WHO announces the development of new guidelines for lenacapavir and updated HIV testing guidelines

GENEVA, Switzerland – WHO is convening a Guideline Development Group (GDG) for the development of new guidelines on the use of injectable lenacapavir as pre-exposure prophylaxis (PrEP) for HIV, and the optimization of HIV testing services for long-acting prevention products. These updates reflect WHO’s commitment to addressing evolving public health needs, particularly for populations disproportionately affected by HIV, and to improving access to high-quality HIV prevention and testing services globally.

GDG members will contribute to the review of systematic reviews, evidence summaries, technical updates, and will propose recommendations. They will also participate in the GDG meeting, which will be held virtually between 28 and 30 January 2025.

The general objective of this meeting is to develop WHO guidelines that will serve as a normative framework for the implementation of lenacapavir, a new HIV prevention product, and for simplified testing delivery models for pre-existing and new long-acting HIV prevention products. Specific objectives include:

1. to evaluate the efficacy, safety, and acceptability of injectable lenacapavir as an additional PrEP option for populations at substantial risk of HIV infection, supporting a recommendation for its use within combination HIV prevention approaches; and
2. to provide evidence-based guidance on HIV testing protocols for individuals using long-acting PrEP options, including lenacapavir, covering initiation, continuation, and discontinuation, with considerations for implementation in low-resource settings.

Guideline development group composition

In accordance with WHO guidelines for developing recommendations, the GDG is composed of members from all WHO regions, serving in their individual capacities rather than as representatives of affiliated organizations. GDG members were selected by WHO technical staff based on their technical expertise, their role as end-users (e.g., programme managers and healthcare providers), and their representation of affected communities. Members do not receive financial compensation for their contributions to this process.

Call for public comments

To ensure transparency and inclusivity, WHO invites members of the public and interested organizations to review the biographies of the GDG members and provide feedback. Comments can be submitted via email to hiv-aids@who.int by latest 20 January 2024.

This feedback helps WHO develop high-quality guidelines that reflect diverse perspectives and respond to the needs of communities worldwide.

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