IAS 2025, Kigali, Rwanda | Conference Coverage

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What the future of HIV science and services might look like without U.S. funding

More diversified, regionally based funding and a greater reliance on China are among the scenarios that may emerge in the wake of what appears to be the end of an era of major U.S. funding for HIV research and programs around the world, a group of leading HIV researchers said at a news conference during the IAS meeting.

In an hour-long briefing, the four experts also defended continued research into formulating an AIDS vaccine and discussed the nuances of integrating HIV services into other healthcare services, including the risk of groups that have been stigmatized dropping out of HIV prevention and care efforts. The sheer abruptness of the cuts in U.S. funding has caused its own set of problems, the researchers said, hobbling a number of research projects that were years in the making and eroding hard-won trust with communities in the process.

From left: Beatriz Grinsztejn, Kenneth Ngure, Linda-Gail Bekker, Sharon Lewin

Spending cuts at the National Institutes of Health (NIH) could unravel a team-based model of scientific research that American funding largely created and that involves large groups of researchers working in many different countries, said one of the researchers, Sharon Lewin, M.D., Ph.D., director of The Peter Doherty Institute for Infection and Immunity in Melbourne, Australia. Team-based science is “the way to tackle really significant, major challenges,” Lewin said. “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, globally, in the same way the NIH has done it,” Lewin said.

The Trump administration’s decisions to slash foreign aid and shutter the United States Agency for International Development (USAID), both of which have affected funding of projects focused on HIV and AIDS, loomed as a darkening backdrop to the IAS meeting, which is structured as a scientific meeting, not a policy one. But this year, sessions were devoted to the consequences of cuts and straitened circumstances resulting from the U.S. cutbacks, and the cutbacks came up often in discussion.

“I would really hope that the African footprint would be larger, not only in the provision of care, which is obviously our mandate, but even in the R&D [research and development] space,” said Linda-Gail Bekker, M.B.Ch.B., Ph.D., director of the Desmond Tutu HIV Centre at the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town in South Africa. Bekker noted earlier in the news conference that African governments had not lived up to the 2001 Abuja Declaration, in which they pledged to allocate 15% of their national budgets to improving healthcare.

The scope of the U.S. funding cuts is difficult to determine, Bekker said. “The confidence intervals about the numbers” have been wide, she said. The United States President’s Emergency Plan for AIDS Relief (PEPFAR) was initially threatened by the Trump administration’s foreign aid freeze but then the administration granted waivers that allow some of its funding to continue. The situation has been complicated by the closing of USAID, which implemented many of the programs funded by PEPFAR.

The net result of the funding pullback so far seems to be preservation of funding for AIDS treatment programs and HIV prevention programs for pregnant and breastfeeding women, but an end to funding for prevention for other groups and for community-oriented HIV programs, some of which focus on stigmatized groups, such as transgender women, men who have sex with men, and sex workers.

Bekker mentioned two projects that have ground to a halt because of the foreign aid freeze’s effect on PEPFAR: MOSAIC, a project designed to promote the development of HIV prevention products for adolescent girls and young women, and CATALYST, designed to test and assess the uptake of different types of HIV preexposure prophylaxis for women. Another researcher on the panel, Kenneth Ngure, Ph.D., M.P.H., M.Sc., an associate professor of global health and dean of the School of Public Health of the Jomo Kenyatta University of Agriculture and Technology in Kenya, also mentioned the MOSAIC project and the promise it held for identifying ways to make prevention products more acceptable. “The science that has been crippled is humongous,” he said.

After positive phase 2 results, Merck plans a phase 3 trial of monthly oral HIV PrEP

An oral version of HIV preexposure prophylaxis (PrEP) that can be taken monthly instead of daily showed good safety and pharmacokinetic characteristics that backed up monthly dosing, according to results presented at the IAS meeting. Merck, the maker of the drug provisionally named MK-8527, has said that it will sponsor two phase 3 trials of MK-8527, one among adolescent girls and young women in Kenya, South Africa and Uganda, and the other in 16 countries worldwide.

The phase 2 results reported at the IAS meeting by Kenneth Mayer, M.D., a professor at Harvard Medical School in Boston, showed a high prevalence of adverse events, with approximately two-thirds of the patients treated with MK-8527 experiencing an adverse event, but most were mild. There was just one serious adverse event that the researchers considered related to the drug.

The pharmacokinetics showed proportionality: The higher the dose of the MK8527, the higher the concentration was in the blood, Mayer said. The pharmacokinetics also indicate that levels stay high enough to fend off an HIV infection over the course of a month, according to data shown by Mayer.

Oral PrEP has been overshadowed recently by the long-acting injectable versions of PrEP. But Mayer remarked that “some people don’t want to take shots” and that although oral PrEP with a daily dosing schedule is protective against HIV infection, the everydayness results in nonadherence. The new World Health Organization (WHO) recommendations for HIV prevention and care issued on the first day of the IAS meeting did not favor one form of PrEP over another. WHO officials have stressed the importance of choice, pointing to research that suggests that when people have options, they are more likely
to use PrEP.

The phase 2 trial that Mayer reported on assessed three different doses of MK8527. The study was conducted in the U.S., South Africa and Israel, with the greatest number of participants coming from the United States.