Gilead Sciences Inc. said nine patients taking its hepatitis C drugs Harvoni or Sovaldi along with the heart treatment amiodarone developed abnormally slow heartbeats and one died of cardiac arrest. Three required a pacemaker to be inserted.
Gilead said in an e-mailed drug warning to health-care providers on Friday that six cases of symptomatic bradycardia occurred within the first 24 hours of treatment and the remaining three within the first two to 12 days. The patients were all taking amiodarone, with three also using Harvoni, five receiving Sovaldi with Bristol-Myers Squibb Co.’s daclatasvir and one on Sovaldi with Johnson & Johnson’s Olysio. Gilead said the combinations aren’t recommended and it will update its product labeling.
The warning might limit the use of Sovaldi and Harvoni, which have transformed how the liver infection hepatitis C is treated, with most patients being cured after 12 weeks. The drugs also have drawn criticism for their cost of more than $1,000 a day before discounts, or as much as $94,500 for a full course of treatment.
Harvoni generated $2.11 billion in sales in the fourth quarter of last year, and Sovaldi brought in $1.73 billion, together contributing more than half of the Foster City, California-based company’s total revenue of $7.31 billion. The drugs’ hefty profit margins helped boost fourth-quarter net income more than fourfold to $3.49 billion.
A competing treatment introduced late last year by AbbVie Inc. has put pressure on Gilead’s prices.