For the first time, a major study suggests that an experimental drug works against the new coronavirus, and U.S. government officials said Wednesday that they would work to make it available to appropriate patients as quickly as possible.
In a study of 1,063 patients sick enough to be hospitalized, Gilead Sciences' remdesivir shortened the time to recovery by 31% -- 11 days on average versus 15 days for those just given usual care, officials said. The drug also might be reducing deaths, although that's not certain from the partial results revealed so far.
"What it has proven is that a drug can block this virus," the National Institutes of Health's Dr. Anthony Fauci said.
"This will be the standard of care," and any other potential treatments will now have to be tested against or in combination with remdesivir, he said.
No drugs are approved now for treating the coronavirus, which has killed about 227,000 people worldwide since it emerged late last year in China. An effective treatment for covid-19 could have a profound effect on the 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 National Institutes of Health, 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.
Dr. Elizabeth Hohmann, who enrolled 49 patients in the experiment at Massachusetts General Hospital, said study leaders were told Tuesday night that the results are based on "the first cut of 460 patients."
"There's over 1,000 in the study so there's a lot more information to come" and full results need to be seen, she said. "I'm cautiously optimistic."
Dr. Babafemi Taiwo, chief of infectious diseases at Northwestern Medicine, which also participated in the study, called the results "really exciting."
"For the first time we have a large, well-conducted trial" showing a treatment helps, he said. "This is not a miracle drug ... but it's definitely better than anything we have."
Fauci said the partial results showed that the drug had "a clear-cut significant positive effect," shortening the time to hospital discharge by four days. 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.
In the remdesivir study, about 8% of those on the drug died versus 11.6% of the comparison group, but the difference is not large enough for scientists to say the drug was the reason.
No information was given on side effects. Fauci said full results would be published in a medical journal soon.
Remdesivir is among dozens of treatments being tried against the coronavirus but was the farthest along in testing. It's given through an IV and blocks an enzyme the virus uses to copy its genetic material.
"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 National Institutes of Health 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."
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.
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.
RUN ON PEPCID
Meanwhile, after reports about a clinical trial of famotidine, the active ingredient in Pepcid, a best-selling antacid, for coronavirus patients at the Feinstein Institutes for Medical Research at Northwell Health, the drug was sold out or in low stock at most major retailers online Monday and Tuesday. Walgreens and CVS told The Washington Post that they have seen a run on the heartburn medicine and are working to resupply.
Experts advise that the drug is unproven as a coronavirus treatment.
The clinical trial using the drug, which was first reported by Science Magazine, began April 7 and has been largely under wraps to ensure that the drug was in supply for other uses.
"If we talked about this to the wrong people or too soon, the drug supply would be gone," Kevin Tracey, a former neurosurgeon in charge of the hospital system's research, told Science Magazine.
While the drug's use for heartburn isn't critical, the over-the-counter medicine has other purposes. Famotidine can be used in emergency rooms as part of a treatment regimen for allergic reactions or in intensive care units for stress ulcer prophylaxis, Bryan Hayes, pharmacist for Massachusetts General Hospital's Department of Emergency Medicine and Harvard University assistant professor, told The Post.
Information for this article was contributed by Marilynn Marchione and Matthew Perrone of The Associated Press; and by Meryl Kornfield of The Washington Post.
A Section on 04/30/2020
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