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In what experts are calling a game-changer in the global fight against HIV, the World Health Organisation (WHO) has formally endorsed lenacapavir (LEN) — a long-acting injection that only needs to be taken twice a year — as a new pre-exposure prophylaxis (PrEP) option.
The landmark announcement of a preventive injection was made in Kigali, Rwanda, at the 13th International AIDS Society Conference (IAS 2025), and is being hailed as a major breakthrough for millions of people at high risk of HIV infection.
Lenacapavir is the first PrEP product in the world to offer six-month protection against HIV with a single injection, giving people a powerful alternative to the daily oral pills that many struggle to take consistently due to stigma, forgetfulness or poor access to health facilities.The move towards this long term injection comes at a time when HIV remains a stubborn global threat, with 1.3 million new infections recorded in 2024 — most of them among key populations such as sex workers, men who have sex with men, transgender people, injecting drug users and adolescents.
To ensure faster access to the injection , WHO has also rolled out a simplified HIV testing protocol using rapid test kits — removing laboratory barriers and making it easier for pharmacies, community clinics and even tele-health platforms to deliver long-acting PrEP.
With this decision, lenacapavir joins daily oral PrEP, injectable cabotegravir and the dapivirine vaginal ring on the growing list of WHO-recommended prevention tools. Although lenacapavir access is still limited outside clinical trials, the WHO says governments and donors must move quickly to add the injection to their national HIV response and collect real-time data on uptake and impact.
In addition, new WHO treatment guidelines now recommend long-acting cabotegravir/rilpivirine (CAB/RPV) injections for people living with HIV who have achieved viral suppression, giving them more flexibility and support with adherence.
Beyond PrEP and treatment, the agency has also issued new service delivery guidance, urging countries to integrate HIV care with hypertension, diabetes and mental health services. Updated STI guidelines now recommend routine gonorrhoea and chlamydia screening for high-risk groups, while people with mpox and HIV are advised to start antiretroviral therapy immediately.
With 40.8 million people still living with HIV and 630,000 deaths in 2024, WHO warned that declining global funding threatens to roll back hard-won gains. Its message out of Kigali is blunt: “We now have the tools. What we need is bold implementation. ”
