Gilead Sciences has issued a warning on the use of its Hepatitis C-drugs Sovaldi and Harvoni.
If taken together with amiodarone, a life-threatening reduction in heart rate may occur. Although amiodarone is a drug used to treat cardiac arrhythmia. This was announced by the US pharmaceutical company at the end of March.
The background to this warning is nine cases to date in which patients of one of the two Hepatitis C-(both contain the active ingredient sofosbuvir) together with the heart medication amiodarone and complained of an abnormally slow heartbeat as a result. One of the patients died of cardiac arrest and three others required a pacemaker.
According to Gilead three of the nine patients took the combination preparation Harvoni (sofosbuvir + ledipasvir). Five took the drug Sovaldi (sofosbuvir) in combination with daclatasvir. And another patient took Sovaldi in combination with Olysio (simeprevir).
According to the Wall Street Journal, there are between 1,000 and 1,500 patients in the USA who are taking both the heart medication and the active ingredient sofosbuvir. A total of 250,000 to 300,000 patients are currently being treated with amiodarone in the USA. In Germany, this active ingredient is marketed as Cordarex®, Amiohexal® and Amiogamma®, among others.
Gilead recommends that patients be observed as inpatients for the first 48 hours after starting therapy. This applies to amiodarone as well as Harvoni or Sovaldi in combination with other DAA agents (DAA stands for direct acting antiviral). And thereafter, the heart rate should be monitored on an outpatient basis or by the patient themselves for at least another 14 days.
Due to the long half-life of amiodarone, patients who stopped taking this drug shortly before taking Sovaldi or Harvoni should also continue to be monitored.
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