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Dear Advocate,

The field of HIV prevention is confronted with two opposing forces; many programs for delivering PrEP have been shuttered all over the world by the withdrawal of the US government from global health, at the same moment as the newest next-generation long-acting PrEP product – injectable lenacapavir (LEN) – is poised to enter the market and help the world achieve epidemic control. These forces are colliding in real time. Navigating the future requires unprecedented coordination, solidarity, and courage. 
 
Read about all of this in the newest issue of PxWire (and below) offering a snapshot of the challenges and opportunities ahead.
 
In addition, last Friday, the new US administration released its topline Fiscal Year 2026 budget proposal, calling for devastating cuts to NIH, CDC, USAID, and a broad range of global health programs. While not yet law, the proposed budget sent to Congress would gut the very research, development and delivery infrastructure needed to deliver on the promise of ending HIV as a public health threat. Join AVAC and partners this Friday for a webinar, Science in the Crosshairs: Research Advocacy in a Time of Crisis, to learn more.

 

Progress in PrEP Uptake: Threatened

  • PEPFAR documented 2.5 million new PrEP users in 2024, who could now lose access to PEPFAR-supported PrEP services. US Department of State issued a limited and inconsistently implemented waiver in February, allowing for continued provision of HIV treatment but restricting PrEP access to pregnant and lactating people only.
  • These actions will result in 3.5 million who identify as key populations (KPs) losing access to all HIV prevention programming under PEPFAR, according to 2024 PEPFAR data tracking KP use of PrEP. These groups have higher rates of HIV incidence and face additional barriers to accessing services now that targeted programs are suspended.
  • PEPFAR had a goal of 100,000 people initiating cabotegravir (CAB) for PrEP in 2025. But only 5,000 individuals had initiated by October 2024. The suspension of PEPFAR funding imperils scale-up of this long-acting product.
  • These figures represent just some of the disruptions that are decimating PrEP delivery. Learn more here: Impact of PEPFAR Stop Work Orders on PrEP
  • Overcoming this challenge, restoring, sustaining, and accelerating PrEP access is imperative and possible if the field works together.

 

PrEParing for New Products

  • Approval by the US Food and Drug Administration (FDA) for injectable 6-month LEN for PrEP is expected in June, with WHO guidelines expected in July. See the full timeline.
  • Modelling data from South Africa demonstrate the potential of injectable PrEP to dramatically reduce HIV incidence by up to 90% by 2044, and potentially even sooner with more aggressive uptake. This potential goes beyond South Africa, lighting the way toward epidemic control the world over.
  • The field must be prepared for swift action once LEN is approved and recommended, to ensure this opportunity is not squandered. As AVAC’s interactive timeline, Tracking LEN Rollout, outlines, donors, ministries of health, manufacturers, regulators, and civil society all have a role to play to pave the way for swift, equitable and effective introduction of LEN for PrEP.
 

PrEParing for New Products: Is rollout still possible?

  • The HIV prevention market is headed toward a period of significant opportunity—and possible congestion—as a slate of new products are on track for continued development and potential introduction to the market in 2027 and 2028.
  • Generics for 2-month CAB and 6-month LEN, along with ViiV’s 4-month CAB, Gilead’s 12-month LEN, and Merck’s monthly oral MK-8527 PrEP pill (if further development and approvals are successful) could all enter the market by 2028.
  • The possibility of so many products on the market, including four different formulations of injectable PrEP, means that it is imperative the field prepares for this future now.
  • Markets and policies must be built to support the products in the market already, so that new options can be rapidly deployed and deliver impact. Otherwise, the field will squander time and money, with epidemic control slipping further out of reach.
  • With US funding cuts to both HIV prevention R&D and delivery, communities must be engaged, supported, and informed about all prevention options, and the choices that all stakeholders will need to make. This means gathering and sharing data and information about cost-effectiveness, user acceptability, program feasibility, and impact. Communities empowered with the facts can advocate for the choices they need, and push ministries of health to make strategic investments and procure the prevention method mix that fits their context and delivers impact.

Prevention Playlist

AVAC develops a wide range of materials and resources to inform decision making and action. Check out the latest:

Join

  • Subscribe to Global Health Watch: AVAC’s weekly newsletter dedicated to breaking down critical developments in US policies and their impact on global health. avac.org/global-health-watch
  • CHANGE: In response to the unfolding crisis, more than 1,500 people from civil society organizations around the world have launched CHANGE—Community Health & HIV Advocate Navigating Global Emergencies—a coalition formed to support urgent action. [email protected]

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