Kigali, Rwanda: In a landmark move to expand HIV prevention options, the World Health Organization (WHO) has officially recommended the use of injectable lenacapavir (LEN) twice a year as a new pre-exposure prophylaxis (PrEP) method.
Announced at the 13th International AIDS Society Conference (IAS 2025) in Kigali, Rwanda, the new guidelines mark a major step forward in global HIV prevention efforts.
Lenacapavir is the first long-acting PrEP product requiring only two injections per year. It offers a highly effective alternative for individuals unable to adhere to daily oral pills due to stigma, limited healthcare access, or personal barriers.
WHO’s endorsement follows strong clinical trial evidence showing near-complete prevention of HIV infection among at-risk individuals.
“While an HIV vaccine remains elusive, lenacapavir is the next best thing,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus.
“This long-acting option gives new hope to communities most vulnerable to HIV. WHO is working with countries and partners to ensure access to this innovation without delay.”
The announcement comes as global HIV prevention efforts stagnate. In 2024 alone, 1.3 million new HIV infections were recorded, with the highest burden among key populations such as sex workers, transgender individuals, men who have sex with men, people who inject drugs, and those in prisons. Children and adolescents are also increasingly affected.
WHO has also recommended simplified testing protocols using rapid HIV tests to support the rollout of long-acting PrEP, including LEN and cabotegravir (CAB-LA).
This public health approach eliminates the need for complex, expensive testing and paves the way for wider community-based delivery through pharmacies, clinics, and telehealth platforms.
Lenacapavir joins an expanding toolkit of WHO-recommended HIV prevention options, including oral PrEP, injectable cabotegravir, and the dapivirine vaginal ring. Although currently not widely available outside clinical trials, WHO has urged governments and global health partners to begin rolling out LEN within national HIV programmes while collecting real-world data on uptake and effectiveness.
In addition to PrEP, WHO also updated its HIV treatment guidelines at the IAS conference. For the first time, it recommends the use of long-acting injectable cabotegravir and rilpivirine (CAB/RPV) for people living with HIV who are virally suppressed on oral ART and do not have hepatitis B infection. The option aims to support those struggling with adherence to daily pills.
New service delivery recommendations emphasize integration of HIV care with noncommunicable disease services, such as for hypertension, diabetes, and mental health, to improve ART adherence and health outcomes.
WHO also issued updated guidance for STI screening and early ART initiation in patients with HIV and mpox, reinforcing the importance of timely testing and treatment.
Amid a tightening global funding environment, WHO released operational guidance to help countries sustain essential HIV services. The document outlines practical steps to prioritize programmes, assess risk, and mitigate disruptions while protecting progress made over the past decades.
“We have the tools and the knowledge to end AIDS as a public health threat,” said Dr Meg Doherty, Director of WHO’s Global HIV, Hepatitis and STI Programmes. “What we need now is bold, equity-driven implementation and strong partnerships to bring these innovations to those who need them most.”
By the end of 2024, an estimated 40.8 million people were living with HIV globally, with 65 percent residing in the WHO African Region.
Approximately 630,000 people died from HIV-related causes, and 31.6 million people were on antiretroviral therapy—up from 30.3 million in 2023.
With HIV still claiming lives, WHO’s new recommendations offer a blueprint for accelerating progress—if matched with political will and rapid, equitable implementation.
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