LONDON: Gilead’s remdesivir drug is not recommended for hospitalized COVID-19 patients, regardless of how ill they are, as there is no evidence that it improves survival or reduces the need for ventilation, a panel from the Organization said on Friday. World Health.
“The … panel found a lack of evidence that remdesivir improved outcomes that are important to patients, such as reduced mortality, the need for mechanical ventilation, time to clinical improvement, and others,” the guideline said.
The advice is another setback for the drug, which attracted global attention as a potentially effective treatment for COVID-19 in the summer after the first trials showed some promise.
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In late October, Gilead cut its 2020 revenue forecast, citing lower-than-expected demand and difficulty predicting remdesivir sales.
The antiviral is one of only two drugs currently licensed to treat COVID-19 patients worldwide, but a large WHO-led trial known as the Solidarity Trial showed last month that it had little to no effect on the mortality of 28 days or the duration of the illness. hospital stays for COVID-19 patients.
The drug was one of the drugs used to treat US President Donald Trump’s coronavirus infection, and previous studies had shown it shortened recovery time. It is licensed or approved for use as a treatment for COVID-19 in more than 50 countries.
Gilead has questioned the results of the Solidarity Trial.
The WHO Guidelines Development Group (GDG) panel said its recommendation was based on a review of the evidence that included data from four international randomized trials involving more than 7,000 hospitalized patients with COVID-19.
After reviewing the evidence, the panel said, they concluded that remdesivir, which must be given intravenously and is therefore expensive and complex to administer, does not have a significant effect on death rates or other important outcomes for patients. patients.
“Especially given the cost and resource implications associated with remdesivir … the panel felt that the onus should be on demonstrating evidence of efficacy, which is not established by the currently available data,” he added.
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The latest advice from the WHO comes after one of the world’s leading bodies representing intensive care physicians said the antiviral should not be used for COVID-19 patients in intensive care wards.
The WHO recommendation, which is not binding, is part of its so-called “life guidelines” project, designed to offer guidance to physicians to help them make clinical decisions about patients in fast-moving situations like the COVID-19 pandemic. 19. . The guidelines can be updated and revised as new evidence and information emerge.
However, the panel said it supported continued enrollment in clinical trials evaluating remdesivir in COVID-19 patients, which it said should “provide greater certainty of evidence for specific groups of patients.”
The recommendation may raise more questions about whether the European Union will need the 500,000 courses of the antiviral worth 1 billion euros it ordered last month.
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