FDA authorizes use of drug that sped up recovery and reduced deaths
BY LISA M. KRIEGER
THE MERCURY NEWS/TNS
SAN JOSE, Calif. – A government-run study of Gilead Science’s remdesivir, the most promising experimental drug to treat COVID-19, shows that it helps patients with advanced disease, shortening their illness and slightly reducing death rates.
In long-awaited news, the National Institute of Allergy and Infectious Diseases announced on Wednesday morning that a preliminary data analysis shows that hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received an inactive placebo.
Specifically, patients who received the drug made by the Foster City, Calif.-based company had a 31% faster time to recovery than those who received placebo. The median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo.
FDA eases rules
Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group.
The U.S. Food and Drug Administration (FDA) announced Wednesday an emergency use authorization for the drug, according to The New York Times. This is an easing of rules, due to the urgency of need, that would allow the drug to be used without formal and time-consuming federal review or approval.
Meeting with reporters at the White House on Wednesday, NIAID Director Dr. Anthony S. Fauci, the federal government’s leading infectious diseases scientist, cautioned that the results still need to be properly peer reviewed.
But he expressed optimism that it could help make a difference in speeding up the recovery of some patients.
“Although a 31% improvement doesn’t seem like a knockout 100%, it is a very important proof of concept because what it has proven is that a drug can block this virus,” said Fauci, according to The New York Times. “This is very optimistic.”
Until now, information about the drug has been leaked out in drips without sufficient data, with conflicting reports about the drug’s potential benefit.
Many of the trials have been uncontrolled or poorly controlled. A Chinese study was stopped early due to too few patients, so it was grossly under-powered.
But the government’s randomized, controlled trial involving 1063 patients, which began on Feb. 21, is considered the gold standard of research. The trial, known as the Adaptive COVID-19 Treatment Trial, or ACTT, is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19.
April 27 review
An independent data and safety monitoring board overseeing the trial met on April 27 to review data and shared their interim analysis with the study team, according to NIAID. The trial closed to new enrollments on April 19.
Based upon their review of the data, they noted that remdesivir was better than placebo from the perspective of the primary endpoint, time to recovery, a metric often used in influenza trials. Recovery in this study was defined as being well enough for hospital discharge or returning to normal activity level.
More detailed information about the trial results, including more comprehensive data, will be available in a forthcoming report, according to NIAID.
“I am so glad that I could be one of the ‘guinea pigs,’ said remdesivir patient Monica YeungArima of Palo Alto, who believes she received the drug while hospitalized for 13 days at Stanford Hospital in early March.
“I’m so glad that there’s positive news and the drug can possibly be used in many patients soon. Even if it’s not a 100% cure, it will put many people at ease to have a solution,” she said.
Infusions for days
Enrolled in a randomized trial at Stanford, Yeung-Arima received intravenous infusions for five days. Three days later, she began to feel better.
Now, nearly two months after becoming infected on a Nile River cruise, she is back to her normal routine, although she still has chest congestion and an intermittent cough.
Also on Wednesday, Gilead said that a different trial showed that patients who were given the drug earlier showed a faster response to treatment.