Dosage & Administration

Important Safety Information

Contraindications

  • SOVALDI combination treatment with ribavirin or with peginterferon alfa plus ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant because of the risk for birth defects and fetal death associated with ribavirin. Contraindications to peginterferon alfa and ribavirin also apply to SOVALDI combination treatment. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.

Dosing & Administration

The recommended dose of SOVALDI for adults is one 400 mg tablet, taken orally, once daily with or without food.

Recommended regimens and treatment duration for SOVALDI combination therapy in HCV mono-infected and HCV/HIV-1 co-infected patients


Genotype 1 and 4

Genotype 2

Genotype 3

  1. See peginterferon alfa prescribing information for dosing recommendation for patients with genotype 1 or 4 CHC.
  2. Dose of ribavirin is weight-based (<75 kg = 1000 mg and ≥75 kg = 1200 mg). The daily dose of ribavirin is administered orally in two divided doses with food. Patients with renal impairment (CrCl ≤50 mL/min) require ribavirin dose reduction; refer to ribavirin prescribing information.

  • No response-guided therapy is required with SOVALDI
  • SOVALDI in combination with ribavirin for 24 weeks can be considered as a therapeutic option for HCV patients with GT 1 infection who are ineligible to receive an interferon-based regimen. Treatment decision should be guided by an assessment of the potential benefits and risks for the individual patient
  • In patients with hepatocellular carcinoma (HCC) 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
  • If the other agents used in combination with SOVALDI are permanently discontinued, SOVALDI should also be discontinued
  • No SOVALDI dose adjustments are necessary based on advanced age, race, mild or moderate renal impairment (eGFR ≥30 mL/min/1.73 m2) or hepatic impairment (Child-Pugh Class A, B, or C). The safety and efficacy of SOVALDI have not been established in patients with severe renal impairment, end stage renal disease (ESRD) or decompensated cirrhosis
  • 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


Important Safety Information

Contraindications

  • SOVALDI combination treatment with ribavirin or with peginterferon alfa plus ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant because of the risk for birth defects and fetal death associated with ribavirin. Contraindications to peginterferon alfa and ribavirin also apply to SOVALDI combination treatment. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.
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