KIGALI, Rwanda — The World Health Organization has recommended the use of injectable lenacapavir (LEN) twice a year as a new option for preventing HIV, in what experts say is a major step forward in the global fight against the virus.
The announcement came Monday during the 13th International AIDS Society Conference on HIV Science. The new guidelines open the door for LEN — a long-acting antiretroviral drug administered just twice annually — to join the list of approved pre-exposure prophylaxis (PrEP) options.
“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. “The launch of WHO’s new guidelines, alongside the FDA’s recent approval, marks a critical step forward… WHO is committed to working with countries and partners to ensure this innovation reaches communities as quickly and safely as possible.”
Lenacapavir becomes the first twice-yearly injectable PrEP option, and is seen by WHO as especially helpful for individuals who struggle with taking daily pills, face stigma, or have limited access to regular health care.
The updated guidance arrives amid concerning data. In 2024, an estimated 1.3 million people acquired HIV globally. Many new infections were concentrated among sex workers, men who have sex with men, transgender people, people who inject drugs, prisoners, and adolescents.
WHO says expanding PrEP options is critical to slowing the spread of the virus. Its recommendation includes using HIV rapid diagnostic tests — a move intended to ease access to long-acting PrEP by cutting out complex, expensive testing procedures and allowing services through community clinics, pharmacies, and telehealth.
“Flexible HIV testing approaches are essential for ensuring that testing does not become a barrier to accessing or continuing PrEP,” the guidelines state.
The organization emphasized that LEN is not a replacement but an addition to existing options. Daily oral PrEP, injectable cabotegravir (CAB-LA), and the dapivirine vaginal ring all remain recommended tools in WHO’s HIV prevention strategy.
Access to LEN remains limited outside clinical trials, but WHO is urging governments and donors to begin introducing it into national HIV programs immediately — while monitoring real-world effectiveness.
The new guidance also expands HIV treatment options. WHO is, for the first time, recommending the long-acting injectable combination of cabotegravir and rilpivirine (CAB/RPV) for people who have achieved viral suppression and do not have hepatitis B. The switch from daily pills to injectables could help people who face challenges sticking to oral therapy.
Dr. Meg Doherty, Director of WHO’s Department of Global HIV, Hepatitis and STI Programmes, said implementation is the next challenge.
“We have the tools and the knowledge to end AIDS as a public health problem,” she said. “What we need now is bold implementation of these recommendations, grounded in equity and powered by communities.”
The updated guidance extends beyond prevention and treatment. WHO is urging countries to integrate HIV services with care for noncommunicable diseases — including hypertension, diabetes, depression, anxiety and alcohol use — as well as screening for sexually transmitted infections like gonorrhoea and chlamydia in key populations.
WHO also recommends rapid initiation of antiretroviral therapy for people newly diagnosed with HIV who also have mpox, and early testing for HIV in people with suspected mpox cases.
An estimated 40.8 million people were living with HIV at the end of 2024, according to WHO data, with about 65 percent of them in sub-Saharan Africa. Approximately 630,000 people died from HIV-related illnesses last year. ART coverage continues to grow, with 31.6 million people receiving treatment in 2024 — up from 30.3 million in 2023.
Still, funding for HIV programs is tightening. WHO’s new operational guidance aims to help countries protect services under budget constraints, outlining steps for risk assessment, disruption monitoring, and system adaptation.
The message from WHO is clear: the tools are here. What’s needed now is action.
