Antiviral drug may speed up recovery process

Fauci says remdesivir showing promise as COVID-19 treatment

A federal trial has shown that treatment with remdesivir, an experimental antiviral drug, can speed recovery in patients infected with the coronavirus, Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said on 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 at least 50,000 people in the United States and infected more than 1 million. Worldwide, the death toll is now at least 220,000. Doctors and patients are desperate for an effective treatment.

Earlier on Wednesday, Gilead had announced that the company was “aware of positive data” from the 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 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 NIAID. The time to recovery averaged 11 days among those who got the drug, compared with 15 days for those who got the placebo.

Dr. Hana El-Sahly, a Baylor College of Medicine professor of molecular virology and microbiology who led the Houston arm of the trial, said Wednesday she wasn’t surprised by the news out of Washington. She said the trial results are “very significant from a public health standpoint,” given lockdowns imposed to enable hospitals to cope with the volume of patients.

“Shortening the duration of the illness by four days per pa

tient on average means that any given hospital can provide care to more patients,” said El-Sahly. “At an individual level, the result signifies that the drug shortened the duration of suffering for the patient himself or herself.”

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. And the study was done with a placebo.

“We found out something,” Finberg said. “If we had done it by anecdote, we would have learned nothing.”

But the disclosure of trial results in a political setting, prior to peer review or publication, is very unusual, said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who has conducted dozens of clinical trials.

“Where are the data?” he asked. Scientists will need to see figures on harms associated with the drug in order to assess its benefits, he added.

“This is too important to be handled in such a sloppy fashion,” Nissen said.

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. Gilead has also sponsored a number of trials without a placebo arm, instead comparing patients based on the duration they got the drug. Houston Methodist Hospital participated in two of those.

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 on Wednesday in the Lancet, found no benefit to the drug compared with a placebo.