The World Health Organization (WHO) has issued new guidelines recommending injectable lenacapavir as a new pre-exposure prophylaxis (PrEP) option for HIV prevention, marking a major step in the global HIV response.
The announcement was made at the 13th International AIDS Society Conference (IAS 2025) in Kigali, Rwanda.
Lenacapavir, the first PrEP product requiring only 2 doses per year, provides a long-acting alternative to daily oral PrEP, with high efficacy demonstrated in clinical trials. The new guidance supports lenacapavir’s use as part of a diversified HIV prevention strategy, particularly for individuals who face barriers to adherence, stigma, or limited healthcare access.
“While an HIV vaccine remains elusive, lenacapavir is the next best thing: a long-acting antiretroviral shown in trials to prevent almost all HIV infections among those at risk,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “WHO is committed to working with countries and partners to ensure this innovation reaches communities as quickly and safely as possible.”
The guidance follows the recent US Food and Drug Administration approval of lenacapavir for PrEP and arrives amid stagnating global HIV prevention efforts. In 2024, there were 1.3 million new HIV infections globally, with disproportionate impacts on key and priority populations such as sex workers, men who have sex with men, transgender individuals, people who inject drugs, incarcerated people, and adolescents.
To support the implementation of long-acting PrEP options, the WHO has also recommended simplified HIV testing strategies, including the use of rapid diagnostic tests. This approach aims to remove access barriers by enabling community-based delivery through pharmacies, clinics, and telehealth.
Lenacapavir now joins the growing range of WHO-recommended PrEP tools, including daily oral PrEP, long-acting injectable cabotegravir, and the dapivirine vaginal ring. While access to lenacapavir remains limited outside clinical trials, the WHO is urging countries, donors, and global partners to integrate it into national HIV prevention programmes and gather data on its real-world use.
Alongside the PrEP guidelines, the WHO also issued updates to its antiretroviral treatment (ART) recommendations. Notably, it now endorses the use of injectable cabotegravir and rilpivirine as an alternative ART option for people with full viral suppression on oral regimens, in the absence of active hepatitis B infection.
The WHO also called for greater integration of HIV services with noncommunicable disease care, including hypertension, diabetes, mental health, and substance use treatment. Additionally, the new guidelines support screening for asymptomatic gonorrhoea and/or chlamydia among key populations, and recommend prompt ART initiation for individuals with HIV and mpox who are either ART-naive or have experienced treatment interruption.
At the end of 2024, an estimated 40.8 million people were living with HIV worldwide, with the WHO African Region accounting for 65% of cases. That year, 630,000 people died of HIV-related illnesses and 120,000 children were newly infected. Despite increased ART access -- 31.6 million people were on treatment in 2024, up from 30.3 million in 2023 -- funding shortfalls threaten progress.
In response, the WHO has released operational guidance to help countries sustain essential HIV services, prioritise interventions, and adapt to shifting financing environments.
“We have the tools and the knowledge to end AIDS as a public health problem,” said Dr Meg Doherty, Director of WHO’s Department of Global HIV, Hepatitis and STI [Sexually Transmitted Infection] Programmes. “What we need now is bold implementation of these recommendations, grounded in equity and powered by communities.”
