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Gilead Claims ‘Positive Data’ to Come From N.I.H. Trial of Remdesivir Remdesivir Shows Promise as Coronavirus Treatment, Fauci Says
(about 4 hours later)
Gilead Sciences on Wednesday announced that the company “is aware of positive data” from a federal trial of its experimental coronavirus drug, remdesivir, even as a new study reported that the drug offered no benefit to severely ill patients in China. A federal trial has shown that treatment with remdesivir, an experimental antiviral drug, can speed recovery in patients infected with the coronavirus, Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said on Wednesday.
Neither Gilead nor officials at the National Institute of Allergy and Infectious Diseases, sponsor of the federal research, provided further details about the trial sponsored by N.I.A.I.D., part of the National Institutes of Health. The Food and Drug Administration is likely at some point to announce an emergency approval for remdesivir, a senior administration official told The New York Times. Eventually the drug, made by Gilead Sciences, could be the first approved treatment for Covid-19, the illness caused by the coronavirus.
President Trump is expected to discuss the findings at a White House briefing later today. In the past, Mr. Trump has hailed remdesivir as a potential “game changer,” despite spotty evidence. The virus has killed at least 60,000 people in the United States and infected more than 1 million. Worldwide, the death toll is now at least 220,000. Doctors and patients are desperate for an effective treatment.
The other study, conducted in China and published in the Lancet, questioned the value of the drug for treatment of severely ill patients but left open the possibility that it might be useful for others. The research was incomplete, however, because not enough participants could be enrolled. Earlier on Wednesday, Gilead had announced that the company was “aware of positive data” from the federal trial. Trading in the company’s stock was halted before the market opened, and the glimmer of good news drove stocks higher, despite poor economic data.
Regarding the federal trial, the brief announcement by Gilead read: “We understand that the trial has met its primary endpoint and that N.I.A.I.D. will provide detailed information at an upcoming briefing.” In a news briefing at the White House, President Trump and Dr. Fauci hailed the early results of the federal trial, holding out hope that the drug could help very ill patients recover more quickly.
Trading in the company’s stock was halted before the market opened. The news drove stocks higher, and the S&P 500 rose about 2 percent in early trading. “It is a very important proof of concept, because what it has proved is that a drug can block this virus,” Dr. Fauci said.
The trial enrolled 1,063 patients who were given remdesivir or a placebo, according to N.I.A.I.D. The time to recovery averaged 11 days among those who got the drug, compared with 15 days for those who got the placebo.
The Food and Drug Administration acknowledged that officials were discussing approval of remdesivir for treatment of Covid-19 patients, presumably under emergency use provisions. There were fewer deaths in the remdesivir group, but the result did not reach statistical significance, Dr. Fauci said. Deaths were not a primary measure in the trial.
The N.I.A.I.D. study includes 400 patients who were hospitalized with Covid-19, the illness caused by the coronavirus, and randomly assigned to take remdesivir or a placebo. Outcomes were scored on a scale ranging from recovery to death. Dr. Fauci cautioned that the results of the study still need to be properly peer reviewed, but he expressed optimism that remdesivir would become “the standard of care” for patients with Covid-19.
“Certainly it’s positive, it’s a very positive event,” Mr. Trump said. In the past, he has hailed remdesivir as a potential “game changer,” despite spotty evidence.
Dr. Robert Finberg, an investigator in the trial, noted that the sample was huge, and the results finished in record time. And the study was done with a placebo.
“We found out something,” Dr. Finberg said. “If we had done it by anecdote, we would have learned nothing.”
But the disclosure of trial results in a political setting, prior to peer review or publication, is very unusual, said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who has conducted dozens of clinical trials.
“Where are the data?” he asked. Scientists will need to see figures on harms associated with the drug in order to assess its benefits, he added.
“This is too important to be handled in such a sloppy fashion,” Dr. Nissen said.
Dr. Michele Barry, an infectious disease expert at Stanford University, said she had faith in Dr. Fauci’s assessment. Still, she added, “It is unusual to call a drug the ‘standard of care’ until peer review of data and publication, and before studies have shown benefit in mortality.”
Remdesivir has never been approved as a treatment for any disease. It was developed to fight Ebola, but results from a clinical trial in Africa were disappointing.Remdesivir has never been approved as a treatment for any disease. It was developed to fight Ebola, but results from a clinical trial in Africa were disappointing.
But as the coronavirus pandemic took hold, the drug emerged as one of the more promising potential treatments. It interrupts the production of the virus in lab studies and seems safe in animals.But as the coronavirus pandemic took hold, the drug emerged as one of the more promising potential treatments. It interrupts the production of the virus in lab studies and seems safe in animals.
Expectations were fueled by anecdotal reports of Covid-19 patients who took remdesivir and recovered. Until now, high expectations for remdesivir have been fueled largely by anecdotal reports of Covid-19 patients who took the drug and recovered.
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Two such reports were published in the prestigious New England Journal of Medicine, lending credibility to what researchers later said were uncertain results. Two such reports were published in the prestigious New England Journal of Medicine, lending credibility to what researchers said were actually uncertain results.
Without trials comparing the drug to a placebo, it has been impossible to know whether the drug made a difference or patients got better on their own with normal supportive care.Without trials comparing the drug to a placebo, it has been impossible to know whether the drug made a difference or patients got better on their own with normal supportive care.
The study of remdesivir published in the Lancet found no benefit to the drug, compared to placebo. A separate study of remdesivir, published on Wednesday in the Lancet, found no benefit to the drug, compared with placebo.
“Unfortunately, our trial found that while safe and adequately tolerated, remdesivir did not provide significant benefits over placebo,” said the lead investigator of the new study, Dr. Bin Cao of the China-Japan Friendship Hospital and Capital Medical University in Beijing.“Unfortunately, our trial found that while safe and adequately tolerated, remdesivir did not provide significant benefits over placebo,” said the lead investigator of the new study, Dr. Bin Cao of the China-Japan Friendship Hospital and Capital Medical University in Beijing.
“This is not the outcome we hoped for,” he added.“This is not the outcome we hoped for,” he added.
The results are hard to interpret, because the study was far smaller than planned — enrolling 236 patients instead of the 453 that had been expected, because there were too few severely ill patients now in China.The results are hard to interpret, because the study was far smaller than planned — enrolling 236 patients instead of the 453 that had been expected, because there were too few severely ill patients now in China.
Dr. Eric Peterson, a clinical trials expert at Duke University, said that with too few patients, “all you can say is it doesn’t seem to work in this population.” If there had been a big effect of the drug, he added, that would have been seen.Dr. Eric Peterson, a clinical trials expert at Duke University, said that with too few patients, “all you can say is it doesn’t seem to work in this population.” If there had been a big effect of the drug, he added, that would have been seen.
He added that the trial should not be repeated with this population but instead in those who are less severely ill. He added that the trial should not be repeated with this population, but instead in those who are less severely ill.
Dr. Michele Barry, an infectious disease expert at Stanford, echoed his observations. “Remdesivir appears not to be a magic bullet,” she said. “This is a flawed study,” Dr. Barry said, but results might improve if the drug were given at a higher dose or earlier in the course of the disease.
Still, she added, “this is a flawed study,” and it remains possible that the drug might help if given at a higher dose or earlier in the course of the disease.
Acceding to demands, Gilead has distributed the drug to hundreds of patients under so-called compassionate use, a regulatory exemption by which patients may receive a drug apart from a clinical trial.Acceding to demands, Gilead has distributed the drug to hundreds of patients under so-called compassionate use, a regulatory exemption by which patients may receive a drug apart from a clinical trial.
Gilead itself published reports of uncontrolled studies. On Wednesday, in another news release, the company announced that a study comparing a five- to 10-day course of treatment with the drug showed that those getting the shorter course of treatment did just as well.Gilead itself published reports of uncontrolled studies. On Wednesday, in another news release, the company announced that a study comparing a five- to 10-day course of treatment with the drug showed that those getting the shorter course of treatment did just as well.
That study had no control group and was “noninformative,” said Dr. Peterson.That study had no control group and was “noninformative,” said Dr. Peterson.
Sheila Kaplan contributed reporting.Sheila Kaplan contributed reporting.