WHO Recommends Injectable Lenacapavir for HIV Prevention

The World Health Organization (WHO) has released new guidelines recommending the use of injectable lenacapavir (LEN) twice a year as an additional pre-exposure prophylaxis (PrEP) option for HIV prevention. This landmark policy action could reshape the global HIV response. The guidelines were issued at the 13th International AIDS Society Conference (IAS 2025) on HIV Science in Kigali, Rwanda.

LEN is the first twice-yearly injectable PrEP product, offering a highly effective, long-acting alternative to daily oral pills and other shorter-acting options. With just two doses per year, LEN is a transformative step forward in protecting people at risk of HIV, especially those who struggle with daily adherence, stigma, or access to health care.

Lenacapavir is a long-acting antiretroviral shown in trials to prevent almost all HIV infections among those at risk. 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.

The new guidelines come at a critical moment as HIV prevention efforts stagnate with 1.3 million new HIV infections occurring in 2024, disproportionately impacting key and priority populations. WHO's recommendation on LEN signals a move to expand and diversify HIV prevention, giving people more options to take control over their health.

As part of these guidelines, WHO has recommended a public health approach to HIV testing using HIV rapid tests to support delivery of long-acting injectable PrEP. The simplified testing recommendation removes a major access barrier by enabling community-based delivery of long-acting PrEP through pharmacies, clinics, and tele-health.

LEN joins other WHO-recommended PrEP options as part of a growing arsenal of tools to end the HIV epidemic. While access to LEN outside clinical trials remains limited, WHO urges governments, donors, and global health partners to begin rolling out LEN immediately within national combination HIV prevention programmes.

WHO's treatment guidelines now include a clear recommendation for the use of long-acting injectable cabotegravir and rilpivirine as an alternative switching option for antiretroviral therapy for adults and adolescents. Updated guidelines on service delivery integration include recommendations to integrate HIV services with noncommunicable diseases and mental health care into HIV services.

WHO has also issued new operational guidance on sustaining priority HIV services in a changing funding landscape. By expanding prevention and treatment options, simplifying service delivery, and promoting integration with broader health services, WHO's guidelines aim to support more efficient, equitable, and resilient HIV responses.

According to the source: News-Medical.