Experimental drug shows early promise, Fauci says
Remdesivir helped ill patients recover faster during trial
A federal trial has shown that treatment with remdesivir, an experimental antiviral drug, can speed recovery in patients infected with the coronavirus, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Wednesday.
The Food and Drug Administration is likely at some point to announce an emergency approval for remdesivir, a senior administration official told The New York Times. Eventually the drug, made by Gilead Sciences, could be the first approved treatment for COVID-19, the illness caused by the coronavirus.
The virus has killed more than 60,000 people in the United States and infected more than 1 million, according to a tally by Johns Hopkins University. Worldwide, the death toll is now at least 226,000.
Doctors and patients are desperate for an effective treatment.
Earlier Wednesday, Gilead had announced that the company was “aware of positive data” from the federal trial. Trading in the company’s stock was halted before the market opened, and the glimmer of good news drove stocks higher, despite poor economic data.
In a news briefing at the White House, Fauci and President Donald Trump hailed the early results of the federal trial, holding out hope that the drug could help very ill patients recover more quickly.
“It is a very important proof of concept, because what it has proved is that a drug can block this virus,” Fauci said.
The trial enrolled 1,063 patients who were given remdesivir or a placebo, according to the NIAID. The time to recovery averaged 11 days among those who got the drug, compared with 15 days for those who got the placebo.
There were fewer deaths in the remdesivir group, but the result did not reach statistical significance, Fauci said. Deaths were not a primary measure in the trial.
Fauci cautioned that the results of the study still need to be properly peer reviewed, but he expressed optimism that remdesivir would become “the standard of care” for patients with COVID-19.
“Certainly it’s positive, it’s a very positive event,” Trump said.
In the past, he has hailed remdesivir as a potential “game changer,” despite spotty evidence.
Dr. Robert Finberg, an investigator in the trial, noted that the sample was huge, and the results finished in record time.
But the disclosure of trial results in a political setting, before peer review or publication, is unusual, said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who has conducted dozens of clinical trials.
“Where are the data?” he asked.
Dr. Michele Barry, global health expert at Stanford University, said she had faith in Fauci’s assessment.
Still, she added, “It is unusual to call a drug the ‘standard of care’ until peer review of data and publication, and before studies have shown benefit in mortality.”
Remdesivir has never been approved as a treatment for any disease. It was developed to fight Ebola, but results from a clinical trial in Africa were disappointing.
But as the coronavirus pandemic took hold, the drug emerged as one of the more promising potential treatments. It interrupts the production of the virus in lab studies and seems safe in animals.
Until now, high expectations for remdesivir have been fueled largely by anecdotal reports of COVID-19 patients who took the drug and recovered.
Two such reports were published in the prestigious New England Journal of Medicine, lending credibility to what researchers said were actually uncertain results.
Without trials comparing the drug to a placebo, it has been impossible to know whether the drug made a difference or patients got better on their own with normal supportive care.
A separate study of remdesivir, published Wednesday in the Lancet, found no benefit to the drug, compared with placebo.
“Unfortunately, our trial found that while safe and adequately t olerated, remdesivir did not provide significant benefits over placebo,” said the lead investigator of the new study,
Dr. Bin Cao of the ChinaJapan Friendship Hospital and Capital Medical University in Beijing.
The results are hard to interpret, because the study was far smaller than planned — enrolling 236 patients instead of the 453 that had been expected, because there were too few severely ill patients now in China.
Dr. Eric Peterson, a clinical trials expert at Duke University, said that with too few patients, “all you can say is it doesn’t seem to work in this population.”
If there had been a big effect of the drug, he added, that would have been seen.