PxWire Volume 15, Issue No. 1

In this special edition of Px Wire, AVAC is going beyond a quarterly update of biomedical HIV prevention. In this issue, we look at how the new US Administration’s attack on global health can be expected to devastate HIV prevention, including the capacity to deliver existing PrEP options, the scale up of new PrEP products, and the paralyzing impact on research and development. A PDF version of this report is also available.

From Research to Rollout: The impact of USG global health pullout

The United States’ presidential regime has launched a sustained, multi-pronged attack against foreign assistance, scientific inquiry, due process and good governance. It threatens economies, human rights, international partnerships, global health at large, and the rule of law. For HIV prevention, a single sentence, issued in a February 6 advisory from the US Department of State, has derailed the entire field, potentially setting back the HIV response by years, if not decades. Read on for resources to support your advocacy and fortify our solidarity at this critical time.

Progress in PrEP Uptake: Threatened

PEPFAR has been pivotal to accelerating PrEP uptake, significantly expanding HIV prevention coverage. The freeze on foreign aid prohibits funding to PEPFAR’s PrEP programs and poses a serious threat to global efforts to control the epidemic.

AVAC’s Global PrEP Tracker has documented cumulative PrEP initiations on a quarterly basis for nearly a decade. This graph presents the final data collected while PEPFAR was fully operational—PEPFAR support was responsible for 79% of PrEP uptake globally in the last year and reached 83% by the end of September of 2024. Data on the fourth quarter of 2024 is inaccessible since PEPFAR was taken offline in late January.

At the time of the foreign aid freeze, PrEP uptake had reached 8 million initiations since 2016, an achievement that’s taken almost 10 years to reach—too slow and too small to reach UNAIDS targets, but a robust foundation to finally accelerate PrEP uptake with next-generation PrEP. Current US policies, instead of expanding PrEP coverage, are leading to the closure of programs, and will reverse global progress against HIV.

Without primary prevention, the HIV epidemic is poised to rage on, with incidence among adults on track to triple over the next ten years. This HIV Synthesis model, developed by the HIV Modelling Consortium, estimates the impact of stopping all HIV prevention services across Africa from now through 2036—including PrEP, voluntary medical male circumcision (VMMC), and free condom distribution.

PrEParing for New Products: Is rollout still possible?

Read more in The Gears of Lenacapavir for PrEP Rollout.

The chaos in foreign assistance programs (including discontinuation of major PrEP programs), cuts in staffing and new demands on donor commitments will make decisions on the procurement of LEN for PrEP more complex and uncertain. In December 2024, the Global Fund and PEPFAR announced a plan to reach 2 million people with LEN for PrEP over three years. Exactly how funding to support this unprecedented introduction program will move forward, in the absence of significant US investment, is far from certain. The other stakeholders, including Global Fund, Gilead, CIFF and the Gates Foundation expressed commitments to the deal, but major questions remain. In the meantime:

• Gilead’s production of LEN for PrEP is continuing, as is the technology transfer to generic license holders.
• The FDA granted Gilead priority review status for LEN for PrEP, with a decision due by June 19, 2025.
• The EMA has agreed to an accelerated review of LEN for PrEP for both European access and as part of the EU-Medicines for all (EU-M4all) program, reducing the review from seven months to five months.
• The WHO’s Guideline Development Group (GDG) met in January, and WHO is expected to issue guidelines by July 2025.

The Latest R&D in the Prevention Pipeline: Supported or undermined?

The stop-work orders have disrupted USAID-supported HIV prevention research, halting critical investigations in vaccine and next-generation PrEP strategies.

• The BRILLIANT and ADVANCE projects’ clinical, preclinical, and experimental trials testing HIV vaccine candidates have been suspended.
• The MATRIX projects’ driving innovation with next-generation PrEP and MPT products, fast-dissolving inserts and vaginal films and rings, have been forced to stop their clinical trials.
• The MOSAIC projects’ have suspended all implementation science activities, including the CATALYST study, investigating choice among oral PrEP, injectable cabotegravir and the dapivirine vaginal ring. Other implementation studies are continuing, but access to the commodities, much of which was procured by PEPFAR is questionable. See AVAC’s Integrated Study Dashboard for details.
• The Coalition to Accelerate and Support Prevention Research (CASPR) has also been paused. Led by AVAC in partnership with a number of leading African civil society organization, CASPR focuses on building an enabling environment for HIV prevention R&D. (Note: In early February, AVAC lead a lawsuit against the State Department seeking emergency relief from the freeze on foreign assistance, including funding for CASPR. The case, AVAC v. United States Department of State, is pending.)

These disruptions delay the development of urgently needed HIV interventions and threaten the sustainability of research infrastructure all over the world, with particularly egregious impacts on the research capacity of regions most impacted by the epidemic.

The abrupt suspension of these trials also raises serious ethical concerns. Stopping trials mid-course undermines trust in research, jeopardizes community engagement, and abandons participants who volunteer their bodies for scientific discovery. It will take years to build back this critical infrastructure—for HIV research and beyond—as well as the community partnership and trust needed to ensure smooth and ethical research.

Prevention Playlist

AVAC develops a wide range of resources to inform decision making and action. Check out the latest:

Join

• Subscribe to Global Health Watch: AVAC’s weekly newsletter dedicated to breaking down critical developments in US policies and their impact on global health. avac.org/signup
• Seeking Visuals and Videos: Leading groups in Washington, DC, are urgently trying to collect videos and photos documenting the impact of the US government’s foreign aid freeze, such as clinic closures despite the waiver. Non-professional phone videos and photos are welcome. Send to [email protected] for more details
• CHANGE: In response to the unfolding crisis, more than 1,300 people from civil society organizations around the world have launched CHANGE—Community Health & HIV Advocate Navigating Global Emergencies—a coalition formed to support urgent action. [email protected]

Use

• Graphic of studies of injectable cabotegravir and the dapivirine vaginal ring in eastern and southern Africa, AVAC
• Most Lifesaving Services Remain Paused: A Rapid Assessment of the PEPFAR Stop Work Order, amfAR, CHANGE, Data ETC
• What Effect are HIV Programmes Having in Africa, The HIV Modelling Consortium
• PEPFAR & Global Fund Support for HIV Programs, amfAR & Data ETC

Watch/Listen

• [LISTEN] Would PEPFAR Survive Trump—and what would it look like?
• The Impact and Implications of Recent US Government Federal Funding Reductions on Health Programmes, The Steve Biko Centre for Bioethics at The University of the Witwatersrand event recording

Read

• AVAC v United States Department of State. On February 10, 2025, AVAC and another nonprofit organization sued the new US Administration, seeking emergency relief from an Executive Order that inhumanely froze all funding for foreign assistance, AVAC