Resources
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Results
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Years Ahead in HIV Prevention Research: Time to Market
This timeline shows the potential time points when the next-generation of HIV prevention options might find their way into new programs.
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Where We Are Now with LEN for PrEP
This timeline tracks the regulatory approval process for lenacapavir (LEN) for HIV prevention from late 2024 through late 2026. Key milestones include FDA Priority Review status, FDA approval in June 2025, expected subsequent approvals from European regulators and WHO, and Global Fund and PEPFAR commitment to roll out LEN to three million people over the next three years.
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Speeding Up Access to PrEP
The timeline for hitting key milestones in product introduction is moving faster for injectable LEN than for any previous PrEP products, starting from the announcement of efficacy results in Phase III trials. LEN’s accelerated timeline compared to oral PrEP, DVR, and CAB reflects a field-wide effort to learn lessons from previous PrEP rollout and not repeat the mistakes of the past.
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Lenacapavir Regulatory Approval
Regulatory approvals, pending decisions, and appeals as of October 2026.
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Injectable PrEP Regulatory Approvals
This graphic tracks regulatory approvals for injectable cabotegravir and lenacapavir for PrEP as of October 2026.
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Lower-Cost HIV Tests: Advocacy for better diagnostic deals
Opportunities to expand access to high quality testing services while freeing up funding for HIV prevention and treatment. Engagement with diagnostic procurers for the purchase of lower cost diagnostic products is critical given reductions in...
AVAC Comment to the Office of AIDS Research Advisory Council
AVAC submitted comment to the Office of AIDS Research Advisory Council (OARAC) to address several critical issues facing the federally-funded HIV/AIDS research and development portfolio that threaten the outlook and trajectory of NIH’s success in delivering innovative prevention and treatment options for the U.S. and the world. Citing threats to clinical trial networks, funding timelines for the Centers for AIDS Research NOFO, and reorganization at NAIAID, the comment urges OARAC and OAR to address and mitigate the destabilization of the HIV research enterprise.
Webinar Summary: Investing in Biomedical Innovation for Health and Economic Growth
This Financial Times webinar, hosted in partnership with ViiV Healthcare, brought together policymakers, funders, researchers, philanthropies and industry leaders to explore how to keep medical innovation moving forward. The conversation examined how to create the right conditions for future breakthroughs – and deliver clear benefits for patients, health systems, economies and society. Speakers discussed how to better recognise the economic, health and social impact of new medicines, how partnerships can help share risk and accelerate progress, and how new funding models could support the next generation of drug development.
Funding for Prevention Rollout, Not Close-Out
AVAC’s new publication, Now What with Injectable LEN for PrEP: How to Translate Ambition into Accelerated Delivery and Impact, outlines pathways to reach at least three million people by the end of 2027, including two scenarios for LEN market...
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Long-Acting PrEP Generic Manufacturers
Licenses have been granted to manufacturers across multiple low- and middle-income countries to produce generic long-acting PrEP products. Cabotegravir (CAB) and Lenacapavir (LEN) are approved and rolling out, while alimatravir (AMI) is in Phase 3 efficacy trials. Generic manufacturing can play an important role in expanding access to PrEP, and licensing to three African manufacturers for AMI is a notable step toward strengthening regional supply and affordability.
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