PxWire Volume 15, Issue 2

The field of HIV prevention is confronted with two opposing forces; programs for delivering PrEP have been shuttered all over the world by the withdrawal of the US government from global health. At this same moment in history, next-generation long-acting products hold great promise to accelerate HIV prevention and help the world achieve epidemic control. Navigating these seismic developments requires unprecedented coordination, solidarity, and courage.

Global health champions can defy the hatred, fear, and greed that are dominating politics in so many places around the world. Together we can innovate, create, and protect the advance of HIV prevention and global health. This issue provides a snapshot on threats to delivering PrEP, the potential of injectable lenacapavir (LEN) for PrEP, and on the implications of upstream research and development of other long-acting PrEP.

Read below or download the PDF version.

Progress in PrEP Uptake: Threatened

  • PEPFAR documented 2.5 million new PrEP users in 2024, who could now lose access to PEPFAR- supported PrEP services. US Department of State issued a limited and inconsistently implemented waiver in February, allowing for continued provision of HIV treatment but restricting PrEP access to pregnant and lactating people only.
  • These actions will result in 3.5 million who identify as key populations (KPs) losing access to all HIV prevention programming under PEPFAR, according to 2024 PEPFAR data tracking KP use of PrEP. These groups have higher rates of HIV incidence and face additional barriers to accessing services now that targeted programs are suspended.
  • PEPFAR had a goal of 100,000 people initiating cabotegravir (CAB) for PrEP in 2025. But only 5,000 individuals had initiated by October 2024. The suspension of PEPFAR funding imperils scale-up of this long-acting product.
  • These figures represent just some of the disruptions that are decimating PrEP delivery. Learn more here: Impact of PEPFAR Stop Work Orders on PrEP
  • Overcoming this challenge, restoring, sustaining, and accelerating PrEP access is imperative and possible if the field works together.

For the last eight years, AVAC has proudly worked with PEPFAR to document PrEP uptake and its impact around the world. That stopped in January with a stop work order from the US government. But protecting access to PrEP is vital. Are you leading a PrEP program? Whether supported by PEPFAR or not, we invite you to work with us to ensure global data on PrEP is not lost. Find us at [email protected].

PrEParing for New Products

  • Approval by the US Food and Drug Administration (FDA) for injectable 6-month LEN for PrEP is expected in June, with WHO guidelines expected in July. See the full timeline.
  • Modelling data from South Africa demonstrate the potential of injectable PrEP to dramatically reduce HIV incidence by up to 90% by 2044, and potentially even sooner with more aggressive uptake. This potential goes beyond South Africa, lighting the way toward epidemic control the world over.
  • The field must be prepared for swift action once LEN is approved and recommended, to ensure this opportunity is not squandered. As AVAC’s interactive timeline, Tracking LEN Rollout, outlines, donors, ministries of health, manufacturers, regulators, and civil society all have a role to play to pave the way for swift, equitable and effective introduction of LEN for PrEP.

The Latest R&D in the Prevention Pipeline

  • The HIV prevention market is headed toward a period of significant opportunity—and possible congestion—as a slate of new products are on track for continued development and potential introduction to the market in 2027 and 2028.
  • Generics for 2-month CAB and 6-month LEN, along with ViiV’s 4-month CAB, Gilead’s 12-month LEN, and Merck’s monthly oral MK-8527 PrEP pill (if further development and approvals are successful) could all enter the market by 2028.
  • The possibility of so many products on the market, including four different formulations of injectable PrEP, means that it is imperative the field prepares for this future now.
  • Markets and policies must be built to support the products in the market already, so that new options can be rapidly deployed and deliver impact. Otherwise, the field will squander time and money, with epidemic control slipping further out of reach.
  • With US funding cuts to both HIV prevention R&D and delivery, communities must be engaged, supported, and informed about all prevention options, and the choices that all stakeholders will need to make. This means gathering and sharing data and information about cost-effectiveness, user acceptability, program feasibility, and impact. Communities empowered with the facts can advocate for the choices they need, and push ministries of health to make strategic investments and procure the prevention method mix that fits their context and delivers impact.

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, at avac.org/global-health-watch
  • CHANGE: In response to the unfolding crisis, more than 1,500 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

Watch/Listen

Read

Avac Event

Science in the Crosshairs: Research Advocacy in a Time of Crisis

AVAC and partners had a critical conversation on the escalating threats to health research and equity-centered science. This webinar unpacked the implications of the proposed FY2026 US federal budget—which includes sweeping cuts to NIH, CDC, USAID, and the elimination of vital global and minority health research programs. Together, we explored what these attacks mean for communities, researchers, and implementers and identified actionable advocacy strategies to fight back.

Recording / Slides / Resources

Research Matters – Resources to Protect Research Funding 

For more than 30 years, AVAC and partners have worked to protect the infrastructure and funding that drives lifesaving HIV and biomedical research. Today, that mission is more urgent than ever. 

Funding from the National Institutes of Health (NIH) fuels innovation, drives the economy, and saves lives. Cuts to this support will make America—and the world—poorer, sicker, and less prepared for future health threats. 

Tomorrow (Wednesday, April 30), the US Senate Appropriations Committee will host a hearing on Biomedical Research: Keeping America’s Edge in Innovation at 10:30am ET. Click here to watch the hearing. 

And be sure to read the written statement to the Committee from AVAC and The Federal AIDS Policy Partnership (FAPP) Research Working Groups, which provides a strong, urgent appeal to Congress to reject future funding cuts to the NIH and shows the importance and impact investments in biomedical research have had on lives and livelihoods. 

Resources for Researchers 

In addition, AVAC, TAG and the HIV Medicine Association (HIVMA) co-created a new resource hub, Research Matters, to support researchers advocating for sustained NIH funding. These tools include an Advocacy Toolkit  to help move our collective efforts forward. Please share this link with any researchers who have received NIH funding—we will continue to update the hub with resources to support continued advocacy for biomedical research.  

Share Your Story 

Additionally, AVAC and partners are collecting stories of impact—if you know someone willing to share their story about how NIH cuts are affecting their work, contact John Meade Jr. at [email protected]. This Huffington Post piece by Katie Edwards at the University of Michigan is a terrific example of a researcher sharing the real-world toll on scientists, trial participants, communities, research and public health. 

Thank you for standing with us to protect science, health, and progress. 

Research Matters Advocacy Toolkit

This toolkit for researchers shares key messages, practical advocacy guides, and resources to help move our collective efforts forward.

Despite USG Global Health Collapse, Here Are Several Data Trackers To Support Your Advocacy

With the collapse in support from the US Presidential administration in global health, data sources tracking the HIV response have been lost, from HIV incidence and prevalence to PrEP uptake and disparities among key populations and regions of the world. Below, AVAC has identified dashboards, data trackers and other resources to inform your advocacy.

Tracking PrEP Access

  • Impact of the Stop-Work Order on PrEP
    On PrEPWatch, this webpage outlines the consequences of PEPFAR stop-work orders on HIV prevention, detailing disruptions to PrEP services, stalled product rollouts (including CAB), halted research, and workforce reductions. It includes downloadable slides to support advocacy and analysis.
  • Tracking Lenacapavir Rollout
    This new online tracker monitors all the key steps, timelines and responsible stakeholders needed to ensure equitable access to injectable lenacapavir (LEN) for PrEP. Find it on PrEPWatch.

Tracking the Impact of US Government Funding Cuts

  • PEPFAR Funding Freeze
    This webpage shares resources developed by a new global civil society coalition, Community Health and HIV Advocates Navigating Global Emergencies (CHANGE) on various impacts of the freeze.
  • Impact of US Funding Cuts on the Global AIDS Response
    UNAIDS’ weekly situation report provides an overview and up-close country snapshots of the impact to service delivery and human resources.

Tracking Court Action

These trackers and additional resources are included in our weekly Global Health Watch newsletter along with the latest policy developments and their implications to keep advocates informed, prepared and connected.

Global Health Watch: Tariffs, NIH Cuts, Black-led HIV Research Agenda & PEPFAR’s Legacy

April 11, 2025: Issue 11

This week brought major developments for global health: new tariffs on pharmaceuticals are pending, a court blocks the cap on NIH indirect costs, and worries a leadership vacuum at the CDC is a cause for yet more concern. Amid the chaos, advocates rallied—defending PEPFAR’s legacy in Congress and launching a national Black-centered, Black-led HIV research agenda. 

Read on for highlights and implications and be sure to check out the What We’re Reading section, which is full of great pieces this week. 

Tariffs and HIV

As the administration created even more chaos with the on-again, off-again sweeping tariffs and threats of major trade wars, a new report highlights concern and potential effects on health systems—including HIV prevention and care. Finished pharmaceuticals are temporarily exempt, but essential components like diagnostic tests, syringes, excipients and other medical supplies may not be protected, raising alarms about cost increases and supply chain delays. And on Tuesday, the President announced at a dinner that new tariffs targeting pharmaceuticals are now officially “coming soon.” 

IMPLICATIONS: If global pharmaceutical manufacturers move their operations to avoid tariffs, FDA inspections—with many fewer resources in the wake of last week’s mass layoffs—could delay approval of new products. Clinics, hospitals and other health systems may face increased costs, limited availability of products and a more fragile supply chain.  

READ:  

NIH Overhead Cuts Blocked by Court 

A federal judge issued a permanent injunction blocking an administration policy that would have capped indirect cost payments at 15% for both new and existing NIH grants. The policy threatened to cut billions in support for universities, academic centers, and research institutions—jeopardizing infrastructure, staff, and ongoing studies. While the administration may appeal the ruling, it marks an important step in what could be a long legal battle over the future of federal research funding. At the same time, massive uncertainty remains at NIH, given the numerous staff and grant terminations. 

READ:  

US CDC Uncertainty

Internal memos reported by Inside Medicine indicate that the US CDC currently has no legally-required Acting Director, which leaves the agency in a leadership vacuum at a critical time. Dr. Susan Monarez, who previously served in an acting capacity, became ineligible for that role after being nominated for the permanent position on March 24. In the meantime, scientists and advocates are calling on federal and state health leaders to protect the nation’s only STD reference laboratory and reinstate over 30 scientists affected by the recent reduction in force (RIF) amid a growing public health crisis of rising STDs and drug-resistant infections. Colleen Kelley, chair of the HIV Medicine Association (HIVMA) testified before Congress Wednesday advocating for the CDC’s prevention division, continued funding in HIV care, prevention and research. 

IMPLICATIONS: Without a legally authorized director, decisions normally reserved for CDC leadership—including the acceptance of upcoming vaccine recommendations by the Advisory Committee on Immunization Practices (ACIP)—must now be made by HHS Secretary Robert F. Kennedy Jr., a known vaccine skeptic. This raises urgent concerns about legal compliance, scientific integrity, and public trust, particularly as thousands of CDC staff have been laid off and critical public health decisions loom.  

READ:  

Making the Case for PEPFAR 

On Tuesday, EGPAF’s Catherine Connor and Ambassador Mark Dybul testified at the US House Appropriations Subcommittee hearing on PEPFAR, issuing powerful affirmations of the program’s life-saving impact—and the bipartisan commitment to its future. Lawmakers from both sides showed strong support for PEPFAR. They also shared an interest in innovation—including the promise of long-acting PrEP—to strengthen the program’s next phase. Their testimony came at the same time that Michel Sidibe and colleagues published new data in a Lancet Correspondence underscoring PEPFAR’s legacy—in saving an estimated 26 million lives, and also in catalyzing a 212% increase in domestic health investment across PEPFAR-supported African countries, since 2004. In the same issue, Lucie Cluver published updated modeling of the impact of potential PEPFAR cuts. 

READ/WATCH:  

A Black-led Agenda for HIV Research

PrEP in Black America (PIBA) and more than 80 Black researchers, scientists, and community leaders, launched the first-ever national Black HIV Prevention Research Agenda this week, a call to action and a blueprint to end HIV in Black communities. The agenda centers Black voices, leadership, and lived experience to influence how HIV prevention research is conducted, funded, and implemented. AVAC’s John Meade described the launch as a moment of “reckoning and resistance,” pointing to the urgent need to protect public health infrastructure, advance equity, and resist political threats to HIV research and LGBTQ+ rights. This domestic research agenda importantly complements the People’s Research Agenda that AVAC and global partners released last October. The two documents provide a truly global, community-led perspective on the future of HIV prevention research. 

READ: 

The Future of Injectable Lenacapavir for PrEP

Clinical Infectious Diseases covered two viewpoints offering different perspectives on the future of injectable lenacapavir for PrEP—and the future of HIV prevention more broadly.

What We’re Reading

Update on AVAC vs. Department of State

Two months ago, AVAC sued the US government over an Executive Order that froze all foreign assistance. 
 
Since then, the court has ordered the government to restart certain payments and uphold its legal obligations. But delays, resistance, and appeals continue—putting global health, HIV prevention, and US credibility on the line. 
 
Read our update on the case and watch our latest episode of PxPulse Live where AVAC’s Executive Director Mitchell Warren and Public Citizen litigator Lauren Bateman unpack the latest legal developments.

Resources

Impact of PEPFAR’s Stop Work Order on PrEP

The impact of the stop-work order on PrEP is expected to be severe. In a set of slides and on our website, PrEPWatch, we have posted the results of an analysis drawing on key informant interviews with representatives of Ministries of Health and PrEP implementers between 27 January 2025, when stop-work orders were issued by the US government, and the end of February 2025, when the vast majority of USAID-funded projects received official termination notices. Find the latest here.

Trials & Projects Halted by USAID Funding Suspension

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

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.

HIV Incidence, Age 15-49

Looking backward and then into the future, this chart shows actual HIV rates alongside projected rates with and without current prevention strategies (PrEP, VMMC, and free condoms).

Global PrEP Uptake and PEPFAR’s Role, 2016-2024

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.