The subject must be willingly and able to provide written informed consent
Age 19 years of age or older (The age of consent in Nebraska)
HCV treatment-naïve, as defined as no prior exposure to any Interferon (IFN), RBV, or other FDA approved or experimental HCV-specific direct-acting antiviral agent
HCV RNA level at most 6 months prior to the Baseline/Day 1 visit.
HCV genotyping 1a, 1b, or mixed 1a/ab. Any non-definitive results will exclude the subject from study participation.
Alcohol misuse as defined by the Alcohol Use Disorders Identification Test (AUDIT) score subjects must score > 8 (associated with harmful or hazardous drinking)
History of a liver biopsy showing cirrhosis (e.g. Metavir score = 4 or Ishak score > 5)
Fibroscan showing cirrhosis or results > 12.5 kPa
FIBRO Spect II index consistent with F3 or F4 AND an AST : platelet ration index (APRI) of > 2 during Screening
Liver biopsy within 2 years of Screening showing absence of cirrhosis
Fibroscan within 6 months of Baseline/Day1 with a result of = 12.5 kPa
FIBRO Spect II Index consistent with F0- F2 AND APRI of = 1 during Screening
Liver imaging within 6 months of Baseline/Day 1 to exclude hepatocellular carcinoma HCC) is required
ALT < 10 x the upper limit of normal (ULN)
AST < 10 x ULN
Direct bilirubin < 2.0 x ULN
Platelets > 50,000
HbA1c < 8.5%
Creatinine clearance (CLcr) = 60 mL /min, as calculated by the Cockcroft-Gault equation
Hemoglobin = 11 g/dL for female subjects; = 12 g/dL for male subjects.
Albumin = 2.5 g/dL
INR = 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.
Subject has not been treated with any investigational drug or device within 30 days of the screening visit.

NCT02759861_inc_T2
Value
19 years of age or older
NCT02759861_inc_T3
Person
Age
NCT02759861_inc_T5
Negation
naïve
NCT02759861_inc_T6
Procedure
treatment
NCT02759861_inc_T7
Condition
HCV
NCT02759861_inc_T9
Drug
Interferon (IFN)
NCT02759861_inc_T8
Drug
RBV
NCT02759861_inc_T11
Negation
no
NCT02759861_inc_T12
Temporal
prior
NCT02759861_inc_T13
Scope
Interferon (IFN), RBV
NCT02759861_inc_T14
Scope
HCV treatment-naïve
NCT02759861_inc_T15
Scope
no prior exposure to any Interferon (IFN), RBV, or other FDA approved or experimental HCV-specific direct-acting antiviral agent
NCT02759861_inc_T16
Measurement
HCV RNA level
NCT02759861_inc_T17
Temporal
at most 6 months prior to the Baseline/Day 1 visit
NCT02759861_inc_T18
Reference_point
the Baseline/Day 1 visit
NCT02759861_inc_T19
Measurement
HCV genotyping
NCT02759861_inc_T20
Value
1a, 1b, or mixed 1a/ab
NCT02759861_inc_T22
Condition
Alcohol misuse
NCT02759861_inc_T23
Measurement
Alcohol Use Disorders Identification Test (AUDIT) score
NCT02759861_inc_T24
Value
> 8
NCT02759861_inc_T25
Procedure
liver biopsy
NCT02759861_inc_T26
Condition
cirrhosis
NCT02759861_inc_T27
Measurement
Metavir score
NCT02759861_inc_T28
Measurement
Ishak score
NCT02759861_inc_T29
Value
= 4
NCT02759861_inc_T30
Value
> 5
NCT02759861_inc_T31
Scope
Metavir score = 4 or Ishak score > 5
NCT02759861_inc_T32
Procedure
Fibroscan
NCT02759861_inc_T33
Condition
cirrhosis
NCT02759861_inc_T34
Value
> 12.5 kPa
NCT02759861_inc_T35
Scope
cirrhosis or results > 12.5 kPa
NCT02759861_inc_T36
Measurement
FIBRO Spect II index
NCT02759861_inc_T37
Measurement
platelet ration index (APRI)
NCT02759861_inc_T38
Value
> 2
NCT02759861_inc_T39
Temporal
during Screening
NCT02759861_inc_T40
Value
F3 or F4
NCT02759861_inc_T41
Value
AST
NCT02759861_inc_T42
Procedure
Liver biopsy
NCT02759861_inc_T43
Temporal
within 2 years of Screening
NCT02759861_inc_T44
Condition
cirrhosis
NCT02759861_inc_T45
Negation
absence
NCT02759861_inc_T46
Procedure
Fibroscan
NCT02759861_inc_T47
Temporal
within 6 months of Baseline/Day1
NCT02759861_inc_T48
Value
= 12.5 kPa
NCT02759861_inc_T49
Measurement
FIBRO Spect II Index
NCT02759861_inc_T50
Value
F0- F2
NCT02759861_inc_T51
Measurement
APRI
NCT02759861_inc_T52
Value
= 1
NCT02759861_inc_T53
Temporal
during Screening
NCT02759861_inc_T54
Procedure
Liver imaging
NCT02759861_inc_T55
Temporal
within 6 months of Baseline/Day 1
NCT02759861_inc_T56
Condition
hepatocellular carcinoma HCC)
NCT02759861_inc_T57
Negation
exclude
NCT02759861_inc_T58
Measurement
ALT
NCT02759861_inc_T59
Measurement
AST
NCT02759861_inc_T60
Value
< 10 x the upper limit of normal (ULN)
NCT02759861_inc_T61
Value
< 10 x ULN
NCT02759861_inc_T62
Measurement
Direct bilirubin
NCT02759861_inc_T63
Value
< 2.0 x ULN
NCT02759861_inc_T64
Measurement
Platelets
NCT02759861_inc_T65
Value
> 50,000
NCT02759861_inc_T66
Measurement
HbA1c
NCT02759861_inc_T67
Value
< 8.5%
NCT02759861_inc_T68
Measurement
Creatinine clearance (CLcr)
NCT02759861_inc_T69
Value
= 60 mL /min
NCT02759861_inc_T70
Qualifier
Cockcroft-Gault equation
NCT02759861_inc_T71
Measurement
Hemoglobin
NCT02759861_inc_T72
Value
= 11 g/dL
NCT02759861_inc_T73
Person
female
NCT02759861_inc_T74
Value
= 12 g/dL
NCT02759861_inc_T75
Person
male
NCT02759861_inc_T76
Scope
= 11 g/dL for female subjects; = 12 g/dL for male
NCT02759861_inc_T77
Measurement
Albumin
NCT02759861_inc_T78
Value
= 2.5 g/dL
NCT02759861_inc_T79
Measurement
INR
NCT02759861_inc_T80
Value
= 1.5 x ULN
NCT02759861_inc_T81
Condition
hemophilia
NCT02759861_inc_T82
Condition
stable on an anticoagulant regimen affecting INR
NCT02759861_inc_T83
Negation
unless
NCT02759861_inc_T84
Scope
hemophilia or is stable on an anticoagulant regimen affecting INR