The World Health Organization (WHO) has officially recommended the global rollout of injectable lenacapavir (LEN) — a groundbreaking, twice-yearly preventive treatment shown to offer near-total protection against HIV infection and the progression to AIDS.
The announcement was made on Monday during the 13th International AIDS Society (IAS 2025) Conference on HIV Science held in Kigali, Rwanda, signaling a landmark advancement in HIV prevention efforts worldwide.
Lenacapavir, administered just twice a year, offers a powerful alternative to daily oral pre-exposure prophylaxis (PrEP) pills and other short-acting options, addressing one of the most persistent challenges in HIV prevention: adherence.
“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, during his keynote address in Kigali.
The WHO’s endorsement follows the recent approval of LEN by the U.S. Food and Drug Administration (FDA), setting the stage for rapid global adoption.
A crucial step in reversing stalled HIV prevention efforts
The WHO recommendation arrives at a critical juncture: global HIV prevention efforts have plateaued, with 1.3 million new infections reported in 2024, according to UNAIDS data.
Key and priority populations — including sex workers, men who have sex with men, transgender individuals, people who inject drugs, people in prison settings, and adolescents — continue to bear the brunt of these new infections.
Dr. Tedros emphasized the urgency of deploying new tools to protect these communities, stating that WHO is working with countries and partners to ensure the rapid and safe introduction of LEN into national HIV prevention strategies.
“WHO is committed to supporting countries to make this innovation accessible and to integrate it into combination prevention packages, ensuring equitable access for all,” he noted.
Flexible options and community-centered approaches
The introduction of LEN represents a decisive shift toward diversifying HIV prevention options, empowering individuals with choices that align with their lifestyles and reduce stigma.
WHO urged governments, donors, and global health organizations to integrate LEN into national programs immediately and to collect real-world data on uptake, adherence, and impact.
Alongside prevention, WHO also highlighted the importance of early HIV testing for individuals presenting with suspected or confirmed mpox (monkeypox) infections, recommending combined HIV and syphilis screening to strengthen public health responses.
Addressing service sustainability amid financial pressures
With global health funding under increasing strain, WHO has issued new operational guidance to help countries sustain essential HIV services. The stepwise framework offers strategies for prioritizing services, assessing risks, monitoring disruptions, and adapting systems to safeguard 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 grounded in equity and powered by communities.”
HIV remains a formidable global challenge
Despite significant progress, HIV remains a major global health concern. By the end of 2024, an estimated 40.8 million people were living with HIV, with 65% residing in the WHO African Region.
Approximately 1.3 million people — including 120,000 children — acquired HIV in 2024, and 630,000 people died from HIV-related causes worldwide.
Access to antiretroviral therapy (ART) continues to expand, with 31.6 million people receiving treatment in 2024, up from 30.3 million in 2023.
A call to action
The WHO’s endorsement of lenacapavir underscores the need for urgent, community-led action to scale up access and close prevention gaps. As countries prepare to integrate LEN into their public health arsenals, experts emphasize the importance of addressing equity, combating misinformation, and sustaining political commitment to finally end AIDS as a public health threat.
