US aid cuts overshadow HIV research advances

Tackling the HIV virus — which sneakily evades the immune system — has been an incredibly complex puzzle for the scientific community. It has required massive investments, expansive collaborations, and the dedication of some of the world’s sharpest minds — committed to the cause over decades. And now the world is equipped with many of the tools that could help bring this epidemic to an end — treatments, the ability to prevent transmission from mother to child, pre- and post-virus exposure prophylaxis, and a breakthrough six-month injectable prevention method, among other interventions. “The potential is in our grasp to end a pandemic and in the process, stop the needless [infections] and deaths that continue to impact millions each year,” said Dr. Beatriz Grinsztejn, president of the International Aids Society, during her organization’s conference in Kigali this week. More research is needed — including efforts to develop a vaccine and cure — but massive U.S. government funding cuts compromise this. Many research efforts have been slashed, and so have programs working to ensure existing innovations are brought to the people needing them the most. “A lot of this research ground to a halt,” said Dr. Linda-Gail Bekker, director of the Desmond Tutu HIV Centre at the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town. “It has left an enormous gap.” For example, the U.S. National Institutes of Health was one of the world’s largest funders of HIV vaccine research, having spent nearly $600 million in 2022 — or 81% of global spending. The Trump administration has proposed cutting $18 billion — or 40% — of NIH’s budget next year. Ensuring access Globally, some 32 million people are on HIV treatment, and some 3.5 million people are on preexposure prophylaxis, or PrEP. The most common way to take PrEP is a daily pill — but global uptake has been slow. The pill isn’t discreet, it’s a daily commitment, and it’s stigmatized. But there are now new forms: The cabotegravir, or CAB-LA, injection that lasts two months, and the dapivirine vaginal ring that lasts a month. There is also a monthly pill entering into late-stage trials. And the recent development of the six-month injectable lenacapavir is considered a game-changer — an easier option to take the drug. Last month, it was approved by the U.S. Food and Drug Administration, and this week the World Health Organization officially recommended its use. But innovations are futile without access. There’s still a long road ahead to ensure innovations such as lenacapavir and CAB-LA are affordable and broadly accessible. “These amazing advances … all cost significant amounts of money and need significant infrastructure to deliver it,” said Dr. Sharon Lewin, director of the Peter Doherty Institute for Infection and Immunity. Under the Trump administration, the U.S. President's Emergency Plan for AIDS Relief, or PEPFAR, which has served as a vehicle to deliver these innovations, has narrowed its focus. PrEP can now only be offered to pregnant and breastfeeding women. That excludes prevention efforts for high-risk groups dependent on it — such as men who have sex with men, drug users, and sex workers. The U.S. Agency for International Development was also a key implementor of PEPFAR — but it’s now dismantled. But there are some efforts to expand access in other ways — although this will take time. This week, the Medicines Patent Pool and ViiV Healthcare extended a voluntary licensing agreement to enable access to CAB LA for treatment in 133 countries. It builds on the voluntary license for CAB LA for PReP. And last week, the Global Fund to Fight AIDS, Tuberculosis and Malaria announced an access agreement with Gilead Sciences to procure lenacapavir for low- and middle-income countries. IAS’s Grinsztejn praised this deal during the Kigali conference, but also criticized that the price reached in the agreement was not disclosed, saying this “diminishes the negotiating power of countries outside of the Global Fund, which includes middle-income countries with stubbornly high incidence.” “For countries that are not included in this group of countries that will [benefit from] this agreement, we have no basis to start the conversation,” she said. “We need a basis to start negotiating.” A Gilead spokesperson told Devex that “pricing reflects the cost of producing and delivering lenacapavir, at no profit to Gilead.” “While the price is confidential under the agreement, we’re proud to reach an agreement to supply lenacapavir for PrEP to the Global Fund to support access to this innovative medicine in the same year it received regulatory approval in the United States. Gilead manufactured at risk to ensure supply until generic manufacturers can fully support demand from global aid organizations and the countries covered by our voluntary licensing program,” this person said. A vaccine and cure The need for research is ongoing, including for an HIV vaccine and cure — which would be more effective than keeping millions of people on PReP and treatment. “I don't know of any epidemic we have treated our way out of. It is incredibly difficult to do that because of the need for ongoing maintenance of antiretrovirals,” Bekker said. “Ultimately, a vaccine is going to allow us to think about finally, truly, ending this epidemic — together with a cure. We then really can wrap it up and can put HIV behind us.” Scientific progress in the search for both an HIV vaccine and a cure has reached a pivotal moment — with researchers closer than ever to achieving what once seemed impossible. But there are still major scientific and clinical challenges and the need for continued and increased investment, according to experts. For example, in May, preliminary research results have shown promise in the use of messenger RNA, or mRNA, to force the virus out of hiding in white blood cells — which has been a major hurdle for scientists in finding a cure. And even existing tools require continual research and innovation due to the virus’ ability to evade the immune system, as well as drug resistance that requires new treatment regimes. “This virus does not stop. It does not rest. We have a single pill today to treat HIV, but we know that this virus has incredible methods to work around,” Bekker said. “Even as we celebrate that Lenacapavir is a terrific breakthrough for prevention, we know that this virus can easily get ahead of us even there. And so we have to constantly be asking: ‘What is the next breakthrough that we are going to need to eventually bring this epidemic to a close?’” ‘The fragility of it all’ NIH’s support for HIV research went beyond funding, experts said; it also includes the creation of research networks. “They have really driven team science. They've driven large groups of scientists to work together in big teams,” Lewin said. “That is a way to tackle really significant, major challenges. You can't do it in isolated, single laboratories, in Cape Town, or Melbourne, or Nairobi. You really need big consortia. And no other funder has done it, I don't think globally, in the same way the NIH has done it, particularly in the area of cure science.” But this year’s massive Trump administration cuts revealed the fragility of it all. “When one funder as large as the U.S. retreats, the whole infrastructure can rapidly change,” Lewin said. And the research was also not only about creating new health products — but ensuring that people actually use them, said Kenneth Ngure, IAS president-elect. This is known as the "science of choice,” he said, which investigates what sort of characteristics consumers want in a product so they will take it. “Sometimes you hear people saying the pill is too large — the packet makes a lot of noise. Those kinds of things we wanted to address in the next generation of products,” he said. But he added that these networks of research have also been crippled. Funding cuts also threaten the fostering of the next generation of HIV scientists. “When young scientists commit to a career … and they see all of this uncertainty ahead of them, we really run the risk of losing great talent,” Lewin said. “That, I think, is a real concern for the sector.” And clinical trial participants have been abandoned, sometimes with study drugs or study devices still in their bodies, said Asia Russell, executive director of Health Gap. And some communities have looked forward with hope to clinical trials that are now not coming. “That kind of ethical harm isn’t easily repaired,” she said. “Many communities who have participated in clinical trials over decades have a massive breach of trust now.” The research community is looking to find support to continue their research in other forms. “Very few funders say: ‘I'm here to fill a gap,’” Lewin said. For example, Horizon Europe is a grant funding scheme that hasn’t yet had a major focus on HIV research, she said. “That's one area that we're very keen to advocate for,” Lewin said. “I doubt China will fund in the same way that the U.S. funds, [the U.S. will] fund the best science in any country. But I think there will be an important partner.” Editor’s note: The International Aids Society supported Devex’s attendance at its conference through a media scholarship. Devex retains editorial independence.