In a groundbreaking development for global HIV prevention, the World Health Organisation (WHO) has released new guidelines recommending the use of injectable lenacapavir (LEN) twice a year as a long-acting pre-exposure prophylaxis (PrEP) option.
The announcement was made at the 13th International AIDS Society (IAS) Conference on HIV Science, held in Kigali, Rwanda.
Lenacapavir is now the first twice-yearly injectable PrEP product to be endorsed by WHO, offering a transformative alternative to daily oral pills, particularly for individuals at higher risk of HIV infection.
“While an HIV vaccine remains elusive, lenacapavir is the next best thing,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.
“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.”
In 2024, 89% of infants received at least one dose of the diphtheria, tetanus and pertussis (DTP) vaccine, and 85% completed all three doses.
Global demand for childhood immunization is strong according to new data from WHO and @UNICEF 🔗https://t.co/2kZnoI3fjn pic.twitter.com/Ob22owl1dL
— World Health Organization (WHO) (@WHO) July 15, 2025
A Game-Changer in HIV Prevention
The WHO notes that lenacapavir will significantly benefit people who struggle with daily pill adherence due to stigma, access barriers, or personal preferences, especially in marginalised or hard-to-reach communities.
The release of the new guidelines comes at a time when global progress in HIV prevention is stalling, with an estimated 1.3 million new infections in 2024.
These infections are disproportionately affecting key populations, including sex workers, men who have sex with men, transgender people, people who inject drugs, and incarcerated individuals.
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Expanded WHO Recommendations
In addition to lenacapavir, WHO’s updated HIV guidance includes several other critical policy shifts:
Simplified HIV testing using rapid tests to reduce service barriers and facilitate community-led delivery of PrEP.
Continued endorsement of existing PrEP tools, including daily oral PrEP, injectable cabotegravir, and the dapivirine vaginal ring.
Introduction of long-acting injectable treatment combinations for people already virally suppressed.
Integrated HIV service delivery with care for noncommunicable diseases (NCDs), mental health, and alcohol use disorders.
Enhanced screening for asymptomatic sexually transmitted infections (STIs), such as gonorrhoea and chlamydia, in high-risk groups.
Recommendations for rapid ART initiation for individuals co-infected with mpox and HIV.
“We have the tools and the knowledge to end AIDS as a public health problem. What we need now is bold action powered by communities,” stated Dr Meg Doherty, WHO Director of Global HIV, Hepatitis, and STI Programmes.
A Call to Action
While access to lenacapavir is currently limited outside clinical trials, WHO is urging governments, donors, and partners to begin implementation within combination HIV prevention programmes and collect real-world data on adherence and outcomes.
By the end of 2024, 40.8 million people were living with HIV globally, including 120,000 newly infected children, and 630,000 HIV-related deaths were recorded.
WHO believes that the latest recommendations represent a critical opportunity to expand prevention choices, simplify service delivery, and accelerate global efforts to end AIDS as a public health threat.