Are there any other warnings one should know regarding Epclusa?

Bradycardia When Coadministered with Sofosbuvir and Amiodarone

The FDA has warned that a serious slowing of the heart rate can occur when using amiodarone along with sofosbuvir, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Taking of amiodarone with Epclusa is not recommended. In patients without alternative viable treatment options, cardiac monitoring is recommended.

Risk of Hepatitis B Reactivation

The FDA has indicated that there is risk of the Hepatitis B virus becoming an active infection again in any patient who has a current or previous infection with Hepatitis B virus and is being treated with Epclusa, a direct-acting antiviral medicine for Hepatitis C virus. In a few cases, Hepatitis B virus reactivation in patients treated with these types of medicines resulted in serious liver problems or death. In addition to a prominent warning being required on the medication’s labeling, healthcare professionals are being directed to also screen and monitor for the Hepatitis B virus in all patients receiving this treatment.

Last Updated: October 2016