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WHO-backed study finds no remdesivir benefit for hospitalized COVID-19 patients
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A multicountry study funded by the World Health Organization found that the antiviral drug remdesivir, developed by Gilead Sciences Inc., didn't reduce deaths from Covid-19 in hospitalized patients, a result that adds to debate over the medicine's utility in treating the new coronavirus.
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The WHO study showed that death rates were about the same in hospitalized patients after 28 days whether they received treatment with remdesivir or standard medical care. The study compared remdesivir and other drugs each against standard treatment in more than 5,000 hospitalized patients across dozens of countries.
In the study, about 11% of patients taking remdesivir died, versus 11.2% of patients receiving standard treatment, according to a preliminary report published online. The report is a "preprint" version of a scientific paper that hasn't yet been published in a peer-reviewed journal. Researchers have made increasing use of preprint databases during the coronavirus pandemic to disseminate information to clinicians quickly.
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The paper is currently in the peer-review revision process and will soon be published in an academic journal, said WHO Chief Scientist Soumya Swaminathan in an interview.
Treatment with remdesivir also had little or no effect on reducing hospital stays or the need for ventilation, the study found. Its authors say the data, when analyzed in the context of previous trials, "absolutely excludes the suggestion that remdesivir can prevent a substantial fraction of all deaths."
The WHO study contrasts with an earlier study funded by the U.S. government that found remdesivir, which is sold under the brand name Veklury, significantly sped up hospitalized patients' recovery compared with a placebo. Based on that study, which was funded by the National Institute of Allergy and Infectious Diseases, remdesivir was granted emergency-use authorization in the U.S. in May.
Antivirals are typically thought to be more effective the earlier they are taken, and remdesivir might still show a benefit in treating patients who aren't hospitalized, said the WHO's Dr. Swaminathan. But across "the whole spectrum of hospitalized patients, there's no benefit in terms of either progression of disease or mortality," she said.
Gilead, which donated remdesivir supplies for the WHO study, questioned the trial's conclusions, in part because the study didn't compare remdesivir to a placebo, a method scientists use to reduce the risk of biasing the results.
"The emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of Veklury," Gilead said in a statement. "We are concerned that the data from this open-label global trial have not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design."
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