Chronic HCV Infection with Genotype 2 or 3
Amiodarone. Subjects previously treated with amiodarone must have stopped the amiodarone at least 60 days prior to day 1 of SOF/LDV FDC
Carbamazepine, phenytoin, phenobarbital, oxcarbazepine
Rifabutin, rifampin or rifapentine
HIV regimens containing tenofovir or tipranavir/ritonavir
St. John's wort
Rosuvastatin
Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
History of hepatic encephalopathy or variceal hemorrhage
Hepatitis B surface antigen positive
Hemoglobin (Hb) < 8 g/dL
Platelets = 50,000/mm3
alanine aminotransferase (ALT), aspartase aminotransferase (AST), or alkaline phosphatase = 10 times upper limit of normal(ULN)
Total bilirubin > 3 mg/dl
Severe renal impairment creatinine clearance (CrCl), i.e. < 30 mL/min.
History of major organ transplantation with an existing functional graft.
History of clinically-significant drug allergy to nucleoside/nucleotide analogs.
Pregnant women or women planning to become pregnant
Women who are breastfeeding
Active or recent history (= 1 year) of drug or alcohol abuse

NCT02858180_exc_T1
Condition
Chronic HCV Infection
NCT02858180_exc_T2
Qualifier
Genotype 2
NCT02858180_exc_T3
Qualifier
Genotype 3
NCT02858180_exc_T4
Scope
Genotype 2 or 3
NCT02858180_exc_T5
Drug
Amiodarone
NCT02858180_exc_T6
Temporal
at least 60 days prior to day 1 of SOF/LDV FDC
NCT02858180_exc_T7
Reference_point
day 1 of SOF/LDV FDC
NCT02858180_exc_T9
Drug
Carbamazepine
NCT02858180_exc_T10
Drug
phenytoin
NCT02858180_exc_T11
Drug
phenobarbital
NCT02858180_exc_T12
Drug
oxcarbazepine
NCT02858180_exc_T13
Drug
Rifabutin
NCT02858180_exc_T14
Drug
rifampin
NCT02858180_exc_T15
Drug
rifapentine
NCT02858180_exc_T17
Drug
tenofovir
NCT02858180_exc_T18
Drug
tipranavir/ritonavir
NCT02858180_exc_T19
Condition
St. John's wort
NCT02858180_exc_T20
Drug
Rosuvastatin
NCT02858180_exc_T22
Condition
hepatic encephalopathy
NCT02858180_exc_T23
Condition
variceal hemorrhage
NCT02858180_exc_T24
Measurement
Hepatitis B surface antigen
NCT02858180_exc_T25
Value
positive
NCT02858180_exc_T26
Measurement
Hemoglobin
NCT02858180_exc_T27
Measurement
Hb
NCT02858180_exc_T28
Value
< 8 g/dL
NCT02858180_exc_T29
Measurement
Platelets
NCT02858180_exc_T30
Value
= 50,000/mm3
NCT02858180_exc_T31
Measurement
alanine aminotransferase
NCT02858180_exc_T32
Measurement
ALT
NCT02858180_exc_T33
Measurement
aspartase aminotransferase
NCT02858180_exc_T34
Measurement
AST
NCT02858180_exc_T35
Measurement
alkaline phosphatase
NCT02858180_exc_T36
Value
= 10 times upper limit of normal
NCT02858180_exc_T37
Scope
alanine aminotransferase (ALT), aspartase aminotransferase (AST), or alkaline phosphatase
NCT02858180_exc_T38
Measurement
Total bilirubin
NCT02858180_exc_T39
Value
> 3 mg/dl
NCT02858180_exc_T40
Condition
renal impairment
NCT02858180_exc_T41
Qualifier
Severe
NCT02858180_exc_T42
Measurement
creatinine clearance
NCT02858180_exc_T43
Measurement
CrCl
NCT02858180_exc_T44
Value
< 30 mL/min
NCT02858180_exc_T45
Condition
major organ transplantation
NCT02858180_exc_T46
Qualifier
existing functional graft
NCT02858180_exc_T47
Condition
drug allergy
NCT02858180_exc_T48
Qualifier
clinically-significant
NCT02858180_exc_T49
Drug
nucleoside
NCT02858180_exc_T50
Drug
nucleotide analogs
NCT02858180_exc_T51
Scope
nucleoside/nucleotide analogs
NCT02858180_exc_T54
Observation
alcohol abuse
NCT02858180_exc_T55
Observation
se
NCT02858180_exc_T56
Temporal
= 1 year
NCT02858180_exc_T57
Scope
drug or alcohol abuse