KAMPALA, Uganda — Uganda has approved a new twice-yearly injection to prevent HIV, marking a major step in the global fight against AIDS.
The National Drug Authority (NDA) has cleared lenacapavir, a long-acting injectable form of pre-exposure prophylaxis, or PrEP, developed by U.S. drugmaker Gilead Sciences. The approval makes Uganda one of the first African countries to authorize the drug for HIV prevention.
Health officials say the move offers new hope in a country where adult HIV prevalence is estimated at about 5.4 percent and where daily HIV prevention pills remain hard for many people to take consistently.
Lenacapavir, marketed for PrEP under the name Yeztugo, is given as a small injection under the skin once every six months. It is designed for HIV-negative people who are at high risk of infection. Unlike daily pills such as Truvada or Descovy, the injection removes the need to remember medication every day.
The NDA announced the approval after Gilead filed regulatory applications in late 2025 for several African countries, including Uganda. The decision clears the way for subsidized distribution through international partners such as the U.S. President’s Emergency Plan for AIDS Relief, known as PEPFAR, and the Global Fund. These programs aim to reach millions of people in low- and lower-middle-income countries.
Lenacapavir works by blocking the HIV capsid, a key part of the virus, disrupting its ability to replicate at several stages. Experts say this makes it especially effective and useful in settings where access to health care and regular medication can be challenging.
Clinical trials have shown strong results. In the PURPOSE 1 study, which involved cisgender women in Uganda and South Africa, no HIV infections were recorded among participants who received lenacapavir. In the PURPOSE 2 trial, which included cisgender men, transgender women, transgender men and gender non-binary people across several countries, the drug reduced the risk of HIV by 96 percent.
The U.S. Food and Drug Administration approved lenacapavir for HIV prevention in June 2025. The World Health Organization followed with new guidelines supporting its use in national HIV programs.
Ugandan researchers played a role in the trials, including scientists from the Makerere University–Johns Hopkins University Collaboration. Local health groups have praised the approval, calling it a breakthrough for HIV prevention and a sign of Uganda’s contribution to global medical research.
In a post on social media, the NDA described the approval as a “great step toward ending AIDS by 2030,” echoing global targets set by UNAIDS.
Some concerns remain. People have raised questions about side effects, access and cost. Reported side effects include pain or swelling at the injection site, nausea and headache, though trials found the drug to be generally safe.
Gilead has said it will allow voluntary licensing so that generic versions can be produced for low-income countries. Health advocates are urging fast action to ensure the drug is affordable and widely available.
Uganda plans to prioritize groups most at risk, including sex workers, men who have sex with men and adolescent girls and young women. The injection could sharply reduce new HIV infections and strengthen the country’s long-running HIV response.
