Washington – U.S. scientists on Wednesday hailed a potential breakthrough in the coronavirus fight as a trial showed patients responding to an antiviral drug, fueling global hopes for a return to normal despite mounting deaths.
In the first proof of successful treatment against the illness that has claimed more than 226,000 lives, a clinical trial of the drug remdesivir showed that patients recovered about 30 percent faster than those on a placebo.
"The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery," Anthony Fauci, the top U.S. epidemiologist who oversaw the study, told reporters at the White House.
Fauci likened the finding to the first retrovirals that worked, albeit with modest success, against HIV in the 1980s.
The trial, which involved 1,063 people across 68 locations in the U.S., Europe and Asia, showed that "a drug can block this virus," Fauci said.
Remdesivir failed in trials against the Ebola virus and a smaller study, released last week by the World Health Organization, found limited effects among patients in Wuhan, China, where the illness was first detected last year.
Senior WHO official Michael Ryan declined to weigh in on the latest findings Wednesday, saying he had not reviewed the complete study.
"We are all hoping — fervently hoping — that one or more of the treatments currently under observation and under trial will result in altering clinical outcomes" and reducing deaths, he said.
The U.N. health agency said its emergency committee would meet Thursday for the first time since it declared coronavirus an international emergency three months ago.
The U.S. Food and Drug Administration said it has been in discussions with Gilead about making remdesivir available to patients as quickly as possible, but the agency declined to comment on any plans to grant the drug regulatory approval.
"I want them to go as quickly as they can," President Donald Trump said, when asked if he wanted the FDA to grant emergency use authorization for remdesivir. "We want everything to be safe, but we would like to see very quick approvals, especially with things that work."
The closely watched drug, given by intravenous infusion to hospitalized patients, has moved markets in the past few weeks following the release of data from several studies that painted a mixed picture of its effectiveness, and Fauci cautioned that the latest data still needs to be analyzed.
Interest in remdesivir has been high as there are no approved treatments or preventive vaccines for COVID-19, and doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in severe cases.
Doctors on the front lines of the COVID-19 battle have been eager for results from the NIH study because it is a large trial in which patients were randomized to treatment with the drug or a placebo without participants or doctors knowing which group they were in — the gold standard for clinical trials.
Gilead earlier this month said the company was prepared to donate to hospitals its existing supply of 1.5 million doses of remdesivir — enough for more than 140,000 patients depending on length of treatment. Regulatory approval of the drug would also clear the way for commercial sales.
The company did not immediately respond to a request for comment on other supply plans.
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, said partial results from its 1,063-patient trial show that hospitalized COVID-19 patients given remdesivir recovered in 11 days, compared to 15 days for patients given a placebo.
The study showed a trend toward better survival for remdesivir — 8 percent of patients given the drug died compared with 11.6% in the placebo group — but the difference was not statistically significant so may not be due to Gilead's drug.
The trial's lead researcher told Reuters on Friday that full results could come by mid-May.
"The full dataset will provide more clarity on how remdesivir can best be used," said Dr. Aneesh Mehta, a researcher on the NIH trial from Emory University School of Medicine in Atlanta.
Despite the excitement, Dr. Lawrence K. Altman, global fellow at The Wilson Center in Washington, DC, was not ready to celebrate the preliminary findings.
The new data "offers a glimmer of hope" that remdesivir has an effect against COVID-19, but more scientific analysis is needed "comparing them to other studies of the drug that have shown mixed results," he said in a statement.
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