Lenacapavir (Yeztugo, Gilead) should be one choice available for people to take as pre-exposure prophylaxis (PrEP) for HIV, according to new guidelines released by WHO during IAS 2025, in Kigali, Rwanda.
Twice-yearly lenacapavir, which was just approved by the FDA in June, should be considered a PrEP option along with other WHO-recommended treatments: daily oral PrEP, injectable cabotegravir (Apretude, ViiV Healthcare) and the dapivirine vaginal ring. (The dapivirine vaginal ring is not approved by the FDA.)
“While an HIV vaccine remains elusive, lenacapavir is the next best thing: a long-acting antiretroviral shown in trials to prevent almost all HIV infections among those at risk,” WHO Director-General Tedros Adhanom Ghebreyesus, PhD, MSc, said in a press statement. “The launch of WHO’s new guidelines, alongside the FDA’s recent approval, marks a critical step forward in expanding access to this powerful tool. WHO is committed to working with countries and partners to ensure this innovation reaches communities as quickly and safely as possible.”
Along with the addition of lenacapavir to the PrEP arsenal, the new WHO guidelines recommend rapid diagnostic testing before and during long-acting injectable PrEP. “The simplified testing recommendation removes a major access barrier by eliminating complex, costly procedures and enabling community-based delivery of long-acting PrEP through pharmacies, clinics, and tele-health,” according to the press release.
Access to lenacapavir needs to be expanded, WHO said, requesting that governments, donors and global health partners work to introduce the drug immediately while also collecting data on uptake, adherence and real-world impact.
The emergence of lenacapavir comes at a critical time. In 2024, there were 1.3 million new HIV infections, with disproportionate impact in populations such as sex workers, men who have sex with men, transgender people, people who inject drugs, people in prisons, and children and adolescents. “The new guidelines come at a critical moment as HIV prevention efforts stagnate,” the press release said. “WHO’s recommendation on [lenacapavir] signals a decisive move to expand and diversify HIV prevention, giving people more options to take control over their health with choices that fit their lives.”
Based on a press release.