FDA Warns about Cardiac Risks Associated With HCV Drug Combination Amiodarone and Sofosbuvir

FDA Warns about Cardiac Risks Associated With HCV Drug Combination Amiodarone and Sofosbuvir

shutterstock_135683396The U.S. Food and Drug Administration (FDA) recently announced a drug safety modification regarding the Warnings and Precautions, Adverse Reactions and Drug Interactions sections for Sovaldi and Harvoni medications.

Sovaldi is an antiviral drug (sofosbuvir) while Harvoni is a combination of two antiviral drugs (sofosbuvir and ledipasvir), both prescribed to treat chronic hepatitis C, a viral infection that can cause serious harm to the liver such as cirrhosis and liver cancer. Both drugs reduce the amount of hepatitis C virus (HCV) in the body by preventing its multiplication. Sovaldi should not be prescribed alone but together with another direct-acting antiviral (DAA) hepatitis C drug.

FDA has now included in the labels of Harvoni and Sovaldi medications the information that amiodarone (an antiarrhythmic drug) should not be co-administered with either of these drugs. This update in drug safety was made based on the report of nine severe cases of symptomatic bradycardia (slow heart rate) and one fatal cardiac arrest in individuals caused by amiodarone and Harvoni or amiodarone and Sovaldi plus another DAA.

Gilead Sciences (Harvoni’s and Sovaldi’s manufacturer) submitted a letter to health care providers stating: “Nine cases of symptomatic bradycardia have been reported during post marketing in patients receiving amiodarone with either Harvoni or Sovaldi in combination with another DAA (daclatasvir, an investigational drug, or Olysio [simeprevir, Janssen Therapeutics]). Seven patients were also receiving a beta blocker.”

According to Gilead’s letter, of the nine reported cases, three were in patients receiving Harvoni, five in patients receiving Sovaldi with daclatasvir, and one case in a patient receiving Sovaldi with simeprevir. One fatal cardiac arrest case was also reported, as well as three others that required pacemaker intervention to regulate their heart rhythms.

“Based on the reports, the concomitant administration of amiodarone with Harvoni, or with Sovaldi in combination with another direct-acting antiviral, may result in a severe or life-threatening bradycardia,” concluded the FDA in its safety announcement. “We will continue to monitor Harvoni and Sovaldi for risks of serious symptomatic bradycardia and further investigate the reason why the use of amiodarone with these hepatitis C drugs led to the heart-related events.” The mechanism underlying this effect is currently unknown.

The FDA urges patients and health care professionals to report side effects involving Harvoni, Sovaldi, or amiodarone.

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Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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