By Deena Beasley and Jennifer Rigby
(Reuters) -Gilead Sciences and the Global Fund to Fight AIDS, Tuberculosis and Malaria said on Wednesday they had finalized plans to supply a long-acting HIV prevention drug to low-income countries, despite the absence of funding from a key U.S. initiative aimed at addressing the global HIV/AIDS epidemic.
Under the agreement, Gilead said it will supply, at cost, enough doses to reach up to 2 million people over three years in countries supported by the Global Fund. Both parties said price terms are confidential, and the Global Fund declined to comment further on how many doses would be ordered immediately.
The U.S. Food and Drug Administration last month approved Gilead’s lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents. The World Health Organization and other regulators are currently reviewing it.
Last year, Gilead signed royalty-free deals allowing six generic drugmakers to make and sell low-cost versions of the drug in 120 low- and middle-income countries, but those supplies will take time to get up and running.
Some AIDS experts have said the new drug could help end the 44-year-old epidemic that infects 1.3 million people a year and is estimated by the World Health Organization to have killed more than 42 million.
The Global Fund said it will prioritize access based on HIV incidence and prevention strategies, including countries in sub-Saharan Africa that have expressed strong interest – notably South Africa, which will be among the first to roll out the drug among around 10 other nations.
The partners aim to have the first delivery reach at least one African country by the end of this year.
“For the first time, a tool to prevent HIV infection is coming available in low and middle-income countries at the same time as in high-income countries,” Peter Sands, executive director of the Global Fund, said in an interview with Reuters. In the past, this has taken years, he added.
Gilead, the Global Fund and the United States President’s Emergency Plan for AIDS Relief had announced the plan in December.
However, the administration of U.S. President Donald Trump, who took office in January, has pulled back on PEPFAR funding, limiting global HIV prevention programs to pregnant and breastfeeding women.
In response to questions about the impact of the cuts on HIV programs worldwide, a U.S. State Department spokesperson told Reuters: “PEPFAR-funded programs that deliver HIV care and treatment or prevention of mother-to-child transmission services are operational… All other PEPFAR-funded services are currently being reviewed.” They did not respond to questions on lenacapavir specifically.
Gilead CEO Daniel O’Day said he is still hopeful that U.S. aid spending to fight the epidemic will resume.
“We want to be spending less over time on HIV because the incidence is lower … we should put resources toward things that actually reduce the burden of disease over time.”
Gilead is also working with middle-income countries, many of which are in Latin America, to make lenacapavir accessible as soon as possible, he said.
The drug, which has the brand name Yeztugo, has an annual list price in the United States of $28,218.
The Children’s Investment Fund Foundation pledged $150 million to the Global Fund earlier this year, including money for the lenacapavir initiative. Sands said more donors were also needed.
(Reporting by Deena Beasley in Los Angeles; additional reporting by Jennifer Rigby; editing by Matthew Lewis and Mark Heinrich)
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