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Gilead Announces Heart Problems With Sovaldi and Harvoni in Nonapproved Combinations

Warning could limit drugs’ use

Gilead Sciences has announced that nine patients taking its hepatitis C drug Sovaldi (sofosbuvir) or Harvoni (ledipasvir/sofosbuvir) along with amiodarone developed abnormally slow heartbeats, and that one died of cardiac arrest. Three required the insertion of a pacemaker.

Gilead said in a drug warning e-mailed to health-care providers on March 20 that six cases of symptomatic bradycardia occurred within the first 24 hours of treatment and that the remaining three occurred within the first 2 to 12 days. The patients were all taking amiodarone, with three also using Harvoni, five receiving Sovaldi with daclatasvir (Bristol-Myers Squibb), and one receiving Sovaldi with simeprevir (Olysio, Johnson & Johnson). Gilead said that these combinations aren’t recommended, and that it will update its product labeling accordingly.

The warning might limit the use of Sovaldi and Harvoni, which have transformed how hepatitis C virus infection is treated, with most patients being cured after 12 weeks of treatment. 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 2014, and Sovaldi brought in $1.73 billion, together contributing more than half of Gilead’s total revenue of $7.31 billion, according to the Bloomberg business website. The drugs’ hefty profit margins helped boost fourth-quarter net income more than fourfold to $3.49 billion.

Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), a competing treatment introduced late last year by AbbVie, has put pressure on Gilead’s prices.

Source: Bloomberg Business; March 23, 2015.

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