The expanded indication to those with severe hepatic impairment has already been granted in the US and EU.
Gilead, the manufacturer of COVID-19 antiviral remdesivir (Veklury), has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has taken up a positive opinion on the use of remdesivir for the treatment of COVID-19 in people with mild to severe hepatic impairment.
The recommendation expands upon recent approvals in both the US and European Union that extend the use of remdesivir for the treatment of COVID-19 in people with renal and hepatic impairment. In the US, remdesivir is approved to treat COVID-19 in adults and children (at least 28 days old and 3 kg) who are hospitalized or who are at high risk of severe or fatal COVID-19.
The CHMP opinion was based on data from a phase 1, multicenter, open-label, single-dose study (GS-US-540-9014) that evaluated pharmacokinetics and safety in patients with moderate to severe liver disease or no hepatic impairment. Two cohorts were formed, 1 with 20 participants (10 with moderate hepatic impairment and 10 matched controls), and 1 with 12 participants (6 with severe hepatic impairment and 6 matched controls.) No new safety signals were observed, indicating that no dose adjustment is necessary across all stages of liver disease.
Notably, the CHMP recommendation does not require liver function testing before or during treatment with remdesivir; however, the expanded US approval, which was granted in August 2023, does require hepatic laboratory testing prior to starting treatment and during treatment as clinically appropriate. The label advises that treatment should be discontinued 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.
“The positive opinion from the Committee helps validate the safety profile of Veklury and is reassuring news to vulnerable populations, such as those living with liver disease that may be facing an increased risk of complications from COVID-19,” said Antonella Castagna, MD, Head of Infectious Diseases at San Raffaele Scientific Institute; Professor, Clinic of Infectious Diseases, Vita-Salute San Raffaele University, in a statement. “Expanding the use of Veklury to those with hepatic impairment will help more people gain access to treatment for COVID-19.”