Day 1 at IAS 2025: Funding cliffs, epidemic-ending possibilities, and essential advocacy

IAS 2025, the 13th International AIDS Society (IAS) Conference on HIV Science, started this week amidst unifying calls to confront the collapse of US support for the HIV response with commitments to reimagine funding, research, development and programming aimed at sustaining progress toward ending the epidemic. At the opening session, the voices of advocates led the way. WACI Health’s Rosemary Mburu said, “the journey to ending the pandemic is not paved with policy papers, scientific publications and procurement plans. It’s carried on the backs of communities, and it needs to be led by communities… Community action is what gives science its soul.”

Following her address, advocates stormed the stage, demanding justice and equity in the HIV response. 

Also at the opening session, Linda-Gail Bekker, CEO and Co-founder of the Desmond Tutu Health Foundation, offered critical milestones for transitioning to resilience in this time of crisis:  

  • Find the estimated 9.2 million people living with HIV who do not have access to treatment. 
  • Eliminate the vertical transmission of HIV from mothers to infants. 
  • Double down on primary prevention, including affordable LEN for PrEP. 
  • Do not stop reaching out to those who have been hardly reached. 
  • Center communities in the response and provide resources to support their leadership. 
  • Be relentless.  

“We as a global community need to reset the paradigm on the scale of prevention that will be needed for significant impact…. We similarly cannot stop innovating, researching and developing to stay at least one step ahead [of the virus],” said Bekker.

AVAC’s Mitchell Warren echoed these calls in an earlier session, 2025: Time to bring HIV, sexual and reproductive health together for better care, sharing guiding principles for the way forward. “We have to collaborate differently. And sustainability cannot just mean budgets; we have to sustain the impact,” he said. 

Released just ahead of the conference, the 2025 Global AIDS Update from UNAIDS, AIDS, Crisis and the Power to Transform, calls for “radical shifts” by countries as imperative to counter the impact of sudden and widespread funding cuts. The report documents the toll of those cuts on communities around the world, from plummeting rates of PrEP use to an anticipated additional six million new cases of HIV between 2025-2029.

At the session Re-imagining Prevention: Planning for Sustainable PrEP Access in the New Funding Context, Warren painted a stark picture of what’s at stake if global HIV prevention continues to be underfunded.

While acknowledging past delays and missed opportunities in the rollout of oral PrEP, the panel made of government officials, donors, implementers and civil society reflected a community that does learn and can be more ambitious. Hiu Yang of the Global Fund talked about their new agreement with Gilead to hopefully reach at least 2 million people with injectable lenacapavir (LEN) for PrEP within three years. But she emphasized, “The two million target for LEN is not a ceiling, it’s a starting point for broader, faster, more inclusive PrEP rollout.” 

Going one step further, Yogan Pillay of the Gates Foundation talked about being more ambitious to reach 7.5 million people over the next few years on the road to a sustainable market with multiple generic manufacturers supplying LEN at a much lower price. This ambition is aligned with AVAC’s recent brief, Now What with Injectable LEN for PrEP?, as well as a new Lancet HIV publication from Sharonann Lynch, Pillay, Raphael, Bekker and others: Lessons for long-acting lenacapavir: catalysing equitable PrEP access in low-income and middle-income countries. 

The kickoff to IAS 2025 mirrored tensions between the resilience needed for sustainability with the stark realities of the impact of funding cuts on lives and livelihoods. Key announcements on Monday also put a spotlight on scientific progress that holds great potential.

WHO LEN and Testing Guidelines Released

The latest WHO recommendations on HIV prevention featured new guidelines on LEN and testing strategies for long-acting injectable pre-exposure prophylaxis. In addition to recommending the six-monthly injectable LEN as a new PrEP option, including for pregnant and breastfeeding people, WHO updates also recommended rapid diagnostic testing (RDT) for anyone initiating or continuing long-acting injectable PrEP, such as LEN and cabotegravir (CAB). HIV self-testing (HIVST) continues to be a recommended option for oral PrEP, the dapivirine vaginal ring (DVR), and for post-exposure prophylaxis (PEP). The guidelines call for further implementation research to “determine the role of HIVST in delivering long-acting injectable PrEP.” 

Experts shared the fundamental role of these recommendations in informing policy and practice. 

With only 3.9 million PrEP users currently, and new cases of HIV plateaued at 1.3 million globally, the HIV response “has to do better,” WHO’s Michelle Rodolph said. LEN, as an additional choice in HIV prevention is part of the solution. “Not all PrEP can be made available everywhere, but the data is clear that choice is critical…as is training providers to offer PrEP.”  

The guidelines call for countries to include models of differentiated service delivery (DSD) and integration.

Injectable LEN is Effective Among Adolescents and Pregnant People

Gilead announced more data from the PURPOSE trials showing that LEN for PrEP was effective in preventing HIV in pregnant and lactating people, in adolescents, and for those taking medication for tuberculosis and other conditions. Researchers also presented preference data showing that 75% of users favored twice-yearly injectable PrEP over daily oral PrEP because they felt more protected from HIV (69%) and were more confident about not missing a dose (77%). 

Merck Launches Phase 3 Trials of a Monthly Pill for PrEP

Merck announced the results of a Phase 2 safety and pharmacokinetics study of an oral monthly pill for PrEP that will now advance to Phase 3 trials known as the EXPrESSIVE trials. The monthly pill under investigation, MK-8527, is a novel, oral, nucleoside reverse transcriptase translocation inhibitor (NRTTI). Phase 2 results found the pill was well tolerated, with a similar safety profile to placebo, among 350 individuals in the randomized study. Merck Principal Scientist Rebeca Plank said, “We envision that monthly oral dosing could transform PrEP delivery and implementation models. If the Phase 3 studies are successful, this product could expand the range of delivery settings beyond medical clinics to locations that allow for flexibility and privacy.” 

See AVAC’s Nandi Sikwana describing the importance of these trials, including the role of Good Participatory Practice in their protocol development. Also stay tuned for a PxPulse episode with Rebeca Plank and AVAC’s Grace Kumwenda, coming soon.  

Find a roadmap of HIV prevention sessions at IAS 2025 and other resources to support your advocacy at AVAC’s dedicated IAS 2025 page. And stay tuned for more coverage ahead.

Global Health Watch: Next steps in LEN for PrEP rollout, new UNAIDS report, reprieve for South Africa and the latest in AVAC’s lawsuit

Issue 24

This week the Global Fund and Gilead announced next steps in the process to rollout injectable lenacapavir, the new UNAIDS Global AIDS Update was released, and South Africa saw a partial reprieve for NIH-funded research. We also track AVAC’s court case against the foreign aid freeze and Congressional advocacy to protect NIH funding. Read on, and be sure to follow AVAC next week as we cover the important discussions at the International AIDS Society (IAS) 2025 conference.

The Global Fund and Gilead Announce Next Steps on LEN for PrEP

The Global Fund and Gilead Sciences announced an access agreement to procure injectable lenacapavir (LEN) for PrEP, an important step in the process of rolling out LEN. The announcement re-confirms their ambition from December with PEPFAR to reach 2 million people over three years with LEN, once WHO recommendations are in place, which are expected to be announced on Monday at the IAS conference. 

IMPLICATIONS: While these announcements mark welcome progress in advancing LEN rollout, key questions remain. The announcements did not include specific volumes or price – and the target of 2 million people over three years is stated as an ambition, not a commitment to procure the full volume required to meet this target. In addition, achieving this ambition will depend on Global Fund replenishment for the next three-year budget. As AVAC and partners have noted, ambitious targets require coordinated, transparent planning and financing to prevent delays and ensure LEN fulfills its promise. Check out AVAC’s new brief that explains it all and proposes an even more ambitious introduction. 

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UNAIDS Releases Global AIDS Update 2025 

Ahead of next week’s IAS 2025 Conference, UNAIDS released its Global AIDS Update 2025, AIDS, Crisis and the Power to Transform, showing that another 1.3 million people acquired HIV in 2024, which is far from the target of reducing infections below 370,000, by 2025. The report warns of severe disruptions to HIV prevention services as US foreign aid and global health financing abruptly collapsed. “This is not just a funding gap—it’s a ticking time bomb,” Winnie Byanyima, UNAIDS executive director said at the launch. She emphasized that community-led services, which are critical for reaching marginalized populations, are being defunded at alarming rates. 

IMPLICATIONS: This year’s report underscores the need for bold, sustained action and funding, calling on donors, governments, and communities to step up and invest urgently in scaling proven prevention, including PrEP in all its forms, to protect gains and advance the goal of ending AIDS as a public health threat by 2030.

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NIH Lessens Blow to South Africa Research 

The National Institutes of Health (NIH) shared guidance with its staff on an “alternative payment scheme” that could allow human clinical research studies in South Africa to continue as “supplements” to existing grants until the agency puts a new tracking system in place, which is expected September 30. While new grant awards to South Africa are still blocked, “ongoing prime awards to South African researchers, ‘may proceed’,” Science reports. The NIH also lifted a hold on many payments for existing grants to South Africa. 

IMPLICATIONS: This slight reprieve for South African research is a positive step forward, but damage has already been done through months of staff layoffs, paused trials and stalled collaborations. And the uncertainty surrounding NIH’s broader, ideologically driven crackdown on grants continues to impact science, collaboration and progress.  

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AVAC vs. Department of State in the Foreign Aid Freeze 

Oral arguments in the AVAC vs. US Department of State lawsuit (joined with Global Health Council vs. Trump) were heard in the Washington, DC Circuit Court of Appeals on Tuesday. The cases seek emergency relief from an Executive Order that inhumanely froze all funding for foreign assistance and challenge the Administration’s shutdown of USAID and foreign aid. AVAC and GHC, and their partner have consistently won in the District Court, and the government appealed the judgements against them to this higher court. A panel of three Circuit Court judges heard the arguments and are expected to rule on the case by August 15. The Administration’s defense argued that the Congressional appropriations are merely “ceilings” rather than binding requirements. The panel of judges seemed to push back, noting that US law and constitutional separation of powers give Congress authority to set spending levels, not the executive branch. 

IMPLICATIONS: The hearing exposed the Administration’s strained arguments attempting to justify the foreign aid freeze and underscored the high stakes of the case: whether the Administration can disregard congressionally mandated funding for global health and foreign assistance programs, including PEPFAR and USAID’s initiatives. Watch AVAC’s Mitchell Warren on the latest in the case. 

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HIV Organizations and Advocates Host NIH Congressional Briefing 

Scientists and leaders in infectious disease research presented at a Congressional briefing, co-hosted by AIDS Action Baltimore, Treatment Action Group, AVAC and 11 other organizations, on the lifesaving impact of NIH-funded infectious disease research. They shared the impact of NIH investment—calling the NIH a “national treasure”—which has driven innovations in HIV prevention, cure, and treatment, TB diagnostics, viral hepatitis treatment, and pandemic preparedness, and underscored how recent funding cuts and threats to NIH-supported research jeopardize public health progress. They urged Congress to sustain support for lifesaving NIH research.   

IMPLICATIONS: The briefing reinforced that continued and expanded NIH investment is critical not only for advancing science, but also for equitable global health outcomes, pandemic readiness, and US health security. As Congress debates the Fiscal Year 2026 budgets and potential rescissions for past years, advocates called on policymakers to protect NIH funding, reject proposed cuts, and recognize research as essential infrastructure for global and domestic health. READ:  

IAS 2025: What you need to know

Follow AVAC’s roadmap to find sessions where prevention and the larger issues of global health equity and sustainability are in the spotlight.

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What We’re Reading

Updated Resources

IAS 2025 Conference

What you need to know

↪ Click here to view our IAS roadmap

IAS 2025, the 13th International AIDS Society (IAS) Conference on HIV Science will be held next week, July 13 – 17 in Kigali, Rwanda. IAS 2025 comes at a defining moment. Scientific advances in prevention, treatment and potential avenues for a cure, are within reach, but global funding cuts are placing these innovations and their scientific discovery at risk. All this is jeopardizing the gains that communities, advocates, and researchers have fought for decades to achieve.

See AVAC’s resources tracking the impacts and consequences of actions to dismantle foreign aid.

New research on the HIV prevention pipeline is expected to be shared alongside evidence on how the dismantling of foreign aid and the retreat from US commitments to science and global health are impacting lives and livelihoods. Every aspect of the HIV response is under attack — from basic research and clinical development to policy, programs, and global access to life-saving treatment and prevention.

See AVAC’s new report, which lays out what’s needed at this critical time to get HIV prevention into the hands of those that need it most, and join us Monday, July 14 for a satellite session, Re-imagining prevention: Ensuring sustainable PrEP access in an evolving funding context.

IAS 2025 Resources

Use AVAC’s Roadmap to find sessions where prevention and the larger issues of global health equity and sustainability are in the spotlight. You can download it as a sortable spreadsheet or PDF. 

Download IAS2025 Roadmap

AVAC Updates from the Conference

AVAC Conference Presentations

Satellites, Sessions and Panels featuring AVAC and Partners 

(All times listed are local in Kigali, Rwanda. See the time zone converter here.) 

Sunday, July 13

Monday, July 14

Tuesday, July 15

Wednesday, July 16

Thursday, July 17

Global Health Watch: Congress Passes “Big Bad Betrayal” Tax Bill, USAID Closes, Key Supreme Court Rulings

Issue 23

This week we saw Congress pass the President’s US domestic policy agenda that will rob approximately 17 million Americans of access to health care, including people living with and vulnerable to HIV, in order to provide tax cuts and workarounds for the rich. We also saw the official closure of USAID; restructuring of WHO leadership amid funding shortfalls; the US Supreme Court’s ruling preserving preventive care, including PrEP, and another ruling limiting federal courts’ ability to block presidential actions.

Read on for more, and be sure to check out the latest issue of PxWire that looks at the scale of shuttered prevention programs for key populations (KPs), the potential market for injectable lenacapavir, and the devastating cuts to research for an HIV vaccine. 

Congress Passes Sweeping Bill to Fulfill President’s Domestic Agenda

Both chambers of the US Congress narrowly passed a massive legislative bill that now codifies, or makes legal, the Presidents domestic policy agenda that extends tax cuts to the wealthy at the expense of social safety net programs. These programs, like Medicaid, were slashed in a futile effort to soften the impact of the bill on dangerously growing the federal deficit. 

IMPLICATIONS: The bill will lead to at least 51,000 excess deaths annually in the US in order to provide ultra-wealthy individuals with an average $309,000 in annual tax cuts. This “Big Bad Betrayal” of a bill not only cuts effective and cost-efficient health care for the poor and uninsured, but also food and nutritional assistance, housing, and adds billions to the growing budget deficit to target, detain, and deport immigrants nationwide.

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USAID Officially Closes 

The US Agency for International Development (USAID) officially closed this week, marking the end of a transformative era in US global health and development leadership—the agency was first founded in 1961 as a mandate from President John F. Kennedy. Past US presidents, former agency employees, advocates and celebrities memorialized the occasion by noting the impact of the agency and its work over the decades. The closure comes amid significant and questionable downsizing and funding cuts initiated by the US DOGE Service, including a proposed rescissions package of $400 million in Congressionally approved PEPFAR funds, which shatters a bipartisan legacy that has delivered health, equity, and collaboration around the world. Remnants of USAID are now being folded into the US State Department. 

IMPLICATIONS: The shuttering of USAID jeopardizes the progress made in global health and development, weakens US credibility as a global health leader, and creates a vacuum that could be filled by other superpowers. A study published this week in the Lancetestimated that USAID programs have saved 90+ million lives in two decades and that if the current cuts continue through 2030, 14 million people who might have otherwise lived could die. Specifically for HIV, at a time when scientific breakthroughs such as injectable lenacapavir for PrEP could accelerate HIV epidemic control, the dismantling of the global health infrastructure needed to deliver these tools threatens to squander this opportunity towards achieving sustainability.

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Ruling on US Affordable Care Act Maintains PrEP Coverage…For Now 

Last Friday, the US Supreme Court issued a ruling, which affirmed the constitutionality of the Affordable Care Act’s (ACA aka ‘Obamacare’) preventive services mandate, which means that insurance providers must continue to cover prevention, including for HIV pre-exposure prophylaxis (PrEP), at no cost to patients. The ruling allows preventive care protections to remain in place while the case continues through the courts.  

IMPLICATIONS: This ruling helps maintain critical protections that millions in the US rely on for equitable access to HIV prevention and other essential health services. However, the “victory [ruling] must be tempered by what has happened with the CDC’s Advisory Committee on Immunization Practices (ACIP), as it could be a harbinger of what a Secretary of HHS can do to twist committees and task forces that should be composed of technical experts guided by science to ones that are guided by ideology, illogic and political whim,” AVAC said in a statement. 

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US Supreme Court Ruling Limits Federal Courts’ Ability to Block Presidential Actions

The Supreme Court also ruled in favor of the US President in the case, Trump v CASA, significantly limiting the power of federal judges to issue nationwide injunctions that block a law or executive branch action while it’s being challenged in federal court. The case was brought in response to the President’s executive order attempting to deny birthright citizenship to children of undocumented immigrants and temporary visa holders. Federal courts blocked this order as unconstitutional. However, this ruling by the Supreme Court will only allow federal courts to block such policies for the parties directly involved in the lawsuits, not nationwide.  

IMPLICATIONS: This ruling is a major victory for the executive branch. It removes a key tool used to halt federal actions that threaten health and rights and puts limits on the checks and balance of executive power. It will make it more difficult for plaintiffs to use federal courts to block harmful policies until broader legal challenges can progress. Dissenting Supreme Court justices warned the decision poses a grave risk to accountability, allowing unconstitutional actions to proceed unless each harmed party sues individually.  

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WHO Announces New Leadership

WHO Director-General Tedros Adhanom Ghebreyesus announced a new leadership team of 36 directors (down from 74), including the appointment of Tereza Kasaeva, former TB lead, to head the newly combined HIV, TB, hepatitis, and STI department. Meg Doherty, who formerly headed the HIV Department, was named as Director of the Department of Science, Research, Evidence and Quality for Health. Significant staff reductions across WHO as well as a significant shift from Geneva to the field are planned in the months ahead. This restructuring is part of a broader effort by WHO to streamline leadership in response to its $1.7 billion shortfall, stemming from the pullout of the US government’s contribution and pressure to decentralize operations. 

IMPLICATIONS: The merging of these disease areas under a single department comes at a critical time for both the HIV and TB responses, with prevention and treatment gains at risk due to shifting ideological priorities from the US government. It will be essential for advocates to monitor this transition, ensure technical expertise is retained within the combined department, champion comprehensive and integrated HIV and TB programs within WHO’s agenda, and ensure progress toward epidemic control does not stall. 

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New Issue of PxWire

This issue looks at the scale of shuttered prevention programs for key populations (KPs), the potential market for injectable lenacapavir for PrEP, and the devastating cuts to research for an HIV vaccine.

Read Now

What We’re Reading

Updated Resources

Supreme Court Upholds ACA Preventive-Care Protections

Important Win for Public Health

AVAC welcomes today’s ruling affirming the constitutionality of the Affordable Care Act’s preventive services mandate, including coverage for HIV pre-exposure prophylaxis (PrEP) at no cost to patients. This decision represents a critical victory for public health, health equity, and the millions of people who rely on preventive services to stay healthy and safe. By rejecting efforts to strip away access to PrEP and other essential services based on ideological objections, the court has reaffirmed that public policy must be grounded in science, not stigma. 

Since the original Braidwood decision, AVAC and our partners have worked tirelessly to raise awareness of the case’s far-reaching implications. We joined legal advocates, public health experts, and community leaders to underscore what was at stake: access to evidence-based care and decades of progress in preventing HIV and other serious conditions. Today’s ruling confirms the power of coordinated advocacy and the importance of protecting science-driven health policy from politically motivated attacks. 

This outcome ensures that individuals can continue to access PrEP, both the medication and the clinical services necessary to support its use, without cost barriers. It preserves critical public health gains and sends a strong message that discrimination has no place in our health care system. 

“This ruling is a relief in maintaining the critical role under the Affordable Care Act to cover preventive care services, including HIV pre-exposure prophylaxis (PrEP),” said Mitchell Warren, AVAC’s Executive Director. “Preventive services across healthcare are cost-saving and life-saving, and I am grateful that the Supreme Court found on the side of evidence, logic, public health, and human rights. There has been enormous progress in the fight to end the HIV epidemic, and just last week the FDA approved the newest form of PrEP, injectable lenacapavir. Lenacapavir can be a transformative option, but only if it is available to people who want and need it, and today’s ruling can make that possible.” 

Looking ahead, AVAC will continue working to ensure that PrEP access is not only protected but meaningfully expanded, particularly for the communities that have long faced systemic barriers to care. This includes advocating for a national PrEP program, strengthening provider and patient education, supporting implementation by community-led organizations, and holding insurers accountable for compliance. Today’s ruling offers a strong foundation to build from, and we remain committed to a future where HIV prevention is accessible, equitable, and fully resourced for all. 

Today’s Supreme Court decision does confirm enormous power with the Secretary of Health and Human Services, which under the current administration is cause for significant concern. “In the midst of today’s victory, we must be tempered by what has happened with the CDC’s Advisory Committee on Immunization Practices (ACIP), as it could be a harbinger of what a Secretary of HHS can do to twist committees and task forces that should be composed of technical experts guided by science to ones that are guided by ideology, illogic and political whim,” said Warren.

Global Health Watch: USAID in the Spotlight, Gavi Replenishment, Defense of the Rescissions Package and ACIP

Issue 22

This week brought major media attention to the devastating dismantling of USAID, even as the FDA’s approval of lenacapavir for PrEP signaled new hope in HIV prevention. At the same time, vaccines were under even greater assault as the US administration announced it would withdraw support from Gavi based on spurious claims, while the CDC’s Advisory Committee on Immunization Practices met for the first time since the Secretary of Health and Human Services fired leading vaccine experts and replaced them with a group of skeptics. Also, top administration officials defended reckless and unlawful proposals and actions in Congressional hearings. This issue unpacks it all.

Media Coverage Highlights USAID Dismantling Amid Regulatory Approval of New PrEP Option

Media outlets including The New York Times, The New Yorker, and NPR’s This American Life podcast spotlighted the devastating consequences of the US Administration’s dismantling of USAID while also covering the US FDA approval of lenacapavir (LEN) for PrEP last Wednesday. AVAC’s latest blog, The Cruel Irony of Prevention, highlights how scientific breakthrough and political sabotage collide at a critical moment in the global HIV response. 

IMPLICATIONS: The approval of LEN should mark a turning point in the fight to end the HIV epidemic. But without restored funding, political leadership, and bold, coordinated action, the promise of this breakthrough could be squandered. AVAC’s court case challenging the foreign aid freeze and our advocacy tools—like the Gears of Lenacapavir for PrEP Rollout—offer a roadmap for protecting progress and accelerating equitable access.  

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Gavi Replenishment Meeting and the Assault on Vaccines 

At this week’s Gavi replenishment meeting, US Health and Human Services Secretary (HHS), Robert F. Kennedy Jr. (RFK Jr.) shared a video message announcing that the US would withdraw support from Gavi, the Vaccine Alliance. Gavi leads efforts to ensure global access to vaccines and finances vaccines for more than 60% of children around the world. The withdrawal of support marks a dramatic departure from decades of bipartisan US leadership in global vaccination efforts. In his remarks, Kennedy amplified misinformation about the combination vaccine for diphtheria, tetanus and pertussis (DTPw vaccine), falsely implying it causes more harm than good. Gavi, which later announced that it secured $9 billion out of its total 2026-30 requirement of US$ 11.9 billion to support immunization in low-income countries through 2030, rejected RFK Jr.’s claims in a statement providing context and linking to data on the positive impact of the DTP vaccine, including saving an estimated 3 million lives every year.  

In further efforts to undermine vaccines and vaccination programs, at the House Energy & Commerce Health Subcommittee hearing, RFK Jr. defended his overhaul of federal health agencies and his removal of all members of the US Advisory Committee on Immunization Practices (ACIP). Lawmakers challenged him sharply, including Rep. Kim Schrier, D-Wash., who is a pediatrician; watch her powerful video here. RFK Jr. appointed a new group of ACIP members, including a number of prominent vaccine skeptics, and the committee this week in sessions filled with mis-information. 

IMPLICATIONS: 

The US withdrawal and spread of vaccine disinformation at the Gavi replenishment threatens global access to vaccines that are part of the foundation of community wellness and resilience in low-income countries. This comes at a time when coverage is already backsliding and outbreaks of vaccine-preventable diseases are on the rise. Losing US support is destabilizing global health and eroding trust in lifesaving programs.  

The hearing made clear that Kennedy’s sweeping restructuring threatens public health infrastructure and disrupts ongoing efforts in HIV prevention, STI research, and vaccine confidence. Discarding experienced experts and sidelining established science advisers risks undermining key disease surveillance and immunization guidance.  

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NIH Staff Ordered to Stop Certain Grant Terminations 

Last week, a federal judge ruled that the National Institutes of Health (NIH)’s termination of more than 900 grants on politically sensitive topics, including vaccine hesitancy, was illegal. This week, the judge also rejected the government’s request to delay enforcement of his ruling, which means that the NIH must begin restoring funding immediately, even if the case goes to appeals. In an email, NIH instructed staff to halt any further grant terminations, however, NIH employees told Science they have not yet received instructions to restore terminated grants. 

IMPLICATIONS: 
This decision shows positive steps in rebuking the Administration’s efforts to dismantle funding for science and biomedical research, and is a step toward preserving crucial grants related to HIV, STI, and DEI-focused research.

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US Senate Hearing on Rescissions Package 

The US Senate Appropriations Committee heard additional testimony, including written testimony from Bill Gates, in another hearing on the US rescissions package, which proposes clawing back $9.4 billion in previously approved spending, including $8.3 billion from foreign aid (including PEPFAR/HIV programs). Budget Director Russell Vought defended the package, while senators, including Committee Chair Susan Collins and Vice-Chair Patty Murray, voiced strong opposition, warning that these cuts could undermine global health, humanitarian aid, and democratic institutions. July 18 is the deadline for the Senate to vote on the package. 

IMPLICATIONS: This package would eliminate over $900 million from global health programs, and passage would codify, or make legal, the unlawful dismantling of USAID. In addition, Congressional approval of this package would lead to more requests for rescissions from the Administration. The proposed Fiscal Year ‘26 budget and rescissions package have far and deep implications for health, science, and research in the US and around the world. As we’ve stated in earlier analysis of the rescission package, it would dismantle the architecture for global health, including health programs and research that have broad bipartisan Congressional and public support, and which support the government’s stated aim of keeping Americans and the world safer, healthier and more prosperous. 

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CDC’s Incoming Director

Susan Monarez, PhD, the current acting director of the US Centers for Disease Control and Prevention (CDC) appeared before the Senate Health Committee. She is the nominee to lead the CDC and is respected among the scientific community. In her testimony, she strongly supported vaccines as safe and effective and pledged for evidence-based decision making in CDC decisions, including defending mRNA vaccine platforms and upholding integrity on the ACIP.  

IMPLICATIONS: Monarez, if appointed, will have the difficult job of following HHS Secretary RFK Jr.’s leadership and evidence-based decision making. With scientific expertise and commitment to vaccine policy, she may serve as a stabilizing force at the CDC. 

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What We’re Reading

Updated Resources

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.

Global Health Watch: LEN for PrEP approved by US FDA, South Africa’s HIV program in crisis, changes to oversight of NIH HIV guidelines

Issue 21

This week, we cover the US FDA approval of injectable lenacapavir (LEN) for PrEP, the “most transformative prevention product we’ve had in 44 years of this epidemic”, which demands urgent action if the remarkable science is translated into public health impact. Plus, updates on South Africa’s HIV program in crisis, oversight changes on NIH’s HIV clinical guidelines, and a court ruling halting illegal grant terminations. Read on.

FDA Approves Lenacapavir for PrEP—Advocates Demand Urgent Action

The US FDA approved injectable lenacapavir (LEN) for HIV prevention as PrEP. Developed by Gilead Sciences, LEN is a twice-yearly injectable that demonstrated nearly complete protection in the landmark PURPOSE 1 and 2 trials. The World Health Organization (WHO) is expected to release updated PrEP guidelines for LEN in July, and regulatory agencies in Brazil, Europe and South Africa are simultaneously reviewing the product. But the current political context, including a shuttered USAID and further disruptions across global health, demands an urgent and courageous response.
 
IMPLICATIONS: LEN for PrEP is poised to re-shape the HIV response, but only if this FDA approval is accompanied by bold, strategic, and equitable rollout. AVAC’s statement and Gears of Lenacapavir for PrEP Rollout outline what’s needed from all stakeholders to avoid repeating past delays in PrEP introduction. Watch AVAC executive director, Mitchell Warren’s take on what this moment demands.

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LEN Statements

South Africa Feels the Impact of US Cuts

South Africa’s HIV research infrastructure and programming are feeling the impact of the US Administration’s draconian actions after significant funding cuts. Cuts to PEPFAR and NIH have created a reported R430 million funding gap resulting in the loss of access to viral load testing, antenatal ARV care and the shutdown of clinics who serve key populations, including sex workers, transgender individuals, and people who inject drugs. 
 
IMPLICATIONS: The impact of these cuts are threatening to reverse years of progress in a country shouldering a disproportionate share of the global burden of HIV and where AIDS denialism once dominated policy. Marginalized communities in South Africa may lose trust in programs and access to care, leading to increased rates of HIV transmission, including mother-to-child transmission, and jeopardizing global targets to end AIDS by 2030. South African stakeholders acknowledge they cannot plug the gap in funding alone.
 
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Administration’s Attempt to Terminate NIH Research Grants Deemed Illegal

A US federal judge ruled that the Administration’s efforts to terminate certain NIH research grants was “void and illegal”. The ruling came during a hearing on the American Public Health Association’s lawsuit and another by a coalition of 16 states, which challenged the Administration’s termination of grants related to diversity, equity, inclusion (DEI), and LGBTQ+ health. Judge William Young, who was appointed by Ronald Reagan, noted, “I have never seen racial discrimination by the government like this” in his 40 years on the bench.
 
IMPLICATIONS: This decision shows positive steps in rebuking the Administration’s efforts to dismantle funding for science and biomedical research, and is a step toward preserving crucial grants related to HIV, STI, and DEI-focused research. However, the decision only applies to grants listed by the plaintiffs, and broader protections will depend on continued legal challenges and congressional decision making.
 
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NIH Support for Clinical Trial Guidelines

The Department of Health and Human Services (HHS) will transfer management of the NIH’s HIV clinical practice guidelines, which have been managed through the Office of AIDS Research (OAR). By June 2026, another HHS agency or organization will oversee the guidelines. An internal memo reports that “in the coming weeks, co-chairs and NIH Executive Secretaries will convene Panel members to discuss options for sustainable maintenance of the guidelines and discuss transition options.”
 
IMPLICATIONS: These guidelines have been a core pillar of HIV science, policy, and clinical alignment and the loss of NIH and OAR oversight of the HIV clinical guidelines is another action in undermining science, research and rights.
 
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What We’re Reading

Updated Resources

FDA Approves Injectable LEN for PrEP

A Historic Milestone Must Now Be Matched by Urgent Action

AVAC welcomes the U.S. Food and Drug Administration (FDA) approval of injectable lenacapavir (LEN) as pre-exposure prophylaxis (PrEP). Developed by Gilead Sciences, LEN is a twice-yearly injectable PrEP option that showed nearly complete protection against HIV in the landmark PURPOSE 1 and 2 trials. Science Magazine named LEN the “Breakthrough of the Year” in 2024, a recognition that reflects its enormous potential. But that promise will only be realized if it is rolled out with speed, scale, and equity.

In our statement issued earlier today, we outline what’s needed from every stakeholder in the HIV response to meet this moment—and not squander yet another PrEP option.

As outlined in our Gears of Lenacapavir for PrEP Rollout, this moment demands unprecedented ambition, commitment, and leadership from governments, funders, implementers, policymakers, and civil society.

Advocacy Tools & Resources

Please check out all of AVAC’s advocacy tools and resources to support our collective work in advancing equitable LEN rollout as part of comprehensive, integrated and sustained HIV programs.

Getting PrEP Rollout Right This Time

Our new report examines key insights from the rollout of oral PrEP and early introduction of injectable cabotegravir and the dapivirine vaginal ring to inform a faster, smarter and more equitable introduction of future HIV prevention tools, including long-acting injectable PrEP, such as lenacapavir.

Gears of Lenacapavir for PrEP Rollout

This document outlines a focused plan for LEN for PrEP rollout over the next few years, specifying priorities by stakeholder and evaluating volume and pricing strategies.

From Clinical Trial Efficacy to Public Health Impact: A Plan for Accelerating Access to Injectable Lenacapavir for PrEP

This plan provides a broad view of all the moving parts and identifies actions and actors responsible for ensuring time is not wasted and opportunity not squandered.

The Lens on LEN: The Basics on Injectable Lenacapavir as PrEP

This advocates’ primer provides background on lenacapavir for PrEP and its trials; a summary of the early findings of PURPOSE 1 & 2; key questions and next steps.

Podcast — Lenacapavir: The case for investing in delivering HIV prevention:

This episode of PxPulse goes deep on LEN for PrEP laying out recent research findings and what they mean. And Chilufya Kasanda Hampongo of Zambia’s Treatment Advocacy and Literacy Campaign and Mitchell Warren of AVAC talk about how to change a long history of squandered opportunities to get rollout right.

Media Coverage

This is the moment for all stakeholders to build on the momentum science. LEN has moved faster through regulatory review than any prevention product to date. Now it’s up to all of us to make sure that that progress translates into real, sustained impact on the epidemic, led by communities around the world.

Let’s get to work.

Global Health Watch: Fired Vaccine Experts; House Rescissions Votes; CDC Staff Called Back; NIH Scientists Speak Out

Issue 20

This week brought the unprecedented removal of the US vaccine advisory committee, layoff reversals and confusion at the US CDC and a public letter signed by over 1,000 NIH scientists denouncing the administration’s actions. And just as this week’s issue was going to press, the US House of Representatives passed the President’s request for a rescission of billions of dollars – primarily for foreign assistance. This week underscored the urgency of defending evidence-based health policy.

US House Votes to Claw Back Funds for Foreign Assistance

The US House of Representatives passed a rescissions package that will claw back $9.4 billion of funds from FY25 spending, funds that were already Congressionally appropriated, but not yet spent. The package eliminates over $900 million from global health programs and includes cuts to PEPFAR, despite bipartisan support for these programs for more than two decades. The package also codifies into law the dismantling of USAID, which was initiated through presidential executive overeach and the reckless actions of DOGE.

IMPLICATIONS: The rescissions package would have far and deep implications for health, science, and research in the US and around the world. The House’s decision is the latest action in support of the Administration’s objective to slash foreign assistance funding and infrastructure. The Senate has until July 18 to approve.  

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Attacks on Vaccine Policy and Science

Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. removed all members of the US Advisory Committee on Immunization Practices (ACIP), a panel of vaccine experts—with decades of experience in vaccine development, delivery and safety—responsible for developing the country’s vaccine recommendations for the Centers for Disease Control and Prevention (CDC), which then shape US health insurance policies and coverage. Kennedy replaced them with new members, many of whom are tied to anti-vaccine groups or have shared anti-vaccine views publicly. 

IMPLICATIONS: These actions are the latest in a series of assaults on vaccine development and delivery systems, including defunding for CDC immunization programs, the NIH’s HIV vaccine development consortia, and global vaccine access efforts like Gavi. This new panel could take actions that turn this trusted scientific body into a platform for mis- and dis-information and anti-vaccine policies. 

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CDC Firings Reversed Amid Much Confusion 

In April, widespread layoffs decimated the CDC and its critical divisions, including Reproductive Health, Population Health, and HIV and STD Prevention. This week, the Administration reversed itself on some of the layoffs. More than 450 CDC staff have been called back, including staff from the National Center for HIV, Viral Hepatitis, STD, and TB Prevention. HHS Secretary RFK Jr. admitted that at least 20% of cuts were “mistakes.”  

IMPLICATIONS: While this reinstatement may restore some capacity, major damage has already been done: STI labs remain unable to collaborate with WHO, samples were discarded in the initial chaos, and costly disruptions are ongoing. Programs tracking HIV, STIs, and global health have been upended, and further reductions in force (RIFs) are still expected.  

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NIH Scientists Publish Declaration Speaking Out 

More than 1,000 current and former NIH staff published and signed a public letter denouncing the Administration’s proposed FY26 budget and the actions taken to date that threaten science, research and public health. The Bethesda Declaration specifically calls out the termination of research programs and the appointment of NIH Director Jay Bhattacharya. The solidarity behind this declaration speaks to the extraordinary harm these policy changes are having on a scientific community that historically avoids public protest. 

IMPLICATIONS: Those that signed the declaration may be at risk of future retribution, but as the NIH faces a proposed $18 billion cut and changes to global partnerships, this effort signals growing pushback to the US government’s hostility to evidence-based science.  

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Senate Hearing on Proposed Fiscal Year 2026 NIH Budget 

At Tuesday’s Senate Appropriations Subcommittee hearing on the NIH’s proposed FY26 budget, Senator Patty Murray and other senators forcefully challenged Dr. Bhattacharya over the drastic $18 billion in proposed cuts. Senator Murray pressed Bhattacharya on the abrupt termination of at least 160 clinical trials and questioned how such cuts will impact HIV research. Bhattacharya acknowledged that fewer clinical trials would be likely under the new budget, though he noted that it will depend on congressional action. Murray pushed back, noting the longstanding US leadership in global HIV research and warning against dismantling scientific partnerships. “We cannot allow politics to compromise science, especially when lives are at stake,” she said.  

IMPLICATIONS: Without strong congressional pushback, the future of HIV clinical trials, the NIH vaccine consortia, and broader research infrastructure are at serious risk. 

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The Scientific Journey of Lenacapavir

AVAC hosted a conversation, The Scientific Journey of Lenacapavir, reviewing how sustained US investment in NIH basic science and South Africa’s clinical research infrastructure made possible the development of lenacapavir (LEN) for PrEP. Linda-Gail Bekker, Wes Sundquist, and Mitchell Warren highlighted LEN’s long scientific journey, beginning with Sundquist’s HIV capsid research in 1991 to the pivotal PURPOSE clinical trials to today. The field is eagerly anticipating US FDA approval by next Thursday and a WHO recommendations next month. This week’s webinar focused on this moment of promise in HIV prevention and how sweeping attacks on science, research and the very systems that made LEN possible may squander this opportunity to bend the curve of the epidemic. 

IMPLICATIONS: The potential of injectable LEN for PrEP is fragile in the midst of an all-out assault on research systems, global partnerships, and public health funding. Cuts to NIH, the dismantling of USAID, the closure of clinical trials, and the termination of HIV vaccine consortia put decades of progress and a pipeline of potential next generation products, at risk. As Bekker warned, “We are losing expertise the world can’t afford to lose.” The message was clear: we must act now to protect what made LEN possible and ensure a future pipeline of prevention. 

READ/WATCH:  

New Report: Getting PrEP Rollout Right This Time

A new AVAC report examines key insights from the rollout of oral PrEP and early introduction of injectable cabotegravir (CAB) and the dapivirine vaginal ring (DVR) to inform a faster, smarter and more equitable introduction of future HIV prevention tools, including long-acting injectable PrEP, such as lenacapavir.

Download the Report

What We’re Reading

Resources

Upcoming Webinars

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

This webinar will explore the urgent risks to health data privacy, particularly for people living with HIV, in the context of rising surveillance and criminalization of healthcare.

June 18, 2025 at 10am ET

Register

Embracing Task Shifting and Innovation to Support Expanded Access to Long Acting Injectable PrEP

This inspiring discussion will cover task shifting and innovation related to improving PrEP access. 

June 26, 2025 at 10am ET

Register