Sofosbuvir-Containing Hepatitis C Treatments (Sovaldi and Harvoni) and Serious Bradycardia Risk Interaction With Amiodarone (Cordarone and Pacerone)
March 25, 2015
Serious heart rate slowing, or bradycardia, may occur in patients using amiodarone (Cordarone and Pacerone) and a hepatitis C treatment regimen containing sofosbuvir (ie, Sovaldi and Harvoni) in combination with another direct-acting antiviral (see examples below). FDA received 9 reports of patients who developed life-threatening bradycardia while taking this combination of agents. The symptomatic bradycardia occurred within the first few hours after starting therapy for some patients to after 2 weeks of therapy for others. One of these patients died from cardiac arrest and three others required pacemakers to regulate their heart rhythms. The other patients recovered after discontinuing one or more of the implicated drugs. The mechanism causing this serious adverse effect with this combination of drugs is currently unclear.
FDA issued a MedWatch alert describing the risk of severe bradycardia with this combination of drugs and added warnings to the Harvoni and Sovaldi package inserts. Avoid prescribing sofosbuvir-containing hepatitis C regimens that include another direct-acting antiviral in patients using amiodarone. If such a combination is unavoidable, use inpatient heart monitoring for the first 48 hours of therapy followed by outpatient monitoring daily for at least the first 2 weeks of therapy. Patients who recently discontinued amiodarone and are starting one of the implicated hepatitis C treatment regimens require the same cardiac monitoring due to the long half-life of amiodarone. Advise patients using this combination of drugs to urgently seek medical care if they experience symptomatic bradycardia. Signs and symptoms include chest pain, confusion or memory issues, dizziness, excessive fatigue, fainting or near-fainting, malaise, shortness of breath, and weakness.
Direct-acting antiviral agents used to treat hepatitis C
- Daclatasvir – investigational agent
- Ledipasvir and sofosbuvir (Harvoni)
- Simeprevir (Olysio)
- Sofosbuvir (Sovaldi)
- Ombitasvir, paritaprevir, ritonavir, and dasabuvir (Viekira Pak)
- MedWatch Safety Alert – March 24, 2015
- FDA Drug Safety Communication – March 24, 2015
March 25, 2015; University of Utah, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.