WHO recommends Uganda-tested HIV prevention drug, issues guidelines on usage

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KIGALI – The World Health Organisation (WHO) has issued new guidelines recommending the use of Uganda-tested injectable drug lenacapavir (LEN) twice a year as an additional pre-exposure prophylaxis (PrEP) option for HIV prevention. The landmark policy action could help reshape the global HIV response.

The recommendation comes just weeks after the US Food and Drug Administration (FDA) approved the drug for use. Lenacapavir trials were conducted in Uganda and South Africa and demonstrated 100% protection, making it the most effective scientific breakthrough in HIV prevention to date.

The WHO recommendation, along with new guidelines, was issued at the 13th International AIDS Society Conference (IAS 2025) on HIV Science, taking place in Kigali, Rwanda.

LEN, the first twice-yearly injectable PrEP product, offers a highly effective, long-acting alternative to daily oral pills and other shorter-acting options. With just two doses per year, LEN marks a transformative step in protecting people at risk of HIV – particularly those who face challenges with daily adherence, stigma, or access to healthcare.

“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, in his virtual address.

“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.”

The new guidelines come at a moment, as HIV prevention efforts have stalled, with 1.3 million new HIV infections recorded in 2024, disproportionately affecting key and priority populations, including sex workers, men who have sex with men, transgender people, people who inject drugs, people in prisons, and children and adolescents.

WHO’s recommendation on LEN signals a decisive move to expand and diversify HIV prevention options, giving people more autonomy over their health with solutions that fit their lives.

As part of these guidelines, WHO has also recommended a public health approach to HIV testing using rapid tests to support the delivery of long-acting injectable PrEP, including LEN and cabotegravir (CAB-LA).

The simplified testing approach removes major access barriers by eliminating complex, costly procedures and enabling community-based delivery of long-acting PrEP through pharmacies, clinics, and tele-health.

LEN will now join other WHO-recommended PrEP options, including daily oral PrEP, injectable cabotegravir, and the dapivirine vaginal ring – as part of a growing arsenal of tools to end the HIV epidemic.

While access to LEN outside clinical trials remains limited for now, WHO urges governments, donors, and global health partners to begin rolling out LEN immediately within national combination HIV prevention programs – while gathering essential data on uptake, adherence, and real-world impact.

“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 Program and incoming Director of Science, Research, Evidence and Quality for Health. “What we need now is bold implementation of these recommendations, grounded in equity and powered by communities.”

What next for Uganda

Dr Flavia Kiweewa Kiwanuka, the principal investigator of the trials in Uganda, in an X (formerly Twitter) space hosted by New Vision Online on July 15, 2025, noted that the FDA’s approval, WHO’s recommendation, and the Global Fund’s commitment to purchase the drug for low- and middle-income countries, including Uganda, is a significant opportunity.

“The Ministry of Health has been allocated shillings 40,840,500,000 (approximately $1.14 million) from the Global Fund to procure drugs for 17,000 people as the first doses. It’s a procurement process, but we hope by 2027 we will have them available,” Dr Kiweewa said.

She added that these 17,000 individuals will receive the drug for one year. “We have gotten support to start us off.”

Kiweewa noted that for a drug to be allowed on the market, it must be approved by the US FDA, recommended by WHO, which also gives guidance on how to use it before local authorities like the National Drug Authority in Uganda and the health ministry allow it in national stores.

Flavia Kyomukama, the executive director and founder of the National Forum of PLHA Networks in Uganda, noted that the Trump-era aid cuts had a far-reaching impact on the HIV community.

“We have learnt that we must be self-sustaining. We can no longer rely on grants to educate each other or even access medicine. We now know that even the Netherlands and the UK are planning to cut aid,” Kyomukama said.

She explained that people living with HIV are adapting to the integration of health services, although some still face the fear of stigma.

Gloria Nawanyaga, an HIV activist currently attending the IAS conference in Kigali, warned that funding cuts could reverse hard-won progress, as the fight against HIV extends beyond just treatment.

“We might end up registering many more new infections if nothing is done about the cuts,” Nawanyaga said. “We have an HIV Parliamentary Committee, but we never heard them say anything on the funding cuts. These are people that did nothing – maybe because some of them are not HIV positive and do not understand the burden,” she added.

HIV remains a major global public health issue. By the end of 2024, an estimated 40.8 million people were living with HIV, with approximately 65% in the WHO African Region. Around 630,000 people died from HIV-related causes globally, and an estimated 1.3 million people acquired HIV, including 120,000 children.

Access to antiretroviral therapy (ART) continues to expand, with 31.6 million people receiving treatment in 2024, up from 30.3 million in 2023.