LONDON (UK) – Gilead’s remdesivir is not recommended for patients hospitalised with COVID-19, regardless of how intense their situation. As there is no evidence that the drug improves survival or reduces the need for ventilation, a World Health Organization panel said on Friday.
“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 guideline said.
The advice has come as another blow for the drug, which had earlier garnered worldwide attention as a potentially effective treatment for COVID-19 after early trials were positive.
At the end of October, Gilead cited lower-than-expected demand and difficulty in predicting sales of remdesivir, also known as Veklury.
Despite the fact that the antiviral is one of only two medicines currently authorised to treat COVID-19 patients across the world, a large WHO-led trial known as the Solidarity Trial found last month that it had little or no effect on 28-day mortality or length of hospital stays for COVID-19 patients.
The medication was among the few drugs used to treat US President Donald Trump’s coronavirus infection. It is authorised or approved for use as a COVID-19 treatment in more than 50 countries.
Gilead has questioned the Solidarity Trial’s results.
“Veklury is recognised as a standard of care for the treatment of hospitalised patients with COVID-19 in guidelines from numerous credible national organisations,” Gilead said in a statement.
“We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with COVID-19.”
The WHO’s Guideline Development Group (GDG) panel said its recommendation was based on an evidence review, which comprised of data from four international randomised trials involving more than 7,000 patients hospitalised with COVID-19.
After reviewing the evidence, the panel said it concluded that remdesivir has no meaningful effect on death rates or other important outcomes for patients.
It added, “Especially given the costs and resource implications associated … the panel felt the responsibility should be on demonstrating evidence of efficacy, which is not established by the currently available data.”
The latest WHO advice comes after one of the world’s top bodies, which stands for intensive care doctors said the antiviral should not made use of, for COVID-19 patients admitted in critical care wards.
Peter Horby, a professor of emerging infectious diseases at the University of Oxford, said the advice should prompt “a rethink about the place of remdesivir in COVID-19”.
“Remdesivir is an expensive drug that must be given intravenously for five to 10 days, so this recommendation will save money and other healthcare resources,” he said.
The WHO’s recommendation is part of its so-called “living guidelines” project, formulated to provide guidance for doctors to help them make decisions about patients clinically amid the COVID-19 pandemic.
The panel added that it was in favour of continued enrolment into clinical trials evaluating remdesivir in COVID patients, which it said should “provide higher certainty of evidence for specific groups of patients”.
The recommendation may bring forth further questions about whether the European Union will need the 500,000 courses of the antiviral worth 1 billion euros that were ordered last month.