Uganda among first to benefit from breakthrough HIV prevention drug

Lenacapavir, trialed in Uganda, offers 100% protection but will it reach those who need it most?

Kampala, Uganda | RONALD MUSOKE | Thanks to a landmark deal announced on July 9 by the Global Fund, Uganda is expected to be among the first countries in sub-Saharan Africa to get access to Lenacapavir, a revolutionary new drug that has proven to offer protection against HIV infection.

The long-acting injectable—developed by U.S. drugmaker Gilead Sciences—was recently approved by the U.S. Food and Drug Administration (FDA) and, for the first time in history, it is being rolled out simultaneously in both wealthy and low- and middle-income countries.

In Uganda, where an estimated 1.5 million people live with HIV, the announcement has sparked hope among public health officials and HIV prevention advocates. According to the Uganda AIDS Commission, the country records about 730 new HIV infections every week, with adolescent girls and young women among the most affected.

Dr. Flavia Kiweewa Matovu, the Director of Research at Makerere University-Johns Hopkins University Care Ltd who also doubles as the National Principal Investigator of the Purpose-1 study on the Lenacapavir trials, confirmed that Ugandan trial participants experienced 100% protection from HIV infection when administered the drug.

“This drug is a real game changer—especially for populations that struggle with the daily burden of oral PrEP,” she recently told Daily Monitor. Unlike the current daily pill for pre-exposure prophylaxis (PrEP), lenacapavir is injected just twice a year, making it discreet and easier to adhere to, especially for young women, sex workers, and others who face stigma or logistical challenges.

As the first twice-yearly, long-acting injectable for pre-exposure prophylaxis (PrEP), lenacapavir expands the HIV prevention choice basket—offering a powerful new option for people who experience stigma, adherence challenges with existing PrEP tools, or other barriers in their daily lives.

The price controversy

But the drug’s eye-watering price tag—currently estimated at over Shs 100 million (US$28,000) per person per year—has raised concerns that this breakthrough could remain out of reach for most Ugandans.

Winnie Byanyima, the UNAIDS Executive Director, came out last month to criticize the pricing, calling it “beyond comprehension” given public investments and the urgent global need.

“We have seen research showing this drug can be produced for just US$40 per person per year—even less with wider rollout,” she said in a statement. “If it remains unaffordable, it will change nothing. I urge Gilead (Sciences) to do the right thing: drop the price, expand production, and ensure the world has a shot at ending AIDS.”

Dr. Matovu noted that Gilead has already signed deals with six generic manufacturers to produce lower-cost versions of Lenacapavir. “We may not be able to afford the branded version, but with generics, there is real potential for scale in Uganda,” she said.

Global Fund to the rescue

However, the Global Fund to Fight AIDS, Tuberculosis, and Malaria (the Global Fund) announced on July 9 it has signed an access agreement with Gilead Sciences to procure Lenacapavir for low- and middle-income countries.

Under this agreement, countries supported by the Global Fund can access Lenacapavir for PrEP. Early access will be prioritised based on HIV epidemiology, national prevention strategies, and available resources.

Countries—particularly those with high HIV incidence, mostly in sub-Saharan Africa—have expressed strong interest in introducing Lenacapavir for PrEP early and at scale. The Global Fund said its ambition is to have the first shipment and delivery of the products reaching at least one African country by the end of 2025, to mark the beginning of a transformational shift in how HIV prevention is delivered to communities with the highest burden of new infections.

“This is not just a scientific breakthrough — it’s a turning point for HIV/AIDS,” said Peter Sands, the Executive Director of the Global Fund. “For the first time, we have a tool that can fundamentally change the trajectory of the HIV epidemic — but only if we get it to the people who need it most. Our ambition is to reach 2 million people with long-acting PrEP.”

“But we can only do that if the world steps up with the resources required. This is a pivotal moment — not just for the fight against AIDS, but for the fundamental principle that lifesaving innovations must reach those who need them most — whoever they are, and wherever they live.”

“The urgency is particularly acute in countries like South Africa, where adolescent girls and young women remain disproportionately affected by HIV. This is a game changer for South Africa,” said Dr. Aaron Motsoaledi, the Minister of Health of South Africa and co-host of the Global Fund’s upcoming Eighth Replenishment.

“Lenacapavir offers young women, and everyone at risk, a discreet, long-acting option to stay HIV-free. For far too long, women and girls in our country have carried the greatest burden of this epidemic. But scientific breakthroughs must be backed by political will, community leadership, and sustained investment. We are determined to ensure no one is left behind.”

HIV/AIDS experts say Lenacapavir for PrEP is one of several essential tools in a comprehensive HIV prevention strategy—alongside condoms, oral PrEP, voluntary medical male circumcision, and other proven methods. “No single tool will end HIV on its own, but together, these tools can help bend the curve toward ending the epidemic,” the South African health minister said.

Meanwhile, the Global Fund noted that as the public health landscape evolves, it remains fully committed to helping countries drive forward HIV prevention with long-acting PrEP. This includes focusing on successful country implementation, ensuring that delivery is community-led, culturally relevant, and sustainable, and demonstrating rapid early gains to catalyse further adoption and scale.

In order to help accelerate access, the Global Fund is leveraging private-sector donor funding to make the introduction and scale-up of Lenacapavir more affordable for the countries and communities it supports. This financing approach is further strengthened by catalytic investments, including the generous support from the Children’s Investment Fund Foundation (CIFF). These efforts ensure that the financial barriers to scaling this new tool are lowered as much as possible, supporting countries to act quickly.

“CIFF remains committed to accelerating access to lifesaving innovations that will break the cycle of HIV infection,” said Kate Hampton, CEO of the Children’s Investment Fund Foundation (CIFF). “Our support of the Global Fund’s efforts to introduce Lenacapavir is about ensuring that no one is left behind and communities who need it the most can access it. We are proud to stand alongside governments, communities, and the Global Fund to help turn this breakthrough into impact—especially for adolescent girls and young women, who continue to bear the brunt of this epidemic.”

Achieving this ambition is made possible through a unique coalition of partners providing vital technical assistance, policy guidance, demand generation, and community mobilisation. Key partners include the World Health Organisation (WHO), UNAIDS, the Gates Foundation, Unitaid, the Elton John AIDS Foundation (EJAF), AVAC, and CIFF, each playing a critical role in helping countries navigate introduction, accelerate regulatory pathways, generate demand, and ensure community-led implementation from day one.

“This agreement is about putting equity into action,” said Hui Yang, Head of Supply Operations at the Global Fund. “Our goal is to make sure that people in the highest-burden countries — are not waiting years to access the latest prevention tools.”

“Lenacapavir is one of several tools in the prevention toolkit, but its unique, long-acting profile could be transformational for millions of people who face barriers to daily or oral PrEP. Implementation will require coordination and commitment, but the potential for impact is enormous.”