WHO does not recommend Gilead remdesivir for all hospitalized COVID-19 patients

Gilead’s remdesivir drug is not recommended for hospitalized patients with COVID-19, regardless of how sick they are, as there is no evidence that it improves survival or reduces the need for ventilation, a World Health Organization committee said Friday. .

“The group … found a lack of evidence that remdesivir improved outcomes that matter to patients, such as reduced mortality, the need for mechanical ventilation, time to clinical improvement and others,” the line says. guide.

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.

At the end of October, Gilead cut its revenue forecast for 2020, citing lower-than-expected demand and difficulties in forecasting remdesivir sales.

Antiviral is one of only two medicines currently licensed to treat COVID-19 patients worldwide, but a large WHO study known as the Solidarity Trial last month showed that it had little or no effect. zero on 28-day mortality or length of hospitalization 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.

Gilead questioned the results of the solidarity process.

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 was 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.

‘Especially given the costs and resource implications associated with remdesivir … the group felt that the responsibility should be to demonstrate evidence of efficacy, which is not established from currently available data,’ he added.

The latest advice from WHO comes after one of the world’s best bodies representing ICU doctors said antiviral should not be used for COVID-19 patients in ICUs.

The WHO recommendation, which is non-binding, is part of its so-called “living guidelines” project, designed to offer guidance to doctors to help them make clinical decisions about patients in fast-moving situations like the COVID-19 pandemic. The guidelines may be updated and revised as new evidence and information emerges.

However, the Panel said it supports continued enrollment in clinical trials evaluating remdesivir in patients with COVID-19, which should “provide greater certainty of evidence for specific patient groups”.

The recommendation could raise further questions about whether the European Union will need the 500,000 € 1 billion worth of antiviral courses it ordered last month.