NIH’s detailed remdesivir data show ventilated COVID-19 patients unlikely to benefit
Three weeks after FDA issued Emergency Use Authorization for Gilead’s remdesivir to treat severe COVID-19, detailed preliminary data that informed the decision support the antiviral’s use but also show the drug isn’t likely to benefit the sickest patients.
Data reported Friday in The New England Journal of Medicine reiterated that the Gilead Sciences Inc. (NASDAQ:GILD) antiviral met the primary endpoint in NIH’s Phase III ACTT study to treat severe COVID-19, leading to an 11-day recovery time vs. 15 days for placebo (p<0.001).
However, while treatment outcomes weren’t statistically linked to baseline disease severity, subgroup analyses showed that remdesivir vs. placebo led to no difference in patients receiving mechanical ventilation or extracorporeal membrane oxygenation (ECMO) as well as high-flow oxygen or non-invasive mechanical ventilation.
In a statement, Gilead highlighted that individuals who required oxygen supplementation but were not mechanically ventilated received the most benefit.
On one of the secondary endpoints, survival at 14 days, there was a trend toward lower mortality rate in patients given remdesivir vs. placebo (7.1% vs 11.9%). The numbers are better than those announced April 30: a mortality rate of 8% mortality in patients on remdesivir vs. 11.6% for placebo (see “Readout for Gilead’s Remdesivir in COVID-19”).
Mortality data at 28 days were not reported as many patients hadn’t completed day 29 visits yet.
Japan approved remdesivir as Veklury to treat COVID-19 on May 7.