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.

Genotype 1

• 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