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The Lens on LEN

8 July 2024

The Basics on Injectable Lenacapavir as PrEP

In late June 2024, Gilead Sciences announced an early review of the data of the PURPOSE 1 trial by an independent monitoring board, which found that injectable lenacapavir (LEN) provided as prevention was safe and highly effective against HIV. The product is being tested among 5,300 HIV-negative cisgender women ages 16-25 in Uganda and South Africa. No infections were seen among those receiving LEN. This advocates’ primer provides further background on the product and trials, raises key questions, and explores next steps.

Topic(s): Research

Product(s): Lenacapavir

Language(s): English

Format(s): Report

Source(s): AVAC

Type: Document

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Featured Resources

Document

From Clinical Trial Efficacy to Public Health Impact: A plan for accelerating access to injectable lenacapavir for PrEP

This plan provides a comprehensive view of all the moving parts for lenacapavir for PrEP introduction and identifies priority actions and actors responsible for ensuring time is not wasted and opportunity not squandered.
Spreadsheet

Access Workbook for Cabotegravir for PrEP, Dapivirine Vaginal Ring, and Lenacapavir for PrEP

This workbook, compiled by the Global Fund, contains key access information relating to cabotegravir (CAB) for PrEP, the dapivirine vaginal ring (DVR), and lenacapavir (LEN) for PrEP for all lower and middle income countries, including eligibility for Global Fund support, PEPFAR support status, regulatory status of CAB for PrEP and the DVR, access to non-profit…
External Link

Expanding Access to Lenacapavir

This United Advocates Network Call, titled Breaking New Ground: Expanding Access to Lenacapavir— Lessons from Dolutegravir and the Future of HIV Prevention, brought together global health experts, community advocates, and civil society organizations to discuss the challenges and opportunities in ensuring equitable access to Lenacapavir.
External Link

Health Impact, Budget Impact, and Price Threshold for Cost-effectiveness of Lenacapavir for HIV Pre-exposure Prophylaxis in Eastern and Southern Africa: A modelling analysis

This article from The Lancet HIV describes the use of the EMOD-HIV model to estimate the health and budget impacts and threshold price at which lenacapavir for PrEP could be cost-effective in eastern and southern Africa.
Document

The Long Wait for Long-acting HIV Prevention and Treatment Formulations

This commentary from The Lancet HIV calls on WHO, financial donors, manufacturers, and governments to take coordinated action to make long-acting HIV prevention and treatment available at scale in lower and middle income countries.
Document

PURPOSE 1 Summary

This factsheet provides a summary of the PURPOSE 1 phase III clinical trial of lenacapavir for PrEP and F/TAF for cisgender women taking place in South Africa and Uganda.
Document

Pre-Exposure Prophylaxis and Adolescent Girls and Young Women in Eastern and Southern Africa: The latest insights

Eastern and southern Africa (ESA) is the world’s most heavily HIV-impacted region, with adolescent girls and young women (AGYW) disproportionately affected. To support the scale-up of PrEP amongst AGYW in ESA, in September 2021 UNICEF and partners released the implementation brief “Improving the Quality of Pre-Exposure Prophylaxis Implementation for Adolescent Girls and Young Women in…
External Link

Integrated Study Dashboard

This dashboard, produced under the BioPIC project, reflects all currently known activities relating to implementation research, modelling, clinical research, and landscaping for new late stage biomedical HIV PrEP options, including cabotegravir for PrEP and the dapivirine vaginal ring. To update or add any activities missing from the dashboard, or if you have questions on using…
External Link

Long-acting HIV Pre-exposure Prophylaxis (PrEP) Approaches: Recent advances, emerging technologies, and development challenges

This review from Expert Opinion on Drug Delivery discusses the current state of the long acting PrEP field, recent advances, and emerging technologies, including ARV prodrug modifications and new drug delivery systems. Technological challenges, knowledge gaps, preclinical testing considerations, and future directions important in the context of clinical translation and implementation of long acting HIV…
External Link

The Years Ahead in Biomedical HIV Prevention Research

This graphic shows the updated status of large-scale prevention trials through 2024.