Gilead Sciences Inc. , the U. S. company that developed the drug, said the effects gave the impression of being inconsistent with evidence from other studies that validated the clinical benefits of remdesivir, which was used to treat the coronavirus infection of US President Donald Trump.
“We are involved in the fact that knowledge of this open global trial has been the subject of the rigorous review required to allow for constructive clinical discussion,” Gilead said.
But Richard Peto, an independent statistician through WHO to review the effects of his Solidarity trial, rejected Gilead’s criticism.
“It’s a trustworthy result, don’t let anyone tell you otherwise, because they’re going to check to do it,” Peto told reporters. “It’s a test of the genuine world. “
The effects of the trial, announced Thursday through WHO, dealt a blow to one of the few medicines used to treat others with COVID-19.
The UN fitness firm said remdesivir gives the impression of having little or no effect on the maintenance of others or on the duration of hospitalization in patients with respiratory diseases.
Their trial was conducted in 11,266 adult patients in more than 30 countries and their effects can simply divert attention from antiviral remedies, such as re-division into new monoclonal antibodies that WHO says can be added to their studies.
In addition to the redesivir, Trump won Regeneron’s experimental monoclonal antibody infection, but another U. S. company, Eli Lilly and Co, said Tuesday that a trial of his own COVID-19 antibody remedy had been suspended for protection reasons.
“Nice place to stay”
Gilead, who temporarily reused what had evolved as an Ebola drug at the beginning of the COVID-19 pandemic, said other smaller trials with remedivir showed that the remedy reduces COVID-19 recovery time for five days and helped reduce the death threat. in some patients who were getting oxygen.
Peto, professor emeritus at Oxford University, said the perceived merit of the smallest check to keep other people alive may have been a mere “lucky. “
“And you have to randomize in giant numbers,” Peto said. “The emphasis is not enough on the desire for giant numbers if reliable results are desired. “
For the reemployment arm of the WHO Solidarity trial, 2,743 patients achieved reemployment, compared to 2,708 in the group. Gilead’s exam had 1,062 participants.
“The real sadness is that remdesivir has also failed in a greater number of cases and in the ‘genuine context’,” said Clemens Wendtner, a leading physician in infectious diseases and tropical medicine at the Schwabing Clinic in Munich.
“A primary clinical breakthrough is different and warns us that the war against COVID-19 is far from won. “
The WHO trial also found that other medicines reused since the onset of the pandemic – antimalarial hydroxychloroquine, the mixture of HIV medicines lopinavir / ritonavir and interferon – had little or no advantage for patients with COVID-19.
Studies on hydroxychloroquine and anti-HIV were discontinued before this year and interferon was discontinued on Thursday.
Guidance will be provided on how countries implement remdesivir within two to three weeks of a review of the data, WHO officials said.
The re-employment officer obtained emergency use authorization from the U. S. Food and Drug Administration. But it’s not the first time May 1.
The European Union granted the remittance of an emergency permit and agreed to a billion euro ($1. 2 billion) re-division agreement on Tuesday, weeks after Gilead reported through WHO on the effects of the Solidarity trial.
The European Medicines Agency said it would review knowledge of the trial “to see if there are adjustments to the way these medicines are used. “
The court cases of some Gilead scientists deserved careful consideration.
Differences between patients who participated in the trial at many clinical sites can influence data quality, said Professor Peter Galle, who oversees infectious diseases at the German University Hospital in Mainz.
But he added: “This provides further evidence that remdesivir is a panacea. “
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