Q1: Answer: A
The Food and Drug Administration issued a postmarketing warning about potential for interaction between sofosbuvir and amiodarone. Nine patients taking sofosbuvir (with other antiviral agents) and amiodarone developed significant bradycardia. Seven patients were on concomitant beta-blockade. One patient died of cardiac arrest while three others required pacemaker placement. Two-thirds of the events occurred within 24 hours of coadministration while the other third occurred within 12 days. Three patients had recurrence of bradycardia with rechallenge of sofosbuvir treatment while on amiodarone. The mechanism of bradycardia is not fully understood. Amiodarone is considered an absolute contraindication to the use of a sofosbuvir-containing regimen. The sofosbuvir-containing regimens listed are endorsed by the AASLD/IDSA joint guidelines for treatment of genotype 1a hepatitis C, as long as the patient is not on amiodarone, although the combination of sofosbuvir and daclatasvir is not FDA approved for genotype 1.
Reference
1. Fontaine H, Lazarus A, Pol S, et al.; Cochin Hepatology and Cardiology Group. N Engl J Med. 2015 Nov 5;373(19):1886-8.
