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Global Health Watch: LEN for PrEP approved by US FDA, South Africa’s HIV program in crisis, changes to oversight of NIH HIV guidelines

This week, we cover the US FDA approval of injectable lenacapavir (LEN) for PrEP, the “most transformative prevention product we’ve had in 44 years of this epidemic”, which demands urgent action if the remarkable science is translated into public health impact. Plus, updates on South Africa’s HIV program in crisis, oversight changes on NIH’s HIV clinical guidelines, and a court ruling halting illegal grant terminations.

Advocates’ Guide to Lenacapavir

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.

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.

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.

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.

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.

Lenacapavir Regulatory Approval

FDA Approves Injectable LEN for PrEP

This is the moment for all stakeholders to build on the momentum science. LEN has moved faster through regulatory review than any prevention product to date. Now it’s up to all of us to make sure that that progress translates into real, sustained impact on the epidemic, led by communities around the world. Let’s get to work.

FDA Approves Injectable Lenacapavir for PrEP

AVAC welcomes the U.S. Food and Drug Administration approval of injectable lenacapavir (LEN) for the prevention of HIV as PrEP.