By Joseph Walker
A multicountry study funded by the World Health Organization
found that the antiviral drug remdesivir, developed by Gilead
Sciences Inc., didn't reduce deaths from Covid-19 in hospitalized
patients, a result that adds to debate over the medicine's utility
in treating the new coronavirus.
The WHO study showed that death rates were about the same in
hospitalized patients after 28 days whether they received treatment
with remdesivir or standard medical care. The study compared
remdesivir and other drugs each against standard treatment in more
than 5,000 hospitalized patients across dozens of countries.
In the study, about 11% of patients taking remdesivir died,
versus 11.2% of patients receiving standard treatment, according to
a preliminary report published online. The report is a "preprint"
version of a scientific paper that hasn't yet been published in a
peer-reviewed journal. Researchers have made increasing use of
preprint databases during the coronavirus pandemic to disseminate
information to clinicians quickly.
The paper is currently in the peer-review revision process and
will soon be published in an academic journal, said WHO Chief
Scientist Soumya Swaminathan in an interview.
Treatment with remdesivir also had little or no effect on
reducing hospital stays or the need for ventilation, the study
found. Its authors say the data, when analyzed in the context of
previous trials, "absolutely excludes the suggestion that
remdesivir can prevent a substantial fraction of all deaths."
The WHO study contrasts with an earlier study funded by the U.S.
government that found remdesivir, which is sold under the brand
name Veklury, significantly sped up hospitalized patients' recovery
compared with a placebo. Based on that study, which was funded by
the National Institute of Allergy and Infectious Diseases,
remdesivir was granted emergency-use authorization in the U.S. in
Antivirals are typically thought to be more effective the
earlier they are taken, and remdesivir might still show a benefit
in treating patients who aren't hospitalized, said the WHO's Dr.
Swaminathan. But across "the whole spectrum of hospitalized
patients, there's no benefit in terms of either progression of
disease or mortality," she said.
Gilead, which donated remdesivir supplies for the WHO study,
questioned the trial's conclusions, in part because the study
didn't compare remdesivir to a placebo, a method scientists use to
reduce the risk of biasing the results.
"The emerging data appear inconsistent with more robust evidence
from multiple randomized, controlled studies published in
peer-reviewed journals validating the clinical benefit of Veklury,"
Gilead said in a statement. "We are concerned that the data from
this open-label global trial have not undergone the rigorous review
required to allow for constructive scientific discussion,
particularly given the limitations of the trial design."
The final trial results from the U.S. government-funded study,
published last week in the New England Journal of Medicine, found
that patients taking remdesivir recovered in 10 days on median,
compared with a median of 15 days among patients receiving a
placebo. About 11.4% of patients taking remdesivir died in the
NIAID study after 29 days, compared with 15.2% of placebo patients
-- a numerical improvement in reducing deaths, though not a
statistically significant one. Statistical significance is a
measure of the probability that the result of an experiment is due
to random chance.
Gilead has said remdesivir did show statistically significant
reductions in death in some patients when the data were analyzed
according to patients' disease severity. Those analyses weren't
part of the original clinical-trial design and carry less
statistical weight than if they were preplanned.
The WHO study, dubbed the Solidarity trial, is known as a
platform trial that evaluates several experimental treatments
simultaneously against a single control group to more quickly get
trial results and reduce the number of patients who aren't given a
potentially beneficial therapy.
The Solidarity trial evaluated four drugs that were either
previously approved or studied for other diseases: remdesivir,
which was studied in Ebola; the HIV medication Kaletra; the
multiple-sclerosis treatment interferon beta-1a; and the malaria
drug hydroxychloroquine. All of the drugs showed little or no
effect in reducing deaths in patients with Covid-19, their length
of hospital stay or the need for ventilation.
Clinical trials comparing experimental drugs with placebos are
considered the most rigorous way to evaluate a medicine's
effectiveness, but the results can sometimes appear rosier than in
real-world settings because patients receive specialized attention
from study investigators, said Peter Bach, director of the Center
for Health Policy and Outcomes at Memorial Sloan Kettering Cancer
The WHO study likely reflects remdesivir's benefit in the
real-world setting, and the benefit appears to be marginal to
nonexistent, said Dr. Bach: "You really have to squint to see
Differences in the way the WHO and NIAID studies were conducted,
however, make it difficult to reconcile the results, said Walid
Gellad, associate professor of medicine at the University of
Pittsburgh. The WHO study, for instance, only counted deaths that
occurred in the hospital but not those that might have occurred in
patients who were discharged. Differences in the quality of health
care in the international locations where the WHO study was
conducted might also influence the results, he said.
Dr. Gellad said he continues to view remdesivir as having some
benefit for Covid-19 patients, albeit a small one, even when
considering the WHO study results. "I would say that it helps
people with Covid get better, but it does not cure Covid and it's
not a slam dunk," said Dr. Gellad. "But I would still want it if I
were in the hospital [with Covid], even with what Solidarity is
Write to Joseph Walker at email@example.com
(END) Dow Jones Newswires
October 16, 2020 21:29 ET (01:29 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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