From AVAC <[email protected]>
Subject Global Health Watch: PEPFAR saved, PrEP pill advances to Ph3, NIH ad councils, IAS highlights, Issue 25
Date July 18, 2025 5:00 AM
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AVAC Advocates' Network Logo July 18, 2025
Global Health Watch is a weekly newsletter breaking down critical developments in US policies and their impact on global health. Tailored for our partners in the US and around the world, this resource offers a concise analysis of the week’s events, supporting advocates to respond to threats, challenges and opportunities in this critical period of change in global health. 

This week’s Global Health Watch highlights major developments in HIV prevention science and policy, spotlighted at the IAS 2025 conference ([link removed]) 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
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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 ([link removed]) 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.

READ/WATCH:
* PEPFAR may escape White House attempt to cut its budget ([link removed]) —PBS Newshour
* Senate blocks $400M cut to PEPFAR, but it's a shell of its former self ([link removed]) —Devex
* The PEPFAR programme keeps millions with HIV alive – a new push seeks to save it from Trump’s aid cuts ([link removed]) —The Independent
* Senate Approves Trump’s Bid to Cancel Foreign Aid and Public Broadcast Funds— ([link removed]) New York Times


** A Growing HIV PrEP Pipeline: Merck’s MK-8527 Monthly PrEP Pill Moves to Phase 3 Trials, WHO Recommends Lenacapavir
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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 ([link removed]) ). The EXPrESSIVE-11 trial ([link removed]) 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 ([link removed]) . 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 ([link removed]) 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 ([link removed]) 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 ([link removed]) . 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.

READ/WATCH:
* Merck to Initiate Phase 3 Trials for Investigational Once-Monthly HIV Prevention Pill ([link removed]) —Merck statement
* Video: New Phase 3 EXPrESSIVE trials announced exploring efficacy of a once-a-month oral PrEP pill ([link removed]) —AVAC
* WHO Adds Lenacapavir to Its HIV PrEP Recommendations Amid Underutilization of PrEP and Severe PEPFAR Funding Cutbacks ([link removed]) —Managed Healthcare Executive
* Lessons for long-acting lenacapavir: catalysing equitable PrEP access in low-income and middle-income countries ([link removed](25)00161-4/fulltext) —Lancet HIV
* WHO recommends injectable lenacapavir for HIV prevention ([link removed]) —WHO statement


** Procurement for LEN for PrEP Begins
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The Global Fund ([link removed]) 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.

READ:
* SA gets R520-million to buy the twice-a-year anti-HIV jab — but there’s a snag ([link removed]) —Bhekisisa
* Now What with Injectable LEN for PrEP? ([link removed]) —AVAC


** NIH Scientists to be Removed from Advisory Councils
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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.

READ:
* Exclusive: NIH to dismiss dozens of grant reviewers to align with Trump priorities ([link removed]) —Nature
* HIV Research on Pause: Impacts of US government cuts on HIV R&D ([link removed]) —AVAC presentation at IAS 2025


** IAS 2025: AVAC's Early Recap
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Read about funding cliffs, epidemic-ending possibilities, and essential advocacy in AVAC’s early recap
Read Now ([link removed])
What We're Reading

• A Venerable AIDS Activist Returns to Battle ([link removed]) —New York Times
• Trump Canceled Their Salaries. These Health Workers in Uganda Showed Up Anyway ([link removed]) —New York Times
• The future of US funding for HIV treatment and prevention ([link removed]) —NPR 1A
• We Didn’t Get Covid Right. But This Is Just Wrong. ([link removed]) —New York Times
• Worlds Historic Pandemic Agreement. Will Uganda seize opportunity?— ([link removed]) New Vision
• Nearly 400 Experts, Faith Leaders Demand Senate Action To Thwart RFK Jr.’s “Systematic Assault” on Global Vaccination ([link removed]) —Public Citizen
• I worked for 20 years for the HHS office that safeguarded people in research studies. DOGE gutted it ([link removed]) —STAT
• The growing influence of vaccine skeptics inside HHS ([link removed]) —STAT
• IAS 2025: HIV care is political: early focus on the funding crisis ([link removed]) —i-Base
• Global Fund Replenishment, Making Sustainability Arguments and Simplification Are Keys To Hitting Goal of 2M on Lenacapavir PrEP, says Mitchell Warren of AVAC | IAS 2025 ([link removed]) —Managed Healthcare Executive
• 'Best of Times, Worst of Times for HIV Prevention,' Says Mitchell Warren of AVAC | IAS 2025 ([link removed]) —Managed Healthcare Executive

RESOURCES

The Kigali Call to Action: Standing Together for the Global HIV Response ([link removed]) , Action Network
• PxWire Volume 15, Issue 3 ([link removed]) , AVAC
• Now What with Injectable LEN for PrEP: How to Translate Ambition into Accelerated Delivery and Impact ([link removed]) , AVAC

In solidarity,

AVAC
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AVAC Global Advocacy for HIV Prevention
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