Documented positive hepatitis B (HBV) surface antigen, and/or HBV DNA prior to enrollment
Any prior exposure to HCV protease inhibitor therapy
HIV co-infection if on a protease inhibitor based regimen
Increase in creatinine of 15% or greater within one month (30 days) of the screening visit
Evidence of hepatocellular carcinoma at the time of enrollment
Liver disease caused by an etiology other than HCV
F4 or decompensated cirrhotic patients
Child Pugh class B or C
AST or ALT >350 within 6 months prior to enrollment
Albumin < 3g/dL at the time of enrollment
Platelet count < 75 at the time of enrollment
History of clinically significant allergy or adverse event with protease inhibitors
Evidence of the acquisition of HCV at the time of or after transplantation
Pregnant or breastfeeding women
Cyclosporine; St. John's Wort; Efavirenz; Phenytoin; Carbamazepine; Bosentan; HIV protease inhibitors; modafinil; ketoconazole; or rifampin use within 7 days of enrollment
Coadministration of more than 20 mg atorvastatin; 10 mg rosuvastatin; 20 mg of fluvastatin, lovastatin or simvastatin

NCT02902120_exc_T1
Measurement
hepatitis B surface antigen
NCT02902120_exc_T2
Value
positive
NCT02902120_exc_T3
Measurement
HBV DNA
NCT02902120_exc_T4
Temporal
prior to enrollment
NCT02902120_exc_T5
Reference_point
enrollment
NCT02902120_exc_T6
Scope
hepatitis B (HBV) surface antigen, and/or HBV DNA
NCT02902120_exc_T7
Procedure
HCV protease inhibitor therapy
NCT02902120_exc_T8
Condition
HIV co-infection
NCT02902120_exc_T9
Drug
protease inhibitor
NCT02902120_exc_T10
Measurement
creatinine
NCT02902120_exc_T11
Value
rease in 15% or greater wi
NCT02902120_exc_T12
Temporal
within one month
NCT02902120_exc_T13
Temporal
30 days
NCT02902120_exc_T14
Condition
hepatocellular carcinoma
NCT02902120_exc_T15
Condition
Liver disease
NCT02902120_exc_T16
Negation
other
NCT02902120_exc_T17
Observation
HCV
NCT02902120_exc_T18
Condition
decompensated cirrhotic
NCT02902120_exc_T19
Observation
F4
NCT02902120_exc_T20
Measurement
AST
NCT02902120_exc_T21
Measurement
ALT
NCT02902120_exc_T22
Value
>350
NCT02902120_exc_T23
Temporal
within 6 months prior to enrollment
NCT02902120_exc_T24
Reference_point
enrollment
NCT02902120_exc_T25
Scope
AST or ALT
NCT02902120_exc_T26
Measurement
Child Pugh class
NCT02902120_exc_T27
Value
B or C
NCT02902120_exc_T28
Measurement
Albumin
NCT02902120_exc_T29
Value
< 3g/dL
NCT02902120_exc_T30
Measurement
Platelet count
NCT02902120_exc_T31
Value
< 75
NCT02902120_exc_T32
Condition
allergy
NCT02902120_exc_T33
Condition
adverse event
NCT02902120_exc_T34
Drug
protease inhibitors
NCT02902120_exc_T35
Scope
allergy or adverse event
NCT02902120_exc_T36
Condition
acquisition of HCV
NCT02902120_exc_T37
Temporal
at the time of or after transplantation
NCT02902120_exc_T38
Reference_point
transplantation
NCT02902120_exc_T40
Drug
Cyclosporine
NCT02902120_exc_T41
Drug
St. John's Wort
NCT02902120_exc_T42
Drug
Efavirenz
NCT02902120_exc_T43
Drug
Phenytoin
NCT02902120_exc_T44
Drug
Carbamazepine
NCT02902120_exc_T45
Drug
Bosentan
NCT02902120_exc_T46
Drug
HIV protease inhibitors
NCT02902120_exc_T47
Drug
modafinil
NCT02902120_exc_T48
Drug
ketoconazole
NCT02902120_exc_T49
Drug
rifampin
NCT02902120_exc_T50
Temporal
within 7 days of enrollment
NCT02902120_exc_T51
Reference_point
enrollment
NCT02902120_exc_T52
Scope
Cyclosporine; St. John's Wort; Efavirenz; Phenytoin; Carbamazepine; Bosentan; HIV protease inhibitors; modafinil; ketoconazole; or rifampin
NCT02902120_exc_T53
Multiplier
more than 20 mg
NCT02902120_exc_T54
Drug
atorvastatin
NCT02902120_exc_T55
Multiplier
 atorvas tin;
NCT02902120_exc_T56
Multiplier
 atorvas tatin
NCT02902120_exc_T57
Drug
rosuvastatin
NCT02902120_exc_T58
Drug
fluvastatin
NCT02902120_exc_T59
Drug
lovastatin
NCT02902120_exc_T60
Drug
simvastatin
NCT02902120_exc_T61
Scope
fluvastatin, lovastatin or simvastatin