Gilead drug proves effective against coronavirus in US study
By MARILYNN MARCHIONE
FILE – In this March 2020 photo provided by Gilead Sciences, a vial of the investigational drug remdesivir is visually inspected at a Gilead manufacturing site in the United States. On Wednesday, April 29, 2020, the company says its experimental antiviral drug has proved effective against the new coronavirus in a major U.S. government study that put it to a strict test. (Gilead Sciences via AP)
An experimental drug has proved effective against the new coronavirus in a major study, shortening the time it takes for patients to recover by four days on average, U.S. government and company officials announced Wednesday.
Gilead Sciences’s remdesivir is the first treatment to pass such a strict test against the virus, which has killed more than 218,000 people since it emerged late last year in China. Having a treatment could have a profound effect on the global pandemic, especially because health officials say any vaccine is likely a year or more away.
The study, run by the National Institutes of Health, tested remdesivir versus usual care in 1,063 hospitalized coronavirus patients around the world. At the White House, NIH’s Dr. Anthony Fauci said the drug reduced the time it takes patients to recover by 31% — 11 days on average versus 15 days for those just given usual care.
He also said there was a trend toward fewer deaths among those on remdesivir, and that full results would soon be published in a medical journal.
“What it has proven is that a drug can block this virus,” Fauci said. “This will be the standard of care.”
A statement from the Food and Drug Administration says that the agency has been talking with California-based Gilead “regarding making remdesivir available to patients as quickly as possible, as appropriate.”
Remdesivir is among many treatments being tested against the coronavirus but was the farthest along in study.
The drug is given through an IV and is designed to interfere with the virus’s ability to copy its genetic material. In animal tests against SARS and MERS, diseases caused by similar coronaviruses, the drug helped prevent infection and reduced the severity of symptoms when given early enough in the course of illness. But it is not yet approved anywhere in the world for any use.
The NIH study quickly enrolled its original goal of 440 patients and then was expanded to give more answers on questions such as which subgroups may or may not benefit, and other factors that may affect success, such as how early in the course of illness the drug was given.
The study’s main goal also was altered. Originally, it was the percentage of patients having various outcomes such as needing a breathing machine, fully recovered or dying 15 days after starting treatment. The new main goal is time to recovery, such as no longer needing oxygen or hospitalization.
“We are excited and optimistic,” said one expert, Vanderbilt University’s Dr. Mark Denison.
A similar drug, Kevzara, did not work as well at low doses in a study of severely ill coronavirus patients, its makers Sanofi and Regeneron said. They’re continuing to test it at higher doses in critically ill patients, though.
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AP reporter Matthew Perrone in Washington contributed to this report.
