Skip to main content
. 2015 Aug 5;16(8):18033–18053. doi: 10.3390/ijms160818033

Table 3.

Inclusion and exclusion criteria of revised clinical studies in patients with advanced renal impairment.

Study Inclusion Criteria Exclusion Criteria HCV GT Patients (n) Therapy
RUBY-1
  • -

    Treatment-naive adults

  • -

    Chronic kidney disease with eGFR <30 mL/min/1.73 m2
  • -

    Clinically significant comorbidity

 GT 1 20 # 3D regimen for 12 weeks (+RBV in GT 1a)
  • -

    HBV and HIV negative

  • -

    Non-cirrhotic *
  • -

    Hemoglobin < 10 g/dL
NCT01958281
  • -

    HBV or HIV negative

  • -

    Cirrhosis determination at screening
  • -

    Prior null response to PEG + RBV

 GT 1 or 3 10 # SOF + RBV for 24 weeks
  • -

    Treatment-naive and experienced adults

  • -

    Chronic kidney disease with eGFR <30 mL/min/1.73 m2
  • -

    Current or prior history of hepatic decompensation
  • -

    Not on hemodialysis
  • -

    Clinically significant comorbidity
C-Surfer
  • -

    Treatment-naive or experienced adults

  • -

    Chronic kidney disease with eGFR <30 mL/min/1.73 m2, including patients on hemodialysis
  • -

    Current or prior history of hepatic decompensation

 GT 1 235 Grazoprevir + Elbasvir for 12 weeks
  • -

    Compensated cirrhosis allowed §

  • -

    HBV and HIV negative
  • -

    Advanced liver cirrhosis

Study oversight of revised clinical studies focusing on patients with advanced renal impairment. (* Histologic diagnosis (Metavir score ≤ 3; Ishak score ≤ 4), or Screening FibroScan < 14.6 kPa or APRI ≤ 2 or Fibro Test ≤ 0.72; # preliminary data; § Histologic diagnosis or Screening FibroScan or Fibro Test).