Twice-a-Year HIV Prevention Shot Backed by WHO in Global Push to Curb Infections
KIGALI — The World Health Organization has officially endorsed Lenacapavir, a twice-yearly injectable drug for HIV prevention, marking a significant policy shift in the global response to HIV.
The announcement was made Sunday during the 13th International AIDS Society Conference (IAS 2025) in Kigali. WHO unveiled new guidelines recommending lenacapavir as an additional pre-exposure prophylaxis (PrEP) method for people at high risk of contracting HIV.
Lenacapavir, which only requires two injections per year, offers an alternative to the daily oral pill and shorter-acting options. WHO Director-General Dr. Tedros Adhanom Ghebreyesus called the drug “the next best thing” in the absence of an HIV vaccine.
“Lenacapavir has shown strong results in trials, preventing almost all infections among people exposed to risk,” Tedros said. “This new recommendation can help change the course of prevention especially for those facing stigma or inconsistent access to care.”
The announcement comes amid growing concern over stalled progress in global HIV prevention. In 2024, 1.3 million new infections were recorded, with the highest burden falling on sex workers, men who have sex with men, transgender individuals, drug users, inmates, and youth.
WHO stressed that new options like Lenacapavir are crucial to reversing this trend.
WHO also introduced a new approach to HIV testing as part of the rollout. The agency now recommends the use of rapid diagnostic tests to support long-acting PrEP delivery. This change removes the need for complex and costly testing procedures, making it easier to distribute injectable PrEP through community outlets, including pharmacies and telehealth.
With this simplified protocol, WHO aims to expand access beyond clinical settings, especially in communities with limited healthcare infrastructure.
The agency urged national governments, health donors, and public health groups to begin planning for lenacapavir’s distribution. WHO is also asking countries to collect real-world data on use and outcomes during the initial phase of implementation.
Lenacapavir joins three other WHO-approved HIV prevention tools: daily oral PrEP, injectable cabotegravir (CAB-LA), and the dapivirine vaginal ring. Access to Lenacapavir remains limited outside clinical trials, but WHO says countries must begin building it into their national HIV prevention programs immediately.
WHO also issued updated treatment guidelines at the Kigali summit. Among the changes is the endorsement of long-acting injectable cabotegravir and rilpivirine as an option for HIV-positive individuals who have achieved viral suppression through oral therapy.
Other updates include integrated HIV and non-communicable disease care, such as hypertension, diabetes, and mental health treatment. WHO also issued new guidance for sexually transmitted infections (STIs), recommending routine screening for gonorrhea and chlamydia in high-risk groups.
People living with HIV who have also contracted Mpox are now advised to begin antiretroviral therapy (ART) immediately, particularly if they are ART-naive or have had prolonged treatment interruptions. WHO also recommends early HIV testing for anyone diagnosed with Mpox.
By the end of 2024, an estimated 40.8 million people were living with HIV. Roughly 65% of them are in the WHO African region. About 630,000 people died from HIV-related causes globally last year, and 120,000 children were newly infected.
While the number of people on PrEP rose from 200,000 in 2017 to 3.5 million in 2023, it still falls far short of the global target of 10.6 million by the end of 2025.
Access to ART has steadily improved. WHO reported that 31.6 million people were receiving treatment in 2024, up from 30.3 million the previous year.
In a statement at the conference, WHO called for bold action amid tightening health budgets and rising infections.
“We have the tools and knowledge to end AIDS as a public health threat,” said Dr. Meg Doherty, Director of WHO’s HIV programs. “Now we must act with urgency, with equity, and with the full engagement of communities.”
With the Kigali announcement, WHO hopes to spark rapid adoption of lenacapavir and other long-acting prevention methods, calling them essential to closing persistent prevention gaps.
The agency will continue spotlighting the drug’s rollout and policy implications throughout the IAS 2025 conference, which runs through July 17.
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