In a landmark development that could reshape the global fight against HIV, the World Health Organization (WHO) is calling for the “immediate” rollout of a breakthrough injectable drug that offers near-total protection from the virus. The drug, known as lenacapavir – or LEN – requires just two injections per year and has demonstrated remarkable efficacy in preventing HIV infection.

The announcement came Monday, July 14, during the 13th International AIDS Society Conference (IAS 2025) on HIV Science held in Kigali, Rwanda, where WHO officials described the innovation as a game-changer in the long-standing struggle to halt the spread of HIV.

“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.”
WHO Director-General Tedros Adhanom Ghebreyesus

Lenacapavir’s appeal lies in its convenience and effectiveness. Unlike daily oral pills or bimonthly injections, LEN’s biannual regimen offers a simpler, less burdensome path to protection. WHO has endorsed its use not only at clinics but also in pharmacies and through online consultations.

This support comes at a critical time when Global HIV prevention efforts have plateaued, and the rate of new infections remains troublingly high. According to WHO, 1.3 million people were newly infected with HIV in 2024, with the most affected populations being sex workers, men who have sex with men, transgender individuals, people who inject drugs, people in prisons, and children and adolescents.

To ease access to the injection, WHO is also advocating for the expanded use of rapid testing kits, which provide quicker and less costly diagnostics compared to traditional laboratory methods.

WHO Pushes For Immediate Access

Currently, access to lenacapavir remains largely confined to clinical trials, but the WHO is urging the swift integration of the drug into national HIV-prevention strategies. Governments, donors, and global partners are being called upon to act without delay.

The recommendation aligns with U.S. health authorities, who approved LEN for use in June. It now joins an expanding arsenal of WHO-backed prevention tools, including oral PrEP tablets, injectable cabotegravir – administered every two months – and the dapivirine vaginal ring, offering women a discreet, self-managed option.

“WHO is committed to working with countries and partners to ensure this innovation reaches communities as quickly and safely as possible.”
WHO Director-General Tedros Adhanom Ghebreyesus

However, the optimism around LEN’s medical potential comes against the backdrop of shrinking global HIV funding. The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), launched in 2003 and instrumental in fighting HIV in Africa, is among the programs affected by financial cutbacks.

To mitigate the effects of these reductions, WHO has released updated operational guidance to help countries maintain priority HIV services even with fewer resources.

Dr Meg Doherty, Director of WHO’s Department of Global HIV, Hepatitis and STI Programmes, echoed the urgency for action: “We have the tools and the knowledge to end AIDS… what we need now is bold implementation of these recommendations, grounded in equity and powered by communities.”

Despite decades of progress, HIV remains a formidable public health challenge. At the close of 2024, approximately 40.8 million people globally were living with the virus, with Africa accounting for around 65 percent of cases. Tragically, an estimated 630,000 people died of HIV-related complications in the same year, including 120,000 children.

On a more hopeful note, access to life-saving antiretroviral treatment is on the rise. In 2024, 31.6 million individuals were on treatment, an increase from 30.3 million in 2023. These drugs prevent the virus from damaging the immune system and progressing to AIDS.

With lenacapavir now in the spotlight, public health leaders hope it could become an important part of global prevention strategies if access is scaled up rapidly and equitably.