Assessment of the clinical cardiac drug-drug interaction associated with the combination of hepatitis C virus nucleotide inhibitors and amiodarone in guinea pigs and rhesus monkeys

Author:

Regan Christopher P.1,Morissette Pierre1,Regan Hillary K.1,Travis Jeffery J.1,Gerenser Pamela1,Wen Jianzhong2,Fitzgerald Kevin1,Gruver Shaun1,DeGeorge Joseph J.3,Sannajust Frederick J.1

Affiliation:

1. Department of Safety & Exploratory Pharmacology; Merck Research Laboratories; West Point PA

2. Pharmacokinetics, Pharmacodynamics & Drug Metabolism; Merck Research Laboratories; West Point PA

3. Safety Assessment and Laboratory Animal Resources; Merck Research Laboratories; West Point PA

Publisher

Wiley

Subject

Hepatology

Reference20 articles.

1. French National Agency for Safety of Health Products and Medicines Safety signal concerning the association of two antivirals, daclatasvir and/or sofosbuvir, in the treatment of chronic hepatitis C and/or amiodarone and the occurrence of cardiac arrhythmias 2015 http://ansm.sante.fr/S-informer/Travaux-de-l-Agence-Europeenne-des-Medicaments-EMA-Comite-pour-l-evaluation-des-risques-en-matiere-de-pharmacovigilance-PRAC/Finalisation-de-la-reevaluation-des-medicaments-contenant-de-l-ambroxol-ou-de-la-bromhexine-retour-d-information-sur-le-PRAC-de-janvier-2015-Point-d-information

2. European Medicines Agency EMA recommends avoidance of certain hepatitis C medicines and amiodarone together 2015 http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/04/news_detail_002313.jsp&mid=WC0b01ac058004d5c1

3. U.S. Food and Drug Administration FDA Drug Safety Communication: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir Harvoni or Sovaldi in combination with another direct acting antiviral drug http://www.fda.gov/Drugs/DrugSafety/ucm439484.htm

4. Amiodarone prescribing information http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf

5. Extreme bradycardia after first doses of sofosbuvir and daclatasvir in patients receiving amiodarone: 2 cases including rechallenge;Renet;Gastroenterology,2015

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