LONDON, Mar 23 (APM) - One person has died and eight others have developed abnormally slow heartbeats after taking Gilead’s hepatitis C drugs Solvaldi (sofosbuvir) or Harvoni (sofosbuvir+ledipasvir) in combination with the heart drug amiodarone, according to a press report.
An emailed warning letter from the company to healthcare professionals explained 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, according to Bloomberg.
One of the patients died of cardiac arrest; three of the nine patients required a pacemaker, it said.
All of the patients were being treated with amiodarone, an antiarrhythmic medication used to treat ventricular tachycardia or ventricular fibrillation, plus a sofosbuvir combination.
Three were on Harvoni, five received Sovaldi plus Bristol-Myers Squibb’s daclatasvir, and one was on Sovaldi plus Johnson & Johnson’s Olysio (simeprevir), the news service said.
Gilead said the combinations are not recommended and it will update its product labelling to reflect this.
Gilead’s Sovaldi, a direct-acting antiviral, was described as a game changer in the treatment of hepatitis C when it was approved in the U.S. in Dec 2013 and in Europe the following month, although the company has been criticised for the high cost. (APMMA 36525) (APMMA 36948)
In its first year on the market, Sovaldi generated sales of $10.28 billion. Sales in the fourth quarter of 2014 amounted to $1.7 billion (APMMA 41334), slowing from the $3.48 billion the drug generated in the second quarter of the year. (APMMA 39193)
This was in part due to the anticipated launch of its combination product Harvoni, and rival new drugs, including AbbVie’s combination therapy Viekirax (ombitasvir+paritaprevir+ritonavir) plus Exviera (dasabuvir).
Following news of safety concerns with sofosbuvir in patients taking amiodarone, Gilead’s share price fell around 2% on the Nasdaq from market close on Friday to opening on Monday.
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