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 "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 is another setback for the drug, which grabbed worldwide
attention as a potentially effective treatment for COVID-19 in the
summer after early trials showed some promise.
At the end of October, Gilead <GILD.O> cut its 2020 revenue
forecast, citing lower-than-expected demand and difficulty in
predicting sales of remdesivir, which is also known as Veklury
The antiviral is one of only two medicines currently authorised to
treat COVID-19 patients across the world, but a large WHO-led trial
known as the Solidarity Trial showed 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 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 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 that included 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, 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.
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"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," it added.
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.
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, which is not binding, is part of its so-called "living
guidelines" project, designed to offer ongoing guidance for doctors to help them
make clinical decisions about patients in fast-moving situations such as the
COVID-19 pandemic.
The panel added that it supported continued enrolment 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 recommendation may raise further questions about whether the European Union
will need the 500,000 courses of the antiviral worth 1 billion euros it ordered
last month.
(Reporting by Kate Kelland; Additional reporting by Mrinalika Roy in Bengaluru;
Editing by Stephen Coates and Mark Potter)
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