TAG launches 2025 HIV Pipeline Reports

TAG’s annual HIV Pipeline Reports are now available for download, covering the clinical research pipelines for:

• Antiretroviral Therapy

Updates on new antiretrovirals in clinical development, including long-acting injectables and oral regimens with weekly dosing schedules.

• HIV Vaccines and Passive Immunization

An effective HIV vaccine remains essential for ending the HIV epidemic. Twelve new clinical trials have been registered over the past year, but the field is being seeing funding reduced for short-sighted political reasons despite significant progress toward solving the challenging conundrum of inducing broadly neutralizing antibodies (bNAbs) capable of protecting against HIV acquisition. Long-acting PrEP is a significant advance, but there are notable limitations including  side effects, drug interactions, and a prerequisite to recognize the need for PrEP.  A major and unique advantage of vaccines is the potential to offer broad population coverage regardless of self-assessment of HIV exposure risk.

• PrEP and Microbicides

The recent approval of twice-yearly lenacapavir PrEP is a huge stride forward for biomedical HIV prevention, but isn’t a panacea. Now that the intervention has emerged from the research pipeline, there are serious questions about how accessible the drug will be for those in greatest need – see the statements from our allies Health GAP, AVAC, Public Citizen and UNAIDS. The decimation of PEPFAR — including the egregious, bigotry-based elimination of HIV prevention programs for key populations — means that lenacapavir PrEP rollout must now navigate the wreckage of a life-saving program that had planned to play a leading role in providing access globally. The next PrEP candidate in the research pipeline to reach the stage of efficacy testing is Merck’s MK-8527, an oral pill dosed monthly.

• Research Toward a Cure and Immune-Based Therapies

The number of individuals cured of HIV by stem cell transplants needed to treat cancer diagnoses continues to increase (ten potential cases have now been reported), but progress toward widely applicable curative interventions is still incremental. The past year has seen encouraging results from studies of bNAbs, but as with all HIV pipelines the assault on scientific research by the current US administration threatens to derail this critical international work. TAG strongly recommends reading the new statement from The Well Project: Bolstering HIV Cure Research in the Current Political Context: A Statement from The Well Project and the Women’s Research Initiative on HIV/AIDS.

The National Institutes of Health (NIH) plays a massive role in funding the science involved in all the HIV pipelines, but is currently overseen by Robert F. Kennedy Jr. who admitted just two years ago that he understands so little that he still believes in AIDS denialism (the false claim that HIV doesn’t cause AIDS). The new NIH Director, Jay Bhattacharya, is now stating that HIV research should be solely focused on implementing currently available therapeutic and preventive options. It’s unclear, at best, whether either of these individuals want there to be any pipelines of new interventions to treat, prevent, and cure HIV.

A take-home message from all TAG’s 2025 HIV Pipeline Reports is that there’s an urgent need for people in the US who care about scientific research and the development of new therapeutics — for any condition — to make their voices heard to Congressional representatives, news outlets, and in their communities. The NIH is by far the largest funder of scientific research in the world, and if its destruction is allowed to proceed there’ll be disastrous consequences for decades to come.