WHO to Develop Lenacapavir and HIV Testing Guidelines

The World Health Organization (WHO) has announced plans to develop new guidelines for lenacapavir and HIV testing. These guidelines aim to establish a framework for implementing lenacapavir as a pre-exposure prophylaxis (PrEP) regimen and to simplify current and long-term options for HIV testing models. The development process will take place during the Guideline Development Group (GDG) meeting, scheduled to be held virtually from January 28-30, 2025. The public is invited to submit questions and provide feedback by emailing hiv-aids@who.int until January 20, 2024.

Lenacapavir, which targets the HIV capsid to prevent virus replication, is currently approved in the United States for treating patients with multi-drug-resistant HIV in combination with other antiretrovirals, but not as a form of PrEP. Gilead, the drugmaker, submitted a new drug application for FDA approval for lenacapavir as a form of PrEP on December 19, 2024, supported by data from the Purpose 1 and Purpose 2 trials. These trials demonstrated high efficacy rates in preventing HIV among cisgender women in Uganda and South Africa.

Despite its potential to change the HIV landscape as an injectable form of PrEP, lenacapavir's high cost remains a significant barrier. In October 2024, Gilead signed royalty-free voluntary licensing agreements with six generic manufacturers to produce the drug in 120 high-incidence, primarily low-income countries, including 18 countries that account for 70% of global HIV cases.

The GDG meeting will also focus on the safety and efficacy of lenacapavir, with particular attention to its initiation in low-resource areas. Members of the GDG, selected from all WHO regions based on their expertise and commitment to ending the HIV epidemic, will participate in the discussions. It is important to note that there is currently no cure for HIV or AIDS.