Uganda Approves Twice Yearly HIV Prevention Drug Lenacapavir

The National Drug Authority (NDA) has formally approved the use of lenacapavir, a twice-yearly injectable HIV prevention drug, marking a significant milestone in the country’s ongoing campaign to end AIDS by 2030.

The announcement was confirmed in a statement from the NDA, which described the approval as a “game changer” for HIV prevention, particularly for populations at high risk of infection.

Lenacapavir is manufactured by Gilead Sciences, a U.S. based biopharmaceutical company, and represents a new class of long-acting HIV preventive treatment known as pre-exposure prophylaxis (PrEP). Unlike traditional daily PrEP pills, the drug is administered as an injection just twice a year, a regimen expected to significantly improve adherence and protection.

In a post on X (formerly Twitter), the NDA highlighted the potential impact of the new option: “This is a game-changer for HIV prevention, especially for those at high risk. This is a great step towards ending AIDS by 2030.”

The injectable is particularly aimed at adults and adolescents at high risk of HIV infection, offering a discreet and convenient alternative to daily medication.

Clinical trials underpinning lenacapavir’s approval have demonstrated exceptionally high effectiveness in preventing HIV infection. Results published from pivotal studies showed near complete protection against the acquisition of the virus when the regimen is followed, contributing to its designation as a breakthrough in HIV prevention.

In the United States, the Food and Drug Administration (FDA) approved lenacapavir under the brand name Yeztugo for HIV PrEP in June 2025, based on data showing ≥99.9 % reduction in infection risk with twice yearly injections in adults and adolescents at risk of HIV acquisition.

Uganda’s decision places it among the growing number of African countries embracing innovative long-acting HIV prevention tools. Regulatory filings and shipment plans across sub-Saharan Africa are underway, including approvals and submissions in nations such as South Africa, Zambia, Kenya, Botswana, Malawi, Namibia, Rwanda, Tanzania, and Zimbabwe, through collaborative efforts with partners and generic manufacturers to expand access.

The approval expands the HIV prevention toolkit and could help reduce new infections — especially among young people, women, and key populations — if it can be rolled out affordably and equitably. Long-acting PrEP options like lenacapavir can overcome barriers associated with daily pills, such as stigma, adherence challenges, and frequent clinic visits.

Winnie Byanyima, Executive Director of UNAIDS, has been a vocal advocate for lenacapavir, hailing it as a revolutionary HIV prevention tool while strongly criticising barriers to equitable global access, particularly Gilead Sciences’ pricing and limited generic licensing.