HIV activists are raising alarms 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 expected to receive donated doses.
Lenacapavir, administered twice a year, has shown high effectiveness as pre-exposure prophylaxis (PrEP) in clinical trials carried out among adolescent girls and young women in Uganda and South Africa — the two African countries where the drug was tested on the continent. Following the promising results, Uganda was slated to receive a USD 1.1 million donation of the drug from the Global Fund in January 2026.
But during a press conference on Tuesday, Kuraish Mubiru, executive director of Uganda Young Positives, warned that Uganda risks missing delivery deadlines because the country lacks approved guidelines, regulations and implementation frameworks required for the rollout.
He urged the NDA to “ensure the necessary guidelines are in place by the end of December,” saying this is essential if Uganda hopes to introduce the drug on schedule in early 2026.
Activists also noted that the Global Fund donation would cover only about 10,000 doses — far short of the country’s needs, with Uganda still recording up to 1,000 new HIV infections every week.
Flavia Kyomukama, executive director of NAFOPHANU, said the U.S. government has committed to providing an additional 200,000 doses but said Uganda must also invest domestic resources to ensure long-term access for those most at risk.
She cautioned that lenacapavir is intended for high-risk groups — such as sex workers, boda boda riders, long-distance truck drivers and people in discordant relationships — and said clear public communication will be crucial to prevent misuse or unrealistic demand once the drug becomes available.
Similar concerns were raised by Dr. Flavia Matovu Kiweewa, a senior research scientist at the Makerere University–Johns Hopkins University Research Collaboration (MU-JHU).
In a recent interview, Matovu, the Uganda lead investigator on the lenacapavir trial, said interest in the drug is already high. She noted that the study sponsor has committed to subsidizing prices in high-incidence countries like Uganda until generic versions become available on the market.
Currently, Uganda has rolled out another long-acting injectable PrEP option, cabotegravir, which requires two initial injections four weeks apart, followed by doses every two months. Lenacapavir, administered only twice a year, is viewed as a more convenient alternative for individuals who struggle with adherence or have difficulty making frequent clinic visits.
Matovu added that the Global Fund plans to supply 36,000 doses to nine health facilities in the first quarter of 2026. If rollout moves forward as planned, lenacapavir would become one of the first HIV prevention innovations to reach communities in Uganda rapidly after completion of clinical trials — a departure from previous decades, when Africa often waited years, or even longer, for access to new HIV medicines.
Activists argue that Uganda must avoid repeating that legacy. They warn that without updated licensing regulations, national guidelines and operational planning, doses could expire in storage or be diverted to limited pilot programs instead of reaching the wider population.
“This is a game-changing opportunity, but only if the systems are ready,” Mubiru said. “We cannot afford delays when so many new infections continue every week.”
Uganda currently records approximately 52,000 new HIV infections annually, according to UNAIDS, despite years of progress in treatment expansion and a declining national prevalence rate. Prevention services, activists say, remain underfunded and unevenly accessed, particularly among young women and key populations who face structural and social barriers to care.
Advocates are now pushing for the Ministry of Health, NDA and development partners to accelerate technical reviews and establish rollout plans before the first shipments arrive early next year. For many, the effort represents not only a regulatory decision but a symbolic moment — a chance for Uganda to be among the first countries globally to adopt a new HIV prevention technology at scale, rather than the last.
“We finally have a tool that meets the reality of many people’s lives,” Kyomukama said. “We need to make sure it gets to them in time.”
On there hand from the moment Gilead Sciences submitted its application to the Medicines Control Authority of Zimbabwe, it started working on the approval. 23 days later, on Nov. 24, 2025, Zimbabwe approved lenacapavir. This reflects a deliberate embrace of regulatory cooperation built on trust and shared global expertise.
South Africa is also moving fast. Gilead submitted lenacapavir to SAHPRA in March 2025, and approval followed on Oct. 27—still significantly faster than traditional timelines and a sign of growing regulatory capacity. Zambia provides another example. Its health minister, Dr. Elijah Muchima, announced that the Zambia Medicines Regulatory Authority approved lenacapavir on Nov. 8, just six weeks after submission.
Zimbabwe, South Africa, and Zambia are now among the first countries to authorize lenacapavir. Medicines Control Authority of Zimbabwe, ZAMRA, and SAHPRA have set a new benchmark—one that calls on regulators, industry, EMA, WHO, and the African Medicines Agency to keep building a future where lifesaving innovations reach every community without delay.
