Cardiac warning added to HCV antiviral simeprevir

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The FDA has approved a label change for the hepatitis C (HCV) antiviral simeprevir (Olysio) to include a warning for increased risk of symptomatic bradycardia when the drug is taken concomitantly with amiodarone and sofosbuvir (Sovaldi).

The new label states that “the coadministration of amiodarone with simeprevir in combination with sofosbuvir is not recommended.” It also warns that patients taking simeprevir with amiodarone and sofosbuvir have an increased risk of liver decompensation and liver failure.

In March, the FDA approved a label update for sofosbuvir and ledipasvir/sofosbuvir (Harvoni) to include a warning for increased risk of cardiac events. The label update came after nine reported cases of treatment-related adverse cardiovascular events, including bradycardia, pacemaker intervention, and death.

The label also provides recommendations for patients who must take the three drugs together. Clinicians should counsel patients about the associated risks, and patients should receive inpatient cardiac monitoring for the first 48 hours of treatment. After the initial inpatient monitoring, patients should undergo outpatient or self-monitoring of heart rate every day for at least 2 weeks.

The updated simeprevir label also informs patients that hepatic decompensation and failure have been recorded in patients treated with simeprevir with peg-interferon alfa and ribavirin or with sofosbuvir.

The FDA approved an updated label for simeprevir that warns of cardiac risks.
The FDA approved an updated label for simeprevir that warns of cardiac risks.

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.

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