Resources
AVAC’s Resource Database contains educational and advocacy materials covering a wide range of issues on biomedical prevention of HIV, STIs, COVID-19 and emerging health threats—from research to rollout.
To search for clinical trials and detailed information on products in development, visit our Prevention Research & Development Database
Results
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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...
Prevention Option:

An Overview of Lenacapavir for PrEP Trials
The PURPOSE trials evaluate the safety and efficacy of injectable lenacapavir (LEN), an investigational antiretroviral (ARV) drug being studied as a potential PrEP product. This graphic shows the latest status of all five trials including the groundbreaking results of PURPOSE 1 and PURPOSE 2.
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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.
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Moving a Product to the Real World
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 cabotegravir.
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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.
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The HIV Prevention Pipeline
This graphic shows currently available options for HIV prevention, newly approved and recommended treatment, and those in development.
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An “Innovation Pile-Up” in Next-Generation LA-PrEP is 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. 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.
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PrEP Delivery Imperiled
Programs for delivering PrEP have been shuttered all over the world by the withdrawal of the US government from global health. This graphic illustrates some of the severe measurable impacts of these cuts.
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Modelling Shows the Potential of LA-PrEP
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.
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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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