Is a new HIV prevention plan ambitious enough? And can it survive Trump?

The announcement by several major global health players of plans to deliver a potentially game-changing HIV prevention technology to 2 million people over three years has drawn a range of civil society reactions, from enthusiasm to criticism that the endeavor is not nearly ambitious enough. And now, in the wake of U.S. President Donald Trump’s inauguration Monday, there are questions about whether the effort will even move forward at all. The proposal, announced by the U.S. President’s Emergency Plan for AIDS Relief, or PEPFAR, and The Global Fund to Fight AIDS, Tuberculosis and Malaria, came late last year. Working with the Gates Foundation and the Children’s Investment Fund Foundation, the donors plan to enable 2 million people to get access to lenacapavir, a twice-yearly injection that showed almost complete efficacy in preventing HIV in two studies released last year. In the HIV community, there is hope that lenacapavir will transform HIV prevention efforts, which are currently lagging. The Joint United Nations Programme on HIV/AIDS, or UNAIDS, has called for 10 million people to be on some form of preexposure prophylaxis, or PrEP, by the end of this year or 21.2 million to have used PrEP at least once this year. PrEP can dramatically reduce the risk of acquiring HIV. But only 3.5 million people were on PrEP in 2023, according to the World Health Organization, and nearly all of them are using a daily oral version. Lenacapavir is “a superior product that holds the key, potentially, to combating the prevention emergency we’re facing, which is 1.3 million new HIV infections every year,” Asia Russell, the executive director of Health GAP, told Devex. In one of the trials, lenacapavir proved 89% more effective at preventing HIV acquisition than oral PrEP. Because it is relatively discreet, unlike a daily pill, it appears to be particularly appealing to the communities that are often most at risk of acquiring HIV, including sex workers and members of the LGBTQ+ community. That is why Russell is alarmed that PEPFAR and the Global Fund are not pushing to reach far more than 2 million people over three years. “The capacity for communities and health systems in the global south is far greater and could absorb much more than that,” she said. It is a perspective shared by the UNAIDS Executive Director Winnie Byanyima. From this week’s World Economic Forum, she issued a statement acknowledging, “Science has delivered a miraculous new tool: medicines that prevent HIV infection with injections just twice a year. ... We must do better this time. Either companies step up, or governments step in. This is our shot to end AIDS — and we cannot afford to miss it.” But some experts still see opportunity in the commitment, even as they acknowledge the potential for more ambition. “Even two million, that is a quantum leap over where we’ve been,” Mitchell Warren, the executive director of the AIDS Vaccine Advocacy Coalition, or AVAC, told Devex. There is some suspicion in the global AIDS sector that the specter of Trump’s return to office and the uncertainty around his ongoing commitment to the global HIV response might have put pressure on the donors to push out an announcement before his inauguration even as they hope to continue to expand its scope. “The more invested and further along we get, the quicker we act, the better we protect initiatives from forthcoming questions,” Peter Maybarduk, the director of Public Citizen’s Access to Medicines group, told Devex. It is unclear whether Trump’s executive order freezing any foreign development assistance for three months would impact the program. United States Sen. James Risch has also put $1 billion in PEPFAR funding on hold, which was followed by reports that four Mozambican nurses who drew $4,100 in salary from the program were involved in providing abortions. U.S. law prohibits any U.S. foreign funding from being spent on abortions. And there are now questions about who will gain access to the lenacapavir that is distributed, particularly as the Trump administration targets transgender people, a community that already faces inequitable access to HIV services globally. In announcing the plan, donors said lenacapavir would be available to people in countries supported by PEPFAR and the Global Fund, though a full list has not been revealed. They did not specify whether they would try to prioritize vulnerable communities facing higher-than-average rates of infection. PEPFAR officials were unable to comment. The announcement of the initiative has been removed from PEPFAR’s website. An archived version can be seen here. Whether Trump’s return hastened the plan, he was certainly not its only catalyst. Warren believes PEPFAR, the Global Fund, and others are learning from the “squandered opportunities” of previous rollouts of prevention technologies. The donors announced their plan even before lenacapavir received regulatory approval and even though there is only currently one manufacturer, Gilead, which holds the patent on the technology. The company has said it has the capacity to supply the doses required to meet the commitment from PEPFAR and the Global Fund. Warren said this is a marked change from past efforts. He pointed to a lack of donor engagement that was partially to blame for the slow rollout of oral PrEP, which was first approved for use in 2012, but also for some newer prevention technologies. These include the vaginal ring, which is impregnated with antiretroviral drugs and replaced each month, and an every-other-month injectable, cabotegravir, which received approval from the U.S. Food and Drug Administration in December 2021. The latter two products have faced other hurdles, including supply limitations and pricing concerns. What this has all added up to is a history of not getting PrEP fast enough to the people who would benefit from it. Now PEPFAR and the Global Fund seem intent on changing that. The lenacapavir proposal would “do in three years what it took a decade to do with oral PrEP,” Warren said. The plan, as announced, is still short on details, including when the rollout will begin. That depends, in part, on the intervention receiving regulatory approval and governments issuing guidelines for its use. There are reports that WHO will convene a group this month to develop guidelines for the technology, which could ultimately be adopted by many low- and middle-income countries. If that all happens quickly, lenacapavir could be available in some of the countries where PEPFAR and the Global Fund operate by late 2025, according to reports. There is also a question about what price Gilead is charging — and whether that might be limiting the ambition of the proposed rollout. None of the players have yet revealed what Gilead is asking per dose. But activists are calling for the company to set the price at no more than $100 per person each year. Gilead did not respond to a request for comment. The bigger question is how quickly — or whether — lenacapavir can come down to $40 per person per year, which would be comparable to the price of oral PrEP. That may not happen until generic versions of the injectible come online. Gilead has issued voluntary licensing agreements to six pharmaceutical companies, which are allowed to provide doses to 120 low- and middle-income countries. But those manufacturers are not likely to be in production for several years, although this initial show of interest from donors could spur them to work faster, some observers said. Gilead’s agreements have also come in for criticism, though, because they exclude many middle-income countries, some of which have seen rising HIV incidence. Some of those middle-income countries, including Brazil and Paraguay, will also be left out of the lenacapavir distribution because they do not host Global Fund or PEPFAR programs. While more and more affordable lenacapavir would be preferable, Warren said the timing of generic production could still line up well for the countries that will have access to those jabs. If the PEPFAR- and Global Fund-supported initiative reduces new infections, governments might be convinced that lenacapavir is a good investment just around the time that affordable versions are becoming available. “The best way to get generics faster is to show them there’s a market for this product so they’ll invest in the infrastructure,” he said. “By the time the window of 2 million people is done, we hope governments are going to want to buy [enough to protect] six or seven million.” But Russell wants to know why donors aren’t looking to achieve those kinds of numbers now. “The Global Fund and PEPFAR are not able to meet the moment,” she said. “The new administration and Congress must prioritize this. There is no path to sustainability in HIV without actually bringing down the numbers of new HIV infections for everyone everywhere.”