Gilead's drug remdesivir is not recommended for patients hospitalized with COVID-19, regardless of how ill they are, as there is no evidence it improves survival or reduces the need for ventilation, a World Health Organization (WHO) panel said on Friday.
The latest WHO advice comes after one of the world's top bodies representing intensive care doctors said the antiviral should not be used for COVID-19 patients in critical care wards.
The medication was one of the drugs used to treat U.S. President Donald Trump's coronavirus infection, and had been shown in previous studies to have cut time to recovery. It is authorized or approved for use as a COVID-19 treatment in more than 50 countries.
The WHO's Guideline Development Group (GDG) panel said its recommendation was based on an evidence review that included data from four international randomized trials involving more than 7,000 patients hospitalized with COVID-19.
After reviewing the evidence, the panel said, it concluded that remdesivir, which has to be given intravenously and is therefore costly and complex to administer, has no meaningful effect on death rates or other important outcomes for patients.
"The ... panel found a lack of evidence that remdesivir improved outcomes that matter to patients such as reduced mortality, need for mechanical ventilation, time to clinical improvement, and others," the WHO guideline said.
"Especially given the costs and resource implications associated with remdesivir ...the panel felt the responsibility should be on demonstrating evidence of efficacy, which is not established by the currently available data," it added.
The panel said, however, that it supported continued enrollment into clinical trials evaluating remdesivir in patients with COVID-19, which it said should "provide higher certainty of evidence for specific groups of patients."
The WHO's recommendation, which is not binding, is part of its "living guidelines" project, designed to offer guidance for doctors to help them make clinical decisions about patients in fast-moving situations such as the COVID-19 pandemic. The guidelines can be updated and reviewed as new evidence and information emerges.