WHO to Develop Lenacapavir and HIV Testing Guidelines

The World Health Organization (WHO) has announced the upcoming development of new lenacapavir and HIV testing guidelines, according to a news release published Monday. Guidelines will be determined during the Guideline Development Group (GDG) meeting, which will be held virtually from Jan. 28-30, 2025. Interested members of the public can submit questions and provide feedback by emailing hiv-aids@who.int until Jan. 20, 2024.

The meeting will establish the framework for implementing lenacapavir as a pre-exposure prophylaxis (PrEP) regimen and simplify current and long-term options for HIV testing models. Members will also discuss the safety and efficacy of lenacapavir, with extra focus paid to initiation in low-resource areas.

Lenacapavir targets the HIV capsid, the genetic shell that protects the virus’s genetic material, preventing replication. It is currently approved in the United States to treat patients with multi-drug-resistant HIV in combination with other antiretrovirals, but not as a form of PrEP.

Drugmaker Gilead submitted a new drug application for FDA approval for lenacapavir as a form of PrEP on Dec. 19, 2024. The submission was supported using data from the Purpose 1 trial, which demonstrated that lenacapavir had 100% efficacy in preventing HIV in cisgender women in Uganda and South Africa, when compared with patients treated with once-daily oral Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg). In the Purpose 2 trial, there was a 99.9% efficacy rate and a 96% reduction in HIV cases, a Gilead news release states.

The FDA also granted lenacapavir a rolling review and breakthrough therapy designation in October 2024. Science Magazine also named it “Breakthrough Drug of the Year.”

As an injectable form of PrEP, lenacapavir has the potential to change the HIV landscape, though its high cost remains a barrier – up to $44,819 per person annually in the United States, despite an estimated mass production cost of less than $100 per person annually, a cost analysis published in the Journal of Antimicrobial Chemotherapy reports. 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. These include 18 countries that account for 70% of global HIV cases.

Members of the GDG come from all WHO regions and are chosen based on their levels of expertise and commitment to educate about and end the HIV epidemic.

There is currently no cure for HIV or AIDS.