A Landmark Step: WHO Recommends Injectable Lenacapavir to Boost HIV Prevention in Africa

The World Health Organization (WHO) has released new global guidelines recommending injectable lenacapavir (LEN) twice a year as an additional pre-exposure prophylaxis (PrEP) option for HIV prevention. Announced on 14 July 2025 at the 13th International AIDS Society Conference on HIV Science (IAS 2025) in Kigali, Rwanda, this move marks a significant step towards reshaping HIV prevention strategies, especially across the African continent where the epidemic remains most severe.

LEN becomes the first twice-yearly injectable PrEP product, offering a long-acting alternative to daily oral pills and other shorter-acting methods. With only two doses per year, it has the potential to transform prevention efforts for people at higher risk of HIV who face challenges with daily adherence, stigma or limited access to health 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 FDA’s recent approval, 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”.

A timely intervention for Africa

The announcement arrives at a time when HIV prevention efforts are stagnating worldwide. In 2024 alone, 1.3 million new infections were reported globally, with the WHO African Region accounting for around 65 per cent of the estimated 40.8 million people living with HIV. Key and priority populations in Africa, including sex workers, men who have sex with men, transgender people, people who inject drugs and adolescents, remain disproportionately affected.

By introducing LEN, WHO aims to expand and diversify the range of HIV prevention tools available, giving individuals more choice over how they protect themselves. Importantly, LEN joins an arsenal of WHO-recommended PrEP options that includes daily oral PrEP, injectable cabotegravir (CAB-LA) and the dapivirine vaginal ring.

Removing barriers and promoting access

In addition to recommending LEN, WHO has simplified testing requirements for long-acting PrEP. New guidance supports using HIV rapid tests rather than complex laboratory tests before starting injectable PrEP, removing a major barrier to access. This public health approach could make it easier to provide long-acting PrEP through community pharmacies, clinics and tele-health platforms, including in resource-limited African settings.

WHO is encouraging governments, donors and health partners to begin rolling out LEN as part of national combination HIV prevention programmes. Alongside scale-up, countries are urged to gather data on uptake, adherence and real-world effectiveness to guide policy and practice.

Expanded treatment options and integrated services

At IAS 2025, WHO also introduced other significant updates. For the first time, the organisation’s treatment guidelines now recommend long-acting injectable cabotegravir and rilpivirine (CAB/RPV) as an alternative option for people with suppressed viral loads who struggle with oral antiretroviral therapy (ART). This could benefit thousands of people living with HIV in Africa who face adherence challenges.

WHO further called for better integration of HIV services with care for noncommunicable diseases (such as hypertension and diabetes) and mental health support for conditions like depression and alcohol use disorders. Updated guidance also recommends screening for asymptomatic gonorrhoea and chlamydia among key and priority populations, and early HIV testing for individuals presenting with suspected or confirmed mpox.

Recognising the growing challenges of declining global funding for HIV programmes, WHO launched new operational guidance to help countries protect essential services and adapt health systems to maintain progress.

The path forward

Dr Meg Doherty, Director of WHO’s Department of Global HIV, Hepatitis and STI Programmes and incoming Director of Science, Research, Evidence and Quality for Health, emphasised that the science and tools to end AIDS as a public health threat are already available. “What we need now is bold implementation of these recommendations, grounded in equity and powered by communities,” she said.

In 2024, 630,000 people died from HIV-related causes worldwide, while 31.6 million people accessed antiretroviral therapy – up from 30.3 million in 2023. These figures highlight both progress and remaining gaps, especially in Africa, where sustained investment and innovation remain vital.

As global health funding becomes increasingly uncertain, WHO’s recommendations underscore the need for countries and partners to act quickly. By broadening prevention choices, simplifying service delivery and integrating HIV care with broader health services, the new guidance offers a path towards a more equitable and effective response.

For detailed information about WHO’s announcements and participation at IAS 2025, visit WHO’s official conference page .

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