The Cruel Irony of Prevention

FDA approves LEN, while the administration destroys USAID

It’s been 22 weeks since the US president issued the executive orders that began the chaotic dismantling of USAID. See recent, remarkable, and much-needed New York Times coverage on the destruction of USAID. And check out this new episode of the This American Life podcast on the aftermath of shutting down USAID.   

We at AVAC took a public stand against this attack on global health and development in our court case, AVAC v. United States Department of State, filed by Public Citizen on February 10. We took this step because we understood the devastation that would come from such drastic and sudden divestment in the HIV response and global health. We also believe it was illegal and unethical.  

In March, US District Court Judge Amir Ali ruled the foreign aid freeze was, indeed, unlawful, and that the administration had “usurped” the authority of Congress. Since that time, some 400 grants have been restored and the government is slowly complying with the Judge’s order to pay all invoices for work conducted through February 13. It’s a mere fraction of USAID’s former self, but each of these restored programs and payments represent an attempt to make America and the world stronger, safer and more prosperous. Just as important, our court case, along with a related one brought by the Global Health Council and colleagues, has forced into the public record the administration’s cynical maneuvers to dismantle global health; information that empowers advocates to fight and, we hope, finally spurs Congress to do its job.

“We cannot cede ground gained against HIV and other global health threats out of fear or paralysis in the face of these reckless actions. It is imperative to hold this administration responsible. And it’s imperative to invest in global health and sustain the gains in HIV. Global health advocates know this better than anyone, and we are fighting back,” said AVAC Executive Director, Mitchell Warren.

Watch AVAC’s Executive Director, Mitchell Warren’s video explaining how this court case is one of many critical steps to safeguard global health and the HIV response.

Nowhere is that fight to safeguard and advance HIV prevention more important than work to rollout injectable lenacapavir (LEN) for PrEP, just approved by the US Food and Drug Administration. LEN approval signals what could be a turning point in the epidemic – but only if the field invests in bold, strategic action. 

“The science is remarkable, and the FDA approval is in. But it’s what happens next that makes the science count. It’s whether or not the technology is made available and becomes truly accessible that will bring impact. Will the world get it right this time? Because for 15 years we’ve squandered the potential of PrEP. That hope depends on fierce and effective advocacy,” said Warren.

HIV prevention advocates around the world are demanding and preparing for injectable LEN to reach the communities that need it most with speed, scale and equity. Watch this video for more on status of LEN rollout and advocacy priorities.

“Scientific progress has been made over the years, and we celebrate them, but without truly having a prevention story to tell…yet. Now it’s time for that story to be told,” said APHA Executive Director Yvette Raphael.

Read this report from Friends of the Global Fight Against AIDS, Tuberculosis and Malaria, Principles of a responsible transition of American leadership to end AIDS: Strategic transition or pandemic resurgence?, on how PEPFAR and US leadership can play an instrumental role in reaching epidemic control.

“There’s much work advocates are doing, and much work ahead. Some donors have come forward, but it’s only a start. We also need to advocate with regulatory authorities at the country level, not to mention pushing for an affordable price, and a big enough supply from Gilead now to support demand creation at scale in order to build a sustainable market, which in turn will support generics and further reductions in price. Advocates are now and will continue to be fighting at the country level and the global level to move all this forward,” said HEPS Uganda Executive Director Kenneth Mwehonge and co-chair of the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP.

Check out the Caucus statement on priorities for LEN rollout, and these resources to support our collective advocacy:

Recent news headlines, including the just published New Yorker magazine article by Science reporter Jon Cohen, capture the power of this moment to reshape the HIV response and finally control the epidemic. As advocates, we know the stakes very well.

“What all of us working together have tried to do for years and years and years, is to overcome the barriers from stigma to disinformation, that we’ve seen with oral PrEP, and with treatment 20 years ago. It will take Gilead, working with all of us advocates, to collectively ensure that this drug is accessible to all, so that the success depends not on the politics but on the product. We have to hold everyone, including ourselves, to account for keeping on task and for making sure that we do not squander this opportunity. So, let’s do this together and lay the groundwork for all future innovations to go faster, with speed, with scale and with equity for all,” Warren said.

The field is at a major inflection point, punctuated by both political challenges and scientific opportunity – and we can’t let the former overtake the latter.

LEN Generics — Can we go faster?

The timeline for generic LEN for PrEP to come to market is expected to be significantly shorter than for CAB for PrEP. Bioequivalence (BE) testing for LEN, which demonstrates a generic product works in the body in the same way as the originator product, is likely to be six months, vs. the 18 months for CAB for PrEP, because of differences in the drug formulation. The rapid granting of voluntary licensing by Gilead also contributes to this shorter timeline. For the latest on LEN, visit here.

AVAC Denounces White House Effort to Codify DOGE Cuts to Health, Research and Foreign Assistance

AVAC denounces recent proposals and actions by the US administration that signal a clear intention to defund and eliminate lifesaving global health research, development and delivery programs. If passed by Congress, proposed funding rescissions for the current year’s budget would claw back billions of Congressionally appropriated dollars for critical, life-saving programs. In addition, the President’s Fiscal Year 2026 (FY26) budget proposal would further cut funding and entrench a wide range of anti-science and anti-public health policies, many of which undermine the rights of communities vulnerable to HIV. AVAC urgently calls on Congress to step-up in bi-partisan support that aligns the US federal budget with evidence and delivers impact.

“These actions are doing irreparable harm to health research and programs that form the backbone of global efforts to end HIV,” said Mitchell Warren, AVAC’s executive director. “This is not just a budget proposal; this is a shortsighted and reckless policy roadmap that provides further proof that this administration has no regard for science, research, or public health. Every day of unchecked executive overreach unravels decades of progress. Congress must fulfill its duties and intervene to protect policies and programs that have made Americans and the world safer, healthier and more prosperous.”

Released in May as a “skinny” version, the President’s full FY26 budget proposal would dismantle the architecture for global health, including programs and research with historically broad bipartisan Congressional and public support. The FY26 budget proposes slashing PEPFAR by 34% and National Institute of Allergy and Infectious Diseases (NIAID) funding by 36%, for a combined total of over $5.5 billion in cuts – potentially crippling HIV programs and research. The FY26 budget further targets the Global Division of HIV and Tuberculosis (DGHT) at the US Centers for Disease Control and Prevention (CDC) by eliminating it along with other global health programming at the agency. PEPFAR is severely weakened without the partnership of CDC’s global health division and USAID, which bring vast expertise and technical assistance in the implementation of programs at the country-level.

Additionally, the proposed rescissions package would eliminate over $900 million from FY25 global health programs. The rescissions package would cancel not-yet-spent funds, and the administration has not excluded PEPFAR from these further reductions. If passed by Congress, it would codify, or make legal, the unlawful dismantling of USAID, which was initiated through presidential executive overreach and reckless actions by DOGE across federal agencies. Just as important, harmful, ideological rhetoric across FY26 budget documents and the rescissions package attempt to justify targeted cuts to services for the LGBTQI+ community, family planning and reproductive health. Such policies are antithetical to a rights-based public health approach to meeting critical needs among communities who are the most marginalized and vulnerable to HIV and other diseases.

These actions by the administration also come on the heels of last week’s announcement of the elimination of NIH funding for the Consortia on HIV/AIDS Vaccine Development (CHAVD). Founded in 2005, the CHAVD programs – based at Duke University and Scripps Research Institute – have been instrumental to advancing HIV vaccine research and development, contributing to progress toward an HIV vaccine and other scientific innovations.

“A shuttered CHAVD imperils the ongoing quest for an HIV vaccine and sidelines scientific discovery at large, leaving some of the most accomplished scientists in the world without the federal resources needed to continue vital research,” said Stacey Hannah, director of Research Engagement at AVAC. “Americans need to be reminded that vaccines are one of, if not the most cost-effective, impactful health interventions. The CHAVD cuts represent an attack on fundamental science that protects the well-being of all and boosts prosperity in our country and the world.”

These actions are part of a broader anti-science agenda from this administration, which has already taken steps to severely constrain the work of the HIV Prevention Trials Network, the HIV Vaccine Trials Network, the Adolescent Medicine Trials Network for HIV/AIDS Intervention, and the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG).

“In a cruel irony, these combined cuts come just as the field reaches a moment of historic promise in HIV prevention,” said John Meade, senior program manager for Policy Advocacy at AVAC. “Later this month, the US FDA is expected to approve lenacapavir (LEN) as a twice-yearly injectable form of PrEP. This product represents the culmination of decades of investment in all stages of scientific innovation, including basic science and global research infrastructure, especially in South Africa. Without NIH investments over the past two decades, the world would not be on the cusp of approval and introduction of LEN for PrEP.”

AVAC calls on Congress to exercise its power of the purse under the Constitution by rejecting the President’s proposed cuts to global health, research, development and science. Congress must maintain this critical funding, which makes the world safer, healthier, and more prosperous. Congress should also immediately reject the rescissions package in its vote expected next week and do all it can to restore funding for HIV research and programming across the federal government.

The field must urgently make the case for sustained investment. Everyone concerned about the devastating effects of ongoing and threatened cuts should reach out to their Senators and Congresspeople immediately. Call the Capitol switchboard at (202) 224-3121, or reach out to your Senators online and Representatives directly.

Press Release

AVAC Denounces White House Effort to Codify DOGE Cuts to Health, Research and Foreign Assistance

Contact: [email protected]

NEW YORK, NY, June 5, 2025 — AVAC denounces recent proposals and actions by the US administration that signal a clear intention to defund and eliminate lifesaving global health research, development and delivery programs. If passed by Congress, proposed funding rescissions for the current year’s budget would claw back billions of Congressionally appropriated dollars for critical, life-saving programs. In addition, the President’s Fiscal Year 2026 (FY26) budget proposal would further cut funding and entrench a wide range of anti-science and anti-public health policies, many of which undermine the rights of communities vulnerable to HIV. AVAC urgently calls on Congress to step-up in bi-partisan support that aligns the US federal budget with evidence and delivers impact.

“These actions are doing irreparable harm to health research and programs that form the backbone of global efforts to end HIV,” said Mitchell Warren, AVAC’s executive director. “This is not just a budget proposal; this is a shortsighted and reckless policy roadmap that provides further proof that this administration has no regard for science, research, or public health. Every day of unchecked executive overreach unravels decades of progress. Congress must fulfill its duties and intervene to protect policies and programs that have made Americans and the world safer, healthier and more prosperous.”

Released in May as a “skinny” version, the President’s full FY26 budget proposal would dismantle the architecture for global health, including programs and research with historically broad bipartisan Congressional and public support. The FY26 budget proposes slashing PEPFAR by 34% and National Institute of Allergy and Infectious Diseases (NIAID) funding by 36%, for a combined total of over $5.5 billion in cuts – potentially crippling HIV programs and research. The FY26 budget further targets the Global Division of HIV and Tuberculosis (DGHT) at the US Centers for Disease Control and Prevention (CDC) by eliminating it along with other global health programming at the agency. PEPFAR is severely weakened without the partnership of CDC’s global health division and USAID, which bring vast expertise and technical assistance in the implementation of programs at the country-level.

Additionally, the proposed rescissions package would eliminate over $900 million from FY25 global health programs. The rescissions package would cancel not-yet-spent funds, and the administration has not excluded PEPFAR from these further reductions. If passed by Congress, it would codify, or make legal, the unlawful dismantling of USAID, which was initiated through presidential executive overreach and reckless actions by DOGE across federal agencies. Just as important, harmful, ideological rhetoric across FY26 budget documents and the rescissions package attempt to justify targeted cuts to services for the LGBTQI+ community, family planning and reproductive health. Such policies are antithetical to a rights-based public health approach to meeting critical needs among communities who are the most marginalized and vulnerable to HIV and other diseases.

These actions by the administration also come on the heels of last week’s announcement of the elimination of NIH funding for the Consortia on HIV/AIDS Vaccine Development (CHAVD). Founded in 2005, the CHAVD programs – based at Duke University and Scripps Research Institute – have been instrumental to advancing HIV vaccine research and development, contributing to progress toward an HIV vaccine and other scientific innovations.

“A shuttered CHAVD imperils the ongoing quest for an HIV vaccine and sidelines scientific discovery at large, leaving some of the most accomplished scientists in the world without the federal resources needed to continue vital research,” said Stacey Hannah, director of Research Engagement at AVAC. “Americans need to be reminded that vaccines are one of, if not the most cost-effective, impactful health interventions. The CHAVD cuts represent an attack on fundamental science that protects the well-being of all and boosts prosperity in our country and the world.”

These actions are part of a broader anti-science agenda from this administration, which has already taken steps to severely constrain the work of the HIV Prevention Trials Network, the HIV Vaccine Trials Network, the Adolescent Medicine Trials Network for HIV/AIDS Intervention, and the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG).

“In a cruel irony, these combined cuts come just as the field reaches a moment of historic promise in HIV prevention,” said John Meade, senior program manager for Policy Advocacy at AVAC. “Later this month, the US FDA is expected to approve lenacapavir (LEN) as a twice-yearly injectable form of PrEP. This product represents the culmination of decades of investment in all stages of scientific innovation, including basic science and global research infrastructure, especially in South Africa. Without NIH investments over the past two decades, the world would not be on the cusp of approval and introduction of LEN for PrEP.”

AVAC calls on Congress to exercise its power of the purse under the Constitution by rejecting the President’s proposed cuts to global health, research, development and science. Congress must maintain this critical funding, which makes the world safer, healthier, and more prosperous. Congress should also immediately reject the rescissions package in its vote expected next week and do all it can to restore funding for HIV research and programming across the federal government.

The field must urgently make the case for sustained investment. Everyone concerned about the devastating effects of ongoing and threatened cuts should reach out to their Senators and Congresspeople immediately. Call the Capitol switchboard at (202) 224-3121, or reach out to your Senators online and Representatives directly.

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About AVAC

AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Bluesky and Instagram. Find more at www.avac.org and www.prepwatch.org.

Avac Event

Fight for Firewalls: HIV and Health Data Privacy in the Snowballing Surveillance State

With the increased abuse of technology in surveilling and criminalizing healthcare, especially abortion and gender affirming care, more and more people are asking: is my personal health data safe?

People living with HIV and human rights advocates have been demanding answers to this question for years, particularly in relation to the collection, sharing, and storing of HIV genetic data without the consent of people living with HIV.

Kendra Albert, a public interest technology lawyer, discussed the current state of health data privacy, especially as it relates to people living with HIV. Participants learned basic concepts in health data privacy and what actions they can take to improve health data privacy on the state level.

Moderator:

  • Martha Cameron, International Community of Women Living with HIV (ICW), North America

Presenters:

  • Kendra Albert, Albert Sellars LLP
  • Kae Greenberg, Center for HIV Law and Policy

Materials:

Protect Federal Funding for HIV, TB, and STI Research and Prevention at the National Institutes of Health

AVAC and 627 organizations, institutions, researchers, clinicians, public health advocates and stakeholders submitted a written letter to the Senate HELP Committee urging lawmakers to reject the cuts to NIH funding for HIV, TB, and STI research and highlighting the impact of these cuts on lifesaving innovation and research infrastructure.

Advocates’ Guide: Understanding the President’s Proposed Fiscal Year 2026 (FY26) Budget and Its Implications for Science, Research and Global Health 

The US administration’s proposed Fiscal Year 2026 (FY26) budget marks a sweeping rollback of federal investment in health, research, and global development. For advocates, researchers, and implementers, this proposal demands urgent attention and action.  

This initial “skinny budget” is a proposal and not yet law. A more detailed proposal will be released by mid-to-late May and the US Congress will ultimately decide actual funding levels for FY26, which begins October 1. So, advocates must speak up now to protect funding for research and programming that saves lives and livelihoods. 

Here’s what advocates need to know and do: 

Big Picture: A Dramatic Retrenchment 

The budget proposes $163 billion in cuts to non-defense discretionary spending, including a 26% reduction to the Department of Health and Human Services (HHS)— the department that oversees the US National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). These cuts are completely offset by an increase to defense spending and reflect a shift toward the elimination of science and programming tied to diversity, equity, inclusion (DEI), gender, and climate, and a redirection of funding toward defense and “America First” priorities—priorities that put the perceived interests of the US and its citizens over other national and global issues. 

Detailed Analysis and Implications

Health and Biomedical Research 

The proposed cuts to HHS would gut federal support for health and biomedical research, dismantling key programs at NIH and CDC. They threaten progress on infectious diseases, health equity, and pandemic preparedness—undermining decades of scientific gains and leaving communities vulnerable. 

NIH is Cut by $17.9 billion losing HIV and global health research 
  • Preserves $28 billion of the $46 billion for NIH overall, but excludes HIV prevention, global health, and health equity research.  
  • Reorganizes NIH into 5 “realigned” institutes, removing focus on climate, gender, racial equity. 
  • Eliminates the Fogarty International Center and the National Institute on Minority Health and Health Disparities. 

Centers for Disease Control and Prevention (CDC): Cut by $3.59 billion 
  • Eliminates Global Health Center and National Centers on environmental health, injury prevention and chronic disease prevention. 
  • Eliminates DEI programs and shifts the burden for pandemic prevention and response. 
Agency for Healthcare Research and Quality: Effectively eliminated 
  • Cited as redundant; targeted for work on climate and gender. 
National Science Foundation (NSF): Cut by $4.9 billion (56%) 
  • Eliminates funding for work seen as ideologically objectionable (e.g., broadening participation and racial equity in STEM). 

Global Health and Development

At a time when the USG should be expanding access to new technologies, the proposed FY26 budget guts foreign assistance funding, threatening pillars of the global HIV response: the President’s Emergency Plan for AIDS Relief (PEPFAR) and US contributions to multilateral initiatives, such as Global Fund and GAVI. The ideological targeting of family planning and gender-related programs will further weaken interventions to address HIV, which have been shown to work best within a comprehensive package of health and social services.  

Global Health Programs: Cut by $6.23 billion

  • Defunds NGOs providing family planning, impacting maternal and child health providers. 
  • PEPFAR preserved only for existing treatment programs and programs for the prevention of mother-to-child transmission (PMCT) , and specifically excludes primary prevention and PrEP, except for pregnant and lactating populations. 

USAID Development Aid: Cut by $8.33 billion 

  • USAID is eliminated with the limited number of existing programs moved into the State Department. 
  • Eliminates DEI, climate, and gender-related programming. 
  • Creates new “America First Opportunity Fund” to replace foreign assistance grants with loans that prioritize US interests over humanitarian needs. 

Centers for Disease Control and Prevention (CDC)

Health Resources and Service Administrations (HRSA): Cut by $1.73 billion

  • Ryan White HIV/AIDS Program activities not deemed core are eliminated. 

Substance Abuse and Mental Health Services Administration (SAMSHA): Cut by $1.065 billion 

  • Eliminates harm reduction and regional substance use program grants. 

Offices of Minority & Women’s Health 

  • Moved under a new, less visible structure. 

New Initiative: “Make America Healthy Again”

  • $500 million focused on lifestyle over treatment. 

What This Means

  • HIV Prevention R&D and global implementation is at risk. Cuts to NIH and USAID directly threaten support for clinical trials, community engagement, and biomedical innovation. 
  • Equity-centered research threatened. Eliminating institutes focused on minority and global health severely undermines inclusive science and jeopardizes future impact. Inclusion is not just a nice to have, it’s integral to achieving impact 
  • PEPFAR protections are narrow. Only existing beneficiaries are covered; scale up and innovation are excluded, compromising the imminent introduction and potential impact of injectable lenacapavir for PrEP. Funding for HIV prevention is also eliminated, except for pregnant and lactating populations. 

Advocacy Priorities

  • Monitor the full FY26 budget release for agency-level detail and justification. 
  • Engage Appropriations and other relevant Committees via coalition efforts (e.g., FAPP, GAPP, GHTC, SHF). 
  • Mobilize your community to contact your Senators and Representatives to let them know you oppose these cuts.  
  • Share your stories from researchers affected by cuts—particularly those whose work is globally focused or funded by NIH/USAID. 
  • Stay up to date with budget briefings and mobilization opportunities. See AVAC’s ‘Research Matters’ resource, which shares guidance and a toolkit for researchers to advocate for continued funding.

This budget is a threat to decades of progress in science, equity, and health—but it is also an opportunity to speak with clarity and urgency about what is at stake. Advocates must ensure that the future of HIV prevention, global health innovation, and equitable science is not written by politics, but by people, evidence, and impact. 

Worldwide Prevention, Shared Protection

Why STI Funding Matters

This Issue Brief describes the impacts of the elimination and reduction of funding that supports sexually transmitted infection (STI) research, testing, and prevention programming. This funding is critically important as STI rates continue to increase globally with more than 1 million curable STIs, including chlamydia, gonorrhea, syphilis, and trichomoniasis, acquired every day. Without appropriate testing, treatment, and prevention programs, there is a risk that STI rates will continue to increase leading to more cases of infertility, pelvic inflammatory disease, and cancers. Further, there is the risk that we will lose the ability to monitor, react to, and prevent the rise of antimicrobial resistant gonorrhea, which has become an issue for the majority of treatment options currently available. 

Find this in STIWatch.org.

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. 

AVAC and FAPP Written Statement: US Senate Hearing on Biomedical Research

AVAC and FAPP submitted written testimony for the US Senate Appropriations Subcommittee’s April 30th hearing, “Biomedical Research: Keeping America’s Edge in Innovation.”

A set of suggested questions for the Senators to consider was also included in hopes of spotlighting key issues around the importance of lifesaving research conducted by the NIH—specifically in the area of HIV—and its critical role in health equity and innovation. We hope that this can be entered into the record for this hearing.