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FDA Approves Veklury® (Remdesivir) for COVID-19 Treatment in People With Mild to Severe Hepatic Impairment Without Dose Adjustment

Friday, August 25, 2023

Gilead Sciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted approval for a supplemental new drug application for the usage of Veklury® (remdesivir) without the need for dosage adjustments in treating COVID-19 among individuals with mild, moderate, and severe hepatic impairment. This decision emphasizes Veklury's safety profile as the exclusive antiviral treatment for COVID-19 that can be applied across all phases of liver disease.

Though the efficacy of Veklury in treating COVID-19 in hospitalized patients has been supported by randomized controlled trials, real-world data, and meta-analyses, its pharmacokinetics in patients with hepatic impairment had not been explored prior to this. This recent approval is grounded in findings from a Phase 1 study, labeled GS-US-540-9014, which examined the safety and pharmacokinetics of the drug in individuals with hepatic impairment. This study didn't reveal any new safety concerns. Consequently, the drug's labeling has been updated to indicate that dose adjustments are not required for individuals with any stage of liver disease. However, the label still recommends initial hepatic laboratory tests for all patients before starting Veklury, periodic tests during treatment, and consideration of discontinuation if alanine transaminase (ALT) levels increase significantly or if ALT elevation is accompanied by signs of liver inflammation.

The U.S. has over 100 million people living with liver disease, a group particularly vulnerable to COVID-19 and its associated complications. Those with severe liver disease have limited treatment options for COVID-19.

Frank Duff, MD, Senior Vice President and Virology Therapeutic Area Head at Gilead Sciences, highlighted, "With the recent increase in levels of COVID-19 circulating in the U.S., the risk to vulnerable individuals persists, including for those with hepatic impairment." This approval underscores Gilead's ongoing commitment to addressing COVID-19 in high-risk populations.

Dr. Douglas Dieterich, Director of the Institute for Liver Medicine and Professor of Medicine at the Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, emphasized the importance of updated safety and dosing recommendations for Veklury in individuals with liver disease. This demographic faces an elevated risk of COVID-19 complications, and the adjusted usage guidelines for Veklury offer added protection.

This approval follows recent decisions by the FDA and European Commission to expand Veklury's usage approval to include COVID-19 treatment for individuals with severe renal impairment, including those undergoing dialysis.

Gilead's ongoing research commitment in addressing the needs of vulnerable patients underlines its dedication to combating COVID-19, and this approval reinforces Veklury's overall safety profile.

The Phase 1 study (GS-US-540-9014) conducted by Gilead evaluated the pharmacokinetics of Veklury and its metabolites in participants with both normal hepatic function and moderate/severe hepatic impairment. Different participant groups were enrolled, with varying degrees of hepatic impairment, including moderate and severe cases, alongside those with normal hepatic function.

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