HIV Activists Decry Long Wait for Prevention Injection Approval

HIV activists are raising alarm over delays by the National Drug Authority (NDA) to evaluate and license the long-acting HIV prevention injection, Lenacapavir, despite Uganda being among the first countries lined up to receive donated doses. 

Lenacapavir, administered twice a year, has been found highly effective 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 in January 2026. 

However, during a press conference on Tuesday, Kuraish Mubiru, the Executive Director of Uganda Young Positives, expressed concern that Uganda risks missing the shipment since there are no approved guidelines, regulations, or implementation strategies, requirements for roll-out of the drug touted as a game changer in HIV prevention. 

Mubiru urged the NDA to “ensure the necessary guidelines are in place by the end of December,” saying this is crucial if Uganda is to meet its early 2026 target for introducing the injection.   

Activists also warned that the expected Global Fund donation will cater for only about 10,000 doses, far below what is required for a country registering up to 1,000 new HIV infections every week. 

Flavia Kyomukama, the Executive Director of NAFOPHANU, said the United States government has committed to providing an additional 200,000 doses. She, however, argued that Uganda must also invest its own resources to ensure sustainable access for people who need the drug most. 

Kyomukama cautioned that while Lenacapavir is intended for people at the highest risk, such as sex workers, Boda Boda riders, long-distance truck drivers, and individuals in discordant relationships, clear communication is needed to prevent misuse or inappropriate demand once the drug becomes available. 

Similar concerns were echoed by Dr Flavia Matovu Kiweewa, a Senior Research Scientist at the Makerere University-Johns Hopkins University Research Collaboration (MU-JHU). 

In an earlier interview, she said interest in the drug is already very high. Matovu, who served as Uganda Lead Investigator on the Lenacapavir study, revealed that the study sponsor has committed to subsidising prices in high-incidence countries like Uganda until generic versions enter the market.

Currently, Uganda has rolled out another long-acting injectable PrEP option, Cabotegravir, which requires more frequent dosing: two initial injections four weeks apart, followed by bi-monthly shots. Lenacapavir, given only twice a year, is seen as a more convenient alternative for individuals who struggle with adherence.  

Matovu noted that the Global Fund plans to supply 36,000 doses to nine health facilities in the first quarter of 2026. If implemented as scheduled, she said, Lenacapavir will become one of the first HIV prevention innovations to reach communities rapidly after the conclusion of clinical trials.