Geneva, Switzerland – The World Health Organization (WHO) has recommended the introduction of injectable lenacapavir as an additional option for preventing HIV in people at high risk of infection. The guidance, released this year, also supports simplified testing through rapid diagnostic tools for patients starting or continuing long-acting pre-exposure prophylaxis (PrEP).
The recommendations are directed at governments and policymakers in low and middle income countries, including Eswatini, where HIV remains a leading health challenge.
The guidance was developed between January and May 2025 by WHO’s Department of Global HIV, Hepatitis and Sexually Transmitted Infections Programmes with input from external researchers and the Guideline Development Group. Their work was informed by systematic reviews, clinical data and a consensus process.
Lenacapavir is a long-acting injectable drug designed to prevent HIV infection and is meant to be used alongside other prevention options such as daily oral PrEP, cabotegravir injections and the dapivirine vaginal ring. Data from two large clinical trials involving more than 8,600 participants showed lenacapavir reduced the risk of HIV by up to 100 percent compared with oral PrEP.
While injection site reactions were the most common side effect, researchers noted they were mostly mild and decreased with time. The trials also showed lenacapavir was safe for pregnant women and did not interfere with contraceptives or hormone therapy.
The WHO acknowledged that research gaps remain for certain groups, including sex workers, people who inject drugs and prisoners. However, ongoing trials are expected to provide further answers.
The organisation also pointed to cost and access challenges, warning that centralised health facilities could make it harder for people in rural or low income areas to benefit from injectable prevention.
On testing, WHO advised the use of rapid diagnostic tests (RDTs) instead of laboratory based methods. A review of 22 studies with more than 15,000 participants showed that RDTs provided same day results, cut down on missed appointments and reduced costs. Patients and health providers both expressed support for the approach, which is expected to make PrEP more accessible by allowing same day initiation.
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