Kigali: The World Health Organization (WHO) has released new guidelines, recommending injectable lenacapavir, known as LEN, as a twice-yearly pre-exposure prophylaxis option for HIV (human immunodeficiency virus) prevention. These guidelines were released at the 13th International AIDS Society Conference on HIV Science in Kigali, Rwanda, from July 13 to 17, 2025.
Presented as the first PrEP product requiring just two doses a year, LEN offers an alternative to daily oral pills or the two-monthly injectable cabotegravir, aiming to ease adherence challenges for those at risk of human immunodeficiency virus, particularly in communities facing stigma or limited healthcare access.
Clinical trials suggest LEN is highly effective, with WHO Director-General Dr. Tedros Adhanom Ghebreyesus describing it as a significant advance, akin to the next best thing to an HIV vaccine, which remains unavailable. The guidelines, aligned with recent U.S. Food and Drug Administration approval, aim to expand access to this long-acting tool, with the WHO pledging to collaborate with countries and partners to reach communities, especially in high-burden regions. In 2024, 1.3 million new HIV infections were reported globally, including 120,000 among children, with key populations like sex workers, men who have sex with men, transgender individuals, people who inject drugs, prisoners, and adolescents disproportionately affected. LEN joins daily oral PrEP, injectable cabotegravir, and the dapivirine vaginal ring, offering more choices to tailor prevention to individual needs.
To improve access to long-acting PrEP like LEN and cabotegravir, the WHO recommends simplified HIV testing with rapid tests, enabling delivery through pharmacies, clinics, or telehealth. This approach seeks to remove barriers like costly, complex procedures, particularly in resource-limited settings. However, LEN’s availability outside clinical trials remains limited, prompting questions about the pace and scale of its rollout. The WHO urges governments and partners to integrate LEN into national HIV prevention programs while tracking uptake, adherence, and real-world outcomes.
The guidelines also address treatment and service delivery. For the first time, long-acting injectable cabotegravir and rilpivirine, known as CAB/RPV, are recommended as an alternative for adults and adolescents on antiretroviral therapy who have achieved viral suppression but face challenges with oral regimens, provided they lack active hepatitis B. The WHO further advocates integrating HIV care with services for noncommunicable diseases like hypertension and diabetes, as well as mental health support for depression, anxiety, and alcohol use disorders, to improve treatment adherence and overall health.
Additional recommendations include screening for asymptomatic gonorrhoea and chlamydia among key populations and rapid antiretroviral therapy initiation for people with HIV and mpox, particularly those not on treatment or with prolonged interruptions. Early HIV and syphilis testing is advised for those with suspected or confirmed mpox. With HIV affecting 40.8 million people globally in 2024—65% in the WHO African Region—and 630,000 deaths from HIV-related causes, these measures aim to address persistent challenges. Antiretroviral therapy access grew to 31.6 million people in 2024, up from 30.3 million in 2023, but declining health funding raises concerns.
To counter this, the WHO issued operational guidance to help countries sustain HIV services, offering a framework to prioritise efforts, monitor disruptions, and adapt systems. Dr. Meg Doherty, Director of WHO’s Department of Global HIV, Hepatitis and STI Programmes, emphasised the need for equitable, community-driven implementation to leverage these tools effectively. At IAS 2025, the WHO is showcasing these guidelines through key sessions, highlighting innovations while warning of risks from reduced global health funding. The conference, a leading platform for HIV research, underscores the urgency of translating these recommendations into action to sustain progress toward ending AIDS as a public health threat.
– global bihari bureau
