An Overview of Lenacapavir for PrEP Trials
Spotlight on MPTs Addressing STIs
This graphic outlines the development journey of multipurpose technologies (MPTs) that guard against STIs, including HIV, while also preventing pregnancy. It tracks the advancement of various potential products through different trial stages, emphasizing their combined protective roles. Excerpted from our Advocates’ Guide to Multipurpose Technologies.
At A Glance: The MPT R&D Pipeline
This graphic shows the status of products in development. Excerpted from our Advocates’ Guide to Multipurpose Technologies.
Advocates’ Guide to Multipurpose Prevention Technologies (MPTs)
Multipurpose prevention technologies (MPTs) are products designed to simultaneously address more than one sexual and reproductive health concern. This advocates’ guide shows the pipeline of products in development, discusses why MPTs are needed, investment, and what advocates can do to push for MPT development and introduction.
The Future of ARV-Based Prevention and More
The pipeline of non-vaccine HIV prevention products includes oral pills, vaginal rings, vaginal and rectal gels, vaginal films, long-acting injectable antiretrovirals and more. Also pictured are the range of MPTs in development that aim to reduce the risk of HIV and STIs and/or provide effective contraception for women.
The Lens on LEN
The Basics on Injectable Lenacapavir as PrEP
In 2024, Gilead Sciences released findings from the PURPOSE 1 and PURPOSE 2 trials testing lenacapavir (LEN) as HIV prevention. The PURPOSE 1 trial found 100% efficacy in preventing HIV in 5,300 cisgender women in Uganda and South Africa, and the PURPOSE 2 trial showed a 96% reduction in HIV incidence among cisgender men, trans, and non-binary individuals across multiple countries. Both trials demonstrated LEN’s safety and effectiveness in reducing HIV transmission. This advocates’ primer provides background on the product and trials; a summary of the early findings of PURPOSE 1 & 2; key questions and next steps.
The HIV Prevention Pipeline
This graphic shows currently available options for HIV prevention, newly approved and recommended treatment, and those in development.
Sexual and Reproductive Health Integration Advocacy Roadmap
This roadmap addresses the critical need for integrated sexual and reproductive health (SRH) and HIV services. This integration is essential for enhancing public health outcomes, socio-economic benefits, and individual health and rights. The Roadmap aims to revitalize and sustain advocacy efforts for SRH and HIV integration, empower communities to hold stakeholders accountable for implementation, increase political and program support to enable the shift from policy to practice, and foster dynamic partnerships across research, advocacy, implementation, and policy sectors.
It was developed by Copper Rose Zambia (CRZ) as part of the Coalition to Accelerate and Support Prevention Research (CASPR). It draws on extensive input, including desk reviews, interviews, focus group discussions, and a specialized workshop held at the 2023 International Conference on AIDS and STIs in Africa (ICASA).
Lenacapavir: The case for investing in delivering HIV prevention
The promise of long-acting PrEP has been super-charged this year by studies showing the powerful efficacy of an antiretroviral known as lenacapavir (LEN).
This episode of PxPulse goes deep on LEN for PrEP. Recorded just days before Gilead’s announcement that PURPOSE 2 also found very high efficacy, Dr. Flavia Kiweewa, a principal investigator of PURPOSE 1, the first trial to announce efficacy, lays out the research findings and what they mean. And Chilufya Kasanda Hampongo of Zambia’s Treatment Advocacy and Literacy Campaign and Mitchell Warren of AVAC talk about how to change a long history of squandered opportunities to get rollout right.
The PURPOSE1 trials announced findings in June that a twice-yearly injection of LEN was 100% effective among cisgender women, with zero new cases of HIV. And the PURPOSE 2 trial among cisgender men, and trans and non-binary people, was shown to reduce the risk of HIV by 96%.
LEN now enters a select category, one of five ARV-based options for PrEP that all protect against HIV if you take them. But many of the people applauding the results from PURPOSE 1 and 2 will tell you that breakthrough science like this is, as hard as it is, is still the easy part. To break the back of the HIV epidemic demands overcoming an altogether different challenge—coordinating and accelerating every step in rolling out new products so that everyone who needs HIV prevention can get it.
Listen to this podcast to learn what must be done to finally deliver on the promise of highly effective HIV prevention, from pills to rings to injectable PrEP and beyond.
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Resources
- Second Pivotal Trial of Twice-Yearly HIV Prevention Injection Safe and Highly Effective: PURPOSE 2 Trial Among Gay Men, Trans and Nonbinary People, AVAC Press Release
- The Lens on LEN: The basics on injectable lenacapavir as PrEP, AVAC
- Country planning matrix, PrEPWatch
- Moving a Product to the Real World, AVAC
- The long wait for long-acting HIV prevention and treatment formulations, Lancet
- A game-changer for PrEP if access is adequate, Lancet
- Allocation of Non-Commercial CAB for PrEP Supply in Low- and Middle-Income Countries, 2023-2025, AVAC
- Generic Cabotegravir Timelines, AVAC
- UNAIDS Exec Summary, UNAIDS
- Lenacapavir: What it would it take to get the 6-monthly anti-HIV jab to SA, Bhekisisa
Second Pivotal Trial of Twice-Yearly HIV Prevention Injection Safe and Highly Effective
AVAC welcomes the groundbreaking results of the PURPOSE 2 HIV prevention study of twice-yearly injectable lenacapavir for PrEP among 3,200 cisgender men, transgender men, transgender women, and nonbinary individuals who have sex with partners assigned male at birth. Among more than 2,000 people in the trial who received lenacapavir, there were only two HIV infections.