Affordability and supply remain critical to the success of long-lasting HIV treatments

Global health experts say affordability and mass distribution are critical to the success of long-acting, injectable HIV prevention drugs that have proven highly effective in human trials.

U.S. drugmaker Gilead Sciences is seeking regulatory approval for lenacapavir in a number of African countries, a move that would make lenacapavir available across the region, where nearly 1 in 25 people live with HIV. This is an important step towards achieving this goal.

Lenacapavir is a long-acting pre-exposure prophylaxis (PrEP) product that works by stopping HIV from entering the body and making copies of itself.

Unlike oral PrEP treatment, which is taken daily, this drug is administered at six-month intervals, making it the longest-acting injectable drug ever produced.

In late-stage trials, lenacapavir reduced HIV infections by 96 percent in diverse groups, including men who have sex with men, transgender and non-binary people.

Only two of the more than 2,000 people who took part in the Aim 2 study became infected with HIV, according to data presented earlier this month at the International AIDS Society's HIV Research Conference for Prevention in Lima, Peru. It was just that.

The study's findings build on a previous Objective 1 study that found that cisgender women (those who identify with the sex they were assigned at birth) did not become infected with HIV while taking the drug.

Hasina Subedar, senior technical advisor at the South African Department of Health, said lenacapavir's real-world impact will depend on the drug's pricing and availability.

“If affordable, lenacapavir could significantly reduce new infections here,” she told SciDev.Net.

Colleen Kelly, associate professor of medicine at Emory University School of Medicine in the United States, said the drug, given twice a year, could overcome a key problem with oral PrEP: patients' inability to stick to the medication. states.

She believes lenacapavir may be particularly beneficial in areas where regular access to health care is difficult, calling it a “highly effective drug for HIV prevention that does not rely on daily oral adherence.” It is described as a “tool”.

1 million goal

Mitchell Warren, executive director of AVAC, a nonprofit organization focused on equitable access to HIV prevention options, said the drug's promise is “remarkable,” but that widespread availability must be ensured. He emphasized the importance of doing so.

“We are calling for aggressive efforts to make lenacapavir available to at least 1 million people in low- and middle-income countries within one year of its rollout,” Warren told SciDev.Net .

He stressed the importance of large-scale production and strong supply chains to ensure medicines reach those who need them most.

Healthcare systems in Africa are often strained, and the cost of treatment is a major concern.

Gilead has a voluntary licensing agreement that allows it to manufacture a generic version of lenacapavir, but the pricing structure remains unclear.

Early models suggest that to achieve widespread uptake, a one-year supply of lenacapavir would require a cost of approximately US$40, comparable to the price of oral PrEP.

Warren said countries with experience in implementing HIV prevention programs, such as Zambia and Kenya, are expected to be early adopters and will serve as a litmus test for real-world impact. If successful, demand for the generic version could increase, driving down prices over time.

Gilead Sciences plans to begin the regulatory process by the end of 2024 in 18 low- and middle-income countries with high HIV prevalence, including Botswana, Kenya, Uganda, South Africa, Nigeria, Tanzania, Zambia, and Malawi.

The company has signed non-exclusive, royalty-free license agreements with six generic drug manufacturers, including Dr. Reddy's, Emcure and Mylan, to manufacture and sell generic versions of lenacapavir in 120 resource-limited countries. It was announced that. Supports low-cost access.

Gilead also said it plans to provide the product at no profit to generic manufacturers until they can fully support demand.

“Given lenacapavir's transformative potential for prevention, we are committed to making lenacapavir widely available as quickly as possible in areas of greatest need,” said Daniel O'Day, Chairman and CEO of Gilead. We are focusing on doing that.”

“The Gilead team is currently working urgently to bring in a large number of generic manufacturers to ensure a rapid transition to these self-licensing partners once lenacapavir for PrEP is approved.” added.

Gilead said it is working within regulatory frameworks such as the European Medicines Agency's “EU Medicines for All” initiative to expedite national approval and WHO prequalification of the drug.

The drug has been approved in Europe and the United States to treat HIV/AIDS, but it has not been approved by regulatory authorities anywhere in the world as an HIV prevention drug.

Building trust

Once approved, producing enough lenacapavir to create a reliable supply chain in Africa could be a major challenge, Warren said.

He said the rollout of PrEP to date has shown the importance of consistent availability to building and maintaining community trust.

There are also concerns about whether patients will come back for shots every six months.

Warren added: “The possibility is interesting, but there are still many questions.”

Chilufya Kasanda from the Zambia Treatment Advocacy and Literacy Campaign stressed the need to provide a choice of treatment options.

“The desire and appetite of the community is huge, but we still have to respect that the community will continue to change the way they think about the product,” Kasanda said.