LONDON, UK — The European Medicines Agency (EMA) is cautioning against combining the antiarrhythmic agentamiodarone with several agents used to treat hepatitis C, including a combo preparation of sofosbuvir (Sovaldi, Gilead Sciences) and ledipasvir (Harvoni, Gilead Sciences) and also the pairing of sofosbuvir with daclatasvir (Daklinza, Bristol-Myers Squibb), based on a data review that found the sofosbuvir-containing combinations may increase the risk of severe bradycardia or heart block[1].
The agency recommends that amiodarone be considered an antiarrhythmic of last resort in patients taking the antiviral agents. "If there is no alternative to giving amiodarone at the same time as the hepatitis C medicine, patients' heart function must be carefully monitored by the doctor. This may include monitoring in the hospital for 48 hours after starting treatment," according to the EMA. "Because amiodarone remains in the body for a long time, monitoring is also needed when the hepatitis C treatment is given to patients who stopped amiodarone treatment within the past few months."
All three antiviral preparations were approved by the EMA in 2014; amiodarone has been available for decades.
Earlier this month, the Food and Drug Administration approved a label change for the hepatitis C antiviral simeprevir (Olysio, Johnson & Johnson) to warn prescribers and patients of an increased risk of serious symptomatic bradycardia when the drug is combined with amiodarone and sofosbuvir, as reported by heartwire from Medscape. In March, the US agency updated labeling information for sofosbuvir and the sofosbuvir-ledipasvir combo preparation for similar reasons.
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Cite this: EMA: Heart Risk From Amiodarone Plus Hepatitis C Antivirals - Medscape - Apr 24, 2015.
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