Sovaldi sofosbuvir regulatory update

EMA recommended against the use of HCV drugs Harvoni ledipasvir/sofosbuvir or Sovaldi sofosbuvir plus Daklinza daclatasvir when given with antiarrhythmic amiodarone due to an increased risk of severe bradycardia or heart block. The agency also updated the labels of the HCV drugs with the warning. FDA issued a similar drug safety alert (see BioCentury, April 6).

When alternative treatment options are unavailable, EMA recommends heart monitoring in an inpatient hospital setting for the first 48 hours. The agency also recommended monitoring for patients beginning treatment with the HCV drugs that have discontinued amiodarone within the past few months due to amiodarone’s long half-life. ...