Global Health Watch: EMA recommends LEN, whistleblower report on foreign aid freeze, changes in NIH policies and new CDC director

Last Friday – just after we published Global Health Watch – the European Medicines Agency recommended injectable lenacapavir for PrEP. This comes amid more political chaos this week that threatens delivery including, a surprise funding freeze and its reversal, a new whistleblower report on the unlawful foreign aid freeze, changes in NIH policies and continued dismantling of federal advisory boards. Read on.

European Medicines Agency Recommends Injectable Lenacapavir for PrEP

The European Medicines Agency (EMA) recommended approval of injectable lenacapavir (LEN) for PrEP across the European Union and globally just weeks after the US FDA granted approval and the WHO issued global guidelines. These regulatory endorsements reflect an accelerated process compared to previous PrEP products and demonstrate the urgency and promise of LEN, with potential to dramatically expand choice in prevention. This is just the second medicine simultaneously reviewed by the EMA for the EU market, under the centralized procedure, and non-EU countries, under the ‘EU-Medicines for all’ program (EU-M4all), and the eighteenth medicine receiving an EMA recommendation under EU-M4all. 

IMPLICATIONS: These milestones represent important steps to advance access to LEN, but much work still remains to be done to ensure LEN reaches those who need it most. Coordination on in-country registrations, financing and procurement, supply chains, health worker training, demand creation, and community-led delivery is needed. See AVAC’s Gears of Lenacapavir for PrEP Rollout plan, which outlines all the moving parts. Now is the time to ensure all of the gears actually begin to turn even faster.

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NIH Disruptions

The US National Institutes of Health (NIH) has proposed changes to how it funds research, which could dramatically reduce the number and amount of research grants in the future. The National Cancer Institute (NCI) confirmed it will reduce the number of new and competing research grants it funds, despite a stable budget, due to rising costs per grant. This is largely due to NIH’s growing reliance on a “multi-year funding” (MYF) model, which requires a larger portion of a grant’s total funding (typically 50%) to be paid in the first year. Although MYF can offer researchers more predictable funding over time, it also creates immediate budget pressures, as more money is tied up upfront. As a result, NIH institutes may be forced to fund fewer grants overall, turning down even top-ranked proposals. Additionally, NIH has signaled that many MYF grants will be limited to four years instead of the traditional five-year period typical of R01 awards. 

In addition, on Tuesday, the administration temporarily halted all NIH funding for research. They then released the funds later in the day. In response to the halt, US Senator Patty Murray (D-WA), Vice Chair of the Senate Appropriations Committee, wrote, “Instead of trying to destroy the NIH, which has long been the envy of the world, President Trump and [OMB Director] Russ Vought should study up on the Constitution, which makes clear they don’t get to decide for themselves that they are going to rip hopes of new treatments and cures away from patients across America.” 

IMPLICATIONS: This new MYF policy undermines the research pipeline by favoring shorter, lower-cost projects, freezing out innovative or large-scale efforts and reducing the long-term funding that research institutions rely on. These maneuvers by the administration bypass Congressional budget authority and could be formalized through additional rescissions.  

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Threats to the US Preventative Services Task Force

It has been reported that US Health Secretary, Robert F. Kennedy Jr. plans to dismiss the 16 members of the US Preventive Services Task Force (USPSTF), which recommends preventive services (including PrEP and cancer screenings) that must be covered by insurers. USPSTF’s decision to recommend HIV PrEP mandates that insurance companies cover it under the Affordable Care Act. The HHS said no final decision has been made, but initial reports cite ideological concerns as the reason for this potential action, similar to how Secretary Kennedy undermined the CDC’s Advisory Committee on Immunization Practices. In response to this reporting, the American Medical Association and 100+ health organizations are urging RFK Jr. to preserve the task force’s independence and evidence-based role. 

IMPLICATIONS: This potential dismissal follows RFK Jr.’s recent dismissal of CDC vaccine advisors and raises concerns for HIV prevention advocates, particularly regarding PrEP. Weakening or politicizing this panel could jeopardize access to HIV prevention and other products for Americans. This is another action undermining science-based decision-making. 

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USAID Whistleblower Shares Details on Termination of Foreign Assistance

A newly released memo by USAID whistleblower Andrea Capellán shares details on the administration’s unlawful termination of nearly all USAID foreign assistance funding. In the memo, Capellán, a senior contracting officer at USAID, describes a six-month period of silence, confusion, and legal violations as staff were ordered to cancel thousands of contracts without proper authority, documentation, or individualized review. These claims are contradictory to the administration’s defense of the process used to carry out the funding freeze. It confirms that terminations were carried out en masse, with some letters even addressed to “Miscellaneous Foreign Awardees,” and that Secretary of State Marco Rubio’s alleged contract reviews were never substantiated.  

IMPLICATIONS: This new account supports AVAC’s ongoing legal battle (see AVAC vs. Department of State) arguing that the foreign aid freeze is illegal. Capellán’s report underscores the need for accountability and urgent restoration of global health programs that were halted midstream.  

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New Director of US CDC Confirmed by Senate 

The US Senate confirmed long-time civil servant Susan Monarez as the new permanent Director of the Centers for Disease Control and Prevention (CDC). Monarez is the first CDC director without a medical degree in 70 years to take on this role. NPR reports that in her confirmation hearing, Monarez “walked a fine line between traditional public health perspectives and those of her boss, Secretary of Health and Human Services Robert F. Kennedy Jr., who has long questioned the safety of vaccines.” 

IMPLICATIONS: Monarez will play a critical role in shaping the CDC’s HIV, STI, and global health work. Her confirmation comes just weeks after mass layoffs across HHS, and as the agency navigates the administration’s directives to reduce contract spending and restructure research funding.  

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What We’re Reading

Resources

Save the Date!

PrEP Implementation — What’s worked and what are we learning

Join AVAC and the South-to-South Learning Network for a webinar exploring lessons from countries that have successfully scaled up oral PrEP and how to apply them to introduce and expand access to long-acting HIV prevention options like CAB, DVR, and LEN.

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EMA Recommends LEN for PrEP

Resources for Advocacy

Momentum continues to build for injectable lenacapavir (LEN) for PrEP as what could be one of the most transformational moments in HIV prevention ever. Just weeks after the US Food and Drug Administration approved LEN for PrEP, the WHO issued new global recommendations for offering LEN, and last week the European Medicines Agency recommended its approval in the EU and globally (even earlier than anticipated).

But getting LEN to those who need and want it depends on addressing an array of complex factors beyond regulatory approvals, including action, coordination and transparency on funding, price and volume agreements, supply chains, health worker training, demand creation, and community engagement. We outlined all of the moving parts in December in Gears of Lenacapavir for PrEP Rollout, and now’s the time to ensure all of the gears actually begin to turn even faster.

The recent advances, of course, arrive amid a cruel irony: just as prevention breakthroughs gain traction, US political decisions are unraveling the systems needed to deliver them. Still, the prevention pipeline continues to grow. In addition to the movement on LEN for PrEP, Merck’s once-monthly oral PrEP pill just entered Phase III trials, another step toward real choice and expanded options in HIV prevention.

Check out AVAC’s resources below (all newly updated) to help advocates track, explain, and take action to meet the moment. And read our insights from the International AIDS Society meeting in Kigali.

Updated Resources

Long-Acting PrEP Status Update
A quarterly update featuring graphic tools for tracking regulatory approvals, implementation science, price and volume agreements, and pipeline overviews. Visit here.

Lenacapavir Regulatory Approval
Regulatory approvals and pending decisions as of July 2025. Download the graphic.

Where We Are Now With LEN for PrEP
A timeline of essential milestones to scaling up LEN for PrEP. View here.

Moving a Product to the Real World
The field is beginning to apply past lessons to accelerate introduction of injectable PrEP options. Download here.

Getting PrEP Rollout Right This Time
Qualitative landscape analysis to identify actionable lessons and recommendations from past PrEP introduction and implications for LEN for PrEP. Read the report.

Now What with Injectable LEN for PrEP?
Outline of what is actually known – and not – and what needs to happen next. Read it here.

All of the LEN for PrEP documents are at avac.org/lenacapavir and be sure to check out PrEPWatch for all of these resources and more.

Global Health Watch: PEPFAR Shutdown Plans + a Bill to Restore its Programs, Contraception & Vaccines Destroyed, IAS Highlights

Issue 26

This week’s issue covers what’s next with PEPFAR, including new reports that the US State Department is planning to dismantle the program, and a new bill in the US Congress that aims to restore its prevention programs. It also highlights a new funding bill that supports global health R&D and spotlights the shocking destruction of contraception and vaccines bound for Africa. Plus: key takeaways from IAS 2025 in Kigali and what they mean for the future of HIV prevention.

What’s Next for PEPFAR

Following last week’s partial victory against the President’s rescissions package, with PEPFAR spared from a $400 million proposed clawback, the HIV community is calling for sustained pressure and bipartisan support to preserve the program’s core budget and fully restore prevention services. This comes as a new report from The New York Times reveals that State Department officials are quietly developing plans to shut down PEPFAR entirely in the coming years.  

IMPLICATIONS: This new reporting confirms what many advocates have warned: PEPFAR is being systematically undermined. Funds are still frozen at FY23 levels, no long-term reauthorization has been secured, and critical program components like PrEP scale up, and community-led service delivery remain unfunded. 

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New Legislation to Expand Access to HIV Prevention Through PEPFAR Proposed

New legislation to guarantee access to HIV prevention through PEPFAR, the HIV Medication Access Act, was introduced by US Representative Yassamin Ansari (AZ-03). The bill would amend the Foreign Assistance Act to include HIV prevention in the definition of ‘life saving humanitarian assistance’ and to ensure all at-risk populations can receive these services. The legislation comes in response to the State Department restricting PrEP to pregnant and breastfeeding women only under the February waiver that supposedly resumed lifesaving foreign aid in the wake of the DOGE fiasco. 

IMPLICATIONS: This new proposed legislation would help protect and restore global access to HIV prevention tools. Advocates are rallying around this bill as a much-needed safeguard against ideologically driven health policies. As AVAC’s Mitchell Warren said, “When access to the fruits of science is dictated by politics rather than evidence, we paralyze progress.” However, the bill faces an uphill battle in the current Congress.  

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New Bill Proposes Strong Funding Levels for Global Health

A proposed bill and report for global health programs in Fiscal Year 2026 (FY26) was introduced Wednesday by the US House Appropriations Subcommittee on National Security, Department of State and Related Programs (NSRP, formerly SFOPs) as part of the annual bipartisan appropriations process. The NSRP subcommittee has jurisdiction over foreign assistance funding, and their report recognizes global health as essential to national security and strongly supports research, innovation, and new technologies to fight HIV, TB, malaria (including positive language on expanding access to microbicides, long-acting PrEP, and PEPFAR). And the bill proposes strong funding levels for key global health priorities including investments in maternal and child health ($528M), Gavi ($300M), TB ($394.5M), malaria ($800M), and neglected tropical diseases ($114.5M). However, it cuts funding for family planning by 24% and includes harmful policy riders that would codify the global gag rule (aka the Mexico City Policy) and bans funding to WHO and UNFPA.  

IMPLICATIONS: While the proposed funding is stronger than expected, it is unclear if the House bill will pass, what the Senate version will look like, and whether the administration would implement the funding. This bill is a positive signal that global health R&D and innovation are being recognized as priorities, which is a testament to the unrelenting advocacy of the HIV community. 

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Contraception and Vaccines Destroyed and Wasted

The new US administration ordered millions of contraceptives including condoms, IUDs and emergency pills intended for sub-Saharan Africa to be destroyed. The Guardian reports that this was $9.7 million worth of contraception. Earlier this month, US Senators Jeanne Shaheen (D-NH) and Brian Schatz (D-HI) introduced the Saving Lives and Taxpayer Dollars Act, legislation to prevent the State Department from destroying family planning commodities instead of donating them to intended beneficiaries. This action is part of the larger destruction of foreign aid. Meanwhile, Politico reports that hundreds of thousands of vaccines purchased by the US for African countries have expired and been wasted due to political delays and a breakdown in coordination. Advocates are working with members of Congress to urge the State Department to act immediately to ship remaining viable mpox vaccines.  

IMPLICATIONS: The destruction of contraception and wasted vaccines reflect a dangerous ideology that is undermining global health and reversing decades of progress. Clinics across Africa are reporting shuttered services and rising unmet need for contraception, while stalled vaccine delivery weakens trust and preparedness in the face of ongoing disease threats. These actions jeopardize integrated HIV prevention strategies and broader sexual and reproductive health goals.  

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International AIDS Society 2025: From Crisis to Resolve

Coverage from last week’s International AIDS Society (IAS) Conference in Kigali, Rwanda, has highlighted the lessons and insights from the shift from a crisis response to the dismantling of foreign aid to collective resolve. The global community is calling for political accountability, funding commitments, streamlined pathways to access, and a pipeline of products that people want and need. 

AVAC’s sessions and resources capture this pivotal moment in the field. Explore AVAC’s full IAS 2025 resource page. 

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Join Us at the STI & HIV 2025 World Congress

The global community will gather next week in Montreal, Canada, for the STI & HIV 2025 World Congress, which comes at a pivotal moment as global STI rates are rising, but investment in prevention, diagnostics and care remain far below what’s needed.

promo tile for this event

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Save the Date! August 14, 2025 @ 7:00am ET

PrEP Implementation — What’s worked and what are we learning

Join AVAC and the South-to-South Learning Network for a webinar exploring lessons from countries that have successfully scaled up oral PrEP and how to apply them to introduce and expand access to long-acting HIV prevention options like CAB, DVR, and LEN.

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What We’re Reading

From Kigali: At IAS 2025, the HIV response rallies to face the crises

The IAS 2025 conference in Kigali will go down as a critical turning point in the history of the HIV response. Every session, every meeting, every presentation played out against an existential threat: will the world find the will to end the HIV epidemic, with tremendous advances in technology underway, or will the momentum seen through 2024 collapse as evidence-based interventions fall way to ideology? Leaders across the field are persevering to push forward the science, policies, programs and partnerships that are essential to achieve impact; and they are calling for solidarity. And advocates are leading the way, cutting a path and demanding equity, human rights and community leadership every step of the way. WACI Health’s Rosemary Mburu captured this call to action at the opening session, saying “Community action is not the soft side of science — it’s what gives science its soul, its reach, and its relevance.” 
 
The Kigali Call to Action, to which AVAC is proudly a co-signor, echoes these demands, calling for new partnerships, rapid scale-up of prevention, a diverse R&D pipeline, evidence-based policy, expanded treatment access and durable protections for human rights. At the opening session, Linda-Gail Bekker of the Desmond Tutu Health Foundation (and an AVAC board member) shared findings that the US funding freeze has led to severe disruptions in oral PrEP initiations (28-65% reduction), diagnostic testing (6-39% reduction) and in monitoring viral loads (16-68% reduction), and also to initiation of treatment (2-22% reduction). Calling it a precipice, Bekker connected these numbers to modelling studies forecasting as many as 5,000-16,000 additional new HIV infections over just one year, with some countries projecting additional deaths as high as 10% by 2030, and millions of new cases of HIV by 2030 (See this, this & this from aidsmap for more). Bekker also implored everyone that “we cannot go back”.
 
These are warnings and calls to actions that cannot be ignored. As Yogan Pillay of the Gates Foundation said at a panel discussion on the issue, “I don’t think we should be adapting to this new normal. I think we do need to be transformative.” Solange Baptiste, of The International Treatment Preparedness Coalition (ITPC) and also on the AVAC board, urged the field to see the bigger picture, “The cuts that we’re seeing now are an opportunity to change the system. More studies, more data will not change minds. This is ideological. The HIV field has always been a leader. We have had ambition; now is the time to set the bar high.” Rising to the challenge means critical next steps for the HIV response.

Reimagined and Refinanced: With the loss of US leadership, the Global Health Community Responds

A session hosted by AVAC and the Zambian Ministry of Health, Re-imagining prevention: Planning for sustainable PrEP access in the new funding context, zeroed in on the ground-level work needed to put in place the policies and programs for new and better systems to deliver HIV prevention. Ministries of Health, implementers, and civil society pointed to key priorities: Engaging the private sector to enable delivery of HIV prevention; demedicalizing PrEP to lower costs and simplify expanded access; strengthening monitoring systems to deliver information on preferences and PrEP coverage; aligning donors behind the necessity of integrating HIV-related care with other health services; embedding implementation science into program delivery for ongoing learning; and defining a minimum package of prevention that is tailored to context and balances program costs and choice, among others.
 
While AVAC’s Mitchell Warren called for “making PrEP simple,” Zambia is one place taking the lead in confronting these issues. At the session, Professor Lloyd Mulenga, Director of Infectious Diseases at Zambia’s Ministry of Health, said finding political will underpins the work ahead. “We need to invest in our own systems and also need a budget line that reflects commitment from government.” Learn more about Zambia’s work in the country snapshot from AVAC’s report Getting Rollout Right This Time. See also this aidsmap coverage to learn more about the conversation at the satellite session.

Upcoming Webinar—join us!

The crisis for key populations lies at the heart of the challenge. IAS 2025 brought together community and government leaders, convened by GBGMC and COMPASS, to chart a path forward, with the understanding that delivering prevention to key populations could determine success or failure of the HIV response.

The meeting showcased evidence-based strategic plans developed by community organizations, which can anchor an HIV response that is based on partnerships of trust, transparency and coordination between governments, industry, donors and community. GBGMC launched a new report — Global Roadmap for Long-Acting PrEP Among Key Populations — featuring a first-ever Global Forecast of Long-Acting PrEP Need  for Key Populations (2025–2030), co-created with AVAC and Avenir Health.

Accelerating Access to New PrEP Options: The devil’s in the details

As the field regroups, making good on the promise of injectable lenacapavir (LEN) for PrEP hangs in the balance. With the release of new WHO recommendations for offering LEN on the first day of the conference, the success of LEN rollout depends on addressing an array of complex factors. Funding, transparent price and volume agreements, supply chain coordination, empowered and trained health care workers, and comprehensive community engagement are required.
 
“I can feel the excitement about these [WHO] guidelines. It now calls for collective action. The next step is the difficult one, access! Access is it, or we go back to the disappointment and mistrust,” said Florence Anam, Co-Executive Director of GNP+.
 
Check out AVAC’s Now What with Injectable LEN for PrEP? that outlines what is actually known — and not — and what needs to happen next.

WHO guidelines for LEN also extended the recommendation to pregnant and lactating populations (PLP), an important advance in access to PrEP. This aligns with data Gilead presented showing efficacy of LEN for PrEP for PLP (see this aidsmap story to learn more). Other announcements at IAS similarly signal progress in this area.

And while much of the buzz centered around rollout of next-gen PrEP injectables, AVAC notes the importance of ongoing research to develop additional products to fill the prevention toolbox. Merck announced the EXPrESSIVE trials, which will be testing efficacy of a monthly pill for PrEP in diverse settings and populations, including PLP. They also presented Phase 2 data, which apart from a positive safety profile at every dosage tested, indicated a predicted time to protection of one hour after intake. See this aidsmap story to learn more along with this new AVAC infographic showing where the trials will take place.

The Dual Prevention Pill, a daily pill for HIV and pregnancy prevention, was also in the spotlight in Kigali, with the launch of #DPPDecoded, a campaign by APHA to raise awareness by and for young women in Africa for this new option. The DPP could be available as early as next year. For more info on the DPP, see this video and resources, and be sure follow @apha_sa for real-time updates.

New Science, New Technology & Emerging Leadership

Striking examples of the use of artificial intelligence (AI) in the delivery of treatment, care and prevention were presented, demonstrating its potential to expand the reach of HIV and other health services. Several countries are using AI technology for interventions from mobile diagnosis to supply chain improvements and in programs supporting adherence to medication. See this aidsmap story for more.
 
African leadership is on the rise in advancing research for cure and vaccine strategies. The Africa Cure Consortium (comprised of the African Alliance, AVAC, CIDRZ, GGTI, HCAAP, IAS & SANTHE) is incorporating community advocacy and research literacy into its efforts to influence policy and investment in cure research on the continent. Scientific insights from recent cure research include the impact of broadly neutralizing antibodies (bNAbs) on viral rebound and other aspects of immune dynamics (see this & this at aidsmap for more). Another IAS session, Success stories and future directions in African HIV vaccine research, showcased African-based research and initiatives that have transformed the field, from clinical trials to community-driven innovation.
 
These far-sighted initiatives are in advocacy, too; be sure to check out the outstanding vision and energy of youth advocates in this episode of A Shot in the Arm podcast, where African youth leaders, members of APHA’s Ground Forces program, call on the field to be prepared to succeed. “You are going to need sunglasses! Because the future will be bright for HIV prevention,” said Sinehlanhla Gogela.
 
These examples of leadership are just the beginning and must be matched with solidarity from across the field and a commitment to fight like hell. As Kenya’s former Minister of Health James Nyikal said, “When you mobilize civil society and the people, and it becomes a crying need amongst the people, politicians listen. That is how the world works.”
 
Global and country leaders, from communities to advocates, from researchers to implementers, from policy makers to donors, must recommit to the HIV response — or gains against HIV will unravel and the epidemic, with its end in sight, will instead intensify, taking with it countless lives. The discussion in Kigali did not finalize the answers at this pressing hour, but the first steps have begun.
 
For AVAC resources supporting your advocacy, including slide decks addressing key issues discussed above, go to AVAC’s dedicated page on IAS2025. Onwards!

Global Health Watch: PEPFAR saved, PrEP pill advances to Ph3, NIH ad councils, IAS highlights

Issue 25

This week’s Global Health Watch highlights major developments in HIV prevention science and policy, spotlighted at the IAS 2025 conference in Kigali, Rwanda. From new WHO guidelines recommending injectable lenacapavir for PrEP to Merck’s once-monthly PrEP pill advancing to Phase 3 trials, the HIV prevention pipeline is expanding and evolving. All this amid an increasingly intense fight to protect global health funding. This week, the US Senate blocked the President’s attempt to cut $400 million to PEPFAR. These advances and challenges were central to conversations in Kigali, where the message was clear: even in the face of funding threats, the HIV response must regroup, refocus and recommit to translating science into impact.

US Senate Removes $400M Proposed Cut to PEPFAR From Rescissions Package 

The US Senate blocked a proposed $400 million cut to PEPFAR as part of the Presidents proposed rescissions package requesting Congress claw back $9.4 billion in already appropriated Fiscal Year 2025 funding. The amendment was passed with bipartisan support and is an unexpected win amid escalating attacks on PEPFAR. While this protects core PEPFAR funds in the short term, the program has already been significantly weakened by the US foreign aid funding freeze, and prevention programs continue to be limited by executive order to providing PrEP only to pregnant and breastfeeding women. No Country Operational Planning (aka COP) meetings have been scheduled this year, making it unclear which programs will be funded or how PEPFAR leadership, partner countries and communities will decide on priorities for maximum impact. Unfortunately, $500 million in rescissions to other global health programs were approved by the Senate, further weakening sexual health services and the global infectious disease response. The US House of Representatives is expected to approve the rescissions by the end of the week. 

IMPLICATIONS: PEPFAR’s ability to deliver life-saving HIV treatment and prevention could be permanently compromised without full funding and reauthorization. Advocates warn that the program’s current status is a “shell of its former self,” making it harder to respond to barriers to care and stagnating incidence, to support community-led responses and key population programs, and to plan for long-term impact, including the introduction of injectable lenacapavir. Political inaction and right-wing misinformation have weakened the program’s bipartisan foundation, with devastating effects already being felt by implementing partners and affected communities. See AVAC’s Impact of PEPFAR Stop Work Orders on PrEP resource. In addition, Congressional approval of this rescissions package codifies DOGE’s unlawful cuts to USAID and foreign assistance overall, essentially giving the Administration clearance to continue to operate without accountability to make unilateral decisions on Congressionally appropriated funds.

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A Growing HIV PrEP Pipeline: Merck’s MK-8527 Monthly PrEP Pill Moves to Phase 3 Trials, WHO Recommends Lenacapavir 

At the IAS 2025 conference, Merck announced plans to launch Phase 3 trials of MK-8527, a once-monthly oral PrEP pill for HIV prevention, after sharing results from its Phase 2 trial showing MK-8527 to be safe and well tolerated (see the abstract). The EXPrESSIVE-11 trial will begin enrolling in August across 16 countries. It will compare MK-8527 with generic daily oral TDF/FTC among cisgender men, transgender women (assigned male sex at birth), transgender men (assigned female sex at birth), and gender nonbinary person. A parallel study among cisgender women in East and Southern Africa will launch later this year as well. See AVAC’s map of trial sites. Merck emphasized that community input played a critical role in shaping trial design, including the selection of the comparator. For more on how community involvement and Good Participatory Practices shaped the EXPrESSIVE trials watch for next week’s new PxPulse episode, Up Next: A monthly pill for PrEP. 

In addition, the World Health Organization released updated guidelines recommending the six-monthly injectable, lenacapavir (LEN) as a new PrEP option, including for pregnant and breastfeeding people. WHO also recommended rapid diagnostic testing for anyone initiating or continuing long-acting injectable PrEP, such as LEN and cabotegravir (CAB). This endorsement follows the FDA’s recent approval of LEN and adds momentum to global efforts to expand the PrEP toolbox. WHO’s recommendation sends a strong signal to countries, funders, and implementers that LEN should be integrated into HIV prevention strategies as part of a rights-based approach to choice and access.  

IMPLICATIONS: WHO’s recommendations of LEN and MK-8527 expanding to Phase 3 trials add to a growing pipeline that could lead to unprecedented choice in HIV prevention. See AVAC’s Innovation Pileup graphic resource. However, with new oral and injectable PrEP options now advancing in parallel, including cabotegravir, lenacapavir, and MK-8527 alongside daily oral PrEP and the dapivirine vaginal ring, the field faces both extraordinary opportunity and growing complexity, especially in the shrinking fiscal space. The field must act quickly to prepare systems, regulatory pathways, and delivery platforms for a more diverse prevention landscape. Innovative products and guidelines are only the beginning, to get HIV prevention products to those who need it requires political will, procurement commitments, and coordinated delivery strategies that center the needs and voices of those most affected by HIV. 

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Procurement for LEN for PrEP Begins

The Global Fund notified nine countries in East, Southern and West Africa to be early adopters to introduce injectable lenacapavir, signaling the start of procurement planning. The nine countries are expected to use their current Global Fund grants to be matched by central funds. The procurement price has not been released publicly, but countries are supposed to provide three-year forecasts by the end of the month. This is progress, but countries must navigate strict regulatory requirements, align national guidelines, and finalize implementation plans to unlock access.  

IMPLICATIONS: Without disclosure of the LMIC “not-for-profit” price by Gilead or Global Fund, it is not clear what volumes of LEN for PrEP will be available to the nine early adopter countries, or to other countries, particularly countries in Asia and Latin America who are not included in current agreements. This makes planning and budgeting extraordinarily hard. 

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NIH Scientists to be Removed from Advisory Councils

The NIH plans to “disinvite” dozens of scientists who had already undergone vetting from the Biden Administration from serving on its advisory councils. These councils play a critical role in final funding decisions for research grants. Staff who would have served on the Councils have been directed to nominate replacements aligned with the new administration’s priorities.  

IMPLICATIONS: There are many concerns that political appointees may override the traditional vetting processes, which could leave many NIH institutes without the scientific diversity and expertise needed to responsibly guide funding decisions. Some advisory panels are already operating with fewer than half their seats filled, which could delay grant approvals and undermine the agency’s ability to support important and equitable research.  

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IAS 2025: AVAC’s Early Recap

Read about funding cliffs, epidemic-ending possibilities, and essential advocacy in AVAC’s early recap.

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What We’re Reading

Resources

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.

Read Now

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.