Chronic Hepatitis C Genotype | Therapy naive Hepatitis C
Item
the subject is chronically infected with hcv genotypes 1, 2, 3, 4, 5, and/or 6 as documented in the subject's medical records and is naïve to hcv treatment (treatment naïve).
boolean
C0524910 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
C0919936 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Hepatitis C, Chronic | HIV coinfection | HIV coinfection Absent
Item
chronic hcv (with or without hiv [human immunodeficiency virus] co-infection) will be documented with historical record of:
boolean
C0524910 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
C4062778 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Hepatitis C RNA positive
Item
a positive hcv rna test result (result generated at least 6 months before the baseline visit)
boolean
C0855842 (UMLS CUI [1])
Hepatitis c viral genotype
Item
a hcv genotype test result (result generated at least 6 months before the baseline visit)
boolean
C4272868 (UMLS CUI [1])
Chronic Hepatitis C Biopsy of liver
Item
a liver biopsy report demonstrating chronic hcv
boolean
C0524910 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Antiviral Therapy | sofosbuvir
Item
--the subject is initiating antiviral therapy with a sofosbuvir regimen as indicated below:
boolean
C0280274 (UMLS CUI [1])
C2976303 (UMLS CUI [2])
Sofosbuvir Plus PEGINTERFERON Plus Ribavirin | PEGINTERFERON Eligible Genotype
Item
sofosbuvir plus peginterferon and ribavirin for 12 weeks (peginterferon eligible genotype 1, 4, 5, or 6)
boolean
C2976303 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0982327 (UMLS CUI [1,3])
C0332287 (UMLS CUI [1,4])
C0035525 (UMLS CUI [1,5])
C0982327 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C1285573 (UMLS CUI [2,3])
Sofosbuvir Plus Ribavirin | Genotype
Item
sofosbuvir plus ribavirin for 12 weeks (genotype 2)
boolean
C2976303 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0035525 (UMLS CUI [1,3])
C1285573 (UMLS CUI [2])
Sofosbuvir Plus Ribavirin | PEGINTERFERON Ineligible Genotype | PEGINTERFERON Unwilling Genotype
Item
sofosbuvir plus ribavirin for 24 weeks (peginterferon ineligible or unwilling genotype 1 or genotype 3)
boolean
C2976303 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0035525 (UMLS CUI [1,3])
C0982327 (UMLS CUI [2,1])
C1512714 (UMLS CUI [2,2])
C1285573 (UMLS CUI [2,3])
C0982327 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
C1285573 (UMLS CUI [3,3])
Age
Item
the subject is at least 18 years of age at the time of enrollment
boolean
C0001779 (UMLS CUI [1])
Availability of Medical Records | Demography | Client Characteristics | Medical History | Virology | Laboratory Results
Item
adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria
boolean
C0470187 (UMLS CUI [1,1])
C0025102 (UMLS CUI [1,2])
C0011298 (UMLS CUI [2])
C0815172 (UMLS CUI [3])
C0262926 (UMLS CUI [4])
C0042762 (UMLS CUI [5])
C1254595 (UMLS CUI [6])
Informed Consent | Informed Consent Patient Representative
Item
the subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s)
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Decompensated liver disease
Item
subjects with history or evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Renal Insufficiency Severe | Kidney Failure, Chronic
Item
subjects with severe renal impairment or end stage renal disease
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022661 (UMLS CUI [2])
Therapy Hepatitis C | Antiviral Therapy Hepatitis C | Antiviral Therapy Investigational Hepatitis C
Item
subjects who are not naïve to hcv therapy with prior exposure to an approved or experimental hcv antiviral therapy
boolean
C0087111 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0280274 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0280274 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0019196 (UMLS CUI [3,3])
Medical contraindication Sofosbuvir | Medical contraindication PEGINTERFERON | Medical contraindication Ribavirin | Pregnancy | Gender Partner Pregnancy | Sovaldi
Item
subject has characteristics that are contraindicated in the fda approved label for sofosbuvir (eg, subjects with contraindications applicable to peginterferon and/or ribavirin, pregnant woman or men whose female partners are pregnant; sovaldi package insert 2013)
boolean
C1301624 (UMLS CUI [1,1])
C2976303 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0982327 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0035525 (UMLS CUI [3,2])
C0032961 (UMLS CUI [4])
C0079399 (UMLS CUI [5,1])
C0682323 (UMLS CUI [5,2])
C0032961 (UMLS CUI [5,3])
C3700471 (UMLS CUI [6])
Therapy Before Transplantation | Therapy Post Transplantation
Item
subject is receiving treatment pre- or post-transplant
boolean
C0087111 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
Study Subject Participation Status Inappropriate | Compliance behavior Unlikely | Medical complication
Item
subject is unsuitable for study participation based on the investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication)
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
C0009566 (UMLS CUI [3])
Study Subject Participation Status Interferes with Clinical Trial
Item
participating in another investigational study that the investigator believes might interfere with the subject's participation in this study
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])