Gilead Sciences’ antiviral drug Remdesivir has failed to accelerate the results of patients with Covid-19 or prevent death, according to a long-awaited clinical trial in China. However, Gilead said the data suggested “potential benefits”.
A summary of the study results was accidentally posted on the World Health Organization website and viewed by STAT on Thursday, but was then removed.
“The authors provided WHO with a draft manuscript that was accidentally posted on the website and removed as soon as the error was noticed. The manuscript is currently being peer reviewed and we are waiting for a final version before WHO comments on it, ”said WHO spokeswoman Daniela Bagozzi.
Gilead spokeswoman Amy Flood said the company believed that “the contribution included inappropriate characterization of the study.” Since the study was terminated prematurely due to the fact that there were too few patients, it “could not provide any statistically meaningful conclusions”. However, she said: “Trends in the data indicate potential benefits for remdesivir, particularly in patients treated early in the disease.”
The data (see screenshot below for details) is being scrutinized, but is likely to be incomplete. The study was stopped early, which could have affected the results. The context that a full manuscript would provide is lacking, and the data has not been verified as it was normally before publication.
Many studies are being done to test remdesivir, and this won’t be the last word. The results of a Gilead study in severe Covid 19 patients are expected soon, although this study may be difficult to interpret because the drug is not compared to patients receiving standard treatment. Encouraging data from patients in this study at the University of Chicago were described by researchers in a virtual town hall and received from STAT last week. In contrast to these data, however, these new results come from a randomized controlled trial, the medical gold standard.
Gilead is also conducting a control group study in more moderate Covid 19 patients, and the National Institute of Allergy and Infectious Diseases is conducting a study comparing remdesivir to placebo. There are other studies on the drug.
According to the summary of the China study, remdesivir was “not associated with a time difference to clinical improvement” compared to a standard of care control. After one month, 13.9% of the remdesivir patients appeared to have died compared to 12.8% of the patients in the control arm. The difference was not statistically significant.
“In this study in adult hospital patients with severe COVID-19 that was terminated prematurely, remdesivir was not associated with any clinical or virological benefits,” the summary said. The study was stopped early because it was difficult to enroll patients in China, where the number of Covid 19 cases decreased.
An external researcher said the results mean that remdesivir is likely to be of little benefit.
“If remdesivir is of no benefit in a study of this size, it suggests that the overall benefit of remdesivir in this advanced infection population is likely to be small in the larger Gilead study,” said Andrew Hill, senior visiting researcher at Liverpool University.
He added that the study’s results should be combined with larger studies conducted by Gilead using a technique called meta-analysis to provide a “balanced view of the effectiveness of remdesivir from all randomized trials”.