Kigali, Rwanda – The World Health Organization (WHO) issued new guidelines recommending the twice-yearly use of injectable lenacapavir (LEN) as an additional pre-exposure prophylaxis (PrEP) option for HIV prevention. This landmark policy announcement, made at the 13th International AIDS Society Conference (IAS 2025) in Kigali, Rwanda, could significantly reshape the global HIV response.
LEN, the first twice-yearly injectable PrEP, offers a highly effective, long-acting alternative to daily oral pills and other shorter-acting options. Requiring only two doses annually, LEN represents a transformative advancement in protecting individuals at risk of HIV, particularly those facing challenges with daily adherence, stigma, or healthcare access.
“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,” stated Dr. Tedros Adhanom Ghebreyesus, WHO Director-General. He added, “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 quickly and safely.”
These new guidelines arrive at a critical juncture, as HIV prevention efforts have stagnated, with 1.3 million new infections in 2024 disproportionately affecting key populations, including sex workers, men who have sex with men, transgender people, people who inject drugs, incarcerated individuals, and children and adolescents.
The WHO’s recommendation on LEN signifies a decisive move to expand and diversify HIV prevention options, empowering individuals to make choices that align with their lives and health needs.
The guidelines also recommend a public health approach to HIV testing using rapid tests to facilitate the delivery of long-acting injectable PrEP, including LEN and cabotegravir (CAB-LA). This simplified testing approach removes a significant access barrier by eliminating complex and costly procedures, enabling community-based delivery of long-acting PrEP through pharmacies, clinics, and telehealth services.
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