The World Health Organization (WHO) has announced new global guidelines recommending injectable lenacapavir (LEN) as a preventive treatment against HIV. Taken just twice a year, LEN is now officially endorsed as a new pre-exposure prophylaxis (PrEP) option, offering a long-acting alternative to daily oral pills.
This groundbreaking move aims to strengthen global efforts in the fight against HIV, especially at a time when progress in prevention has stalled. In 2024 alone, 1.3 million new infections occurred, disproportionately affecting high-risk groups such as sex workers, men who have sex with men, transgender individuals, people who inject drugs, and young people.
“While an HIV vaccine is still out of reach, lenacapavir is the next best thing,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General. “It is a powerful, long-acting medicine that can prevent almost all HIV infections among those at risk.”
A New Era in HIV Prevention
Lenacapavir becomes the world’s first HIV prevention injection that only requires two doses a year. It offers a discreet and simple solution for people who struggle to take daily pills or face barriers such as stigma or lack of regular access to healthcare.
By adding LEN to its list of recommended PrEP tools—alongside oral PrEP, the dapivirine vaginal ring, and injectable cabotegravir—WHO hopes to expand choices and make HIV prevention more accessible and personal.
Simplified Testing Removes Key Barrier
One major update in the guidelines is the recommendation to simplify HIV testing for people starting long-acting PrEP like LEN and CAB-LA. WHO now endorses the use of rapid HIV tests instead of more complex laboratory tests. This change is expected to make it easier to provide PrEP through local clinics, pharmacies, and even telehealth services.
This new approach removes a major hurdle and opens the door for broader community-based rollout, especially in areas with limited healthcare infrastructure.
WHO Calls for Immediate Rollout
Though access to LEN outside of clinical trials is still limited, WHO is urging countries, donors, and healthcare partners to start incorporating it into national HIV prevention programs immediately. At the same time, WHO encourages the collection of real-world data to monitor uptake, effectiveness, and long-term impact.
LEN’s approval by the U.S. FDA earlier this year also adds momentum to its global rollout.
Additional WHO Updates at IAS 2025
At the IAS 2025 conference, WHO also released several other important updates related to HIV treatment and care:
Long-Acting HIV Treatment: WHO now recommends injectable cabotegravir and rilpivirine (CAB/RPV) for people with HIV who have undetectable viral loads and no active hepatitis B infection. This option offers relief for those who struggle with daily pills.
Integrated Health Services: WHO recommends combining HIV care with services for noncommunicable diseases like diabetes and hypertension, and mental health conditions such as depression and alcohol use disorders.
Sexually Transmitted Infections (STIs): New guidance supports the routine screening for gonorrhea and chlamydia in key populations, even when symptoms are not present.
HIV and Mpox: For people with HIV and suspected or confirmed mpox (formerly known as monkeypox), WHO strongly recommends starting antiretroviral therapy (ART) quickly—especially for those who have never taken ART or have interrupted their treatment. Early HIV testing is also advised in all such cases.
Operational Guidance: WHO also released new guidance to help countries prioritize essential HIV services and manage health systems more effectively amid declining global funding.
“We have the science and tools to end AIDS,” said Dr. Meg Doherty, Director of WHO’s Global HIV, Hepatitis and STI Programmes. “What we need now is bold, community-led implementation based on equity.”
HIV by the Numbers: 2024 Snapshot
As of the end of 2024:
- 40.8 million people were living with HIV
- 31.6 million were receiving ART, up from 30.3 million in 2023
- 1.3 million new infections occurred globally, including 120,000 children
- 630,000 people died from HIV-related causes
- 65% of those living with HIV are in the WHO African Region
Related topics:
