Age
Item
males and females, ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Hepatitis C Genotype | Prior Therapy failed | peginterferon alfa-2a | peginterferon alfa-2b | Ribavirin | Therapy non-responder | Partial responder to therapy | Intolerance to PEGINTERFERON/RIBAVIRIN | Ineligibility PEGINTERFERON/RIBAVIRIN | Neutropenia | Anemia | Depressive disorder | Thrombocytopenia | Fibrosis | Liver Cirrhosis | Therapy naive
Item
hcv genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, or intolerant or ineligible to p/r due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, or treatment naive
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0391001 (UMLS CUI [3])
C0796545 (UMLS CUI [4])
C0035525 (UMLS CUI [5])
C0919875 (UMLS CUI [6])
C1740822 (UMLS CUI [7])
C1744706 (UMLS CUI [8,1])
C1875630 (UMLS CUI [8,2])
C1512714 (UMLS CUI [9,1])
C1875630 (UMLS CUI [9,2])
C0027947 (UMLS CUI [10])
C0002871 (UMLS CUI [11])
C0011581 (UMLS CUI [12])
C0040034 (UMLS CUI [13])
C0016059 (UMLS CUI [14])
C0023890 (UMLS CUI [15])
C0919936 (UMLS CUI [16])
Hepatitis C virus RNA assay
Item
hcv rna ≥ 10,000 iu/ml
boolean
C1272251 (UMLS CUI [1])
HIV Seronegative | Hepatitis B Surface Antigens Seronegative
Item
seronegative for human immunodeficiency virus (hiv) and hepatitis b surface antigen (hbsag)
boolean
C0019682 (UMLS CUI [1,1])
C0521144 (UMLS CUI [1,2])
C0019168 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
Compensated cirrhosis
Item
subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)
boolean
C1608426 (UMLS CUI [1])
Prior Therapy Hepatitis C | HCV DIRECT ACTING ANTIVIRALS
Item
prior treatment of hcv with hcv direct acting antiviral (daa)
boolean
C1514463 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0220847 (UMLS CUI [2,1])
C3653501 (UMLS CUI [2,2])
Medical condition Contributing Chronic liver disease | Exception Hepatitis C
Item
evidence of a medical condition contributing to chronic liver disease other than hcv
boolean
C3843040 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
End Stage Liver Disease | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
boolean
C0745744 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])
Liver carcinoma | Liver carcinoma Suspected | Cancer Other | Cancer Other Suspected
Item
diagnosed or suspected hepatocellular carcinoma or other malignancies
boolean
C2239176 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1707251 (UMLS CUI [3])
C1707251 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Diabetic - poor control | Uncontrolled hypertension
Item
uncontrolled diabetes or hypertension
boolean
C0421258 (UMLS CUI [1])
C1868885 (UMLS CUI [2])