Data on Gilead’s remdesivir, released by accident, show no benefit for coronavirus patients. Company still sees reason for hope
By ED SILVERMAN , ADAM FEUERSTEIN , and MATTHEW HERPER
APRIL 23, 2020
Bottles of remdesivir in a hospital for Covid-19 patients in Wuhan, China.FEATURECHINA VIA AP
The antiviral medicine remdesivir from Gilead Sciences failed to speed the improvement of patients with Covid-19 or prevent them from dying, according to results from a long-awaited clinical trial conducted in China. Gilead, however, said the data suggest a “potential benefit.”
A summary of the study results was inadvertently posted to the website of the World Health Organization and seen by STAT on Thursday, but then removed.
“A draft document was provided by the authors to WHO and inadvertently posted on the website and taken down as soon as the mistake was noticed. The manuscript is undergoing peer review and we are waiting for a final version before WHO comments,” said WHO spokesperson Tarik Jasarevic.
Gilead spokesperson Amy Flood said the company believes “the post included inappropriate characterization of the study.” Because the study was stopped early because it had too few patients, she said, it cannot “enable statistically meaningful conclusions.” However, she said, “trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease.”
The data will be closely scrutinized but are also likely imperfect. The study was terminated prematurely, which could have affected the results. The context that would be provided by a full manuscript is missing, and the data have not been reviewed as normally occurs before publication.
Related:
The coronavirus pandemic could shrink some biotech startup valuations
Many studies are being run to test remdesivir, and this one will not be the final word. Results are expected soon from a Gilead-run study in severe Covid-19 patients, although that study may be difficult to interpret because the drug is not compared to patients receiving only standard treatment. Encouraging data from patients in that study at the University of Chicago were described by researchers at a virtual town hall and obtained by STAT last week. However, unlike those data, these new results are from a randomized controlled trial, the medical gold standard.
Gilead is also running a study with a control group in more moderate Covid-19 patients, and the National Institute of Allergy and Infectious Diseases is running a study that compares remdesivir to placebo. There are even more studies of the drug ongoing.
According to the summary of the China study, remdesivir was “not associated with a difference in time to clinical improvement” compared to a standard of care control. After one month, it appeared 13.9% of the remdesivir patients had died compared to 12.8% of patients in the control arm. The difference was not statistically significant.
“In this study of hospitalized adult patients with severe COVID-19 that was terminated prematurely, remdesivir was not associated with clinical or virological benefits,” the summary states. The study was terminated prematurely because it was difficult to enroll patients in China, where the number of Covid-19 cases was decreasing.
An outside researcher said that the results mean that any benefit from remdesivir is likely to be small.
“If there is no benefit to remdesivir in a study this size, this suggests that the overall benefit of remdesivir in this population with advanced infection is likely to be small in the larger Gilead trial,” said Andrew Hill, senior visiting research fellow at Liverpool University.
He added that the results of the study should be pooled with larger studies being conducted by Gilead using a technique called meta-analysis to allow for “a balanced view of the efficacy of remdesivir from all randomized trials.”
https://www.statnews.com/2020/04/23...ent-show-no-benefit-for-coronavirus-patients/
By ED SILVERMAN , ADAM FEUERSTEIN , and MATTHEW HERPER
APRIL 23, 2020
The antiviral medicine remdesivir from Gilead Sciences failed to speed the improvement of patients with Covid-19 or prevent them from dying, according to results from a long-awaited clinical trial conducted in China. Gilead, however, said the data suggest a “potential benefit.”
A summary of the study results was inadvertently posted to the website of the World Health Organization and seen by STAT on Thursday, but then removed.
“A draft document was provided by the authors to WHO and inadvertently posted on the website and taken down as soon as the mistake was noticed. The manuscript is undergoing peer review and we are waiting for a final version before WHO comments,” said WHO spokesperson Tarik Jasarevic.
Gilead spokesperson Amy Flood said the company believes “the post included inappropriate characterization of the study.” Because the study was stopped early because it had too few patients, she said, it cannot “enable statistically meaningful conclusions.” However, she said, “trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease.”
The data will be closely scrutinized but are also likely imperfect. The study was terminated prematurely, which could have affected the results. The context that would be provided by a full manuscript is missing, and the data have not been reviewed as normally occurs before publication.
Related:
The coronavirus pandemic could shrink some biotech startup valuations
Many studies are being run to test remdesivir, and this one will not be the final word. Results are expected soon from a Gilead-run study in severe Covid-19 patients, although that study may be difficult to interpret because the drug is not compared to patients receiving only standard treatment. Encouraging data from patients in that study at the University of Chicago were described by researchers at a virtual town hall and obtained by STAT last week. However, unlike those data, these new results are from a randomized controlled trial, the medical gold standard.
Gilead is also running a study with a control group in more moderate Covid-19 patients, and the National Institute of Allergy and Infectious Diseases is running a study that compares remdesivir to placebo. There are even more studies of the drug ongoing.
According to the summary of the China study, remdesivir was “not associated with a difference in time to clinical improvement” compared to a standard of care control. After one month, it appeared 13.9% of the remdesivir patients had died compared to 12.8% of patients in the control arm. The difference was not statistically significant.
“In this study of hospitalized adult patients with severe COVID-19 that was terminated prematurely, remdesivir was not associated with clinical or virological benefits,” the summary states. The study was terminated prematurely because it was difficult to enroll patients in China, where the number of Covid-19 cases was decreasing.
An outside researcher said that the results mean that any benefit from remdesivir is likely to be small.
“If there is no benefit to remdesivir in a study this size, this suggests that the overall benefit of remdesivir in this population with advanced infection is likely to be small in the larger Gilead trial,” said Andrew Hill, senior visiting research fellow at Liverpool University.
He added that the results of the study should be pooled with larger studies being conducted by Gilead using a technique called meta-analysis to allow for “a balanced view of the efficacy of remdesivir from all randomized trials.”
https://www.statnews.com/2020/04/23...ent-show-no-benefit-for-coronavirus-patients/
