WHO Endorses Game-Changing Twice-Yearly HIV Prevention Injection
The World Health Organization (WHO) today announced new guidelines endorsing the use of injectable lenacapavir (LEN) administered twice yearly as an additional pre-exposure prophylaxis (PrEP) option to prevent HIV infection. This landmark policy, unveiled at the 13th International AIDS Society Conference (IAS 2025) in Kigali, Rwanda, represents a major breakthrough in the global HIV response, offering a long-acting, highly effective alternative to daily oral prevention pills.
LEN is the first PrEP product designed for twice-yearly injection, providing a transformative choice for people at risk of HIV — especially those who face barriers to daily pill adherence, stigma, or limited healthcare access. By reducing the need for frequent dosing, LEN empowers individuals to better protect themselves from HIV infection.
“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,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus. “WHO is committed to working with countries and partners to ensure this innovation reaches communities as quickly and safely as possible.”
The updated guidelines also simplify HIV testing protocols by recommending the use of rapid HIV tests, enabling broader community-based delivery of injectable PrEP through clinics, pharmacies, and tele-health services. This approach lowers barriers to access by eliminating complex, costly testing procedures.
LEN joins an expanding arsenal of WHO-recommended HIV prevention tools, including daily oral PrEP, injectable cabotegravir, and the dapivirine vaginal ring. The WHO urges governments and global health partners to begin immediate rollout of LEN within combination prevention programs, while gathering data on real-world uptake and impact.
Additional WHO recommendations at IAS 2025 include new guidelines for the use of long-acting injectable antiretroviral therapy (ART) with cabotegravir and rilpivirine (CAB/RPV) for adults and adolescents with full viral suppression, offering an alternative to oral ART regimens and addressing adherence challenges.
The WHO also calls for integration of HIV services with care for noncommunicable diseases and mental health, updated management of asymptomatic sexually transmitted infections, and rapid ART initiation for people living with HIV diagnosed with mpox.
Despite significant progress, HIV remains a critical global health challenge. In 2024, an estimated 40.8 million people were living with HIV worldwide, with 65% in the WHO African Region. There were 1.3 million new infections and 630,000 HIV-related deaths globally. Access to ART is increasing, with 31.6 million people receiving treatment in 2024.
Dr. Meg Doherty, Director of WHO’s Department of Global HIV, Hepatitis and STI Programmes, emphasized, “We have the tools and the knowledge to end AIDS as a public health problem. What we need now is bold implementation of these recommendations, grounded in equity and powered by communities.”
