A multilateral study funded by the World Health Organization found that the antiviral drug remdesivir, developed by Gilead Sciences Inc., did not reduce Covid-19 deaths in inpatients, a result that adds to the debate about the drug’s usefulness in treating the new coronavirus.
The WHO study showed that the mortality rate was approximately the same in inpatients after 28 days, regardless of whether they received treatment with remdesivir or standard medical treatment. The study compared remdesivir and other drugs each against standard treatment in more than 5,000 inpatients in dozens of countries.
In the study, approx. 1
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The newspaper is currently in the peer review review process and will soon be published in an academic journal, WHO chief researcher Soumya Swaminathan said 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 that the data, when analyzed in the context of previous trials, “absolutely precludes the suggestion that belt dives can prevent a significant proportion of all deaths.”
The WHO study stands in contrast to a previous study funded by the US government, which found belt straps sold under the Veklury brand significantly accelerated hospitalization of hospitalized patients compared to placebo. Based on this study, funded by the National Institute of Allergy and Infectious Diseases, remdesivir was granted permission for emergency use in the United States in May.
Antivirals are typically thought to be more effective the earlier they are taken, and remdesivir may still show an advantage in treating patients who are not hospitalized, WHO Drs. Swaminathan. But across the “entire spectrum of inpatients, there is no benefit in terms of either disease progression or mortality,” she said.
Gilead, who donated remdesivir supplies to the WHO study, questioned the trial’s findings, in part because the study did not compare remdesivir with placebo, a method researchers use to reduce the risk of affecting outcomes.
“The new data appear to be inconsistent with more robust evidence from several randomized, controlled trials 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 experiment have not undergone the rigorous review required to allow for constructive scientific discussion, especially given the limitations of the experimental design.”
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The final trial results from the U.S. government-funded study published last week in the New England Journal of Medicine showed that patients taking remdesivir recovered at a median of 10 days, compared with a median of 15 days among patients who received placebo. Approx. 11.4% of patients taking remdesivir died in the NIAID study after 29 days compared with 15.2% of placebo patients – a numerical improvement in death reduction but not a statistically significant one. Statistical significance is a measure of the probability that the result of an experiment is due to random chance.
Gilead has said that remdesivir showed statistically significant reductions in deaths in some patients when the data were analyzed according to the severity of the patients’ disease. These analyzes were not part of the original clinical trial design and have less statistical weight than if they were pre-planned.
The WHO study, called the Solidarity Trial, is known as a platform trial that evaluates multiple experimental treatments simultaneously against a single control group to more quickly obtain trial results and reduce the number of patients not receiving a potentially beneficial treatment.
The solidarity trial evaluated four drugs that had either been previously approved or tested for other diseases: remdesivir, which was tested in Ebola; HIV medicine Kaletra; the multiple sclerosis treatment interferon beta-1a; and the malaria drug hydroxychloroquine. All drugs showed little or no effect in reducing death in patients with Covid-19, their hospital stay or the need for ventilation.
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Clinical trials comparing experimental drugs with placebo are considered the most rigorous way to evaluate the effectiveness of a drug, but the results can sometimes look brighter than in real-world settings because patients receive special attention from investigators, said Peter Bach, director of the Center. for Health Policy and Results at Memorial Sloan Kettering Cancer Center.
The WHO study probably reflects the advantage of belt devices in the real world, and the benefit appears to be marginal to non-existent, said Dr. Bach: “You really have to squint to see someone.”
However, differences in the way the WHO and NIAID studies were conducted make it difficult to reconcile the results, said Walid Gellad, an associate professor of medicine at the University of Pittsburgh. For example, the WHO study only counted deaths that occurred in the hospital, but not those that could have occurred in patients who were discharged. Differences in the quality of health care at the international sites where the WHO survey was conducted could also affect the results, he said.
Dr. Gellad said he continues to view strap disivir as a benefit for Covid-19 patients, albeit a small one, even when considering WHO study results. “I would say it helps people with Covid get better, but it does not cure Covid and it is not a slam dunk,” said Dr. Gellad. “But I still want it if I was in the hospital [with Covid], even with what Solidarity shows. “