COVID-19 Antiviral Veklury Approved for Use in Patients With Hepatic Impairment

Veklury is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor. Credit: Getty Images.

The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Veklury^® (remdesivir) to include COVID-19 treatment in patients with mild to severe hepatic impairment with no dose adjustments.

Veklury, a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor, is indicated for the treatment of COVID-19 in adults and pediatric patients (28 days of age and older and weighing at least 3 kg) who are: hospitalized, or not hospitalized and have mild to moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

Previously, the pharmacokinetics of Veklury had not been evaluated in patients with hepatic impairment. The updated labeling now states that no dosage adjustment is recommended for patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C).

Data from a phase 1 safety and pharmacokinetics study showed that compared with individuals with normal hepatic function, mean exposures of remdesivir and its metabolite were similar in participants with moderate hepatic impairment and higher in those with severe hepatic impairment. The exposure differences in individuals with severe hepatic impairment were not considered to be clinically significant.

Hepatic laboratory testing should still be performed in all patients before starting Veklury and while receiving treatment, as clinically appropriate. Discontinuation of Veklury should be considered if ALT levels increase to greater than 10 times the upper limit of normal or if ALT elevation is accompanied by signs or symptoms of liver inflammation.