On Thursday, the U.S. government announced a significant investment in lenacapavir, a new HIV prevention drug that has garnered attention from the medical community as a potential “breakthrough” and “game changer.”
The Department of State revealed plans to reach up to 2 million people by 2028 with this antiretroviral medication, which could save hundreds of thousands of lives.
In the coming months, the U.S. will collaborate with countries facing the most severe HIV/AIDS epidemics to devise rollout strategies, particularly emphasizing the prevention of mother-to-child transmission.
Researchers and specialists in the field of HIV/AIDS welcomed this announcement, particularly as it follows a period in which the Trump administration’s cuts to foreign aid severely impacted clinics and programs in lower-resource countries focusing on HIV prevention and treatment.
Last year, clinical trials for lenacapavir demonstrated that twice-yearly injections could provide nearly complete protection against HIV for individuals at risk and help prevent mother-to-child transmission. The drug is also effective as a treatment for HIV.
The foundational research that led to lenacapavir’s development was funded by the National Institutes of Health (NIH), giving credit to U.S. support for the discovery.
Dr. Linda-Gail Bekker, director of the Desmond Tutu HIV Centre in South Africa, emphasized that lenacapavir is a critical tool in controlling the HIV epidemic, stating, “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 effort with the Global Fund, a major contributor to the fight against HIV, tuberculosis, and malaria, as well as Gilead Science, the California-based biopharmaceutical company that produces lenacapavir.
Jeremy Lewin, a senior State Department official involved in Foreign Assistance, Humanitarian Affairs, and Religious Freedom, declined to disclose the precise dollar figure of the U.S. investment in this initiative.
This financial backing aims to guarantee that the medication will be accessible in select low- and middle-income countries heavily affected by HIV.
While Lewin did not specify which countries would be receiving the doses, he assured that further information would be forthcoming in the upcoming weeks.
“Many of us were in a great deal of dismay and despair,” Dr. Bekker noted, recalling the devastating consequences of the significant aid cuts to HIV programs. “This announcement brings hope. It’s huge.”
She played a vital role in conducting the lenacapavir trials in South Africa, which reassures many experts in the community about the drug’s potential impact.
This latest announcement marks a renewed commitment to combating HIV/AIDS after years of dwindling support. For decades, the U.S. led global efforts against the HIV/AIDS epidemic through initiatives like the President’s Emergency Plan for AIDS Relief (PEPFAR).
PEPFAR has garnered strong bipartisan backing, yielding over $120 billion in funding since its inception in 2003, making it the largest global commitment by any nation to address a single disease.
In prior years, PEPFAR introduced innovative HIV prevention drugs, most notably pre-exposure prophylaxis (PrEP), a daily pill that prevents HIV infections. According to estimates, PEPFAR has accounted for more than 90% of global PrEP initiations.
However, under President Trump’s administration, a stop-work order issued in January halted ongoing foreign aid projects, severely impacting clinics and systems that supported PrEP, resulting in service reductions or complete shutdowns.
In the following week, Secretary of State Marco Rubio provided waivers to allow funds to continue flowing to PEPFAR, albeit with limited terms focusing solely on preventing mother-to-child transmission.
Mitchell Warren, the executive director of the AIDS Vaccine Advocacy Coalition (AVAC), described the previous cuts as catastrophic for prevention programs, stating, “Prevention programs were absolutely gutted.”
Warren expressed optimism about the new lenacapavir announcement, viewing it as an important declaration that the U.S. government is renewing its focus on HIV prevention initiatives.
He remarked, “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 and Trump administrations have aimed to shift responsibility for AIDS responses to national governments rather than relying solely on PEPFAR.
Warren emphasized that rolling out lenacapavir is essential to achieving this broader objective and reflects a strategic approach to constructing transition plans for individual countries.
“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—those often funded by PEPFAR and the Global Fund—we need to stop the rate of new infections going up,” he explained.
Peter Sands, the executive director of the Global Fund, echoed Warren’s concerns, highlighting that lenacapavir could significantly reduce the 1.3 million new HIV infections occurring annually.
Sands emphasized, “We can change the nature of the HIV/AIDS pandemic quite dramatically. That will obviously save lives but will also reduce future health system costs significantly. If an 18-year-old gets infected with HIV, you’re talking about 50 to 60 years of treatment that someone in the system will have to bear.”
Lewin stated that the announcement indicates the future direction of PEPFAR’s work and North American global health efforts.
He said, “This is the type of thing we’re going to do more of. 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 underscored that this initiative operates in coordination with national health systems rather than through NGOs and international health organizations as was customary in previous initiatives.
“There are no NGOs involved in this. There are none of those sort of beltway bandits here,” he asserted. “It is not the United States’ job to be paying shadow healthcare workers—Americans to be in these countries telling local healthcare systems that they’re doing things wrong and offering a competitor to the healthcare system. That creates a bad incentive for the country not to develop its own national healthcare infrastructure.”
Warren from AVAC expressed concern that the decision to exclude NGOs might limit the effective reach and impact of lenacapavir since many clinics and programs are run by these organizations. Yet, he agreed that it is critical for countries to own their AIDS response efforts.
HIV/AIDS specialists are currently working on the logistics of rolling out lenacapavir with the goal of making the drug available in epidemic hotspots in Africa by the end of this year or early next year.
However, the approval of lenacapavir is needed from African countries, similar to the endorsements already received from the U.S. Food and Drug Administration, the World Health Organization, and the European Medicines Agency.
Warren anticipates that those approvals will start coming through in the next few months, allowing for a quicker rollout.
Dr. Bekker commented that clinics on the ground are ready to mobilize for the rollout, stating, “We are ready. We have sites and facilities that are willing and able. It’s very doable and very urgent.”
The U.S. support is expected to help offset the costs associated with lenacapavir, although the exact pricing from Gilead is not publicly available; estimates suggest it may cost around $100 per person per year, more than double the price of the traditional oral PrEP.
Gilead’s CEO, Daniel O’Day, stated that the company is providing lenacapavir to PEPFAR and the Global Fund at cost and without profit, attributing this initiative to 17 years of research and dedicated development.
O’Day noted, “The support of the U.S. government through PEPFAR means that we can get to places with the greatest need faster.”
A generic version of lenacapavir is in the works, as Gilead Sciences has shared licenses and manufacturing information with six generic manufacturers.
Nevertheless, Dr. Bekker reassured that those generic options will likely not be available until 2027 due to the time needed for production and necessary testing.
In the interim, she indicated that lenacapavir may exceed the budgets of many governments in low- and middle-income nations.
Reflecting on this significant announcement, Dr. Bekker acknowledged the transformative power of PEPFAR, stating, “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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