Gilead Warns of Cardiac Issues With Sovaldi and Harvoni

The company has announced that patients on Sovaldi or Harvoni who were also on the heart medication amiodarone developed abnormally slow heartbeats. This warning by Gilead could limit the drug's use.

Gilead Sciences Inc. said 9 patients taking its hepatitis C drugs Harvoni or Sovaldi along with the heart treatment amiodarone developed abnormally slow heartbeats and 1 died of cardiac arrest. Three required a pacemaker to be inserted.

Gilead said in an e-mailed drug warning to healthcare providers on Friday that 6 cases of symptomatic bradycardia occurred within the first 24 hours of treatment and the remaining 3 within the first 2 to 12 days. The patients were all taking amiodarone, with 3 also using Harvoni, 5 receiving Sovaldi with Bristol-Myers Squibb Co.’s daclatasvir and 1 on Sovaldi with Johnson & Johnson’s Olysio. Gilead said the combinations aren’t recommended and it will update its product labeling.

Link to the Bloomberg report: