Hepatitis C antivirals: risk of severe bradycardia

26 May 2015

Clinically significant arrhythmias have been reported when Harvoni (sofosbuvir + ledipasvir) or Daklinza (daclatasvir) in combination with Sovaldi (sofosbuvir) are given concomitantly with amiodarone, the MHRA has warned.

In amiodarone-treated patients bradycardia was observed within 24 hours of initiating hepatitis C treatment in some cases and as long as 12 days after in others. | SCIENCE PHOTO LIBRARY

Patients with cardiac rhythm disorders taking the fixed-dose combination of sofosbuvir and ledipasvir, or sofosbuvir in combination with daclatasvir, should be closely monitored if they are receiving concomitant amiodarone, especially during the first few weeks of concomitant treatment. Continuous monitoring for 48 hours is required for patients at high risk of bradyarrhythmia.

Further information
MHRA Drug Safety Update

Owing to the long half-life of amiodarone, patients who have discontinued the antiarrhythmic within the past few months and are to be initiated on either of the above antiviral combinations should be monitored.

Amiodarone should only be initiated in patients taking these antiviral combinations if patients are unable to tolerate or cannot take other antiarrhythmics. Healthcare professionals should advise patients to urgently report signs and symptoms of bradycardia and cardiac block including: