A multi-country study funded by the World Health Organization found that the antiviral drug remdesivir, developed by Gilead Sciences Inc., did not reduce deaths from Covid-19 in hospital patients, a finding that adds to the debate on the drug’s usefulness in treating the novel coronavirus.
The WHO study showed that death rates were about the same in patients hospitalized after 28 days, whether they received treatment with remdesivir or standard medical care. The study compared remdesivir and other drugs each to standard treatment in more than 5,000 hospital patients in dozens of countries.
In the study, about 11% of patients taking remdesivir died, compared to 11.2% of patients receiving standard treatment, according to a preliminary report published online. The report is a “pre-printed” version of a scientific article that has not yet been published in a peer-reviewed journal. Researchers increasingly used preprinted databases during the coronavirus pandemic to quickly disseminate information to clinicians.
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The document is currently under peer review and will soon be published in an academic journal, WHO chief scientist Soumya Swaminathan said in an interview.
Treatment with remdesivir also had little or no effect on reducing hospital stays or the need for ventilation, according to the study. 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 US government-funded study that found that remdesivir, sold under the brand name Veklury, significantly accelerated recovery in hospital patients compared to placebo. Based on this study, funded by the National Institute of Allergy and Infectious Diseases, remdesivir was granted emergency use approval in the United States in May.
Antivirals are generally considered to be more effective the earlier they are taken, and remdesivir may still show an advantage in treating patients who are not hospitalized, WHO’s Dr Swaminathan said. But across the “spectrum of inpatients, there is no benefit in terms of disease progression or mortality,” she said.
Gilead, who donated remdesivir supplies for the WHO study, questioned the trial’s findings, in part because the study did not compare remdesivir to placebo, a method that scientists use it to reduce the risk of biasing the results.
“The emerging data appear inconsistent with stronger evidence from several 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, global trial has not undergone the rigorous review required to allow for constructive scientific discussion, especially given the limitations of the trial design. “
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The final results of the US government-funded study, published last week in the New England Journal of Medicine, found that patients taking remdesivir recovered in 10 days on the median, compared with a median of 15 days in those taking remdesivir. patients receiving placebo. About 11.4% of patients taking remdesivir died in the NIAID study after 29 days, compared with 15.2% of patients taking placebo – a numerical improvement in the reduction in deaths, but not statistically significant. Statistical significance is a measure of the likelihood that the outcome of an experiment is due to chance.
Gilead said remdesivir showed statistically significant reductions in mortality in some patients when data was analyzed based on the severity of the patients’ illness. These analyzes were not part of the initial clinical trial design and carry less statistical weight than if they were pre-planned.
The WHO study, dubbed the Solidarity Trial, is known as a platform trial that evaluates multiple experimental treatments simultaneously against a single control group to get trial results faster and reduce the number of patients who do not receive potentially beneficial treatment.
The Solidarity trial evaluated four drugs previously approved or studied for other diseases: remdesivir, which has been studied in Ebola; the anti-HIV drug Kaletra; the treatment of interferon beta-1a multiple sclerosis; and hydroxychloroquine, an antimalarial drug. All drugs have shown little or no effect on reducing deaths in patients with Covid-19, length of hospital stay, or the need for ventilation.
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Clinical trials comparing investigational drugs with placebos are considered the most rigorous way to assess a drug’s effectiveness, but sometimes the results can look rosier than in the real world, as patients receive specialist attention. from the study researchers, said Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center.
The WHO study likely reflects the benefits of remdesivir in the real world, and the benefits appear to be marginal or nonexistent, said Dr Bach: “You really have to squint to see it. ”
However, differences in the way the WHO and NIAID studies were conducted make it difficult to reconcile the results, said Walid Gellad, associate professor of medicine at the University of Pittsburgh. The WHO study, for example, only counted deaths that occurred in hospital, but not those that might have occurred in patients who were discharged. Differences in the quality of healthcare in the international regions where the WHO study was conducted could also influence the results, he said.
Dr Gellad said he continues to view remdesivir as having benefits for patients with Covid-19, albeit modest, even considering the results of the WHO study. “I would say it helps people with Covid get better, but it doesn’t cure Covid and it’s not a slam dunk,” Dr Gellad said. “But I still would if I was in the hospital [with Covid], even with what Solidarity shows. ”