Gilead’s Remdesivir Might Not Be as Effective For 'Moderate' Cases of COVID-19, Finds New Study

Remdesivir is being studied in multiple ongoing international clinical trials and has been approved by multiple regulatory authorities around the world, including in the European Union and Japan. Remdesivir has not been approved by the US Food and Drug Administration (FDA) for any use but has been granted an Emergency Use Authorization (EUA) in the US for the treatment of hospitalized patients with severe COVID-19. Dr. Diana Brainard, head of clinical research at Gilead, told Reuters that earlier this month, Gilead had submitted a formal application to the FDA seeking approval for the use of remdesivir in all hospitalized patients with COVID-19.

According to Reuters, despite the latest mixed trial results, which showed that a five-day course of intravenous remdesivir modestly helped less severely ill COVID-19 patients, whereas a 10-day course did not show any benefit, the FDA could update its EUA for remdesivir to include patients hospitalized with moderate COVID-19, thus widening its use. For the study, Brainard's group looked at 584 moderately ill hospitalized patients who received either five days of remdesivir administered intravenously; 10 days on the same regimen, or standard care without remdesivir. The researchers found that 11 days after starting treatment, 65% of the 10-day remdesivir patients, 70% of the 5-day patients and 60% of the standard care patients had left the hospital. Moderately ill patients treated with the antiviral drug for up to five days demonstrated significantly higher odds of improvement in certain areas, such as whether or not they needed supplemental oxygen, as compared to patients given standard treatment. Brainard told Reuters that the clinical importance of the benefit for those patients was uncertain, due to continued questions about how best to measure patient outcomes other than survival.

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