Indicated for patients with genotypes 1-6 without cirrhosis or with compensated cirrhosis

Treatment-experienced patients with genotype 1 previously treated with a regimen containing NS5A inhibitor or an NS3/4A protease inhibitor, but not both

3 tablets (ie, 300 mg/120 mg total dose) PO qDay

Recommended duration

• Treatment-naïve patients

• Genotypes 1-6, no cirrhosis or compensated cirrhosis (Child-Pugh A): 8 weeks

• Treatment-experienced patients

  • No cirrhosis
    • Genotype 1 and NS5A inhibitor without prior treatment with an NS3/4A protease inhibitor (PI): 16 weeks
    • Genotype 1 and NS3/4A PI without prior treatment with an NS5A inhibitor: 12 weeks
    • Genotypes 1, 2, 4, 5, or 6 (prior treatment with simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin): 8 weeks
    • Genotype 3 (prior treatment with simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin): 16 weeks
  • Compensated cirrhosis (Child-Pugh A)
    • Genotype 1 and NS5A inhibitor without prior treatment with an NS3/4A protease inhibitor (PI): 16 weeks
    • Genotype 1 and NS3/4A PI without prior treatment with an NS5A inhibitor: 12 weeks
    • Genotypes 1, 2, 4, 5, or 6 (prior treatment with simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin): 12 weeks
    • Genotype 3 (prior treatment with simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin): 16 weeks

• Liver or kidney transplant recipients

  • Treatment duration is 12 weeks

  • 16-week treatment duration recommended

    • Genotype 1-infected patients who are NS5A inhibitor-experienced without prior treatment with an NS3/4A protease inhibitor
    • Genotype 3-infected patients who are treatment experience with regimens containing (peg)interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor

Dosage Modifications

Renal impairment

• Mild, moderate, or severe, including patients on dialysis: No dosage adjustment required

Hepatic impairment

• Mild (Child-Pugh A): No dosage adjustment required
• Moderate-to-severe (Child-Pugh B or C): Contraindicated
• Patients with any history of prior hepatic decompensation: Contraindicated

Dosing Considerations

Test for evidence of current or prior hepatitis B virus (HBV) infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment

Interactions

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