The FDA review of post postmarketing adverse event identified 9 cases of bradycardia including one fatality.
The cause of these events could not be determined therefore the FDA is advising health care professionals not to prescribe either Harvoni or Sovaldi combined with another direct-acting antiviral drug with amiodarone.
However, in cases where alternative treatment options are unavailable, the FDA recommends cardiac monitoring in an inpatient hospital setting for the first 48 hours. Subsequently, monitoring in a doctor’s office or self-monitoring of the heart rate should be done every day through at least the first 2 weeks of treatment.
Furthermore, due to the long half-life of amiodarone, patients discontinuing amiodarone just prior to starting Harvoni, or Sovaldi in combination with another direct-acting antiviral, should also undergo similar cardiac monitoring as outlined above.
The current UK SPCs for Harvoni and Sovaldi do not include any warnings regarding the co-administration of these products with amiodarone.