Advocacy Coalition (AVAC), an HIV prevention organization that works globally. "[This announcement about lenacapavir] is a really important statement that PEPFAR and the U.S. government are back in the PrEP business. [It's] a step forward from where we've been in a fairly paralytic state for the last seven months, and I hope that this breaks the logjam and at least can get prevention back on the agenda."
Both the Biden administration and the Trump administration have focused on transitioning responsibility for AIDS responses to national governments and away from PEPFAR. Warren says rolling out lenacapavir is key to that broader goal and shows that the administration is thinking strategically about transition plans.
"The best way to support that transition is by driving down the rate of new infections. Because if countries are going to have to start picking up the treatment costs — that were often being supported by PEPFAR and the Global Fund — we need to stop the rate of new infections going up," he explains.
Peter Sands, executive director of the Global Fund, echoed that sentiment, pointing out that lenacapavir could help reduce the 1.3 million new HIV infections that happen each year.
"We can change the nature of the HIV/AIDS pandemic quite dramatically," Sands says. "That will obviously save lives, but it will also reduce significantly future health system costs because if an 18-year-old gets infected with HIV, you're talking about 50 [to] 60 years of [HIV] treatment that someone in the system is going to have to bear."
Lewin said this announcement is an indication of what type of work PEPFAR will be doing in the future and, more broadly, what global health work will look like under the Trump administration.
"This is the type of thing we're going to do more of," he said at a press briefing on Thursday. "There's been a lot of media attention on some of the programs that we have cut because they're no longer aligned with our priorities. This is where our focus is going to be: On the purchasing, at scale, of commodities that can really help have an outsized impact in fighting HIV and across our various global health disease areas."
Lewin also emphasized that this work is in coordination with countries and national health systems rather than non-governmental organizations [NGOs] and international health organizations, as was the case in the past.
"There are no NGOs involved in this. There are none of those sort of beltway bandits here," he said. "It is not the United States job to be paying shadow health care workers — Americans to be in these countries telling local health care systems that they're doing things wrong and offering a competitor to the health care system. That creates a bad incentive for the country not to develop its own national health care infrastructure."
Warren of AVAC said he is worried this exclusion of NGOs "would diminish the reach and impact" of the drug, making it harder to get it to the people who need it since the nongovernmental groups run a lot of the programs and clinics that will be involved in the rollout. But he agreed that countries need to own and operate their own AIDS responses.
When will the drug be available?
HIV/AIDS experts are thinking through the logistics and timeline of the rollout with the hope that drugs could make it to hot spots in Africa by the end of this year or early next year.
But first African countries have to green light the drug –– as the U.S. Food and Drug Administration, World Health Organization and European Medicines Agency have already done. Warren says he expects those approvals to begin in the next few months.
Bekker says, on the ground, clinics are able to mobilize quickly to support the rollout. "We are ready. We. have sites and facilities that are willing and able. It's very doable and very urgent," she says.
The U.S. support will help defray the cost — although the exact price tag Gilead is charging is not public, Warren estimates it is around $100 per person per year. That's more than double the cost of oral PrEP.
Gilead's CEO, Daniel O'Day, says the company is offering this drug to PEPFAR and the Global Fund at cost and without a profit. He said this is the result of 17 years of research and development work. "The support of the U.S. government through PEPFAR means that we can get to places with the greatest need faster," O'Day said.
A cheaper generic version is coming. Gilead Sciences has shared the license for lenacapavir as well as information on how to make it with six generic manufacturers. However, Bekker says, generics won't likely be available until 2027 because of the time needed to start production and do the required testing. Until then, she says, lenacapavir "is probably outside of most government's budgets in low and middle income countries."
Bekker says this announcement has her reflecting on the power of PEPFAR — in the past and today.
"I'm eternally grateful to the American taxpayers for just what they have done for us [in Africa]. It's changed lives, communities. It's completely transformed what could have been an everlasting tragedy, and now we have hope."
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