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AVAC Advocates' Network Logo June 20, 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, we cover the US FDA approval of injectable lenacapavir (LEN) for PrEP, the “most transformative prevention product we’ve had in 44 years of this epidemic ([link removed]) ”, which demands urgent action if the remarkable science is translated into public health impact. Plus, updates on South Africa’s HIV program in crisis, oversight changes on NIH’s HIV clinical guidelines, and a court ruling halting illegal grant terminations. Read on.


** FDA Approves Lenacapavir for PrEP—Advocates Demand Urgent Action
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The US FDA approved injectable lenacapavir ([link removed]) (LEN) for HIV prevention as PrEP. Developed by Gilead Sciences, LEN is a twice-yearly injectable that demonstrated nearly complete protection in the landmark PURPOSE 1 and 2 trials. The World Health Organization (WHO) is expected to release updated PrEP guidelines for LEN in July, and regulatory agencies in Brazil, Europe and South Africa are simultaneously reviewing the product. But the current political context, ([link removed]) including a shuttered USAID and further disruptions across global health, demands an urgent and courageous response.

IMPLICATIONS: LEN for PrEP is poised to re-shape the HIV response, but only if this FDA approval is accompanied by bold, strategic, and equitable rollout. AVAC’s statement ([link removed]) and Gears of Lenacapavir for PrEP Rollout ([link removed]) outline what’s needed from all stakeholders to avoid repeating past delays in PrEP introduction. Watch ([link removed]) AVAC Executive Director, Mitchell Warren’s take on what this moment demands.

READ:
* FDA Approves Injectable Lenacapavir for PrEP: A Historic Milestone Must Now Be Matched by Urgent Action ([link removed]) —AVAC statement
* Regulators Approve a Twice-Yearly Shot to Prevent H.I.V. Infection ([link removed]) —The New York Times
* Will long-lasting HIV preventive be a game changer—or a missed opportunity? ([link removed]) —Science
* A Perfect Storm: “Gamechanger” HIV Prevention Medicine Launches In The Midst Of Health System And Public Health Cuts ([link removed]) —Health Affairs
* FDA approves twice-yearly shot for HIV prevention ([link removed]) —Healio
* Where We Are Now with LEN for PrEP ([link removed]) —AVAC infographic


LEN STATEMENTS
• Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection ([link removed]) —Gilead
• Gilead Statement on Access Planning for Lenacapavir for HIV Prevention in Low- and Middle-Income Countries ([link removed]) —Gilead
• Lenacapavir for PrEP Approved — Now Comes the Fight for Global Access ([link removed]) —GBGMC
• Statement from amfAR on FDA Approval of Lenacapavir for HIV Pre-Exposure Prophylaxis ([link removed]) —amfAR
• PrEP4All Statement on FDA Approval of Lenacapavir as PrEP ([link removed]) —PrEP4All
• Gilead’s Greed Imperils Global Access to Newly FDA-Approved Breakthrough HIV Prevention Shot While Estimates of New HIV Infections Rise Sharply Due to Trump Administration’s HIV Cuts ([link removed]) —Health Justice Initiative, Health GAP, Just Treatment, ABIA (Brazilian Interdisciplinary AIDS Association), aSankalp Rehabilitation Trust
• PrEP in Black America (PIBA) Coalition Celebrates FDA Approval of Twice-Yearly Lenacapavir for HIV Prevention ([link removed]) —PrEP in Black America
• FDA approval of injectable lenacapavir marks progress for HIV prevention ([link removed]) —World Health Organization
• UNAIDS urges Gilead to drop price of new HIV prevention shot ([link removed]) —UNAIDS
• Unitaid welcomes U.S. FDA approval of lenacapavir and calls for urgent action on affordability and access ([link removed]) —Unitaid


** South Africa Feels the Impact of US Cuts
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South Africa’s HIV research infrastructure and programming are feeling the impact of the US Administration’s draconian actions after significant funding cuts. Cuts to PEPFAR and NIH have created a reported R430 million funding gap resulting in the loss of access to viral load testing, antenatal ARV care and the shutdown of clinics who serve key populations, including sex workers, transgender individuals, and people who inject drugs.

IMPLICATIONS: The impact of these cuts are threatening to reverse years of progress in a country shouldering a disproportionate share of the global burden of HIV and where AIDS denialism once dominated policy. Marginalized communities in South Africa may lose trust in programs and access to care, leading to increased rates of HIV transmission, including mother-to-child transmission, and jeopardizing global targets to end AIDS by 2030. South African stakeholders acknowledge they cannot plug the gap in funding alone.

READ:
* South Africa Built a Medical Research Powerhouse. Trump Cuts Have Demolished It. ([link removed]) —The New York Times
* No, South Africa’s HIV care is not ‘under control’. To pretend so recalls the dark days of Aids denialism ([link removed]) —The Guardian
* The Scientific Journey of Lenacapavir: From basic science to clinical development to impact ([link removed]) —AVAC webinar


** Administration’s Attempt to Terminate NIH Research Grants Deemed Illegal
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A US federal judge ruled that the Administration’s efforts to terminate certain NIH research grants was “void and illegal”. The ruling came during a hearing on the American Public Health Association’s lawsuit and another by a coalition of 16 states, which challenged the Administration’s termination of grants related to diversity, equity, inclusion (DEI), and LGBTQ+ health. Judge William Young, who was appointed by Ronald Reagan, noted, “I have never seen racial discrimination by the government like this” in his 40 years on the bench.

IMPLICATIONS: This decision shows positive steps in rebuking the Administration’s efforts to dismantle funding for science and biomedical research, and is a step toward preserving crucial grants related to HIV, STI, and DEI-focused research. However, the decision only applies to grants listed by the plaintiffs, and broader protections will depend on continued legal challenges and congressional decision making.

READ:
* The decision by a federal court in Boston hands a temporary victory to researchers ([link removed]) —STAT
* Exclusive: NIH documents reveal inconsistencies in grant terminations as agency reviews 3200 more ([link removed]) –Science


** NIH Support for Clinical Trial Guidelines
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The Department of Health and Human Services (HHS) will transfer management of the NIH’s HIV clinical practice guidelines, which have been managed through the Office of AIDS Research (OAR). By June 2026, another HHS agency or organization will oversee the guidelines. An internal memo reports that “in the coming weeks, co-chairs and NIH Executive Secretaries will convene Panel members to discuss options for sustainable maintenance of the guidelines and discuss transition options.”

IMPLICATIONS: These guidelines have been a core pillar of HIV science, policy, and clinical alignment and the loss of NIH and OAR oversight of the HIV clinical guidelines is another action in undermining science, research and rights.

READ:
* HIV Clinical Guidelines Members Letter ([link removed]) —Department of Health and Human Services

What We're Reading

• Congress should be ashamed over helping Trump cut foreign aid, activists say ([link removed]) —The Independent
• The retreat from aid is a costly mistake ([link removed]) —Washington Post
• Africa's Shift From Aid Dependency ([link removed]) —Think Global Health
• The trickle-down effect of President Trump's massive NIH budget cuts ([link removed]) —USA Today
• Treating HIV/AIDS Abroad Without US Aid and PEPFAR | The Brian Lehrer Show-WNYC ([link removed])
• ‘I Think He Is About to Destroy Vaccines in This Country’— ([link removed]) The New York Times
• Supreme Court Upholds State Ban on Transgender Care for Minors ([link removed]) —The New York Times
• Mistrust, Trump and Multilateralism: Key Ingredients of the Pandemic Agreement ‘Recipe’ ([link removed]) —Health Policy Watch
• NIH chief sidesteps controversy while other officials court it ([link removed]) —Axios

UPDATED RESOURCES
• The Scientific Journey of Lenacapavir ([link removed]) , AVAC
•
Moving a Product to the Real World ([link removed]) , AVAC
• The HIV Prevention Pipeline ([link removed]) , ([link removed]) AVAC
•
LEN Generics — Can we go faster? ([link removed]) , AVAC
•
Lenacapavir Regulatory Approval ([link removed]) , AVAC
• An Overview of Lenacapavir for PrEP Trials ([link removed]) , AVAC
• Advocates’ Guide: Understanding the President’s Proposed Fiscal Year 2026 (FY26) Budget and Its Implications for Science, Research and Global Health ([link removed]) , AVAC
• Research Matters ([link removed]) , AVAC, HIVMA, TAG
•
HIV Prevention R&D at Risk ([link removed]) , AVAC

In solidarity,

AVAC
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AVAC Global Advocacy for HIV Prevention
+1 212 796 6423 [email protected] (mailto:[email protected]) www.avac.org ([link removed])
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