Usual Adult Dose for Chronic Hepatitis C

Ledipasvir 90 mg-sofosbuvir 400 mg orally once a day

Recommended Regimen and Duration of Therapy:
GENOTYPE 1:

• Therapy-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks
• Therapy-experienced patients without cirrhosis: Ledipasvir-sofosbuvir for 12 weeks
• Therapy-experienced patients with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 24 weeks
• Therapy-naive and therapy-experienced patients with decompensated cirrhosis (Child-Pugh B or C): Ledipasvir-sofosbuvir plus ribavirin for 12 weeks

• Therapy-naive and therapy-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir plus ribavirin for 12 weeks

• Therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks

• Relapse rates are affected by baseline host and viral factors and differ between durations of therapy for some subgroups.
• Dose recommendations also apply to HCV/HIV-1-coinfected patients.
• Therapy-naive genotype 1 patients without cirrhosis: Ledipasvir-sofosbuvir for 8 weeks can be considered in those who have pretreatment HCV RNA less than 6 million international units/mL.
• Therapy-experienced patients have failed a peginterferon alfa (with or without ribavirin)-based regimen with or without an HCV protease inhibitor.
• Therapy-experienced genotype 1 patients with cirrhosis: Ledipasvir-sofosbuvir plus ribavirin for 12 weeks can be considered in those eligible for ribavirin.
• If applicable, the manufacturer product information should be consulted for ribavirin dose recommendations; the manufacturer product information for ribavirin should be consulted for further information regarding dosing and dose adjustments.

• For genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
• In combination with ribavirin: For genotype 1 infection with decompensated cirrhosis
• In combination with ribavirin: For genotype 1 or 4 infection in liver transplant recipients without cirrhosis or with compensated cirrhosis

Usual Pediatric Dose for Chronic Hepatitis C

3 years or older:

• Weight less than 17 kg: Ledipasvir 33.75 mg-sofosbuvir 150 mg orally once a day
• Weight 17 to less than 35 kg: Ledipasvir 45 mg-sofosbuvir 200 mg orally once a day
• Weight at least 35 kg: Ledipasvir 90 mg-sofosbuvir 400 mg orally once a day

• Therapy-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks
• Therapy-experienced patients without cirrhosis: Ledipasvir-sofosbuvir for 12 weeks
• Therapy-experienced patients with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 24 weeks
• Therapy-naive and therapy-experienced patients with decompensated cirrhosis (Child-Pugh B or C): Ledipasvir-sofosbuvir plus ribavirin for 12 weeks

• Therapy-naive and therapy-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir plus ribavirin for 12 weeks

• Therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks

• Relapse rates are affected by baseline host and viral factors and differ between durations of therapy for some subgroups.
• Dose recommendations also apply to HCV/HIV-1-coinfected patients.
• Therapy-naive genotype 1 patients without cirrhosis: Ledipasvir-sofosbuvir for 8 weeks can be considered in those who have pretreatment HCV RNA less than 6 million international units/mL.
• Therapy-experienced patients have failed a peginterferon alfa (with or without ribavirin)-based regimen with or without an HCV protease inhibitor.
• Therapy-experienced genotype 1 patients with cirrhosis: Ledipasvir-sofosbuvir plus ribavirin for 12 weeks can be considered in those eligible for ribavirin.
• If applicable, the manufacturer product information should be consulted for ribavirin dose recommendations; the manufacturer product information for ribavirin should be consulted for further information regarding dosing and dose adjustments.

• For genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
• In combination with ribavirin: For genotype 1 infection with decompensated cirrhosis
• In combination with ribavirin: For genotype 1 or 4 infection in liver transplant recipients without cirrhosis or with compensated cirrhosis

Renal Dose Adjustments

Mild, moderate, or severe renal dysfunction: No adjustment recommended.

Comments:

• No safety data available in patients with both decompensated cirrhosis and severe renal dysfunction.
• No safety data available in pediatric patients with renal dysfunction.
• The manufacturer product information for ribavirin tablets should be consulted for ribavirin dose adjustment in patients with CrCl up to 50 mL/min (if applicable).

Liver Dose Adjustments

Mild, moderate, or severe liver dysfunction (Child-Pugh A, B, or C): No adjustment recommended.

Comments:

• Clinical and hepatic monitoring (as clinically indicated) recommended for patients with decompensated cirrhosis using this drug plus ribavirin.

Precautions

US BOXED WARNING:

• RISK OF HBV REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV: All patients should be tested for evidence of current/prior HBV infection before starting this drug. HBV reactivation has been reported during or after completion of HCV direct-acting antiviral therapy in HCV/HBV-coinfected patients who were not receiving HBV antiviral therapy; some cases resulted in fulminant hepatitis, hepatic failure, and death. HCV/HBV-coinfected patients should be monitored for hepatitis flare or HBV reactivation during HCV therapy and posttherapy follow-up; appropriate patient management for HBV infection should be started as clinically indicated.

Dialysis

ESRD requiring dialysis: No adjustment recommended.

Comments:

• No safety data available in dialysis patients with decompensated cirrhosis.

Other Comments

Administration advice:

• Before starting this drug, test all patients for evidence of current/prior HBV infection; measure hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).
• Administer with or without food.
• Use the oral pellets in pediatric patients who cannot swallow the tablet formulation; consult the manufacturer product information (Instructions for Use) for details regarding administration.
• Do not chew the oral pellets.
• If administered with food, sprinkle the oral pellets on at least 1 spoonful of nonacidic soft food (e.g., pudding, chocolate syrup, mashed potato, ice cream) at or below room temperature; administer oral pellets within 30 minutes of gently mixing with food and swallow the entire contents without chewing (to avoid bitter aftertaste).
• Consult the manufacturer product information regarding missed doses.

• Store below 30C (86F).
• Tablets: Dispense only in original container.

• Oral pellets: The manufacturer product information should be consulted.

• The manufacturer product information for ribavirin should be consulted for additional information (if applicable).

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Avoid missing doses and complete the entire course of therapy.

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