A randomized trial conducted by the World Health Organization found that remdesivir, an antiviral drug authorized to treat COVID-19, was not found to shorten hospital stays nor improve mortality.
The WHO studied the impacts of four drugs, including remdesivir, in a study on more than 11,000 people in 30 countries. Remdesivir has been widely used and become part of the standard of care for COVID-19 patients in the United States.
The study found that remdesivir produced "no material effects on ventilation initiation or time to discharge," in hospitals the study authors wrote. The data published late Thursday is preliminary and has not been peer reviewed.
A decrease in hospital stay duration was one of Gilead's justifications for pricing remdesivir at $3,120 per five-day treatment course. Gilead claimed in June that supposed earlier hospital discharges could save U.S. hospitals $12,000 per patient. Health policy experts have been skeptical of savings estimates for hospitals.
Gilead challenged the WHO study's findings in a written statement highlighting the potential differences in execution of the trial over such a wide range of medical systems.
"The trial design prioritized broad access, resulting in significant heterogeneity in trial adoption, implementation, controls and patient populations and consequently, it is unclear if any conclusive findings can be drawn from the study results," Gilead stated.
But Dr. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, who called for more research before the U.S. government decided to aggressively secure supplies of remdesivir, called for Gilead to drop the drug's price to production cost until the company can prove a benefit in severely ill COVID-19 patients receiving the steroid dexamethasone.
"They have banked billions already from remdesivir sales, so they can afford to do this critical study that will help us know in whom this treatment should be used," Bach said.
The Institute for Clinical and Economic Review's cost-effectiveness analysis of remdesivir dropped from a maximum of $5,080 per 10-day treatment course if remdesivir were shown to have a mortality benefit compared with $310 if it were not.
HHS is no longer overseeing distribution of remdesivir to hospitals as of Oct. 1, as the agency said that demand has waned and production has expanded.
The FDA issued an emergency use authorization for remdesivir in May based on a National Institute for Allergy and Infectious Diseases study that found the drug decreased time to recovery.