The National Drug Authority (NDA) has approved the long-acting HIV prevention injection Lenacapavir for use in Uganda, marking a major milestone in the country’s HIV prevention efforts.
In a statement posted on X (formerly Twitter), the NDA said it had completed the evaluation and licensure of the twice-yearly injectable drug manufactured by Gilead Sciences, a United States-based pharmaceutical company.
Lenacapavir demonstrated high effectiveness as pre-exposure prophylaxis (PrEP) in clinical trials conducted among adolescent girls and young women in Uganda and South Africa. Following these results, Uganda was earmarked to receive a donation worth USD 1.1 million from the Global Fund this month, placing the country among the first beneficiaries of donated doses.
While the regulator has described the approval as a game-changer for HIV prevention, particularly for people at high risk of infection, and a significant step toward ending AIDS by 2030, activists have raised concerns about potential access challenges once the drug becomes available.
Earlier interviews by Uganda Radio Network (URN) quoted Kuraish Mubiru, the Executive Director of Uganda Young Positives, who warned that the expected Global Fund donation would cover only about 10,000 doses, far below the country’s needs, given that Uganda records up to 1,000 new HIV infections every week.
Similarly, Flavia Kyomukama, the Executive Director of NAFOPHANU, noted that while the United States government has committed to providing an additional 200,000 doses, Uganda must also invest domestic resources to ensure sustainable access for those who need the drug most.
Speaking at a press conference held ahead of World AIDS Day last month, Kyomukama cautioned that although Lenacapavir is intended for individuals at the highest risk, such as sex workers, boda boda riders, long-distance truck drivers, and people in HIV-discordant relationships, clear communication will be critical to prevent misuse or inappropriate demand once it is rolled out.
Uganda has already introduced another long-acting injectable PrEP option, Cabotegravir, which requires more frequent dosing: two initial injections four weeks apart, followed by injections every two months. By contrast, Lenacapavir is administered only twice a year, making it a more convenient alternative for individuals who struggle with daily pills or frequent clinic visits.
The first batch of Lenacapavir is expected to arrive in Uganda this month. The Global Fund plans to supply 36,000 doses to nine health facilities during the first quarter of 2026.
****URN****