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ZURICH: A dispute broke out on Friday over a World Health Organization (WHO) clinical trial that concluded that the antiviral drug remdesivir has little or no impact on a patient’s chances of surviving Covid-19.
Gilead Sciences Inc., the US company that developed the drug, said the findings appeared inconsistent with evidence from other studies validating the clinical benefit of remdesivir, which was used to treat US President Donald Trump’s coronavirus infection.
“We are concerned that the data from this global open-label trial has not undergone the rigorous review necessary to allow for constructive scientific discussion,” said Gilead.
But Richard Peto, an independent statistician hired by the WHO to analyze the results of its Solidarity trial, dismissed Gilead’s criticism.
“It’s a reliable result, don’t let anyone tell you otherwise, because they will try,” Peto told reporters. “This is real world evidence.”
The results of the trial, announced by the WHO on Thursday, dealt a blow to one of the few drugs used to treat people with Covid-19.
The UN health agency said remdesivir appeared to have little or no effect on keeping people alive or on the length of hospitalizations among patients with the respiratory disease.
Their trial was conducted in 11,266 adult patients in more than 30 countries, and their findings may shift the focus of treatments from antivirals like remdesivir to new monoclonal antibodies that the WHO says could be added to their studies.
In addition to remdesivir, Trump received the experimental monoclonal antibody infection from Regeneron. But another American company, Eli Lilly and Co, said on Tuesday that a test of its own Covid-19 antibody treatment had been stopped for safety reasons.
Gilead, which quickly repurposed what it had developed as an Ebola drug when the Covid-19 pandemic began, said other smaller trials of remdesivir showed the treatment reduced Covid-19 recovery time by five days and helped. reduce the risk of death in some patients. they were receiving oxygen.
Peto, a professor emeritus at the University of Oxford, said the perceived benefit of the smaller trial in keeping people alive could have been “fluke.”
“And you have to randomize in large numbers,” Peto said. “The need for large numbers is not stressed enough if you want really reliable results.” For the remdesivir group of the WHO Solidarity trial, remdesivir was administered to 2,743 patients, compared with 2,708 in the control group. The Gilead study had 1,062 participants.
“The real disappointment is that remdesivir has also failed in greater numbers of cases and in the ‘real-world environment,'” said Clemens Wendtner, chief physician for infectology and tropical medicine at the Schwabing Clinic in Munich.
“A major clinical breakthrough looks different and warns us that the battle against Covid-19 is far from won.”
The WHO trial also found that other drugs reused since the pandemic began – hydroxychloroquine, antimalarial drug, HIV drug combination lopinavir / ritonavir, and interferon – offered little or no benefit to Covid-19 patients.
Hydroxychloroquine and anti-HIV studies were dropped earlier this year and interferon was phased out on Thursday.
Guidance on how countries should implement remdesivir will come in two to three weeks after a data review, WHO officials said.
Remdesivir received emergency use authorization from the US Food and Drug Administration on May 1.
The European Union granted an emergency authorization to remdesivir and agreed to a $ 1.2 billion remdesivir deal on Tuesday, weeks after WHO briefed Gilead on the results of the Solidarity trial.
The European Medicines Agency said it would review the trial data “to see if changes are needed in the way these medicines are used.”
Some scientists said Gilead’s complaints deserve scrutiny.
Differences in the patients who participated in the trial at hundreds of clinical sites may undermine the quality of the data, said Professor Peter Galle, who oversees infectology at Mainz University Hospital in Germany.
But he added: “This provides further evidence that remdesivir is not a panacea.”
According to analysts, the results announced on Friday do not negate the previous ones, and the WHO study was not as rigorous as the previous one led by the US National Institutes of Health. But concerns are mounting about how much value the expensive drug gives. because none of the studies have found that it can improve survival.
The results have not been published in a journal or reviewed by independent scientists, but instead were published on a site that researchers use to share results quickly.
The big story is the finding that remdesivir has no significant impact on survival, Martin Landray, a professor at the University of Oxford who led other research on coronavirus treatment, said in a statement.
“This is a drug that needs to be given by intravenous infusion over five to 10 days and costs about $ 2,550 per course of treatment,” he said. “Covid affects millions of people and their families around the world. We need scalable, affordable and equitable treatments. “
Posted in Dawn, Oct 17, 2020
