WHO to Develop Guidelines for Gilead’s Twice-Yearly HIV PrEP Injection (Lenacapavir)

The World Health Organization (WHO) has announced the development of new guidelines for the use of injectable lenacapavir as pre-exposure prophylaxis (PrEP) for HIV, aiming to create a normative framework for its implementation globally31.

A Guideline Development Group meeting was scheduled for January 28-30, 2025, to review evidence, engage stakeholders, and propose recommendations regarding lenacapavir’s use and the optimization of HIV testing models31.

Lenacapavir (brand name Yeztugo) is a long-acting HIV-1 capsid inhibitor administered as a twice-yearly injection, recently approved by the US FDA as the first of its kind for HIV prevention24.

Clinical trials in women in sub-Saharan Africa and men/gender-diverse individuals showed a risk reduction in HIV transmission of over 99.9%, with lenacapavir performing better than daily oral PrEP options24.

WHO’s guideline update reflects the increasing focus on long-acting HIV prevention methods, improved adherence, and greater access for populations disproportionately affected by HIV3.

The most common side effects observed in trials included injection site reactions, headache, and nausea24.

Sources:

1. https://www.managedhealthcareexecutive.com/view/who-to-develop-lenacapavir-and-hiv-testing-guidelines

2. https://globalnation.inquirer.net/281188/us-approves-gileads-twice-yearly-injection-to-prevent-hiv

3. https://www.who.int/news/item/06-01-2025-who-announces-the-development-of-new-guidelines-for-lenacapavir-and-updated-hiv-testing-guidelines

4. https://medcitynews.com/2025/06/gilead-sciences-lands-first-fda-approval-of-a-twice-a-year-hiv-prep-drug/