What It Took to Make LEN for PrEP Possible + What’s at Risk Now

June 3, 2025

The US presidential administration released its full US FY26 budget proposal on Friday, and it includes a series of devastating cuts that threaten to roll back HIV prevention efforts in the US and globally by decades. In a cruel irony, this proposal comes just as the field reaches a moment of historic promise in HIV prevention. 

Lenacapavir (LEN), the twice-yearly injectable form of HIV PrEP, is expected to be approved by the US Food and Drug Administration (FDA) later this month, and WHO is expected to release a recommendation and guidelines in July. Named Science magazine’s 2024 “Breakthrough of the Year,” LEN for PrEP represents the culmination of decades of investment in the earliest stages of scientific innovation, from basic science to global partnerships.  

LEN for PrEP shows what’s possible when the world invests in HIV prevention. However, the NIH is initiating a new policy to prevent international research, including within the HIV clinical trial networks, other HIV clinical trials are halted, leading HIV vaccine discovery research is terminated, and PEPFAR prevention programming is defunded.  

Just how important is basic science research to product development? And how vital is the South African research infrastructure for innovation in HIV and TB? Well, as just one example, without NIH investments over the past two decades, the world would not be on the cusp of approval and introduction of LEN for PrEP. 

Join us on Wednesday, June 11 at 11am ET for an essential conversation on what’s at stake. 


The Scientific Journey of Lenacapavir: From basic science to clinical development to impact

Learn how sustained US support from NIH discovery science to South Africa’s clinical research infrastructure made the development of LEN for PrEP possible. 

Speakers include: 

  • Wes Sundquist (University of Utah), on the early-stage science behind capsid inhibitors. 
  • Linda-Gail Bekker (Desmond Tutu HIV Foundation), on the PURPOSE 1 trial in South Africa, where not a single HIV infection occurred. 

This couldn’t be more timely, or important! This Thursday, Dr. Sundquist, Moupali Das of Gilead Sciences and Yvette Raphael of Advocates for the Prevention of HIV in Africa (APHA) will be honored together by the American Association for the Advancement of Science (AAAS) with the Mani L. Bhaumik Breakthrough of the Year Award for their leadership in the discovery and development of LEN for PrEP. Their roles in advancing LEN as an option for HIV prevention show what’s possible with well-funded basic research, international collaborations and community-centered priorities. 

Advances like these take time, money, support, commitment and global partnerships. Defending why research matters depends on understanding its value and telling its story. The field must urgently make the case for sustained investment. Join us June 11 and see more resources to support your advocacy below.