This wide-ranging slide deck gives a complete overview of lenacapavir — showing the overall prevention product pipeline, describes lenacapavir, compares it to other options, discusses the trials testing the product, next steps, and links to advocacy resources.
Advocates’ Guide to Lenacapavir
Trial results and steps toward ensuring access
The HIV Prevention Pipeline
This graphic shows currently available options for HIV prevention, newly approved and recommended treatment, and those in development.
Where We Are Now with LEN for PrEP
The chaos in foreign assistance programs (including discontinuation of major PrEP programs), cuts in staffing and new demands on donor commitments will make decisions on the procurement of LEN for PrEP more complex and uncertain.
In December 2024, the Global Fund and PEPFAR announced a plan to reach 2 million people with LEN for PrEP over three years. Exactly how funding to support this unprecedented introduction program will move forward, in the absence of significant US investment, is far from certain. The other stakeholders, including Global Fund, Gilead, CIFF and the Gates Foundation expressed commitments to the deal, but major questions remain.
Moving a Product to the Real World
The rollout of oral PrEP demonstrates that people don’t take PrEP simply because it’s available—there needs to be a demand for it, and it needs to be accessible, acceptable and used effectively by those who need and want it. These are the lessons the field is applying to the rollout of the dapivirine vaginal ring (DVR), and injectable cabotegravir (CAB) and lenacapavir (LEN) for PrEP. To reach the UNAIDS target of 10 million PrEP users by 2025, initiations of oral PrEP alone will not be enough—and this graphic shows that the field is beginning to apply past lessons to accelerate introduction of injectable PrEP options.
For the latest on lenacapavir, visit here.
LEN Generics — Can we go faster?
The timeline for generic LEN for PrEP to come to market is expected to be significantly shorter than for CAB for PrEP. Bioequivalence (BE) testing for LEN, which demonstrates a generic product works in the body in the same way as the originator product, is likely to be six months, vs. the 18 months for CAB for PrEP, because of differences in the drug formulation. The rapid granting of voluntary licensing by Gilead also contributes to this shorter timeline. For the latest on LEN, visit here.
An Overview of Lenacapavir for PrEP Trials
Lenacapavir Regulatory Approval
Regulatory approvals, pending decisions, and appeals as of June 2025, including US Food and Drug Administration approval. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
The Scientific Journey of Lenacapavir — and the Urgency to Defend HIV Prevention Science
On June 11, AVAC hosted a conversation, The Scientific Journey of Lenacapavir: From basic science to clinical development to impact, to explore how US support from NIH for basic science and South Africa’s clinical research infrastructure made possible the development of lenacapavir for PrEP (LEN), a discovery in HIV prevention that went on to be named Science magazine’s 2024 Breakthrough of the Year.
As the field anticipates initial regulatory approval from the US FDA by June 19 and a WHO recommendation in July, Linda-Gail Bekker of the Desmond Tutu Health Foundation, Wes Sundquist of the University of Utah and Mitchell Warren of AVAC underscored how this moment of promise is threatened by sweeping attacks on science, research and the very systems that made the development of LEN possible.
Getting PrEP Rollout Right This Time
Lessons from the Field
Thirteen years after oral PrEP’s introduction, global uptake remains slow, with just over 9 million initiations—falling short of UNAIDS’ 2025 targets. While HIV infections are declining in some regions, others are experiencing increasing epidemics. Despite challenges, lessons from oral PrEP and CAB rollout have strengthened health systems for scaling up longer-acting PrEP.
AVAC undertook a qualitative landscaping analysis to identify actionable lessons and recommendations across seven countries—Brazil, Kenya, Nigeria, South Africa, Vietnam, Zambia, and Zimbabwe—exploring themes of:
- Successes and challenges with daily oral PrEP introduction and scale-up and what can be done differently for new PrEP products.
- Public health system readiness for the introduction and scale-up of new PrEP products.
- Considerations for improving and accelerating PrEP regulatory approval, normative guidance, demand generation, stakeholder engagement, and health systems strengthening.
This analysis, conducted across seven countries before the January 2025 US foreign aid freeze, identifies urgent actions to sustain momentum. US foreign aid cuts are severely impairing PrEP delivery, jeopardizing remarkable progress made in the last 20 years. In the wake of this disruption, it is vital that efforts to mobilize and sustain an effective HIV response learn from the past and reach UNAIDS’ targets for 2030 by incorporating these insights into future planning.
Visit PrEPWatch for the full report and individual country profiles.
HIV Prevention R&D at Risk
Tracking the Impact of US Funding Cuts
The US presidential administration is actively working to dismantle HIV research and demolish the architecture of global health. The entire HIV response — from basic research and clinical development to policy, programs, and global access to life-saving treatment and prevention — is now under attack, and the world runs the risk of reversing the strides made to end HIV.
AVAC has put together this report, highlighting the impact of US cuts on the pipeline of HIV prevention research and development. AVAC will continue to track these cuts and their impact, to amplify the damage they will cause, and to fight for their reversal.