Zero-infection HIV drug ‘must be affordable’

[KAMPALA] An HIV prevention drug proven to protect women from the virus with just two injections a year must be made available at an affordable price for those at risk in low- and middle-income countries, advocacy groups urge.

Two injections a year of the antiretroviral drug lenacapavir resulted in zero infections among adolescent girls and young women ages in a large-scale phase 3 clinical trial carried out by Gilead Sciences in South Africa and Uganda.

Researchers say the drug, which proved 100 per cent effective in the human trial, could revolutionise prevention and treatment of HIV, a disease that affects around 40 million people, more than two thirds of whom live in Sub-Saharan Africa.

“It is the first time we are seeing zero infections in any study, and this is because of the effectiveness of the product.” Flavia Matovu Kiweewa, director of research, Makerere University-John Hopkins University research collaboration

UNAIDS said in a statement this week that the result “provides hope of accelerating efforts to end AIDS … but only if Gilead ensures that all people who need it can have access to this game-changing medicine”.

The drug is currently only available in a few wealthy countries, including in the US where it costs US$42,250 per patient in the first year of treatment.

Gilead has committed to quickly making large volumes of the drug available in “high-incidence, resource-limited countries”.

It says it will ensure a dedicated supply of lenacapavir in the countries where the need is greatest until voluntary licensing partners are able to supply low-cost versions.

A voluntary license can be used to give generic firms a license to supply medicines at lower prices than the patent-holder, as opposed to a compulsory license where patent-free access to critical medicines is imposed by governments.

However, Winnie Byanyima, executive director of UNAIDS, said: “It is concerning that Gilead’s latest announcement seems to mention neither upper-middle income countries, where people cannot afford anything like lenacapavir’s current US$42,250 price tag, nor a commitment to work with the UN-backed Medicines Patent Pool.

“Without these safeguards, it cannot be assured that this game-changing medicine will reach all those who need it.”

Lillian Mworeko, the executive director at the International Community of Women living with HIV/AIDS, urged Gilead to commit to making the drug accessible by immediately ensuring access through open-label extension studies and regulatory approvals by the World Health Organization, US drug Authority Food and Drug Agency and African regulatory authorities.

Open label extension studies extend a trial for several months, giving researchers extra time to gather data on the drug’s long-term safety, tolerability, and efficacy. This keeps the drug available to patients who participated in the original trial and enables researchers to collect long-term safety and efficacy data.

Bridget Ndagaano Jjuuko, activist and director of ACTS101-Uganda, urged major donors like PEPFAR and the Global Fund to make large-scale purchases of lenacapavir, which would significantly drive down the drug’s market price.

“We want to see affordable lenacapavir in the hands of those that need it in the shortest time possible,” said Jjuuko.

“We need commitments from donors like the U.S. President’s Emergency Plan for AIDS Relief and the Global Fund that purchases large quantities of drugs to lower the prices of lenacapavir as it hits the market,” Jjuuko added.

The interim trial results, presented last month (20 June), indicate that the drug was safe and highly effective, with no infections reported among trial participants who received the injection.

Final results are expected to be shared at the coming AIDS 2024 conference in Munich, Germany, this July.

The study, known as the PURPOSE 1 trial, screened over 10,000 girls and enrolled 5,000 into the study.

Because effective HIV prevention drugs already exist, scientists decided it would be unethical to give participants a dummy placebo injection. Instead, twice-yearly lenacapavir injections were compared with existing daily oral HIV prevention drugs Descovy and Truvada.

While there were no infections in the group of women taking lenacapavir, there were 16 cases among the 1,000 women who were given Truvada and 39 cases among 2,000 women given Descovy.

Flavia Matovu Kiweewa, the lead investigator for Uganda and director of research, Makerere University-John Hopkins University research collaboration, said: “It is the first time we are seeing zero infections in any study, and this is because of the effectiveness of the product.

“This is what the world has been waiting for – this is going to change the approach to HIV pre-exposure prophylaxis worldwide,” Kiweewa, who is also the Uganda National Principal Investigator for the PURPOSE 1 study, said.

Pre-exposure prophylaxis—or PrEP—is a general term for the use of medications used to prevent the spread of HIV in people who have not yet been exposed to the disease.

The researchers also sought to understand if lenacapavir could prevent HIV infection among pregnant women.

“In the study, we have a component that if someone gets pregnant in the study, they consent and agree to stay on the study product,” said Kiweewa.

“We are looking at the safety of the product in pregnant women, in their unborn baby, and after the baby is born. Babies will be followed up for 12 months.”

Pontiano Kaleebu, the director of the Uganda Virus Research Institute (UVRI), an institution that was part of the study, says the news of 100 per cent protection is exciting and offers many advantages.

“It will have an impact on lowering HIV incidence, particularly among high-risk populations, and help us with the adherence issue that we are grappling with,” said Kaleebu.

Lazarus Momanyi, a technical advisor for HIV at the National AIDS and STI Control Programme at the Ministry of Health Kenya, said the HIV injections are groundbreaking.

“One of the challenges we have been having with oral PrEP is adherence because we are giving people a drug when they are not sick so the motivation for taking it is limited.

“My reservations though are on the pricing and availability for developing countries like Kenya because it is expensive.”

He says the study was done in women and they await to see how it works in men.

This piece was produced by SciDev.Net’s Sub-Saharan Africa English desk.