Harvoni® (ledipasvir and sofosbuvir) and Hepatitis C

Are there any other warnings one should know regarding Harvoni®?

Use with Antiarrhythmic Drug Amiodarone

The FDA has warned that a serious slowing of the heart rate can occur when using amiodarone along with either Harvoni® (ledipasvir/sofosbuvir) or Sovaldi® (sofosbuvir) in combination with another direct acting antiviral for treatment of Hepatitis C. The FDA has warned that a serious slowing of the heart rate, known as symptomatic bradycardia, is cause to recommend that health care professionals not prescribe either Harvoni or Sovaldi combined with another direct acting antiviral, such as daclatasvir or Olysio® (simeprevir), with amiodarone. Patients should not stop taking any of their medicines without first talking to their health care professionals.

Use with Potent P-gp Inducers

Drugs that are potent P-gp inducers in the intestine may significantly decrease ledipasvir and sofosbuvir plasma concentrations potentially reducing the therapeutic effect of Harvoni®. Therefore, using P-gp inducers such as rifampin and St. John’s wort should not be used with Harvoni®.

Risk of Hepatitis B Reactivation

The FDA has indicated that there is risk of the Hepatitis B virus becoming an active infection again in any patient who has a current or previous infection with Hepatitis B virus and is being treated with Harvoni, a direct-acting antiviral medicine for Hepatitis C virus. In a few cases, Hepatitis B virus reactivation in patients treated with these types of medicines resulted in serious liver problems or death. In addition to a prominent warning being required on the medication’s labeling, healthcare professionals are being directed to also screen and monitor for the Hepatitis B virus in all patients receiving this treatment.

Last Updated: October 2016

What types of adverse reactions were reported when taking Harvoni®? How can I get assistance paying for Harvoni®? Is Harvoni® covered by insurance?

References

"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." U.S. Food and Drug Administration, http://www.fda.gov/Drugs/DrugSafety/ucm439484.htm. Retrieved April 10, 2015.

"Full Prescribing Information." Gilead.com. Gilead Sciences, Inc., http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf. Retrieved April 10, 2015.

"Harvoni® Coupon and Savings." Gilead.com. Gilead Sciences, Inc., https://www.harvoni.com/co-pay-coupon-registration. Retrieved April 13, 2015.

"Patient Information: Harvoni®." Gilead.com. Gilead Sciences, Inc., http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_patient_pi.pdf. Retrieved April 13, 2015.

"Support Path Harvoni® and Sovaldi® Tablets Treatment Support." Gilead.com. Gilead Sciences, Inc., https://www.harvoni.com/co-pay-coupon-registration. Retrieved April 13, 2015.