Usual Adult Dose for Chronic Hepatitis C

400 mg orally once a day

Recommended Regimen and Duration of Therapy:

• Genotype 1 or 4: Sofosbuvir, peginterferon alfa, and ribavirin for 12 weeks
• Genotype 2: Sofosbuvir and ribavirin for 12 weeks
• Genotype 3: Sofosbuvir and ribavirin for 24 weeks
• Hepatocellular carcinoma awaiting liver transplantation: Sofosbuvir and ribavirin for up to 48 weeks or until liver transplantation (whichever occurs first)

Comments:

• Genotype 1, 4: This regimen is recommended for therapy-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh A).
• Genotype 2, 3: Both regimens are recommended for therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A).
• Therapy-experienced patients have failed an interferon-based regimen (with or without ribavirin).
• The dose recommendations for genotype 1, 2, 3, or 4 should be followed for HCV/HIV-1-coinfected patients.
• The manufacturer product information should be consulted for ribavirin tablet dose recommendations; with genotype 1 or 4, the manufacturer product information for peginterferon alfa should also be consulted for dose recommendations.
• Sofosbuvir and ribavirin for 24 weeks can be considered for patients with genotype 1 infection who cannot use an interferon-based regimen; treatment decision should be guided by benefit/risk assessment for the individual patient.
• The regimen for patients with hepatocellular carcinoma awaiting liver transplantation is recommended to prevent posttransplant HCV reinfection.

Use: As a part of a combination antiviral treatment regimen, for the treatment of chronic HCV infection

• In combination with pegylated interferon and ribavirin: For genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis
• In combination with ribavirin: For genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis

Usual Pediatric Dose for Chronic Hepatitis C

3 years or older:

• Weight less than 17 kg: 150 mg orally once a day
• Weight 17 to less than 35 kg: 200 mg orally once a day
• Weight at least 35 kg: 400 mg orally once a day

Recommended Regimen and Duration of Therapy:

• Genotype 2: Sofosbuvir and ribavirin for 12 weeks
• Genotype 3: Sofosbuvir and ribavirin for 24 weeks
• Hepatocellular carcinoma awaiting liver transplantation: Sofosbuvir and ribavirin for up to 48 weeks or until liver transplantation (whichever occurs first)

Comments:

• Both regimens are recommended for therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A).
• Therapy-experienced patients have failed an interferon-based regimen (with or without ribavirin).
• The manufacturer product information should be consulted for ribavirin dose recommendations.
• The same dose recommendations should be followed for HCV/HIV-1-coinfected patients.
• The regimen for patients with hepatocellular carcinoma awaiting liver transplantation is recommended to prevent posttransplant HCV reinfection.

Use: In combination with ribavirin, for the treatment of chronic HCV genotype 2 or 3 infection in patients without cirrhosis or with compensated cirrhosis

Renal Dose Adjustments

Mild or moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction (estimated glomerular filtration rate [eGFR] less than 30 mL/min/1.73 m2): Data not available

Comments:

• Safety and efficacy of this drug not established in patients with severe renal dysfunction.
• The manufacturer product information for ribavirin and peginterferon alfa should be consulted for patients with CrCl less than 50 mL/min.

Liver Dose Adjustments

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

Comments:

• Safety and efficacy of this drug not established in patients with decompensated cirrhosis.
• The manufacturer product information for peginterferon alfa should be consulted for contraindication in hepatic decompensation.

Dose Adjustments

Dose reduction of this drug is not recommended.

If a serious side effect potentially related to peginterferon alfa and/or ribavirin develops, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued, if appropriate, until the side effect abates or decreases in severity. The manufacturer product information for peginterferon alfa and ribavirin should be consulted for information regarding dose reduction and/or discontinuation.

If the other drugs used in combination with this drug are permanently discontinued, this drug should also be discontinued.

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.

CONTRAINDICATIONS:

• Combination Therapy: Contraindications to ribavirin
• Combination Therapy: Contraindications to peginterferon alfa (if applicable)

HCV genotype 1 or 4: Safety and efficacy have not been established in patients younger than 18 years.
HCV genotype 2 or 3: Safety and efficacy have not been established in patients younger than 3 years.

Consult WARNINGS section for additional precautions.

Dialysis

ESRD requiring hemodialysis: Data not available

Comments:

• Safety and efficacy of this drug not established in patients with ESRD requiring hemodialysis.

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.
• If peginterferon alfa and/or ribavirin are permanently discontinued, discontinue this drug.
• 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.

Storage requirements:

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

Reconstitution/preparation techniques:

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

General:

• Treatment regimen and duration depend on viral genotype and patient population.
• The manufacturer product information for ribavirin (and peginterferon alfa, if applicable) should be consulted for additional information.

Patient advice:

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

Frequently asked questions

• What are the new drugs for the treatment of hepatitis C?
• What is the cost of Sovaldi? Why is it so expensive?
• What is the difference between Sovaldi and Harvoni?
• Does Sovaldi cure hepatitis C?