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The WHO-supported study found no benefit of remdesivir for hospitalized patients with COVID-19.



A multilateral study funded by the World Health Organization found that the antiviral drug remdezivir, developed by Gilead Sciences Inc., did not reduce mortality from Covid-19 in hospitalized patients, a result that added to the debate over the drug’s usefulness in treating the new coronavirus.

The WHO study showed that mortality was approximately the same in hospitalized patients after 28 days, regardless of whether they received treatment with remdezivir or standard medical care. The study compared remdezivir and other drugs against standard treatment in more than 5,000 hospitalized patients in dozens of countries.

In the study, about 1

1% of patients taking remdezivir 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 have increasingly used pre-printed databases during the coronavirus pandemic to spread information quickly among clinicians.

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The article is currently being reviewed and will soon be published in an academic journal, said WHO chief scientist Sumia Suminatan in an interview.

Remdezivir treatment 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 experiments, “absolutely rule out the assumption that remdezivir can prevent a significant proportion of all deaths.”

The WHO study contrasts with an earlier study funded by the US government, which found that remdesivir sold under the Veklury brand significantly accelerated the recovery of hospitalized patients compared to placebo. Based on this study, funded by the National Institute of Allergy and Infectious Diseases, remdezivir was approved for emergency use in the United States in May.

Antiviral drugs are generally thought to be more effective the earlier they are taken, and remdezivir may still show benefit in treating patients who are not hospitalized, said Dr. Swaminathan of the WHO. But “across the spectrum of hospitalized patients, there is no benefit in terms of disease progression or mortality,” she said.

Gilead, which donated supplies of remdezivir to the WHO study, questioned the study’s findings, in part because the study did not compare remdezivir with placebo, a method scientists use to reduce the risk of addictive results.

“The emerging data appear to be incompatible with more reliable evidence from a number of randomized, controlled trials published in peer-reviewed journals confirming the clinical benefit of Veklury,” Gilead said in a statement. “We are concerned that the data from this open global study have not passed the rigorous review required for constructive scientific discussion, especially given the limitations of the test design.”

A WHO study showed that mortality was approximately the same in hospitalized patients after 28 days, regardless of whether they received treatment with remdezivir or standard medical care. (Gilead Sciences via AP)

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The final results of a study funded by the US government, published last week in the New England Journal of Medicine, found that patients taking remdezivir recovered in 10 days with a median, compared with a median of 15 days among patients receiving placebo. . About 11.4% of patients taking remdezivir died in the NIAID study after 29 days, compared with 15.2% of patients on placebo, a numerical improvement in the reduction in deaths, although not statistically significant. Statistical significance is a measure of the probability that the result of an experiment is due to a chance chance.

Gilead said that remdezivir showed a statistically significant reduction in mortality in some patients when data were analyzed according to the severity of the patient’s disease. These analyzes were not part of the original design of the clinical trial and have less statistical weight than if previously planned.

The WHO study, called the Solidarity Study, is known as a platform experiment that evaluates several experimental treatments against one control group at the same time to get faster results from the study and to reduce the number of patients who are not given potentially useful therapy.

The Solidarity trial evaluated four drugs that were either pre-approved or tested for other diseases: remdezivir, which was tested for Ebola; the HIV drug Kaletra; the treatment of multiple sclerosis interferon beta-1a; and the malaria drug hydroxychloroquine. All drugs showed little or no effect in reducing deaths in patients with Covid-19, the length of their hospital stay, or the need for ventilation.

Gilead said that remdezivir showed a statistically significant reduction in mortality in some patients when the data were analyzed according to the severity of the patient’s disease. (AP Photo / Eric Risberg, File)

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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 rosier than in real life, as patients receive specialized attention from the study’s researchers. said Peter Bach, director of health policy and results at the Memorial Sloan Kettering Cancer Center.

The WHO study probably reflects the benefits of remdezivir in the real world, and the benefits seem to be negligible to non-existent, said Dr. Bach: “You really have to close your eyes to see one.”

However, differences in the way the WHO and NIAID research are conducted make it difficult to reconcile the results, said Walid Gelad, an associate professor of medicine at the University of Pittsburgh. For example, the WHO study only considers deaths that have occurred in the hospital, but not those that may have occurred in discharged patients. Differences in the quality of health care in the international locations where the WHO study was conducted could also affect the results, he said.

Dr Gelad said he continued to see remdezivir as a benefit to patients with Covid-19, albeit a small one, even when the results of the WHO study were taken into account. “I’d say it helps people with Covid get better, but it doesn’t cure Covid and it’s not a helmet,” Dr. Gelad said. “But I still wish I was in the hospital [with Covid], even with what solidarity shows. “


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