UNAIDS welcomes WHO guidelines on Uganda-tested HIV prevention drug, calls it fresh option

The Joint United Nations Programme on HIV/AIDS (UNAIDS) has welcomed the World Health Organisation guidelines on Lenacapavir–a long-acting, six-monthly injectable HIV prevention drug.

The guidelines come after WHO recommended the drug as an additional HIV prevention choice as part of combination HIV prevention approaches.  

The WHO recommendation early this week also came after the United States Food and Drug Administration (FDA) approved lenacapavir for HIV prevention in mid-June 2025.

The news was met with great expectations of new infections being reduced by huge margins. 

"Lenacapavir, a new pre-exposure prophylaxis (PrEP) medicine, has the potential to increase the uptake of PrEP and bolster HIV prevention overall as it allows people to choose a method that they prefer. Lenacapvir, administered twice a year, is highly effective at reducing the risk of HIV acquisition," UNAIDS says. 

UNAIDS says the long-acting injectable medicine is a fresh option for all people at risk of contracting HIV at a time when funding cuts by the US President Donald Trump administration could lead to an additional 6 million HIV infections and 4 million AIDS-related deaths by 2029.

This is key for those who face higher HIV infection risk and in locations where the virus is highly prevalent: Adolescent women and girls, sex workers and people who use drugs. 

The new medicine, manufactured by Gilead Sciences, will be sold under the name Yeztugo. In an interview last month with the New York Times, Gilead Sciences said the drug would cost $28,218 (about shillings 102 million) per person per year. 

"As Gilead has not yet registered Lenacapavir for regulatory approval in all countries, many people, including those facing disproportionate risk for HIV, may have to wait longer than others to access this life-saving tool," the statement issued on July 15 reads.
 
The cost question and access

UNAIDS called for transparency in production costs and pricing strategies is fundamental to removing some market barriers to universal access to innovative products.

The UN agency said it is committed to ensuring full transparency from originator pharmaceutical companies regarding how much health technologies cost to produce and at what level they are priced.

"Lenacapavir is no exception. Research shows that Lenacapavir can be produced at a thousandth times less than its US price".

However, lower-income countries, among which Uganda is, are expected to gain access to a "game-changing" HIV-prevention drug with a new deal signed between Gilead and the Global Fund, the health financing group.

Dozens of developing countries have been excluded from the licences for generic Lenacapavir and for cabotegravir (another long-acting injectable antiretroviral for HIV manufactured by ViiV Healthcare.  

The Global Fund, the group set up to battle AIDS, tuberculosis and malaria, described the deal to procure lenacapavir for low- and middle-income countries (LMICs) as "a significant milestone for global health equity".

"This marks the first time in history that an HIV prevention product will be introduced in LMICs at the same time as in high-income countries," the Global Fund said in a statement.

Under the agreement, countries supported by the Global Fund can access lenacapavir for PrEP, the organisation said, adding that it aimed for the first shipment and delivery to reach at least one African country by the end of this year.

This, it said, would mark the start of "a transformational shift in how HIV prevention is delivered to communities with the highest burden of new infections".

UNAIDS also urged Gilead to swiftly register Lenacapavir for regulatory approval in all low- and middle-income countries, starting with those with the highest HIV incidence and to ensure affordable access for everyone who could benefit, wherever they live.

It is also encouraging countries to prioritise prevention options that deliver impact and use simplified and differentiated delivery of prevention services to reach those in need. 

"There is no more time to waste. Governments, civil society, and the private sector need to take all steps necessary to enable equitable, global access to new health technologies for HIV such as Lenacapavir and Cabotegravir".

UNAIDS works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals.

What Next for Uganda

As of December 2023, the estimated number of people living with HIV in Uganda stood at 1.492 million. While the HIV prevalence has declined to 5.1%, women remain disproportionately affected. Additionally, 38,000 new infections are recorded annually, with a third occurring among youth aged 15 to 24 years.

Despite progress, Uganda’s HIV epidemic remains severe.

“The estimated number of people living with HIV is 1.492million and this is as of December 2023. The burden of HIV is still higher in females than males. The HIV prevalence is coming down, currently averaging at 5.1 per cent, but still higher among women than men and new HIV infections are now 38,000. Again, the bulk of HIV infections occurs in women compared to men,” Dr Vincent Bagambe, the Uganda AIDS Commission director in charge of planning and strategic information, said recently.
Youth aged 15-24 years account for a third of new HIV infections.

“To give you an example, out of 100 people living with HIV in the world, four are Ugandans. We derive this considering the fact that Uganda has a population of only 46 million people and it has 3.8 % of people living with HIV in the world,” he said.

Moreover, an estimated 200,000 people remain undiagnosed and untreated each year.
Dr Flavia Kiweewa Kiwanuka, the principal investigator of the trials in Uganda, in an X (formerly Twitter) space hosted by New Vision Online on July 15, 2025, noted that the FDA’s approval, WHO’s recommendation, and the Global Fund’s commitment to purchase the drug for low- and middle-income countries, including Uganda, is a significant opportunity.

“The Ministry of Health has been allocated shillings 40,840,500,000 (approximately $1.14 million) from the Global Fund to procure drugs for 17,000 people as the first doses. It’s a procurement process, but we hope by 2027 we will have them available,” Dr Kiweewa said.

She added that these 17,000 individuals will receive the drug for one year. “We have gotten support to start us off.”

Kiweewa noted that for a drug to be allowed on the market, it must be approved by the US FDA, recommended by WHO which also gives  on how to use before local authorities like the National Drug Authority in Uganda and health ministry allow it in national stores.

Flavia Kyomukama, the executive director and founder of the National Forum of PLHA Networks in Uganda, noted that the Trump-era aid cuts had a far-reaching impact on the HIV community.

“We have learnt that we must be self-sustaining. We can no longer rely on grants to educate each other or even access medicine. We now know that even the Netherlands and the UK are planning to cut aid,” Kyomukama said.