The Global Fund will guarantee access to lenacapavir, a revolutionary HIV prevention drug, for countries in the Global South.

The Global Fund , which fights AIDS , tuberculosis , and malaria, announced this Wednesday the signing of an access agreement with the US pharmaceutical company Gilead, the manufacturer of lenacapavir , an antiviral drug with nearly 100% efficacy in preventing HIV, for its introduction in low- and middle-income countries. "A turning point in the fight against the virus" and a "milestone for global health equity," according to the fund's officials.

According to the Global Fund, "This is the first time in history that an HIV prevention drug will be delivered to low- and middle-income countries at the same time as high-income countries."

Long-acting lenacapavir , administered twice a year as a subcutaneous injection, could be a game-changer for HIV prevention, far more effective than condoms or traditional PrEP (pre-exposure prophylaxis).

“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 two million people with lenacapavir. But we can only do this if the world steps up with the necessary resources,” said Peter Sands, executive director of the Global Fund, in a statement.

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.

Peter Sands, Executive Director of the Global Fund

The problem with lenacapavir is its marketed price. In the United States, for example, where the Food and Drug Administration (FDA) approved the drug in June, it will cost more than $28,000 per person per year.

Winnie Byanyima, executive director of UNAIDS , estimated in an interview with this newspaper last week that researchers at the University of Liverpool have calculated that lenacapavir could be produced for just 25 euros per person per year if Gilead were to authorize its mass generic manufacture.

Global Fund sources have explained to this newspaper that to finance a "significant deployment of this game-changing prevention tool," they are using grants from the Global Fund, financed by numerous countries, including Spain , and additional support from private foundations.

"We have secured an access price for countries covered by the voluntary license that allows for the early, large-scale introduction of lenacapavir, but the specific financial details of the agreement are confidential," Global Fund sources told this newspaper.

According to this organization, the voluntary licensing agreements (when the company holding the patent allows another company to produce it under mutually agreed-upon conditions) that Gilead has signed with generic manufacturers cover up to 120 countries. Countries supported by the Global Fund within those 120 countries will be eligible for this agreement.

According to Winnie Byanyima of UNAIDS, Gilead has licensed six companies to manufacture generics. But none are located in Latin America, where infections are rising, and in Africa, only one company in Egypt has a license.

A transformative change

For this ambitious project, the Global Fund cites the extraordinary financial support of the Children's Investment Fund Foundation (CIFF) and the technical and political backing of a coalition of partners such as the World Health Organization (WHO), UNAIDS, the Gates Foundation, Unitaid, the Elton John AIDS Foundation (EJAF) and AVAC .

The goal is for the first shipment and delivery to reach at least one African country by the end of 2025, "marking the beginning of a transformative shift in how HIV prevention is delivered in communities with the highest burden of new infections," the Global Fund celebrates. According to UNAIDS, 1.3 million infections were recorded worldwide in 2024.

The destinations will be locations with a “high burden and incidence” of HIV, and “the goal is to ensure that, once generics are available, countries can smoothly transition to more affordable supply options.”

“Our goal is to ensure that people in countries with the highest HIV burden don't have to wait years for access to the latest prevention tools,” explained Hui Yang, head of supply operations at the Global Fund.

Our goal is to ensure that people in countries with the highest HIV burden do not have to wait years for access to the latest prevention tools.

Hui Yang, Global Fund

The urgency is particularly acute in countries like South Africa , where adolescent girls and young women continue to be disproportionately affected by the virus, the Global Fund stresses.

“Lenacapavir offers young women, and all people at risk, a discreet, long-acting option to stay HIV-free,” said Aaron Motsoaledi, South Africa’s Minister of Health, referring to the stigma attached to other, more visible forms of prevention, such as daily pill-based treatments, for those at risk.

UNAIDS believes that the abrupt funding cuts from the United States, the major funder of the fight against the virus, could lead to an additional 6.6 million new infections by 2029. Given this scenario, lenacapavir is the great hope.

“It would allow us to stop new infections very quickly. And if we stop them, we will end AIDS, because it will mean we will continue to care for those who are already HIV-positive, but there will be no new infections. In a couple of years, we could be closer than ever to ending the disease,” said Winnie Byanyima in her interview with Planeta Futuro.