Remdesivir proves effective against coronavirus in major study: ‘We’ve got a drug that works,’ UIC researcher says

The Food and Drug Administration says that the agency has been talking with the California-based Gilead about making remdesivir available to patients as quickly as possible.

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In this photo illustration a Gilead logo is displayed on a smartphone next to a screen showing a coronavirus graphic on March 25, 2020 in Arlington, Virginia. - Gilead announced on March 25, 2020 that it has submitted a request to the Food and Drug Administration to rescind the exclusive marketing rights it had secured for remdesivir, an antiviral drug that shows promise in treating Covid-19, the disease caused by the new coronavirus.

Photo by OLIVIER DOULIERY/AFP via Getty Images

Promising results from a major study into an experimental drug used to treat the new coronavirus should give people a sense of relief that “we’ve got a drug that works,” a physician at University of Illinois at Chicago Health who participated in the study says.

“They’re really good results,” Dr. Richard Novak, chief of infectious disease at UIC, told the Sun-Times Wednesday of the drug made by Gilead Sciences, called remdesivir.

He added: “That’s great and should give some people a sense of relief who are concerned about getting sick.”

Remdesivir is the first drug to show such promising results against the virus, which has killed more than 218,000 people since it emerged late last year in China. Having a treatment could have a profound effect on the global pandemic, especially because health officials say any vaccine is likely a year or more away.

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The study, run by the National Institutes of Health, tested remdesivir versus the usual care given 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% — 11 days on average versus 15 days for those just given usual care.

Can block virus

He also said there was a trend toward fewer deaths among those on remdesivir, and that full results would soon be published in a medical journal.

“What it has proven is that a drug can block this virus,” Fauci said. “This will be the standard of care.”

A statement from the Food and Drug Administration says that the agency has been talking with California-based Gilead “regarding making remdesivir available to patients as quickly as possible, as appropriate.”

The drug is given through an IV and is designed to interfere with the virus’s ability to copy its genetic material. In animal tests against SARS and MERS, diseases caused by similar coronaviruses, the drug helped prevent infection and reduced the severity of symptoms when given early enough in the course of illness. But it is not yet approved anywhere in the world for any use.

Only hospitalized patients can use

Because the drug is given through an IV, only patients who are hospitalized will be able to receive it for the time being, Novak said.

“It’s going to be challenging to give in an outpatient setting,” Novak said.

The drug will also continue to be tested with other drugs to see if a combination of treatments will produce more positive outcomes, he said.

“We’re not done yet. We still need to find more and better treatments,” Novak said.

A less encouraging picture came from partial results from a separate study testing remdesivir in severely ill patients in China, published Wednesday in the British medical journal Lancet. Treatment did not speed recovery in that study, which was stopped after only 237 of a planned 453 patients were enrolled.

2nd study shows improvements

Separately on Wednesday, Gilead announced partial results from its own ongoing study of the drug in severely ill, hospitalized COVID-19 patients. The company said of patients who were treated with remdesivir within five days of an onset of symptoms, 65% achieved clinical recovery and 60% were discharged.

However, the results are difficult to interpret because there is no comparison group of people getting usual care, so it’s impossible to know how much patients would have improved on their own.

Stroger Hospital, which is taking part in the trial, has seen results that are “similar and consistent” with the overall results released by Gilead so far, said Dr. Gregory Huhn, an infectious disease physician for Cook County Health and principal site investigator for the trial here.

Huhn, however, said it will take more than a single drug to beat back this novel coronavirus.

“We need multiple strategies to defeat COVID-19,” Huhn said. “I think this drug ... in combination with a future vaccine, [could] provide a multi-pronged attack on COVID-19. So, I really think that an effective therapeutic along with effective prevention is going to get us to the other side of this pandemic.”

Stroger is also taking part in a trial examining more moderate COVID-19 cases. No results have yet been announced from that second study, which does have a comparison group getting usual care. The company said no new safety problems emerged in that study, and that it would publish results in a medical journal soon.

Other drugs researched

In other treatment-related news this week, two studies gave updates on anti-inflammatory drugs that aim to tamp down the severe inflammation that often develops in later stages of severe COVID-19 and often proves fatal.

A French hospital consortium reported success with using Acetemra, a Roche drug sold for rheumatoid arthritis and some other conditions, in a study of 129 coronavirus patients where 65 got the drug and the rest, usual care. No details were released; doctors said they were preparing to publish results.

A similar drug, Kevzara, did not work as well at low doses in a study of severely ill coronavirus patients, its makers Sanofi and Regeneron said. They’re continuing to test it at higher doses in critically ill patients, though.

Social distancing still needed

Novak said that the success of treating patients with remdesivir doesn’t mean that its use will necessarily have a significant impact on the need to continue social distancing.

“People are still dying from COVID-19, even with treatment from remdesivir,” Novak said. “The biggest concern has been [sick patients] overwhelming our hospitals with the number of cases. This won’t change that. We still need to be reducing the number of new cases.”

Contributing: AP

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