Generic name: SOFOSBUVIR 400mg
Dosage form: tablet, film coated
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Recommended Dose in Adults
The recommended dose of SOVALDI is one 400 mg tablet, taken orally, once daily with or without food [See Clinical Pharmacology (12.3)].
SOVALDI should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of CHC in adults. The recommended regimen and treatment duration for SOVALDI combination therapy is provided in Table 1.
|Patients with genotype 1 or 4 CHC||SOVALDI + peginterferon alfa* + ribavirin†||12 weeks|
|Patients with genotype 2 CHC||SOVALDI + ribavirin†||12 weeks|
|Patients with genotype 3 CHC||SOVALDI + ribavirin†||24 weeks|
SOVALDI in combination with ribavirin for 24 weeks can be considered as a therapeutic option for CHC patients with genotype 1 infection who are ineligible to receive an interferon-based regimen [See Use in Specific Populations (8.8) and Clinical Studies (14.4)]. Treatment decision should be guided by an assessment of the potential benefits and risks for the individual patient.
Patients with Hepatocellular Carcinoma Awaiting Liver Transplantation
SOVALDI in combination with ribavirin is recommended for up to 48 weeks or until the time of liver transplantation, whichever occurs first, to prevent post-transplant HCV reinfection [See Use in Specific Populations (8.9)].
Dose reduction of SOVALDI is not recommended.
Genotype 1 and 4:
If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. Refer to the peginterferon alfa and ribavirin prescribing information for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dose.
Genotype 2 and 3:
If a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity. Table 2 provides guidelines for dose modifications and discontinuation based on the patient's hemoglobin concentration and cardiac status.
|Laboratory Values||Reduce Ribavirin Dose to 600 mg/day* If:||Discontinue Ribavirin If:†|
|Hemoglobin in patients with no cardiac disease||<10 g/dL||<8.5 g/dL|
|Hemoglobin in patients with history of stable cardiac disease||≥2 g/dL decrease in hemoglobin during any 4 week treatment period||<12 g/dL despite 4 weeks at reduced dose|
Discontinuation of Dosing
If the other agents used in combination with SOVALDI are permanently discontinued, SOVALDI should also be discontinued.
Severe Renal Impairment and End Stage Renal Disease
No dose recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73m2) or with end stage renal disease (ESRD) due to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite [See Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].