A real hope? Antiviral drug can be used to block the coronavirus

People in masks to protect against coronavirus, walk past a boarded up storefront along 14th Street in Northwest Washington, Wednesday, April 29, 2020. (AP Photo/Andrew Harnik)

The Associated Press

Dr. Anthony Fauci: 'What it has proven is that a drug can block this virus'

The Associated Press

Scientists on Wednesday announced the first effective treatment against the coronavirus — an experimental drug that can speed the recovery of COVID-19 patients — in a major medical advance that came as the economic gloom caused by the scourge deepened in the U.S. and Europe.

The U.S. government said it is working to make the antiviral medication remdesivir available to patients as quickly as possible.

“What it has proven is that a drug can block this virus,” said Dr. Anthony Fauci, the U.S. government's top infectious-disease expert. “This will be the standard of care.” 

Still, word of the new drug came as the U.S. government reported that American economic output is shriveling in the biggest and fastest collapse since the Depression. The virus has killed over 220,000 people worldwide, including more than 60,000 confirmed deaths in the U.S., and led to lockdowns and other restrictions that have closed factories and other businesses around the globe.

Confirmed infections globally reached about 3.2 million, including 1 million in the U.S., according to a tally by Johns Hopkins University. The true numbers of deaths and infections are believed to be much higher because of limited testing, differences in counting the dead and concealment by some governments.

California-based biotech company Gilead Sciences and the U.S. government reported that in a major study, remdesivir shortened the time it takes for COVID-19 patients to recover by four days on average — from 15 days to 11. Also, a trend toward fewer deaths was seen among those on the drug, Fauci said.

The study was run by the U.S. National Institutes of Health and involved 1,063 hospitalized coronavirus patients around the world. 

In a study of 1,063 patients sick enough to be hospitalized, Gilead Sciences's remdesivir shortened the time to recovery by 31% — 11 days on average versus 15 days for those just given usual care. The drug also might be reducing deaths, although that's not certain from results of the study so far.

An effective treatment could have a profound effect on the outbreak, since a vaccine is probably a year or more away.

No drugs are currently approved for treating the coronavirus, which has killed about 226,000 people worldwide since it emerged late last year in China. An effective treatment could have a profound effect on pandemic's impact, especially because a vaccine is likely to be a year or more away. 

Fauci revealed the results while speaking from the White House. Remdesivir was being evaluated in at least seven major studies, but this one, led by the NIH, was the strictest test. Independent monitors notified study leaders just days ago that the drug was working, so it was no longer ethical to continue with a placebo group.

The drug had "a clear-cut significant positive effect," shortening the time to hospital discharge by four days, Fauci said. 

By comparison, antiviral drugs for the flu shorten illness by about one day on average and only when started within a day or two of symptoms first appearing. 

About 8 percent of those on the drug died versus 11.6 percent of the comparison group, but the difference is not large enough for scientists to say that remdesivir was the reason.

Remdesivir is among dozens of treatments being tested against the coronavirus but was the farthest along in study. It's given through an IV and blocks an enzyme the virus uses 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. 

"We are excited and optimistic" about the new results, said Vanderbilt University's Dr. Mark Denison. His lab first tested remdesivir against other coronaviruses in 2013 and has done much research on it since, but was not involved in the NIH study.

"It's active against every coronavirus that we've ever tested," Denison said. "It was very hard for the virus to develop resistance to remdesivir. That means the drug would likely be effective over longer term use."

The NIH study quickly enrolled its original goal of 440 patients and then was expanded to give more answers on questions such as which subgroups may or may not benefit, and other factors that may affect success, such as how early the drug was given. Fauci said full results would soon be published in a medical journal.

The study only tested the drug in patients sick enough to be hospitalized, so its safety and effectiveness for people less ill isn't known, Fauci said.

The study also will continue to enroll new patients. It was set up as an umbrella trial to test many treatments, although they now will have to be tested against remdesivir or with it, Fauci said.

Separately on Wednesday, California-based Gilead announced partial results from its own ongoing study of the drug in severely ill, hospitalized COVID-19 patients. The company said patients treated for five days "achieved similar improvement" in health as others treated for 10 days. However, that result is hard 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. 

Yet another study tested remdesivir in severely ill patients in China, which was stopped after only 237 of a planned 453 patients were enrolled. Partial results published Wednesday in the British medical journal Lancet suggest the drug did not speed recovery in that study, but it was too small to be definitive, Fauci and study leaders said.

Gilead also is testing remdesivir in a separate study of moderately ill coronavirus patients. No results have yet been announced from that study, which does have a comparison group. 

Besides these studies, Gilead also has given remdesivir to more than 1,700 patients on a case-by-case emergency basis. The drug is not yet approved anywhere in the world for any use.

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

Gilead said it was ramping up production and aims to have more than 140,000 treatment courses by the end of May, more than 500,000 by October and more than 1 million by December. 

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WSullivan
WSullivan

Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial:

“Findings: Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less (hazard ratio 1·52 [0·95–2·43]). Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early.

Interpretation: In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits. However, the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies.”


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