The World Health Organization (WHO) has recommended the global use of injectable lenacapavir (LEN) twice a year to provide near-total protection against HIV infection and the development of AIDS.
The announcement was made on Monday during the 13th International AIDS Society (IAS 2025) Conference on HIV Science in Kigali, Rwanda.
The injectable offers 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, particularly those who face challenges with daily adherence, stigma, or access to health care.
“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 Dr Tedros Adhanom Ghebreyesus, WHO Director-General.
He added that 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,” he said.
HIV infections remain high among vulnerable populations
WHO’s recommendation comes at a critical time, as global HIV prevention efforts have stalled, with 1.3 million new infections recorded in 2024.
The burden of these infections falls disproportionately on key and priority populations, including sex workers, men who have sex with men, transgender individuals, people who inject drugs, people in prisons, and children and adolescents.
WHO has emphasized that its endorsement of injectable lenacapavir (LEN) marks a decisive step toward expanding and diversifying HIV prevention. The goal is to give individuals more options to take control of their health with flexible choices that suit their lives.
While access to lenacapavir outside clinical trials remains limited for now, WHO is calling on governments, donors, and global health partners to immediately begin rolling out LEN within national combination HIV prevention programmes.
The agency also recommends collecting essential data on real-world uptake, adherence, and impact.
In addition to expanding prevention options, WHO advises early HIV testing for individuals presenting with suspected or confirmed mpox (monkeypox) infections. Standard operating procedures further recommend both HIV and syphilis testing for all individuals with suspected or confirmed mpox cases.
Sustaining services amid shifting funding landscapes
Addressing broader challenges in HIV programme sustainability, WHO has also issued new operational guidance aimed at helping countries maintain critical services amid evolving funding landscapes.
The stepwise framework is designed to support service prioritization, risk assessments, disruption monitoring, and systems adaptation to preserve health outcomes and hard-won progress.
“We have the tools and the knowledge to end AIDS as a public health problem,” said Dr Meg Doherty, Director of WHO’s Department of Global HIV, Hepatitis and STI Programmes and incoming Director of Science, Research, Evidence and Quality for Health. “What we need now is bold implementation of these recommendations, grounded in equity and powered by communities.
Global burden of HIV remains significant
Despite major advancements, HIV remains a serious global public health concern. By the end of 2024, an estimated 40.8 million people were living with HIV 65% of them in the WHO African Region.
Around 1.3 million people acquired HIV that year, including 120,000 children, and approximately 630,000 people died from HIV-related causes globally.
Access to antiretroviral therapy (ART) continues to grow, with 31.6 million people receiving treatment in 2024, up from 30.3 million in 2023.
At a time of shrinking global health budgets, WHO’s new and updated guidelines offer practical, evidence-based strategies to sustain momentum in the fight against HIV and AIDS.
