The Ministry of Health is assessing a new biannual HIV prevention injection for inclusion in essential medicines, with the goal of providing free access, the Uganda Aids Commission has indicated.

Lenacapavir, the injectable drug developed by a US-based company, Gilead Sciences, was trialled (tested) in Uganda and South Africa. The trial results released last year indicate that it’s 100 percent effective in protecting HIV-negative individuals from acquiring the infection.

The drug has also recently been approved by the US Food and Drug Administration (FDA), a milestone which the Aids Commission says paves the way for national approval in Uganda to catalyse the drive to end HIV/Aids as a public health threat by 2030.

Dr Vincent Bagambe, the director of Planning and Strategic Information at the Commission, however, told Daily Monitor he is unsure when the drug will be available to Ugandans under the government’s arrangement.

“The approval by the US FDA is a stringent process, so when they approve, it shows that it is a very good drug. But that does not mean it will be available immediately in Uganda until we can afford it,” he said.

Lenacapavir is regarded as a significant step in improving prevention options for people at risk of HIV infection around the world. But available media reports indicate that the drug could cost up to $28,218 (Shs103m) per person per year, which many may not afford, given the GDP per capita of $1,263 (Shs4.5m).

“Right now, it is undergoing a review by the Ministry of Health, and that includes guidelines for health workers. But what we are giving right now is much cheaper than the new drug [lenacapavir],” Dr Bagambe observed. “And we are hoping that as people use it [lenacapavir], it will also become affordable and maybe the government can bring it.”

Asked whether there is a special arrangement between the government and the manufacturer, given the medicine was tested here, Dr Bagambe said, “Not yet.”

Uganda is still grappling with a high HIV/Aids burden, with around 1.5 million people living with HIV, and 730 new infections are happening every week, according to information from the Uganda Aids Commission.

Low-cost option for Uganda

The country’s Lead Researcher for Lenacapavir, Dr Flavia Matovu Kiweewa, however, indicated that the nation may obtain the drugs at a lower cost under a special arrangement by the drug developers.

“They have already signed agreements with six generic manufacturers. They will come in to make lower-cost versions of Lenacapavir, high quality but lower cost. We may not be able to afford the brand version of Lenacapavir,” Dr Kiweewa said.

“But before that, they have also committed to give the brand drugs at a low cost to 18 countries, including Uganda and South Africa, to be able to accelerate access in our settings.”

Dr Kiweewa also revealed that those who participated in the trials are already accessing the drugs. The trials in three sites in Uganda (Mityana, Masaka, and Kalangala) and 28 sites in South Africa were among 5000 sexually active, HIV-negative girls who were at risk of contracting HIV.

In a drive to ensure all people at risk of acquiring HIV access Lenacapavir, on July 18, the Joint United Nations Programme on HIV/AIDS (UNAIDS), following the approval of the drug by the FDA, called on the manufacturer, Gilead, to reduce the drug price.

“In a research paper published in The Lancet HIV this week, experts found that generic lenacapavir could cost $35-$46 per person-year. This could fall to $25 per person-year for a committed demand of five to ten million people within the first year, bringing pricing in line with or lower than current oral Pre-exposure Prophylaxis (PrEP),” UNAIDS said in a June 18 statement.

Existing options/govt actions

In the meantime, the UAC, in a press statement on Saturday, said oral Pre-exposure prophylaxis (PrEP will continue to be offered at designated facilities in the country for those at high risk of acquiring HIV.

The oral PrEP is a very effective option, but the issue has been with adherence, as persons at high risk of infection should take it daily to protect themselves from infection, according to researchers.

“Carbotegravir, another highly effective injectable PrEP given every two months, has already been incorporated into the Ministry of Health HIV prevention guidelines, and efforts to make it locally available are in advanced stages,” UAC stated.

UAC, which is in charge of coordinating the HIV response, also indicated in the press statement that the Ministry of Health, working with relevant stakeholders, will undertake relevant activities to approve Lenacapavir in Uganda and guide health workers on its use.

The Commission said this drive is part of the country’s commitment to providing effective and innovative solutions to end AIDS as a public health threat by 2030.

“The National Drug Authority will have to evaluate and license the drug for use in the country. [The Ministry of Health will] update national HIV prevention guidelines to guide the use of Lenacapavir in the country,” the statement reads.

UAC also indicated that the Ministry will “train the healthcare providers; equip them with knowledge and skills to prescribe and monitor Lenacapavir use and incorporate Lenacapavir into the essential drugs list of the country.”

The Commission also said the Ministry will revise tools to enable the capture of data on the use of Lenacapavir in order to be able to monitor clients on Lenacapavir and give accountability.

“Once these steps have been completed, Lenacapavir will be integrated into Uganda’s HIV prevention programme, expanding options for individuals at high risk of HIV infection,” the statement reads.

Why lenacapavir

The Ugandan government is considering adding a new, twice-yearly injectable HIV prevention drug, lenacapavir, to its list of essential medicines following its recent FDA approval.

This long-acting injectable offers a significant breakthrough in HIV prevention, providing a highly effective alternative to daily pills for those at risk.

The Food and Drug Administration approved Gilead’s twice-yearly antiviral drug for preventing HIV.

The company and some experts say it is a milestone that could help bring the world closer to ending the decadeslong epidemic caused by the virus.