By Michael Gwarisa
In a landmark move that could transform the global fight against HIV, the World Health Organization (WHO) today issued new guidelines endorsing the use of injectable lenacapavir (LEN) administered twice a year as an additional pre-exposure prophylaxis (PrEP) option. The announcement was made at the 13th International AIDS Society Conference (IAS 2025) on HIV Science, currently underway in Kigali, Rwanda.
LEN is the first long-acting injectable PrEP designed to protect people at risk of HIV with just two doses annually, offering a highly effective alternative to daily oral pills and other shorter-acting prevention methods. This new option represents a major advance for HIV prevention, particularly for those who struggle with daily adherence, face stigma, or have limited access to healthcare services.
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.
“The launch of WHO’s new guidelines, alongside the recent approval of LEN by the U.S. Food and Drug Administration (FDA), 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 approval and recommendation of LEN come at a pivotal moment in the HIV response. After years of progress, global prevention efforts have recently stagnated, with 1.3 million new HIV infections reported in 2024 alone. The epidemic continues to disproportionately affect key populations including sex workers, men who have sex with men, transgender people, people who inject drugs, those incarcerated, and adolescents and children.
By adding LEN to the prevention toolbox, WHO aims to diversify and expand options, empowering individuals to choose methods that best suit their lifestyles and needs.
In a complementary development, WHO’s guidelines also recommend a public health approach to HIV testing that simplifies access to long-acting injectable PrEP such as LEN and cabotegravir (CAB-LA). The new testing protocol leverages HIV rapid diagnostic tests, eliminating complex and costly laboratory procedures.
This simplification is a major breakthrough, as it allows for community-based delivery of injectable PrEP through pharmacies, clinics, and telehealth platforms, expanding reach and convenience, especially in resource-limited settings.
While LEN is currently available only through clinical trials or limited access programs, WHO is urging governments, donors, and global health partners to begin integrating LEN into national HIV prevention strategies without delay. The organization stresses the importance of collecting real-world data on uptake, adherence, and impact to refine implementation approaches and maximize benefits.
LEN joins a growing suite of WHO-recommended PrEP options, including daily oral pills, injectable cabotegravir, and the dapivirine vaginal ring — all part of a multipronged strategy to end the HIV epidemic.
At IAS 2025, WHO unveiled further important updates to HIV treatment and service delivery guidelines.
For the first time, WHO endorses the use of long-acting injectable cabotegravir and rilpivirine (CAB/RPV) as an alternative “switching” option for antiretroviral therapy (ART). This option targets adults and adolescents who have achieved viral suppression on oral ART and do not have active hepatitis B infection. This recommendation aims to support people living with HIV who face challenges adhering to daily oral regimens.
The updated guidelines also encourage integrating HIV services with noncommunicable disease (NCD) care — including hypertension and diabetes management — and mental health services addressing depression, anxiety, and alcohol use disorders. This integrated model enhances holistic care and supports ART adherence.
WHO further recommends routine screening for asymptomatic sexually transmitted infections (STIs), such as gonorrhoea and chlamydia, among key and priority populations, recognizing the interplay between STIs and HIV transmission.
Responding to mpox outbreaks, WHO strongly advises rapid ART initiation for people living with HIV who are either treatment-naive or have interrupted therapy and recommends early HIV testing for anyone suspected or confirmed to have mpox infection. HIV and syphilis testing are emphasized for all mpox cases.
Acknowledging a tightening global funding landscape, WHO issued operational guidance to help countries sustain priority HIV services. This framework supports governments in prioritizing essential services, assessing risks, monitoring disruptions, and adapting systems to safeguard health outcomes and maintain progress.
“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 Programmes. “What we need now is bold implementation of these recommendations, grounded in equity and powered by communities.”
HIV remains a significant global health issue. By the end of 2024, an estimated 40.8 million people worldwide were living with HIV, with approximately 65% residing in the WHO African Region. That year, 630,000 people died from HIV-related causes, while 1.3 million individuals—including 120,000 children—acquired HIV.
Despite these challenges, progress continues. The number of people accessing ART increased to 31.6 million in 2024 from 30.3 million in 2023, underscoring ongoing expansion in treatment coverage.
In a time of reduced international funding and mounting global health challenges, WHO’s new and updated guidelines offer pragmatic, evidence-based strategies to sustain momentum in the HIV response. By expanding prevention and treatment options, simplifying service delivery, and promoting integration with broader health services, these guidelines aim to foster more efficient, equitable, and resilient HIV programmes worldwide.
