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.
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.
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.
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.
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.
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.
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.
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.
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+.
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.
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.
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.
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.
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.
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.
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.”
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.”
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.
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.
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.
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.
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, 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.
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.
The future of HIV prevention clinical trials, Satellite, 18:00 – 19:30, featuring AVAC’s Grace Kumwenda presenting on community perspectives in HIV prevention clinical research
Co-Chair’s choice, Oral abstract, 15:00 – 16:00, featuring a presentation of the Phase 2 safety and pharmacokinetic study of MK-8527 as once-monthly oral PrEP
Getting to grips with prevention, Plenary, 09:00 – 10:30, featuring updates on HIV vaccine discovery medicine and evidence-based innovations to simplify and de-medicalize PrEP choice
Pregnancy and long-acting ARVs for prevention and treatment, Symposium, 13:45 – 14:45, featuring AVAC partner Chilufya Kasanda of Ascend Futures Foundation in Zambia and updates from Merck, ViiV and Gilead on their respective PrEP programs
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.
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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A Second Opinion—Former Republican Senator and Majority Leader Bill Frist’s Substack
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.
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.
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.
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.
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.
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.
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.
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.
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.
