New HIV prevention drug offers hope but Uganda may have to wait

“I highly doubt that it will be readily available for us in Uganda immediately… The cost is very high,” said Dr Watiti.

Lenacapavir, approved by the US Food and Drug Administration, stands out for its twice-yearly injection schedule and high efficacy. (File photo)
By John Masaba
Journalists @New Vision
#HIV infections #PEPFAR #Drug #Lenacapavir

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In a landmark initiative to curb new HIV infections globally, the US government, through the President’s Emergency Plan for AIDS Relief (PEPFAR), has announced an advanced market commitment to purchase the long-acting injectable drug lenacapavir.

The plan, co-funded with the Global Fund, aims to deliver the drug to 8–12 high-burden HIV countries, including Uganda, beginning in 2026.

According to a press release issued by the US Department of State, the US government will partner with American pharmaceutical company Gilead Sciences to secure lenacapavir for up to two million individuals by 2028.

Gilead has also agreed to provide the drug at cost and license its intellectual property to generic manufacturers—an unprecedented move expected to facilitate widespread production and eventual affordability, according to a press release dated September 4, 2025, from the US Department of State.

Lenacapavir, approved by the US Food and Drug Administration, stands out for its twice-yearly injection schedule and high efficacy. This is after a large clinical trial showed that over 99% of participants remained HIV-negative while using the drug.

According to the press statement, initial distribution will prioritise pregnant and breastfeeding mothers, a key focus population in PEPFAR’s prevention strategy.

“This groundbreaking approach offers convenience, cost-efficiency, and effectiveness,” the U.S. State Department noted, adding that fewer clinic visits will ease strain on health systems and improve adherence.

Uganda, a key recipient of PEPFAR support, has over 1.4 million people living with HIV who benefit from improved access to antiretroviral therapy (ART).

Reacting to the development, Dr Stephen Watiti, a board member of the Uganda AIDS Commission, medical doctor, and person living with HIV, welcomed the scientific progress but expressed cautious optimism regarding Uganda’s immediate access.

“I haven’t seen the news yet,” Dr Watiti told New Vision. “But the truth is that the drug has been approved for prevention—specifically for people who are not infected but are at high risk.”

While he acknowledged lenacapavir’s potential, Dr Watiti warned that cost and regulatory hurdles could delay its rollout in Uganda.

“I highly doubt that it will be readily available for us in Uganda immediately… The cost is very high,” he said.

“And it is not yet registered by the National Drug Authority.”

He also stressed that Uganda’s priority currently remains access to treatment for those already living with HIV, noting that 80% of the cost of antiretroviral therapy (ART) in the country is currently funded by PEPFAR.

“The most important thing we are struggling with now is to ensure that people who are already infected access the medicine.”

Dr. Watiti compared lenacapavir’s prospects to those of cabotegravir, another long-acting injectable that has shown promise but is currently available in Uganda only through limited research initiatives.

“Long-acting cabotegravir … has been approved for treatment, and a few people [in Uganda] are on it—mainly under research. Not research to show that it works; it does. But every country wants its own local evidence.”

However, Dr Watiti remains hopeful that with time and proper regulatory frameworks, lenacapavir could become a valuable tool in Uganda’s HIV prevention arsenal.

“It is good news that this medicine is available. That means eventually we may also get it.”