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Summary of Recommendations for Patients with Renal Impairment, Including Severe Renal Impairment (CrCl <30 mL/min) or ESRD Requiring Hemodialysis or Peritoneal Dialysis
 

Recommended Dosage Adjustments for Patients with Mild to Moderate Renal Impairment
 

  • For patients with mild to moderate renal impairment (CrCl 30 mL/min-80 mL/min), no dosage adjustment is required when using daclatasvir (60mg*), fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg), fixed-dose combination of sofosbuvir (400mg)/velpatasvir (100mg), or fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) with (or without for HCV genotype 4 infection) twice-daily dosed dasabuvir (250 mg), simeprevir (150 mg), or sofosbuvir (400 mg) to treat or retreat HCV infection in patients with appropriate genotypes.
    Rating: Class I, Level A

Recommended Regimens for Patients with Severe Renal Impairment, Including Severe Renal Impairment (Creatinine Clearance [CrCl] <30 mL/min) or End-Stage Renal Disease (ESRD)
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • For patients with genotype 1a, or 1b, or 4 infection and CrCl below 30 mL/min, for whom treatment has been elected before kidney transplantation, daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100mg) for 12 weeks is a Recommended regimen.
    Rating: Class IIa, Level B

     
  • For patients with genotype 1b infection and CrCl below 30 mL/min for whom the urgency to treat is high and treatment has been elected before kidney transplantation, daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) plus twice-daily dosed dasabuvir (250 mg) for 12 weeks is a Recommended regimen.
    Rating: Class IIb, Level B

     
  • For patients with HCV genotype 2, 3, 5, or 6 infection and CrCl below 30 mL/min for whom the urgency to treat is high and treatment has been elected before kidney transplantation, PEG-IFN and dose-adjusted ribavirin** (200 mg daily) is a Recommended regimen.
    Rating: Class IIb, Level B

 

*The dose of daclatasvir may need to increase or decrease when used concomitantly with cytochrome P450 3A/4 inducers and inhibitors, respectively. Please refer to the prescribing information and the section on HIV/HCV coinfection for patients on antiretroviral therapy.

**Caution is recommended in this group, owing to the potential for hemolytic anemia due to impaired renal clearance in this population, and ribavirin should be restricted to those with a baseline hemoglobin concentration above 10 g/dL.
 

Alternative Regimen for Genotype 1a-infected Patients with CrCl Below 30 mL/min
 

  • For HCV genotype 1a infection, daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) plus twice-daily dosed dasabuvir (250 mg) and dose-adjusted ribavirin** (200 mg daily) for 12 weeks is an Alternative regimen.
    Rating: Class IIb, Level B

 

**Caution is recommended in this group, owing to the potential for hemolytic anemia due to impaired renal clearance in this population, and ribavirin should be restricted to those with a baseline hemoglobin concentration above 10 g/dL.

Changes made July 6, 2016.