By Jennifer Rigby
LONDON (Reuters) – A new long-acting HIV preventive drug could reach the world's poorest countries in late 2025 or early 2026, a global health official told Reuters on Tuesday.
The ambition is to begin deliveries of Gilead (NASDAQ:) Sciences' lenacapavir on that schedule, said Hui Yang, head of supply operations at the Global Fund to Fight AIDS, Tuberculosis and Malaria. However, he said many things must happen first, including for the injectable drug to receive regulatory approvals from authorities such as the U.S. Food and Drug Administration and the World Health Organization.
Lenacapavir is already approved for use as a treatment against multidrug-resistant HIV and costs about $42,250 for the first year of therapy in the United States. Clinical trials this year showed it is also highly effective in preventing infections, and Gilead is seeking approvals for the new use globally.
“We don't want…low- and lower-middle-income countries to wait, to be at the back of the line” when these approvals come, Yang said, an equality issue that has plagued the fight against HIV for decades. .
To prevent this, the Global Fund said on Tuesday it would join forces with the US President's Emergency Plan for AIDS Relief (PEPFAR), with funding from the Children's Investment Fund Foundation and the Bill & Melinda Gates Foundation, to support affordable access to expensive medicine in the countries they work with “from day one.”
The groups did not provide further details on how this might work, other than to say their goal was to reach at least two million people within three years.
Gilead signed deals in October this year with six generic drug makers to manufacture and sell lenacapavir at a lower price in 120 low- and middle-income countries. The measure was criticized for leaving out countries, especially in Latin America.
No deal has been signed yet with Gilead or any of these generic producers, Yang said, but they will work with all the companies involved.
Gilead CEO and President Daniel O'Day said the initiative would help accelerate access so that more people could access lenacapavir from the start.
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