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Posted: 2020-07-11 03:43:29

In the latest analysis, Gilead said it analysed data from 312 patients treated in its late-stage study and a separate real-world retrospective cohort of 818 patients with similar characteristics and disease severity.

Rubber stoppers are placed onto filled vials of the investigational drug remdesivir at a Gilead manufacturing site in the United States.

Rubber stoppers are placed onto filled vials of the investigational drug remdesivir at a Gilead manufacturing site in the United States.Credit:AP

Gilead's late-stage study evaluated the safety and efficacy of five-day and 10-day dosing durations of remdesivir in hospitalised patients. The study did not have a placebo comparison.

Dr Susan Olender from Columbia University Irving Medical Centre said in the Gilead statement that the analysis draws from a real-world setting and serves as an important adjunct to clinical trial data even as it is not as vigorous as a randomised controlled trial.

However, Dr Walid Gellad, a professor at University of Pittsburgh’s medical school, called it "a joke" to compare clinical trial data with observational data and conclude anything definitive about mortality.

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"The mortality in the remdesivir trials has generally been lower for both control and intervention groups than other trials and other real world cohorts I've seen," Gellad said in an email.

"The real world patients are taken care of at different hospitals than those in the trial and potentially different adjunct treatments. They're different."

Findings from the analysis showed that 74.4 per cent of remdesivir-treated patients recovered by Day 14 versus 59 per cent of patients receiving standard of care, the company said.

The mortality rate for patients treated with remdesivir in the analysis was 7.6 per cent at Day 14, compared with 12.5 per cent among patients not on the drug.

The US government trial in April showed that patients given remdesivir recovered 31 per cent faster than those given a placebo.

The government has allocated more than 11,000 courses of the treatment to the four states now being hardest hit by the fast-spreading outbreak in the US. It is being distributed to Texas, Florida, California and Arizona by Monday, according to a US Department of Health and Human Services website.

Gilead's shares rose 2 per cent to $US76.27 in afternoon trading.

Reuters

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