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Gilead’s remdesivir is not recommended for hospitalized patients with COVID-19, regardless of how sick they are, as there is no evidence that the drug improves survival or reduces the need for ventilation, a World Organization committee said on Friday. health care.
The team found “a lack of evidence that remdesivir improved outcomes that matter to patients,” the guideline states.
“Especially given the costs and resource implications associated with remdesivir … the panel felt that the responsibility should be to demonstrate evidence of efficacy, which is not established from currently available data.”
The advice is another setback for the drug, which garnered worldwide attention as a potentially effective treatment for COVID-19 in the summer after early studies showed some promise.
Antiviral, known under the brand name Veklury, is one of only two medicines currently authorized for the treatment of COVID-19 patients worldwide. But a large WHO study known as the Solidarity Trial showed last month that it had little or no effect on 28-day mortality or length of hospital stay for COVID-19 patients.
The drug was one of the drugs used to treat US President Donald Trump’s coronavirus infection and in previous studies had shown that it reduced the time to recovery. It is authorized or approved for use as a COVID-19 treatment in more than 50 countries. This includes Canada, where a limited number of patients have been treated with the drug under Health Canada’s special access program.
Gilead questioned the results of the solidarity process and said in a statement Friday that he was “disappointed” by the new WHO guidelines.
“Veklury is recognized as a standard of care for the treatment of hospitalized patients with COVID-19 in the guidelines of several credible national organizations,” he said.
“WHO guidelines appear to be ignoring this evidence at a time when cases are increasing dramatically around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with COVID-19.”
The WHO board raises questions about whether the European Union will need the 500,000 courses of antiviral, worth 1 billion euros ($ 1.86 billion), ordered last month.
The Italian drug regulatory authority, AIFA, said it had “underlined the modest effectiveness of remdesivir for weeks”.
“We’ve basically been saying for some time that it doesn’t take much,” the regulator said.
Expensive, no impact on death rates noted
The WHO’s Guideline Development Group (GDG) panel said its recommendation was based on a review of the evidence that included data from four international randomized studies involving more than 7,000 hospitalized patients with COVID-19.
After reviewing the evidence, the Panel said it concluded that remdesivir, which must be administered intravenously and is therefore expensive and complex to administer, has no significant effect on mortality rates or other important outcomes for patients. .
Peter Horby, professor of emerging infectious diseases at the University of Oxford in the UK, said the new WHO board should prompt “a rethinking of the position of remdesivir in COVID-19”.
“Remdesivir is an expensive drug that has to be administered intravenously for 5-10 days, so this recommendation will save money and other health resources,” he said.
At the end of October, Gilead cut its revenue forecast for 2020, citing lower-than-expected demand and difficulties in forecasting remdesivir sales.
The new advice also comes after one of the world’s leading bodies representing ICU physicians said remdesivir should not be used for COVID-19 patients in ICU.
The recommendation, which is not binding, is part of its so-called “living guidelines” project, designed to offer ongoing guidance to doctors. The group said they support continued enrollment in clinical trials evaluating remdesivir in patients with COVID-19, which should “provide greater certainty of evidence for specific patient groups.”
The European Commission on Friday said there have been no changes in the authorized uses of remdesivir.
“We note that WHO has now updated its guidelines on the use of remdesivir,” a Commission spokesperson said in an email.
The European drug regulator has requested full data from the WHO-led Solidarity study on the drug and will evaluate the evidence, along with other available data, to see if changes to its market authorization are needed, he said.
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