Applies to the following strength(s): 400 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Chronic Hepatitis C
400 mg orally once a day
Recommended Regimens and Duration of Therapy:
-Genotype 1 or 4 chronic hepatitis C (CHC): Sofosbuvir, peginterferon alfa, and ribavirin for 12 weeks
-Genotype 2 CHC: Sofosbuvir and ribavirin for 12 weeks
-Genotype 3 CHC: 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)
-This drug should be used in combination with ribavirin or with pegylated interferon and ribavirin.
-Efficacy was established in patients with HCV genotype 1, 2, 3, or 4 infection, including patients with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and HCV/HIV-1 coinfected patients.
-Sofosbuvir and ribavirin therapy for 24 weeks can be considered for patients with genotype 1 CHC who cannot use an interferon-based regimen; treatment decision should be guided by benefit/risk assessment for the individual patient.
-Sofosbuvir and ribavirin therapy is recommended for patients with hepatocellular carcinoma awaiting liver transplantation to prevent posttransplant HCV reinfection.
Use: As a part of a combination antiviral treatment regimen, for the treatment of chronic hepatitis C infection
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
-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.
-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 reduction of this drug is not recommended.
Genotype 1 and 4: 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. The manufacturer product information for peginterferon alfa and ribavirin should be consulted for information regarding dose reduction and/or discontinuation.
Genotype 2 and 3: If a serious side effect potentially related to ribavirin develops, the ribavirin dose should be modified or discontinued, if appropriate, until the side effect abates or decreases in severity. The manufacturer product information for ribavirin should be consulted for information regarding dose modifications and discontinuation based on hemoglobin level and cardiac status.
If the other drugs used in combination with this drug are permanently discontinued, this drug should also be discontinued.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
End-stage renal disease requiring hemodialysis: Data not available
-Use in combination with ribavirin or with peginterferon alfa and ribavirin; do not use as monotherapy.
-This drug may be taken without regard to food.
-If peginterferon alfa and/or ribavirin are permanently discontinued, discontinue this drug.
-Consult the manufacturer product information regarding missed doses.
-Store in the original container at room temperature below 30C (86F)
-Treatment regimen and duration depend on viral genotype and patient population.
-Treatment response varies based on baseline host and viral factors.
-The manufacturer product information for ribavirin and peginterferon alfa should be consulted for additional information.
More about sofosbuvir
- Other brands: Sovaldi