HCV Antiviral Simeprevir Label Now Warns of Cardiac Risk

April 16, 2015

SILVER SPRING, MD — The US Food and Drug Administration (FDA) has approved a label change for the hepatitis C (HCV) antiviral simeprevir (Olysio, Janssen Therapeutics) to warn prescribers and patients of an increased risk of serious symptomatic bradycardia when the drug is combined with amiodarone and the antiviral sofosbuvir (Sovaldi, Gilead Sciences).

The label change also warns of an increased risk of liver decompensation and liver failure when simeprevir is used with amiodarone and sofosbuvir.

In March, the FDA updated labeling information for sofosbuvir and the HCV antiviral combination of ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) to reflect an increased risk of cardiac eventsafter the manufacturer reported nine cases of treatment-related adverse events, including bradycardia, pacemaker intervention, and even death, in patients taking amiodarone and other antiviral agents, including simeprevir.

As part of the new simeprevir labeling change, there is now a warning of postmarketing cases of symptomatic bradycardia and pacemaker intervention when used with amiodarone and sofosbuvir.

"The coadministration of amiodarone with simeprevir in combination with sofosbuvir is not recommended," the updated label states.

If a patient must take the three agents together, they should be counseled about the risks and receive inpatient cardiac monitoring for the first 48 hours of treatment. After discharge, outpatient or self-monitoring of heart rate should be done on a daily basis for a minimum of 2 weeks.

The label also states that hepatic decompensation and hepatic failure, including fatal cases, have been documented in patients treated with simeprevir in combination with peg-interferon alfa and ribavirin or in combination with sofosbuvir. "Most cases were reported in patients with advanced and/or decompensated cirrhosis who are at increased risk for hepatic decompensation or hepatic failure," according to the updated label.


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