Harvoni® (ledipasvir and sofosbuvir) and Hepatitis C
What is the dosage for Harvoni®?
According to Gilead, developer of Harvoni®, one tablet should be taken once daily with or without food. The duration varies depending on whether a patient is treatment-naïve or treatment-experienced as well as whether he/she has cirrhosis.
- Treatment-naïve without cirrhosisi or with compensated cirrhosis – 12 weeks*
- Treatment-experienced** without cirrhosis – 12 weeks
- Treatment-experienced** with compensated cirrhosis – 24 weeks
- Treatment-naïve or experienced** with decompensated cirrhosis – 12 weeks + Ribavirin
Genotype 1 or 4
- Treatment-naïve or experienced** liver transplant recipients without cirrhosis, or with compensated cirrhosis – 12 weeks + Ribavirin
Genotype 4, 5, or 6
- Treatment-naïve or experienced** without cirrhosis or with compensated cirrhosis – 12 weeks
*Gilead states that Harvoni® for a duration of 8 weeks can be considered for treatment-naïve genotype 1 patients without cirrhosis having HCV RNA less than 6 million IU/ml before treatment.
**Those who have failed treatment with either peginterferon alfa + ribavirin OR an HCV protease inhibitor + peginterferon alfa + ribavirin.
For those with severe renal impairment and end stage renal disease, no dose recommendation for Harvoni can be given due to higher exposures of the predominant sofosbuvir metabolite.
Last Updated: November 2016
"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.