Antiviral drug remdesivir shortens time to recover from pandemic virus, top U.S. health official says

A top U.S. health official said GileadSciences Inc's experimental antiviral drug remdesiviris likely to become the standard of care for COVID-19 afterearly results from a key clinical trial on Wednesday showed ithelped certain patients recover more quickly from the illnesscaused by the coronavirus.

The study, run by the U.S. National Institutes of Health, tested remdesivir versus usual care in 1,063 hospitalized coronavirus patients around the world. At the White House, NIH's Dr. Anthony Fauci said the drug reduced the time it takes patients to recover by 31 per cent11 days on average versus 15 days for those just given usualcare.

Gilead earlier on Wednesday said remdesivir helped improveoutcomes for patients with COVID-19 in the government-run trial,and provided additional data suggesting it worked better whengiven earlier in the course of illness. The statement sent its shares up seven per cent on the Nasdaq.

"The data shows that remdesivir has a clear cut significantpositive effect in diminishing the time to recover. This isreally quite important," Fauci told reporters at the WhiteHouse, likening it to a moment in 1986 "when we were strugglingfor drugs for HIV and we had nothing."

"This will be the standard of care," Fauci predicted,adding, "The FDA, literally as we speak, is working with Gileadto figure out mechanisms to make this easily available to thosewho need it."

Several studies have painted amixed picture of its effectiveness, and Fauci cautioned that thefull data still needs to be analyzed.

"Although with 31 per cent improvement doesn't seem like a knockout 100 per cent, it is a very important proof of concept, because what it is proven is that a drug can block this virus."

"There's now enough data to support consideration of accessunder an emergency use authorization by FDA," former U.S. Foodand Drug Administration Commissioner Scott Gottlieb said onTwitter.

Gilead provided information on two clinical trials. Thestudy conducted by the U.S. National Institute of Allergy andInfectious Diseases (NIAID), part of the National Institutes ofHealth, met its main goal of helping patients with a range ofseverity of COVID-19, the disease caused by the novelcoronavirus.

Mixed results

Despite the excitement, Dr. Lawrence K. Altman, globalfellow at The Wilson Center in Washington, DC, said moreinformation is needed.

"While a new study offers a glimmer of hope that ...remdesivir has an effect against COVID-19, determination of itsbenefit for the general population must await release ofpertinent details to evaluate the study's findings and
scientific analysis comparing them to other studies of the drugthat have shown mixed results," he said in a statement.

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Gilead also provided data on a study in severe COVID-19patients it has conducted in dozens of medical centres, whichdoes not have a placebo comparison but tested the drug given byintravenous infusion under five-day and 10-day regimens.

In that 397-patient trial, Gilead said 62 per centof patientstreated early with remdesivir were discharged from the hospital,compared with 49 per centof patients who were treated later in thecourse of the infection.

Gilead Chief Medical Officer Merdad Parsey in a statementsaid a five-day regimen, "could significantly expand the numberof patients who could be treated with our current supply ofremdesivir."

Also on Wednesday, results were published by the Lancetmedical journal of a trial conducted in China that concludedremdesivir failed to improve patients' condition or reduce thepathogen's presence in the bloodstream. Gilead said previouslythat those findings, released inadvertently by the World HealthOrganization last week, were inconclusive because the study wasterminated early.

Gilead chief executive Daniel O'Day earlier this month saidthe company was prepared to donate 1.5 million doses ofremdesivir to hospitals dealing with severely ill patients.Regulatory approval of the drug would also clear the way forcommercial sales.

Remdesivir, which previously failed as a treatment forEbola, is being tried against COVID-19 because it is designed todisable the mechanism by which certain viruses make copies ofthemselves and potentially overwhelm their host's immune system.

The company is also studying the drug in patients with lesssevere COVID-19, but those results are not expected until laternext month.

Dr MikeRyan, head of the WHO's emergencies program, told an onlinebriefing it can sometimes takea number of publications to determine a drug's efficacy.

"Clearly we have the randomized control trials that areunderway both in the U.K. and U.S, the 'Solidarity trials' withWHO. Remdesivir is one of the drugs under observation in many ofthose trials. So I think a lot more data will come out," hesaid.

Ryan added: "But we are hopeful this drug and others mayprove to be helpful in treating COVID-19."