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

Issue 21

June 20, 2025

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

FDA Approves Lenacapavir for PrEP—Advocates Demand Urgent Action

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

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LEN Statements

South Africa Feels the Impact of US Cuts

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

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

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

Updated Resources