The World Health Organization on Thursday recommended not to use the antiviral remdesivir, a drug that had generated great interest as a treatment for Covid-19.
An expert group “concluded that remdesivir had no significant effect on mortality or on other important patient outcomes, such as the need for mechanical ventilation or the time needed for clinical improvement” , said WHO. The committee published its review in The BMJ. The report does not completely rule out the drug’s use as a Covid treatment, but said evidence was lacking to recommend its use.
Gilead Sciences, maker of remdesivir, whose trade name is Veklury, said in a statement that its drug “is recognized as a standard of care for the treatment of hospital patients with Covid-19 in the guidelines of many credible national organizations,” including the US National Institutes of Health and Infectious Diseases Society of America, Japan, UK and Germany. He added that there are “several randomized, controlled studies published in peer-reviewed journals that demonstrate the clinical benefits of Veklury.”
The potential usefulness of remdesivir had been the subject of debate and skepticism for months, and particularly in recent weeks, after the Food and Drug Administration approved it as the first treatment for Covid-19 in late October. A large study, sponsored by the National Institutes of Health, found that the drug reduced the recovery time of hospital patients by 15 to 11 days. Two other trials reviewed by the agency, sponsored by Gilead, did not include placebo controls, which are considered essential for judging effectiveness.
President Trump received remdesivir along with other treatments last month when he was hospitalized with Covid.
Since at least March, when the pandemic began to spread from China to Europe via the United States, pharmaceutical companies and researchers have been working on the fly, and practicing doctors have experimented with any treatment that shows promise. including steroids. In September, the WHO expert group strongly recommended the use of steroids for critically ill patients.
For the new analysis, the panel looked at evidence from four trials, including one conducted by the NIH and one sponsored by the WHO and recently posted to a pre-print server, which included around 5,000 patients, the largest in this day. The article has not been peer reviewed or published in a scientific journal.
The results of this trial “called into question some of the benefits that were seen earlier in the NIH study,” said Dr. Bram Rochwerg, associate professor of medicine at McMaster University in Hamilton, Ont. and co-chair of the WHO panel.
Dr Rochwerg said the expert panel “made it clear in the document that trials with remdesivir should continue and some populations could benefit.” But the drug is expensive and administered intravenously, he noted. Its use could divert resources that could be deployed more efficiently, Dr Rochwerg said.
Remdesivir has been cleared for emergency use since the spring in the United States, and in October Gilead reported that it had generated $ 873 million in revenue so far this year.
The widely adopted use of the drug for Covid symptoms had baffled some experts long before FDA approval.
“This is a completely appropriate decision by the WHO,” wrote Dr Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, in an email. “Remdesivir costs thousands of dollars, the largest randomized trial examining its use in Covid suggests that it may have no benefit of any kind, and the only positive study dates back to an era prior to the use of the dexamethasone for serious illness, ”he added. to a steroid now commonly used in hospitals.
Dexamethasone is a treatment that helps patients with Covid-19 at certain stages of the disease.
The WHO expert group report, called the “Living Guideline,” is an initiative to continuously inform physicians and patients when new evidence emerges that is changing current medical practice.
“It’s a little troubling that we haven’t found much that works yet,” said Dr Rochwerg. “But I hope that ongoing research will identify other drugs that improve survival and symptoms.”
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