IN A MAJOR advance for HIV prevention, the World Health Organization (WHO) has officially recommended the use of injectable lenacapavir (LEN) as a twice-yearly pre-exposure prophylaxis (PrEP) option, marking a significant milestone in efforts to curb global HIV infections.
The announcement was made at the 13th International AIDS Society (IAS 2025) Conference in Kigali, Rwanda. LEN, a long-acting antiretroviral, is the first HIV PrEP product administered just twice a year. It offers a crucial alternative for individuals who struggle with daily oral PrEP regimens due to adherence challenges, stigma, or limited access to health services. WHO’s updated guidelines also support a simplified HIV testing approach using rapid tests to facilitate broader, decentralised rollout of LEN and other long-acting PrEP options, such as injectable cabotegravir.
Clinical trials have shown LEN to be highly effective in preventing HIV infections, with near-complete protection among participants at high risk. In 2024, an estimated 1.3 million people acquired HIV, a number that remains stubbornly high despite the availability of prevention tools. Key and priority populations, including sex workers, men who have sex with men, transgender people, people who inject drugs, and adolescents, continue to be disproportionately affected. WHO estimates that expanding access to long-acting PrEP options like LEN could substantially reduce new infections, particularly when interventions are community-based and supported by simplified testing protocols.
The updated guidelines also include broader recommendations to strengthen HIV responses: integrating care for noncommunicable diseases and mental health into HIV services, updating antiretroviral therapy strategies with injectable regimens for those with adherence challenges, and improving STI screening and mpox management among people living with HIV. WHO’s strategic focus aims to protect progress amid a shifting funding landscape by promoting integration, efficiency, and community-driven implementation.
LEN’s approval and WHO’s endorsement represent a transformative shift in HIV prevention. With global leadership and effective national implementation, LEN could play a central role in ending HIV as a public health threat.
Reference
World Health Organization. WHO recommends injectable lenacapavir for HIV prevention. 2025. Available at: https://www.who.int/news/item/14-07-2025-who-recommends-injectable-lenacapavir-for-hiv-prevention. Last accessed: 15 July 2025.
