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More positive results for antiviral drug remdesivir in battle against COVID-19

Wednesday, June 03, 2020
Chicago Tribune
by Hal Dardick

The antiviral drug remdesivir appears to be promoting recovery in patients who are moderately ill with COVID-19, according to new trial results.

The results, released by remdesivir maker Gilead Sciences but not yet peer reviewed and published, involved patients who had COVID-caused pneumonia without reduced oxygen levels in their blood. Those who received the intravenous drug were 65% more likely to improve than those provided with “standard” care, researchers found.

Improvement in that group would generally be determined by discharge from the hospital or a decision that no further treatment was needed for COVID-related conditions, said Dr. Gregory Huhn, an infectious disease expert who is leading an arm of the trial for the Cook County Health and Hospitals System.

It’s the second set of encouraging results for the drug, which was originally designed to treat Ebola, albeit with limited success. Back in late April, a National Institutes of Health trial concluded that severely ill COVID-19 patients given remdesivir recovered 31% faster than patients given a placebo.

That trial, plus an earlier Gilead study that found five-day treatments were as effective as 10-day treatments, led the U.S. Food and Drug Administration to allow emergency use of the drug in severely ill patients, or those whose blood oxygen level has dropped below 95% or otherwise require supplemental oxygen.

The drug is still considered experimental and has not been approved for general use. Further studies by the Institutes of Health and medical facilities working with Gilead continue to evaluate the drug, and those trials will figure into the FDA’s ultimate decision.

 

“Now with solid evidence of clinical improvement for both severe illness and moderate illness ... I would believe that these data would move the FDA for licensure consideration,” Huhn said.

The recent finding that improvements were statistically significant in patients who got the drug for five days — and those who received it for 10 days did no better than the five-day group — was considered a positive development.

That’s because remdesivir can be complicated and expensive to make, so being able to treat patients with a five-day supply rather than the amount required for 10 days means the available drug supplies could go twice as far. The current stockpile was donated by Gilead to the federal government, which is distributing the drug to hospitals based on determinations of need.

Gilead also is exploring whether it can produce an inhalable form of the drug, which would allow the medication to be administered outside hospital settings. An inhalable version also could be better at targeting SARS-CoV-2, the virus that causes COVID-19, because it would quickly hit nasal passages where the virus typically gets its toehold.

The only other drug to receive emergency use authorization from the FDA for treating COVID-19 is hydroxychloroquine. But recent studies on that particular medicine, which has been touted by President Donald Trump, have not been encouraging and suggest the drug can do more harm than good. That has led European countries to move toward halting the use of hydroxychloroquine to treat COVID-19.



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