KUALA LUMPUR, April 24 – Gilead Sciences insisted that remdesivir had a potential benefit for Covid-19 patients, even though their condition did not improve faster with the antiviral drug in an aborted clinical trial.
STAT reported that the World Health Organization (WHO) accidentally posted to its website the summary of the results of an experiment by Gilead in China on remdesivir for Covid-19 patients.
“A draft manuscript 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 now undergoing peer review and we are waiting for a final version before WHO comments on it,” said WHO spokesperson Daniela Bagozzi, according to STAT.
WHO’s post, which was taken down later, showed negative study results, with remdesivir failing to increase the recovery rate of patients or stop death due to Covid-19.
Despite this, Gilead Sciences is still claiming a potential benefit from the clinical trial conducted in China.
STAT quoted Gilead spokesperson Amy Flood as saying that WHO’s post included “inappropriate characterisation of the study”, stressing that statistically meaningful conclusions cannot be drawn from the study that ended prematurely because it had too few patients.
But Flood was quoted as saying also that “trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease”.
Flood also reportedly said that the company regrets that “the WHO prematurely posted information regarding the study, which has since been removed” and emphasised that the researchers running the study “did not provide permission for publication of results.”
The summary of the China experiment said that remdisivir was “not associated with a difference in time to clinical improvement”.
The study also saw that after a month, 13.9 per cent of the patients treated with the drug had died, compared to 12.8 per cent of patients in the control study. There was no statistical significance in the difference.
The clinical trial had a total of 237 Covid-19 patients participating, comprising 158 of those under the remdesivir drug experiment and 79 in the control group. One patient withdrew from the control group without receiving any study treatment.
“In this study of hospitalised adult patients with severe Covid-19 that was terminated prematurely, remdesivir was not associated with clinical or virological benefits,” the summary stated, as reported by STAT.
“The study was terminated prematurely because it was difficult to enroll patients in China, where the number of Covid-19 cases was decreasing,” said WHO’s post.
“Adverse events were reported in 65.2 per cent of remdesivir recipients versus 64.1 per cent in placebo recipients. Remdesivir was stopped early in 18 (11.6 per cent) patients because of adverse effects, compared to four (5.1 per cent) in the control group.”
According to the WHO’s post, for time to clinical improvement, the hazard ratio was 1.23, which meant that the patients on remdesivir improved more slowly than those in the control group.
“However, in a previous note to investors preparing them for the data, Umer Raffat, a biotech analyst at Evercore ISI, had said to expect the opposite arrangement: that a hazard ratio of 1.2 would show patients were doing better. It is not certain how the hazard ratio is being described in the abstract,” STAT said.