Shorter 5-day course of remdesivir works as well as 10-day: Gilead study
SAN FRANCISCO, California: Gilead Sciences Inc, which has suggested that a shorter treatment duration could extend limited supplies of its drug remdesivir, on Wednesday published results of a study showing no significant difference in outcomes between 5- and 10-day courses of the drug for patients with severe COVID-19.
Gilead announced "top-line" findings from the trial on Apr 29. The full results were published in the New England Journal of Medicine.
Gilead's trial involved 397 patients hospitalised with severe COVID-19, most of whom were not on ventilators. The company said the study, which did not include a placebo comparison, showed that 14 days after treatment with the intravenous drug, 64 per cent of patients treated for five days and 54 per cent treated for 10 days showed some clinical improvement.
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At the 14-day mark, 8 per cent of patients in the five-day group and 11 per cent of patients in the 10-day group had died.
Gilead said the results should not be interpreted as indicating that the shorter duration worked better since evidence of improved outcomes occurred early on, leading investigators to attribute the difference to imbalances in patient status at enrollment.
Adverse events included nausea and worsening respiratory failure. The company said 2.5 per cent of patients in the five-day group and 3.6 per cent in the 10-day group discontinued treatment due to elevated liver enzymes.
The US Food and Drug Administration granted emergency use authorisation to remdesivir on May 1, citing results from a different study run by the National Institutes of Health showing that the drug reduced hospitalization stays by 31 per cent compared to a placebo treatment.
READ: US doctors call for remdesivir data to guide coronavirus treatment
Gilead has said it anticipates results from a company study of remdesivir in patients with more moderate COVID-19 around the end of this month.
Gilead has pledged to donate 1.5 million doses of remdesivir - or enough to treat at least 140,000 patients - to fight the global pandemic.
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