Study: Remdesivir appears to speed recovery times in hospitalized COVID-19 patients

Study: Remdesivir appears to speed recovery times in hospitalized COVID-19 patients

The first possible scientifically proven treatment for COVID-19 emerged Wednesday with early data from a global study finding patients given the experimental drug remdesivir recovered faster and may be less likely to die.

Early results released from the global study conducted by the U.S. National Institute of Allergy and Infectious Diseases found patients who received remdesivir had a 31% faster recoverytime than those who received a placebo.

While not a "knock out," NIAID director Anthony Fauci said at an Oval Office meeting Wednesday the study results were "a very important proof of concept."

President Donald Trump added, “But certainly ... it's a positive, it's a very positive event.”

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In this March 2020 photo provided by Gilead Sciences, rubber stoppers are placed onto filled vials of the investigational drug remdesivir at a Gilead manufacturing site in the United States.

The data released Wednesday was from a subset of patients, about half the total, said Aneesh Mehta, lead investigator for the portion of the trial at Emory University in Atlanta, Georgia.

There also was some evidence the mortality rate in those given remdesivir was lower than in those who got the placebo but it was not as statistically significant, he said.

"The data indicate there may be some benefit in overall mortality, these are preliminary data, we need to wait for final data," he said.

Remdesivir is an experimental antiviral drug from the American biotech firm Gilead Sciences. It was originally developed to treat Ebola but didn’t work, and it has been re-purposed as a possible COVID-19 treatment.

The NIAID study involved 1,063 hospitalized COVID-19 patients whose lungs were affected.

A subset of about half those patients who got remdisivir had a median recoverytime of 11 days while patients who got a placebo had a median recoverytime of 15 days. Recovery was defined as being well enough to be discharged from the hospital or able to return to normal levels of activity.

The patients given remdesivir also had a lower mortality rate – 8% of them died compared with 11.6% of the placebo group.

"We don’t have enough data to know if that’s a statistically significant difference yet or not," Mehta said.

At the Oval Office meeting, Fauci read a summary of the Gilead trials to reporters. He said the tests showed "a drug can block this virus," and noted the findings would be peer-reviewed.

"This is really quite important," he said. "It is highly significant."

The Food and Drug Administration is working with Gilead, Fauci said.

As part of the FDA's commitment to expediting the development and availability of potential COVID-19 treatments, spokesman Michael Felberbaum said the agency has been engaged in sustained and ongoing discussions with Gilead regarding making remdesivir available to patients as quickly as possible and appropriate.

Gilead stock rose 5.68% on Wednesday's news.

The optimism of the NIAID study was muted somewhat by another published Wednesday in the British medical journal The Lancet that found no clinical benefits to the drug.

The randomized, double-blind, placebo-controlled trial at 10 hospitals in Wuhan, China, found no statistically significant difference in how quickly patients improved. Though a higher number of patients receiving remdesivir showed a faster time to clinical improvement the numbers weren't enough to be more than chance.

The Chinese study hoped to enroll 325 patients but because the outbreak was waning in Wuhan, researchers were only able to enroll 237, reducing its statistical power from 80% to 58%. They called for larger studies to be done.

Emory researcher Mehta, however, called the NIAID study findings "an important development."

“We believe remdesivir is the first medication to show a positive effect on patients with COVID-19,” he said. "We look forward to more data coming to confirm these preliminary data.”

Mehta stressed remdesivir and other antivirals are not "silver bullets" that immediately get rid of an infection and the damage doesn't just "all go away" when the virus is gone.

"These antivirals are only part of the treatment,” he said. "They take time to work and they work by slowly preventing the virus from making more of itself."

An important question to answer moving forward is whether outcomes differed depending on when sick patients received the antiviral drug.

"We know from other infectious diseases that the sooner you treat someone with an antiviral, the better they do," said Rajesh Gandhi, an infectious diseases physician at Massachusetts General Hospital in Boston.

"Once we know more we will be in a better place, but this is encouraging, we were looking for something that we could build on," he said.

Preliminary data released Wednesday from a different study conducted by Gilead seemed to indicate that patients who received just five days of remdesivir did as well as those who received 10 days. That could be important depending on the cost of the drug when it is available for sale.

Source: https://www.usatoday.com/story/news/2020/04/29/coronavirus-remdesivir-may-speed-recovery-times-covid-19-patients/3048073001/

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