By Jean-Pierre A
Uganda’s National Drug Authority (NDA) has approved Lenacapavir, a twice-yearly injectable pre-exposure prophylaxis (PrEP) medicine manufactured by Gilead Sciences, a United States-based pharmaceutical company.
The approval marks an important milestone in HIV prevention efforts in the East African country.
“This is a game-changer for HIV prevention, especially for those at high risk,” the country’s drug authority stated on X (formerly Twitter) on 5 January. The authority described the approval as a significant breakthrough that could transform how HIV prevention is delivered in Uganda.
The Uganda National Drug Authority further added: “This is a great step towards ending AIDS by 2030.” Lenacapavir (LEN), sold under the brand name Sunlenca, among others, is a long-acting antiretroviral medication used to treat and prevent HIV/AIDS. Unlike daily oral PrEP pills, Lenacapavir is administered only twice a year, offering a more convenient option for users.
The new injectable drug has been shown in recent clinical trials to prevent more than 99 percent of new HIV infections among people in high-risk groups. Health experts say this level of effectiveness could significantly reduce new infections if the drug is widely adopted and accessible.
Uganda has been selected among 10 high-burden countries to benefit from support under the United States President’s Emergency Plan for AIDS Relief (PEPFAR).
According to media reports published in October 2025, efforts are underway to ensure the affordability of the new drug. The US government and the Global Fund were co-financing an advanced market financing arrangement. Under this plan, Uganda is expected to use approximately US$1.14 million from its existing Global Fund grant to support the launch of the Lenacapavir programme.
In July 2025, the World Health Organisation (WHO) released new policy guidelines recommending Lenacapavir as a key tool for HIV prevention. The guidance followed growing evidence from clinical trials demonstrating the drug’s effectiveness.
“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 US Food and Drug Administration’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,” he added.
According to WHO, the new guidelines come at a critical moment, as global HIV prevention efforts have stagnated. An estimated 1.3 million new HIV infections occurred in 2024, with a disproportionate impact on key and priority populations. These include sex workers, men who have sex with men, transgender people, people who inject drugs, people in prisons, as well as children and adolescents.
Multiple reports estimate that the number of people living with HIV in Uganda currently stands at 1,527,240, highlighting the continued public health challenge the country faces despite progress in treatment and prevention.
Following the announcement, several people took to X to welcome the approval of the new twice-yearly injectable drug. Some users also called for greater recognition of the role played by Ugandan scientists in the development of the medicine.
“This is a big milestone. Please also acknowledge the role of Ugandan researchers in developing the PrEP. It means a lot. Thanks,” posted Jim Spire Ssentongo, a university lecturer, cartoonist and columnist.
The WHO is urging governments, donors and global health partners to begin rolling out Lenacapavir immediately within national combination HIV prevention programmes. The organisation also called for the collection of essential data on uptake, adherence and real-world impact as countries adopt the drug.
“LEN is a transformative step forward in protecting people at risk of HIV — particularly those who face challenges with daily adherence, stigma, or access to health care,” the global health body noted in a press release.
A number of African countries have already approved Lenacapavir and begun implementation. South Africa, Zambia, Eswatini and Zimbabwe have approved LEN and are rolling out the new HIV prevention drug. Kenya, Nigeria, Lesotho, Mozambique, Malawi, Rwanda, Tanzania, Botswana and Namibia are either in early adoption stages or planning national roll-outs.
