The drug is the first approved antiviral COVID-19 treatment that could be used across all stages of liver disease.
The FDA has approved a supplemental New Drug Application for remdesivir (Veklury; Gilead Sciences) with no dose adjustments to treat COVID-19 in patients with mild, moderate, and severe hepatic impairment, according to a press release published by Gilead.
This latest approval is based on results from a phase 1 study of safety and pharmacokinetics in individuals with hepatic impairment, called GS-US-540-9014. Previously, the clinical benefit of remdesivir in hospitalized populations with COVID-19 was demonstrated by randomized controlled trials, real-world evidence, and meta-analyses.
“With the recent increase in levels of COVID-19 circulating in the US, the risk to vulnerable individuals persists, including for those with hepatic impairment,” said Frank Duff, MD, senior vice president and virology therapeutic area head at Gilead Sciences, in the press release. “This approval demonstrates Gilead’s ongoing commitment to COVID-19, including our focus on vulnerable populations.”
No new safety signals were observed in the study. The label for the drug was updated based on the results to indicate that no dose adjustment is required across all stages of liver disease. However, it still recommends initial hepatic laboratory testing in all patients before starting treatment and throughout treatment as clinically appropriate.
Furthermore, discontinuation of remdesivir should be considered if alanine transaminase (ALT) levels increase to 10 times the upper limit of normal, or if ALT elevation is accompanied by signs or symptoms of liver inflammation.
Individuals with liver disease represent a population that is especially vulnerable to COVID-19 and are at an increased risk of morbidity and mortality. Over 100 million patients in the United States are living with liver disease, and there are currently limited treatment options for this subset of individuals who contract COVID-19.
The approval extends the recent FDA and European Commission decisions to the approved use of remdesivir to treat COVID-19 in patients with severe renal impairment, including those who are on dialysis.
“The update to the safety profile and dosing recommendations for Veklury for those living with liver disease is important to this vulnerable population who faces an increased risk of complications from COVID-19,” said Douglas Dieterich, MD, director of the Institute for Liver Medicine and professor of Medicine in the Division of Liver Diseases at Icahn School of Medicine at Mount Sinai. “While COVID-19 is no longer a public health emergency, the virus continues to present a threat to those with underlying conditions.”
Gilead. FDA approves Veklury (remdesivir) to treat COVID-19 in people with mild to severe hepatic impairment with no dose adjustment. News release. Accessed August 24, 2023. Published August 24, 2023. Accessible at https://www.gilead.com/news-and-press/press-room/press-releases/2023/8/fda-approves-veklury-remdesivir-to-treat-covid19-in-people-with-mild-to-severe-hepatic-impairment-with-no-dose-adjustment