The World Health Organisation (WHO) has for the first time recommended the use of injectable lenacapavir (LEN) as a twice-yearly HIV prevention option, marking a breakthrough in the global fight against the disease.
The announcement was made on Sunday evening during the ongoing 13th International AIDS Society Conference (IAS 2025) on HIV Science in Kigali, Rwanda.
With just two doses a year, LEN becomes the first long-acting, injectable pre-exposure prophylaxis (PrEP) drug that the WHO is recommending as an additional tool in its HIV prevention arsenal.
Experts say it offers new hope to people at risk of HIV, especially those who struggle with daily pills due to stigma, access issues or adherence challenges.
Director-General of WHO, Dr Tedros Adhanom Ghebreyesus, described lenacapavir as “the next best thing” in the absence of an HIV vaccine.
“Lenacapavir is a long-acting antiretroviral shown in trials to prevent almost all HIV infections among those at risk,” he said.
“The launch of WHO’s new guidelines, alongside the FDA’s recent approval, marks a critical step forward in expanding access to this powerful tool. WHO is committed to working with countries and partners to ensure this innovation reaches communities as quickly and safely as possible.”
The new WHO recommendation comes amid growing concern that global HIV prevention efforts are stagnating. In 2024 alone, 1.3 million new infections were recorded, many among key and vulnerable groups such as sex workers, men who have sex with men, transgender people, people who inject drugs, prisoners, and adolescents.
WHO believes that expanding PrEP options will empower individuals with more control over their health choices. LEN now joins other WHO-approved PrEP methods, including daily oral pills, injectable cabotegravir (CAB-LA), and the dapivirine vaginal ring.
To support wider access, WHO also introduced new guidance simplifying HIV testing protocols. It now recommends the use of HIV rapid tests for initiating long-acting PrEP options like LEN and CAB-LA.
The move eliminates the need for complex testing procedures, which have often been a barrier to PrEP delivery, particularly in community-based or low-resource settings.
With these changes, long-acting PrEP may now be offered in pharmacies, clinics and even via telehealth platforms.
Despite LEN’s proven effectiveness in clinical trials, access to the drug remains limited outside research settings. WHO is urging governments, donors, and global health organisations to integrate LEN into their national HIV prevention strategies immediately.
The agency also encouraged countries to collect real-world data on uptake, adherence and impact to inform future scale-up.
Also at IAS 2025, WHO updated its HIV treatment guidelines to include long-acting injectable cabotegravir and rilpivirine (CAB/RPV) as a switch option for people with full viral suppression who do not have hepatitis B. This could benefit people living with HIV who face difficulties sticking to daily oral medications.
WHO further recommended integrating HIV services with those for noncommunicable diseases like hypertension, diabetes, and mental health conditions such as depression and anxiety.
It also introduced new guidance on screening asymptomatic sexually transmitted infections, especially gonorrhoea and chlamydia, among at-risk populations.
In addition, people living with HIV who contract mpox are now advised to initiate antiretroviral therapy (ART) rapidly, especially if they are ART-naïve or have experienced treatment interruptions.
The updated guidelines are being launched at a time when international HIV programmes face a reduction in funding.
WHO’s newly issued operational guidance on sustaining HIV services urges countries to prioritise essential services, monitor disruptions, and adapt delivery models to protect gains made in the fight against the epidemic.
“We have the tools and the knowledge to end AIDS as a public health problem,” said Dr Meg Doherty, WHO’s Director of Global HIV, Hepatitis and STI Programmes, and incoming Director of Science, Research, Evidence and Quality for Health.
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“What we need now is bold implementation of these recommendations, grounded in equity and powered by communities.”
According to WHO, an estimated 40.8 million people were living with HIV by the end of 2024, with around 65 per cent residing in Africa. During the same year, about 630,000 people died from HIV-related illnesses while 1.3 million people, 120,000 of them children, were newly infected.
However, access to treatment continues to improve, with 31.6 million people on antiretroviral therapy globally in 2024, up from 30.3 million in 2023.
IAS 2025, which runs from July 13 to 17, is the world’s largest scientific gathering on HIV research. Held in Kigali, the biennial conference features cutting-edge research and critical discussions aimed at influencing policy and accelerating the global HIV response.
WHO is participating in several high-level sessions to highlight key innovations, equity in access, and the urgent need for sustained health funding.
