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Important Update to Label for Sovaldi, Harvoni

The FDA announced an update to the label for Hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) that includes a warning of serious symptomatic bradycardia when either drug is coadministered with the antiarrhythmic therapy, amiodarone.1,2 Amiodarone, which is commercially branded as Cordarone, Nexterone or Pacerone, is prescribed for patients with heart arrhythmia.

The drug maker, Gilead, warned healthcare providers that in a total of 9 patients taking amiodarone, a total of 6 cases of symptomatic bradycardia occurred within 24 hours of starting either Sovaldi or Harvoni. In 3 other cases, bradycardia occurred within two to twelve days of patients starting either drug. One of the 9 patients died of cardiac arrest

Of the 9 patients, 3 were given Harvoni, 6 were given Sovaldi plus daclatasvir, and 1 was given Sovalidi plus Olysio. All 9 patients were also taking amiodarone.

Gilead stated, “”The mechanism of the potential interaction between amiodarone and Harvoni, or Sovaldi in combination with another DAA (direct antiviral agent) is unknown.”

Concurrent use of amiodarone with either Sovaldi or Harvoni is not recommended. However, if coadministration is necessary, it is recommended that patients who need amiodarone and Sovaldi be monitored in an inpatient setting for the first 48 hours, followed by daily outpatient or self-monitoring of their heart rate for at least the first two weeks of treatment.

It’s also important to note that because amiodarone has a long half-life, even patients who have recently stopped taking amiodarone ahead of starting Harvoni or Sovaldi along with a direct antiviral agent should be monitored.

As always, it is important to talk to your doctor about the risks and benefits of taking any medication, and always make sure he or she knows what other treatments you are taking for other conditions.

  1. Barber, J. Gilead's shares slip on hepatitis C drug-interaction warning. FirstWordPharma.
  2. Leuty, R. Gilead stock drops on hepatitis C drug's heart warning. San Francisco Business Times. BiotechSF.