CATIE HepCinfo Update 6.6

hepCinfoUpdates logoNew warning issued for serious heart problems when Harvoni or sofosbuvir is taken with amiodarone

The U.S. Food and Drug Administration (FDA) is warning that serious slowing of the heart rate (symptomatic bradycardia) can occur when the drug amiodarone, which is used to treat an irregular heartbeat, is taken together either with Harvoni or with sofosbuvir (Sovaldi) in combination with another direct-acting antiviral (DAA), such as daclatasvir or simeprevir (Galexos).

The FDA recommends that amiodarone not be prescribed with Harvoni or sofosbuvir combined with another DAA. If there is no alternative to taking amiodarone, the FDA recommends for patients to be monitored on a daily basis by their doctor. (fda.gov, March 2015, in English)