Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)

Antiviral Effect and Safety of Once Daily BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naive Patients for 12 or 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Randomised, Open Label, Phase II)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00984620

Enrollment

160

Registered

2009-09-25

Start date

2009-09-30

Completion date

Unknown

Last updated

2015-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Brief summary

To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1

Interventions

DRUGBI 201335

BI 201335

DRUGPegylated Interferon-alpha (IFN)

Pegylated Interferon-alpha

DRUGRibavirin (RBV)

Ribavirin (RBV)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Chronic hepatitis C infection of genotype 1 2. Therapy-naïve to interferon, pegylated interferon, and ribavirin 3. HCV viral load \> 100.000 IU/ml at screening 4. Liver biopsy or fibroscan within two years prior to screening that provides evidence of any degree of fibrosis or cirrhosis 5. Normal retinal finding on fundoscopy within 6 months prior to Day 1 6. Age 18 to 70 years

Exclusion criteria

1. HCV of mixed genotype (1/2, 1/3, and 1/4) . 2. Patients who have been previously treated with at least one dose of any protease inhibitor 3. Evidence of liver disease due to causes other than chronic HCV infection 4. Positive for HIV-1 or HIV-2 antibodies 5. Hepatitis B virus (HBV) infection 6. Decompensated liver disease, or history of decompensated liver disease 7. Active malignancy or history of malignancy within the last 5 years 8. History of alcohol or drug abuse (except cannabis) within the past 12 months. 9. Body Mass Index \< 18 or \> 35 kg/m2. 10. Usage of any investigational drugs within 30 days prior to enrolment 11. Alpha fetoprotein value \>100ng/mL at screening; 12. Total bilirubin \> 1.5 x ULN with ratio of direct/indirect \> 1. 13. ALT or AST level \> 10 x ULN

Design outcomes

Primary

Measure	Time frame	Description
Virological Response at Week 28 (W28VR)	28 weeks	Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.

Secondary

Measure	Time frame	Description
Virological Response at Week 24 (W24VR)	24 weeks	virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24.
Virological Response at Week 36 (W36VR)	36 weeks	Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36.
End of Treatment Response (ETR)	up to 48 weeks	End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy.
Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy	72 weeks	Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy.
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	From baseline to 72 weeks	Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits.
Time to Reach a Plasma HCV RNA Level BLD While on Treatment	48 weeks	Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment
Laboratory Test Abnormalities and Study Medication Tolerabilities	48 weeks	Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic.
Rapid Virological Response at Week 4 (RVR)	4 weeks	Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	baseline and 48 weeks	Change from baseline (CFB) in Red blood cells.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	baseline and 48 weeks	Change from baseline (CFB) in haematocrit and Eosinophils.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	baseline and 48 weeks	Change from baseline (CFB) in Platelets and white blood cells.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	baseline and 48 weeks	Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	baseline and 48 weeks	Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	baseline and 48 weeks	Change from baseline (CFB) in PT-INR (ratio).
Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination	48 weeks	No number of participants with clinically relevant abnormalities in vital signs and physical examination.

Countries

Austria, Canada, France, Germany, Romania, United States

Participant flow

Participants by arm

Arm	Count
Faldaprevir 120 mg (12 Weeks) Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	81
Faldaprevir 120 mg (24 Weeks) Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	79
Total	160

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	5	5
Overall Study	Lost to Follow-up	1	1
Overall Study	reason other than listed above	0	4
Overall Study	Withdrawal by Subject	0	2

Baseline characteristics

Characteristic	Faldaprevir 120 mg (12 Weeks)	Faldaprevir 120 mg (24 Weeks)	Total
Age, Continuous	48.1 years STANDARD_DEVIATION 9.4	44.9 years STANDARD_DEVIATION 11.9	46.5 years STANDARD_DEVIATION 10.8
Sex: Female, Male Female	27 Participants	34 Participants	61 Participants
Sex: Female, Male Male	54 Participants	45 Participants	99 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	73 / 80	68 / 79
serious Total, serious adverse events	3 / 80	3 / 79

Outcome results

Primary

Virological Response at Week 28 (W28VR)

Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.

Time frame: 28 weeks

Population: Per Protocol Set (PPS): included all patients in the FAS without important protocol deviations.

Arm	Measure	Value (NUMBER)
Faldaprevir 120 mg (12 Weeks)	Virological Response at Week 28 (W28VR)	61 participants
Faldaprevir 120 mg (24 Weeks)	Virological Response at Week 28 (W28VR)	60 participants

p-value: 0.85595% CI: [-14.3, 11.8]Cochran-Mantel-Haenszel

Secondary

End of Treatment Response (ETR)

End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy.

Time frame: up to 48 weeks

Population: PPS

Arm	Measure	Value (NUMBER)
Faldaprevir 120 mg (12 Weeks)	End of Treatment Response (ETR)	65 participants
Faldaprevir 120 mg (24 Weeks)	End of Treatment Response (ETR)	67 participants

p-value: 0.58895% CI: [-8.1, 14.6]Cochran-Mantel-Haenszel

Secondary

Laboratory Test Abnormalities and Study Medication Tolerabilities

Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic.

Time frame: 48 weeks

Population: Treated Set (TS): comprised all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment regardless of randomisation.

Arm	Measure	Group	Value (NUMBER)
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	haematocrit: high(N=81, N=79)	0 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	AST/GOT, SGOT: high (N=75, N=71)	3 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	platelets: low(N=81, N=78)	5 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	ALT/GPT, SGPT: high (N=68, N=64)	3 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	white blood cell count: low(N=81, N=79)	56 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	alkaline phosphatase: high (N=80, N=79)	1 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	eosinophils: high (N=81, N=79)	1 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	GGT: high (N=74, N=72)	4 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	Red blood cell count: low (N=81, N=79)	9 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	creatine kinase: high (N=80, N=79)	0 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	sodium: low (N=81, N=79)	1 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	lipase: high (N=79, N=79)	1 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	PT-INR: high (N=81, N=79)	1 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	amylase: high (N=81, N=79)	1 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	bicarbonate: low (N=79, N=74)	6 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	glucose: low (N=80, N=79)	0 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	haematocrit: low (N=81, N=79)	30 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	cholesterol, total: high (N=80, N=75)	6 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	bicarbonate: high (N=79, N=74)	1 participants
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	triglyceride: high (N=74, N=71)	13 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	bicarbonate: high (N=79, N=74)	1 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	haematocrit: high(N=81, N=79)	1 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	PT-INR: high (N=81, N=79)	1 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	triglyceride: high (N=74, N=71)	18 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	Red blood cell count: low (N=81, N=79)	8 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	white blood cell count: low(N=81, N=79)	60 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	platelets: low(N=81, N=78)	2 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	eosinophils: high (N=81, N=79)	5 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	sodium: low (N=81, N=79)	1 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	bicarbonate: low (N=79, N=74)	11 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	haematocrit: low (N=81, N=79)	21 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	AST/GOT, SGOT: high (N=75, N=71)	3 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	ALT/GPT, SGPT: high (N=68, N=64)	5 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	alkaline phosphatase: high (N=80, N=79)	0 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	GGT: high (N=74, N=72)	8 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	creatine kinase: high (N=80, N=79)	3 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	lipase: high (N=79, N=79)	3 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	amylase: high (N=81, N=79)	2 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	glucose: low (N=80, N=79)	2 participants
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Abnormalities and Study Medication Tolerabilities	cholesterol, total: high (N=80, N=75)	2 participants

Secondary

Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)

Change from baseline (CFB) in Red blood cells.

Time frame: baseline and 48 weeks

Population: TS

Arm	Measure	Group	Value (MEAN)	Dispersion
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB,Day 1(N=77,N=75)	0.0 10^12 cells/L	Standard Deviation 0.3
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, wk2 (N=75,N=77)	-0.3 10^12 cells/L	Standard Deviation 0.5
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, wk36(N=4, N=2)	-0.9 10^12 cells/L	Standard Deviation 0.9
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, EoT(N=67, N=73)	-1.2 10^12 cells/L	Standard Deviation 0.6
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, wk4(N=74, N=76)	-0.8 10^12 cells/L	Standard Deviation 0.5
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, wk8(N=75, N=74)	-1.0 10^12 cells/L	Standard Deviation 0.5
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, wk12(N=74,N=74)	-1.1 10^12 cells/L	Standard Deviation 0.6
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, wk18(N=66,N=69)	-1.2 10^12 cells/L	Standard Deviation 0.6
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, wk24(N=12, N=4)	-1.2 10^12 cells/L	Standard Deviation 0.7
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, wk28(N=4, N=3)	-1.1 10^12 cells/L	Standard Deviation 0.4
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, wk4(N=74, N=76)	-0.8 10^12 cells/L	Standard Deviation 0.6
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB,Day 1(N=77,N=75)	-0.1 10^12 cells/L	Standard Deviation 0.3
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, wk24(N=12, N=4)	-0.9 10^12 cells/L	Standard Deviation 0.4
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, wk2 (N=75,N=77)	-0.4 10^12 cells/L	Standard Deviation 0.5
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, wk28(N=4, N=3)	-0.9 10^12 cells/L	Standard Deviation 0.7
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, wk8(N=75, N=74)	-1.0 10^12 cells/L	Standard Deviation 0.5
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, wk36(N=4, N=2)	-1.4 10^12 cells/L	Standard Deviation 0.2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, wk18(N=66,N=69)	-1.2 10^12 cells/L	Standard Deviation 0.5
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, EoT(N=67, N=73)	-1.2 10^12 cells/L	Standard Deviation 0.5
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Red blood cell (10^12cells/L) CFB, wk12(N=74,N=74)	-1.2 10^12 cells/L	Standard Deviation 0.5

Secondary

Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)

Change from baseline (CFB) in haematocrit and Eosinophils.

Time frame: baseline and 48 weeks

Population: TS

Arm	Measure	Group	Value (MEAN)	Dispersion
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, wk8 (N=75, N=74)	-8.4 % of laboratory test substance	Standard Deviation 4.6
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, wk36 (N=4, N=2)	-3.0 % of laboratory test substance	Standard Deviation 8
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, wk24 (N=11, N=4)	-6.6 % of laboratory test substance	Standard Deviation 6.2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, EoT (N=66, N=70)	-6.0 % of laboratory test substance	Standard Deviation 4.7
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, wk4 (N=74, N=76)	-8.0 % of laboratory test substance	Standard Deviation 4.9
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, day1 (N=77, N=75)	0 % of laboratory test substance	Standard Deviation 1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, wk12 (N=72, N=74)	-8.5 % of laboratory test substance	Standard Deviation 4.9
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, wk2 (N=75, N=76)	0 % of laboratory test substance	Standard Deviation 2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, wk12 (N=72, N=72)	0 % of laboratory test substance	Standard Deviation 2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, wk4 (N=73, N=74)	-1 % of laboratory test substance	Standard Deviation 1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, wk2 (N=75, N=77)	-4.3 % of laboratory test substance	Standard Deviation 4.4
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, wk8 (N=74, N=73)	0 % of laboratory test substance	Standard Deviation 2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, wk24 (N=12, N=4)	-1 % of laboratory test substance	Standard Deviation 1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, wk18 (N=62, N=65)	0 % of laboratory test substance	Standard Deviation 3
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, wk28 (N=4, N=3)	-1 % of laboratory test substance	Standard Deviation 1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, wk18 (N=66, N=69)	-7.3 % of laboratory test substance	Standard Deviation 5.4
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, wk36 (N=4, N=2)	-1 % of laboratory test substance	Standard Deviation 1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, wk28 (N=4, N=3)	-3.8 % of laboratory test substance	Standard Deviation 3.9
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, EoT (N=66, N=70)	0 % of laboratory test substance	Standard Deviation 2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, Day1 (N=77, N=75)	-0.9 % of laboratory test substance	Standard Deviation 3
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, EoT (N=66, N=70)	1 % of laboratory test substance	Standard Deviation 5
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, Day1 (N=77, N=75)	-1.3 % of laboratory test substance	Standard Deviation 2.7
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, wk2 (N=75, N=77)	-4.7 % of laboratory test substance	Standard Deviation 4.2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, wk4 (N=74, N=76)	-7.9 % of laboratory test substance	Standard Deviation 4.5
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, wk8 (N=75, N=74)	-7.1 % of laboratory test substance	Standard Deviation 4
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, wk12 (N=72, N=74)	-7.8 % of laboratory test substance	Standard Deviation 3.9
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, wk18 (N=66, N=69)	-6.5 % of laboratory test substance	Standard Deviation 4.4
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, wk24 (N=11, N=4)	-2.7 % of laboratory test substance	Standard Deviation 2.4
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, wk8 (N=74, N=73)	0 % of laboratory test substance	Standard Deviation 5
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, wk12 (N=72, N=72)	0 % of laboratory test substance	Standard Deviation 3
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, wk18 (N=62, N=65)	0 % of laboratory test substance	Standard Deviation 2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, wk28 (N=4, N=3)	-1.2 % of laboratory test substance	Standard Deviation 4.4
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, wk36 (N=4, N=2)	-3.6 % of laboratory test substance	Standard Deviation 0
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	haematocrit (%) CFB, EoT (N=66, N=70)	-6.0 % of laboratory test substance	Standard Deviation 4.6
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, day1 (N=77, N=75)	0 % of laboratory test substance	Standard Deviation 1
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, wk2 (N=75, N=76)	0 % of laboratory test substance	Standard Deviation 1
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, wk4 (N=73, N=74)	0 % of laboratory test substance	Standard Deviation 2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, wk24 (N=12, N=4)	-1 % of laboratory test substance	Standard Deviation 2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, wk28 (N=4, N=3)	-2 % of laboratory test substance	Standard Deviation 2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Eosinophils(%), CFB, wk36 (N=4, N=2)	-1 % of laboratory test substance	Standard Deviation 0

Secondary

Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)

Change from baseline (CFB) in Platelets and white blood cells.

Time frame: baseline and 48 weeks

Population: TS

Arm	Measure	Group	Value (MEAN)	Dispersion
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, EoT (N=67, N=73)	-3.4 10^9 cells/L	Standard Deviation 1.5
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, wk2 (N=74, N=74)	-35 10^9 cells/L	Standard Deviation 40
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, wk4 (N=73, N=74)	-35 10^9 cells/L	Standard Deviation 41
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, wk18 (N=66, N=68)	-55 10^9 cells/L	Standard Deviation 46
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, wk24 (N=12, N=3)	-46 10^9 cells/L	Standard Deviation 37
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, wk28 (N=4, N=2)	-22 10^9 cells/L	Standard Deviation 77
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, wk2 (N=75, N=77)	-2.2 10^9 cells/L	Standard Deviation 1.5
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, wk4 (N=74, N=76)	-2.6 10^9 cells/L	Standard Deviation 1.5
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, Day 1 (N=77, N=73)	3 10^9 cells/L	Standard Deviation 35
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, wk8 (N=73, N=71)	-55 10^9 cells/L	Standard Deviation 37
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, wk12 (N=72, N=72)	-61 10^9 cells/L	Standard Deviation 38
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, wk36 (N=4, N=2)	-47 10^9 cells/L	Standard Deviation 31
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, EoT (N=67, N=71)	-59 10^9 cells/L	Standard Deviation 46
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, day1 (N=77, N=75)	-0.1 10^9 cells/L	Standard Deviation 1.1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, wk8 (N=75, N=74)	-3.2 10^9 cells/L	Standard Deviation 1.5
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, wk12 (N=74, N=74)	-3.4 10^9 cells/L	Standard Deviation 1.5
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, wk18 (N=66, N=69)	-3.2 10^9 cells/L	Standard Deviation 1.4
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, wk24 (N=12, N=4)	-4.0 10^9 cells/L	Standard Deviation 1.3
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, wk28 (N=4, N=3)	-2.8 10^9 cells/L	Standard Deviation 1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, wk36 (N=4, N=2)	-2.5 10^9 cells/L	Standard Deviation 0.9
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, wk28 (N=4, N=3)	-1.9 10^9 cells/L	Standard Deviation 2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, wk36 (N=4, N=2)	-85 10^9 cells/L	Standard Deviation 2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, wk2 (N=74, N=74)	-35 10^9 cells/L	Standard Deviation 34
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, wk18 (N=66, N=69)	-3.1 10^9 cells/L	Standard Deviation 1.6
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, wk4 (N=73, N=74)	-39 10^9 cells/L	Standard Deviation 42
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, wk12 (N=72, N=72)	-50 10^9 cells/L	Standard Deviation 40
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, EoT (N=67, N=71)	-50 10^9 cells/L	Standard Deviation 48
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, wk18 (N=66, N=68)	-51 10^9 cells/L	Standard Deviation 45
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, Day 1 (N=77, N=73)	2 10^9 cells/L	Standard Deviation 29
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, wk24 (N=12, N=3)	-50 10^9 cells/L	Standard Deviation 43
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, day1 (N=77, N=75)	0.3 10^9 cells/L	Standard Deviation 1.3
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, wk4 (N=74, N=76)	-2.6 10^9 cells/L	Standard Deviation 1.9
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, wk2 (N=75, N=77)	-1.8 10^9 cells/L	Standard Deviation 1.9
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, wk24 (N=12, N=4)	-2.0 10^9 cells/L	Standard Deviation 1.7
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, EoT (N=67, N=73)	-3.1 10^9 cells/L	Standard Deviation 1.6
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, wk8 (N=75, N=74)	-2.9 10^9 cells/L	Standard Deviation 1.4
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, wk36 (N=4, N=2)	-3.0 10^9 cells/L	Standard Deviation 1.1
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, wk8 (N=73, N=71)	-48 10^9 cells/L	Standard Deviation 38
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	white blood cell CFB, wk12 (N=74, N=74)	-2.8 10^9 cells/L	Standard Deviation 1.8
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Platelets CFB, wk28 (N=4, N=2)	-83 10^9 cells/L	Standard Deviation 6

Secondary

Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)

Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.

Time frame: baseline and 48 weeks

Population: TS

Arm	Measure	Group	Value (MEAN)	Dispersion
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, Day 1(N=77, N=74)	0 mmol/L	Standard Deviation 2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, wk2 (N=76, N=78)	0 mmol/L	Standard Deviation 2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, wk18 (N=68, N=70)	0 mmol/L	Standard Deviation 2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, wk8 (n=75, N=76)	-0.58 mmol/L	Standard Deviation 0.59
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, wk36 (n=4, N=2)	-0.35 mmol/L	Standard Deviation 0.14
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, EoT (n=67, N=73)	-0.43 mmol/L	Standard Deviation 0.7
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, EoT (N=67, N=73)	0.1 mmol/L	Standard Deviation 0.6
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, wk8 (N=74, N=76)	-0.1 mmol/L	Standard Deviation 1.3
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, wk12 (N=73, N=76)	-0.3 mmol/L	Standard Deviation 1.1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, wk18 (N=67, N=70)	-0.4 mmol/L	Standard Deviation 1.2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, wk24 (N=12, N=4)	-0.7 mmol/L	Standard Deviation 1.3
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, wk28 (N=4, N=3)	-1.2 mmol/L	Standard Deviation 2.1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, wk4 (N=76, N=77)	0 mmol/L	Standard Deviation 2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, wk8 (N=73, N=76)	1 mmol/L	Standard Deviation 3
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, wk12 (N=75, N=76)	0 mmol/L	Standard Deviation 2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, wk24 (N=12, N=4)	-1 mmol/L	Standard Deviation 2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, wk28 (N=5, N=3)	-2 mmol/L	Standard Deviation 2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, wk36 (N=4, N=2)	-1 mmol/L	Standard Deviation 2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, EoT (N=67, N=73)	0 mmol/L	Standard Deviation 2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, day1 (N=76, N=75)	0.1 mmol/L	Standard Deviation 1.4
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, wk2 (N=75, N=78)	-0.2 mmol/L	Standard Deviation 1.4
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, wk4 (N=74, N=77)	-0.1 mmol/L	Standard Deviation 1.3
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, wk8 (N=74, N=76)	-0.1 mmol/L	Standard Deviation 1.3
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, wk12 (N=74, N=76)	-0.3 mmol/L	Standard Deviation 1.2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, wk18 (N=66, N=69)	-0.3 mmol/L	Standard Deviation 1.6
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, wk24 (N=12, N=4)	-0.4 mmol/L	Standard Deviation 1.4
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, wk36 (N=4, N=2)	-2.6 mmol/L	Standard Deviation 2.3
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, EoT (N=64, N=71)	-0.2 mmol/L	Standard Deviation 1.6
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, day1 (n=77, N=75)	0.03 mmol/L	Standard Deviation 0.47
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, wk2 (n=76, N=78)	-0.48 mmol/L	Standard Deviation 0.57
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, wk4 (n=76, N=77)	-0.51 mmol/L	Standard Deviation 0.55
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, wk12 (n=75, N=76)	-0.64 mmol/L	Standard Deviation 0.62
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, wk18 (n=68, N=70)	-0.51 mmol/L	Standard Deviation 0.64
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, wk24 (n=12, N=4)	-0.36 mmol/L	Standard Deviation 0.46
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, wk28 (n=5, N=3)	0.10 mmol/L	Standard Deviation 0.53
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, day1 (N=77, N=75)	-0.1 mmol/L	Standard Deviation 0.5
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, wk2 (N=76, N=78)	0.1 mmol/L	Standard Deviation 0.5
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, wk4 (N=76, N=77)	0.1 mmol/L	Standard Deviation 0.5
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, wk8 (N=75, N=76)	0.1 mmol/L	Standard Deviation 0.5
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, wk12 (N=75, N=76)	0.1 mmol/L	Standard Deviation 0.6
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, wk18 (N=68, N=70)	0.0 mmol/L	Standard Deviation 0.5
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, wk24 (N=12, N=4)	-0.2 mmol/L	Standard Deviation 0.7
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, wk28 (N=5, N=3)	0.0 mmol/L	Standard Deviation 1.3
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, wk36 (N=4, N=2)	-0.3 mmol/L	Standard Deviation 0.7
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, day1 (N=76, N=75)	-0.1 mmol/L	Standard Deviation 1.3
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, wk2 (N=75, N=78)	-0.1 mmol/L	Standard Deviation 1.3
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, wk4 (N=74, N=77)	-0.2 mmol/L	Standard Deviation 1.3
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, wk28 (N=5, N=3)	-0.4 mmol/L	Standard Deviation 1.1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, wk36 (N=4, N=2)	-0.1 mmol/L	Standard Deviation 0.7
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, EoT (N=66, N=71)	-0.4 mmol/L	Standard Deviation 1.2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, wk24 (N=12, N=4)	-0.5 mmol/L	Standard Deviation 1.9
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, Day 1(N=77, N=74)	1 mmol/L	Standard Deviation 2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, wk28 (N=4, N=3)	-0.2 mmol/L	Standard Deviation 0.9
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, wk2 (N=76, N=78)	0 mmol/L	Standard Deviation 2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, wk12 (N=75, N=76)	1 mmol/L	Standard Deviation 2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, wk4 (N=76, N=77)	0.2 mmol/L	Standard Deviation 0.6
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, wk4 (n=76, N=77)	-0.67 mmol/L	Standard Deviation 0.68
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, wk36 (N=4, N=2)	-1.0 mmol/L	Standard Deviation 0.7
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, EoT (N=67, N=73)	0.1 mmol/L	Standard Deviation 0.6
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, wk36 (n=4, N=2)	-0.23 mmol/L	Standard Deviation 0.2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, EoT (N=64, N=71)	-0.1 mmol/L	Standard Deviation 1.4
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, wk36 (N=4, N=2)	0.1 mmol/L	Standard Deviation 0.5
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, wk8 (N=75, N=76)	0.1 mmol/L	Standard Deviation 0.4
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, wk4 (N=74, N=77)	0.1 mmol/L	Standard Deviation 0.9
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, day1 (n=77, N=75)	-0.05 mmol/L	Standard Deviation 0.48
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, wk8 (N=74, N=76)	0.1 mmol/L	Standard Deviation 0.9
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, wk36 (N=4, N=2)	-0.1 mmol/L	Standard Deviation 0.4
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, wk12 (N=73, N=76)	-0.1 mmol/L	Standard Deviation 1
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, wk2 (n=76, N=78)	-0.54 mmol/L	Standard Deviation 0.57
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, wk18 (N=67, N=70)	-0.1 mmol/L	Standard Deviation 0.7
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, wk12 (N=75, N=76)	0.1 mmol/L	Standard Deviation 0.5
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, wk24 (N=12, N=4)	-0.4 mmol/L	Standard Deviation 0.7
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, wk8 (n=75, N=76)	-0.60 mmol/L	Standard Deviation 0.62
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, day1 (N=76, N=75)	0.2 mmol/L	Standard Deviation 0.9
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, wk4 (N=76, N=77)	0 mmol/L	Standard Deviation 2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, wk12 (n=75, N=76)	-0.74 mmol/L	Standard Deviation 0.63
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, wk8 (N=73, N=76)	1 mmol/L	Standard Deviation 2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, wk18 (N=68, N=70)	0.2 mmol/L	Standard Deviation 0.5
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, wk18 (N=68, N=70)	0 mmol/L	Standard Deviation 2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, wk18 (n=68, N=70)	-0.80 mmol/L	Standard Deviation 0.69
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, wk24 (N=12, N=4)	0 mmol/L	Standard Deviation 1
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, wk28 (N=5, N=3)	0.1 mmol/L	Standard Deviation 0.7
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, wk28 (N=5, N=3)	-1 mmol/L	Standard Deviation 3
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, wk24 (n=12, N=4)	-0.37 mmol/L	Standard Deviation 0.3
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, wk36 (N=4, N=2)	-1 mmol/L	Standard Deviation 2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, wk24 (N=12, N=4)	0.2 mmol/L	Standard Deviation 0.3
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Sodium (mmol/L) CFB, EoT (N=67, N=73)	0 mmol/L	Standard Deviation 3
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, wk28 (n=5, N=3)	-0.09 mmol/L	Standard Deviation 0.2
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, day1 (N=76, N=75)	0.2 mmol/L	Standard Deviation 1.3
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Cholesterol tot. (mmol/L), CFB, EoT (n=67, N=73)	-0.74 mmol/L	Standard Deviation 0.68
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, wk2 (N=75, N=78)	0.0 mmol/L	Standard Deviation 1.3
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, wk2 (N=75, N=78)	0.1 mmol/L	Standard Deviation 1
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, wk4 (N=74, N=77)	-0.1 mmol/L	Standard Deviation 1.3
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, day1 (N=77, N=75)	-0.1 mmol/L	Standard Deviation 0.3
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, wk8 (N=74, N=76)	0.0 mmol/L	Standard Deviation 1.4
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, wk28 (N=5, N=3)	0.4 mmol/L	Standard Deviation 0.4
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, wk12 (N=74, N=76)	-0.4 mmol/L	Standard Deviation 1.5
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Triglyceride (mmol/L), CFB, wk2 (N=76, N=78)	0.1 mmol/L	Standard Deviation 0.4
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Bicarbonate (mmol/L), CFB, wk18 (N=66, N=69)	-0.4 mmol/L	Standard Deviation 1.3
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Glucose (mmol/L), CFB, EoT (N=66, N=71)	-0.1 mmol/L	Standard Deviation 1.3

Secondary

Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)

Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase.

Time frame: baseline and 48 weeks

Population: TS

Arm	Measure	Group	Value (MEAN)	Dispersion
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, wk8 (N=74, N=76)	-22 U/L	Standard Deviation 36
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, wk12 (N=74, N=76)	-24 U/L	Standard Deviation 29
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, day1 (N=76, N=75)	1 U/L	Standard Deviation 24
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, wk2 (N=75, N=78)	-37 U/L	Standard Deviation 36
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, wk4 (N=74, N=77)	-37 U/L	Standard Deviation 40
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, wk12 (N=74, N=76)	-37 U/L	Standard Deviation 36
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, wk2 (n=76, N=78)	5 U/L	Standard Deviation 10
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, wk4 (n=76, N=77)	7 U/L	Standard Deviation 13
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, wk36 (n=4, N=2)	-5 U/L	Standard Deviation 16
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, EoT (n=67, N=73)	1 U/L	Standard Deviation 22
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, day1 (N=77, N=75)	-5 U/L	Standard Deviation 39
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, wk2 (N=76, N=78)	-34 U/L	Standard Deviation 71
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, wk4 (N=76, N=77)	-59 U/L	Standard Deviation 86
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, day1 (N=77, N=75)	-2 U/L	Standard Deviation 52
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, EoT (N=67, N=73)	-6 U/L	Standard Deviation 82
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, day1 (N=77, N=75)	1 U/L	Standard Deviation 26
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, wk2 (N=76, N=78)	5 U/L	Standard Deviation 41
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, wk24 (N=12, N=4)	-14 U/L	Standard Deviation 35
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, Day 1(N=74, N=75)	0 U/L	Standard Deviation 28
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, wk2 (N=75, N=78)	-24 U/L	Standard Deviation 30
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, wk4 (N=74, N=76)	-25 U/L	Standard Deviation 31
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, wk18 (N=67, N=70)	-25 U/L	Standard Deviation 33
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, wk24 (N=12, N=4)	-23 U/L	Standard Deviation 60
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, wk28 (N=5, N=3)	-20 U/L	Standard Deviation 27
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, wk36 (N=4, N=2)	-21 U/L	Standard Deviation 40
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, EoT (N=66, N=71)	-25 U/L	Standard Deviation 41
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, wk8 (N=74, N=76)	-36 U/L	Standard Deviation 43
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, wk18 (N=67, N=70)	-41 U/L	Standard Deviation 40
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, wk24 (N=12, N=4)	-40 U/L	Standard Deviation 50
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, wk28 (N=5, N=3)	-45 U/L	Standard Deviation 38
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, wk36 (N=4, N=2)	-47 U/L	Standard Deviation 46
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, EoT (N=66, N=71)	-42 U/L	Standard Deviation 42
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, day1 (n=77, N=75)	1 U/L	Standard Deviation 11
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, wk8 (n=75, N=76)	7 U/L	Standard Deviation 13
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, wk12 (n=75, N=76)	5 U/L	Standard Deviation 14
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, wk18 (n=68, N=70)	-2 U/L	Standard Deviation 20
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, wk24 (n=12, N=4)	-14 U/L	Standard Deviation 24
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, wk28 (n=5, N=3)	-2 U/L	Standard Deviation 14
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, wk8 (N=75, N=76)	-76 U/L	Standard Deviation 96
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, wk12 (N=75, N=76)	-71 U/L	Standard Deviation 103
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, wk18 (N=68, N=70)	-62 U/L	Standard Deviation 105
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, wk24 (N=12, N=4)	-118 U/L	Standard Deviation 200
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, wk28 (N=5, N=3)	-52 U/L	Standard Deviation 126
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, wk36 (N=4, N=2)	-23 U/L	Standard Deviation 132
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, EoT (N=67, N=73)	-39 U/L	Standard Deviation 106
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, day1 (N=76, N=75)	-2 U/L	Standard Deviation 140
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, wk2 (N=75, N=78)	-59 U/L	Standard Deviation 158
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, wk4 (N=74, N=77)	-69 U/L	Standard Deviation 173
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, wk8 (N=74, N=76)	-92 U/L	Standard Deviation 176
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, wk12 (N=74, N=75)	-98 U/L	Standard Deviation 186
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, wk18 (N=67, N=70)	-93 U/L	Standard Deviation 202
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, wk24 (N=12, N=4)	-69 U/L	Standard Deviation 78
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, wk28 (N=5, N=3)	-48 U/L	Standard Deviation 75
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, wk36 (N=4, N=2)	-68 U/L	Standard Deviation 83
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, EoT (N=66, N=71)	-89 U/L	Standard Deviation 187
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, wk2 (N=76, N=78)	5 U/L	Standard Deviation 65
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, wk4 (N=76, N=76)	-1 U/L	Standard Deviation 52
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, wk8 (N=75, N=76)	-11 U/L	Standard Deviation 69
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, wk12 (N=75, N=75)	-12 U/L	Standard Deviation 70
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, wk18 (N=68, N=70)	-13 U/L	Standard Deviation 64
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, wk24 (N=12, N=4)	2 U/L	Standard Deviation 31
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, wk28 (N=5, N=3)	-1 U/L	Standard Deviation 13
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, wk36 (N=4, N=2)	-4 U/L	Standard Deviation 12
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, wk4 (N=76, N=77)	2 U/L	Standard Deviation 30
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, wk8 (N=75, N=76)	-5 U/L	Standard Deviation 33
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, wk12 (N=75, N=75)	-10 U/L	Standard Deviation 33
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, wk18 (N=68, N=70)	-7 U/L	Standard Deviation 34
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, wk28 (N=5, N=3)	-21 U/L	Standard Deviation 34
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, wk36 (N=4, N=2)	-35 U/L	Standard Deviation 24
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, EoT (N=67, N=73)	0 U/L	Standard Deviation 37
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, wk8 (N=75, N=76)	-2 U/L	Standard Deviation 29
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, wk8 (N=74, N=76)	-27 U/L	Standard Deviation 47
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, wk12 (n=75, N=76)	6 U/L	Standard Deviation 14
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, wk24 (N=12, N=4)	-42 U/L	Standard Deviation 30
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, day1 (N=76, N=75)	-2 U/L	Standard Deviation 22
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, wk18 (n=68, N=70)	5 U/L	Standard Deviation 14
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, wk2 (N=75, N=78)	-34 U/L	Standard Deviation 40
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, wk24 (N=12, N=4)	-17 U/L	Standard Deviation 22
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, wk8 (N=74, N=76)	-35 U/L	Standard Deviation 49
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, wk24 (n=12, N=4)	13 U/L	Standard Deviation 13
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, wk28 (N=5, N=3)	-32 U/L	Standard Deviation 26
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, wk2 (n=76, N=78)	7 U/L	Standard Deviation 11
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, wk28 (n=5, N=3)	15 U/L	Standard Deviation 3
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, wk28 (N=5, N=3)	-8 U/L	Standard Deviation 7
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, wk36 (n=4, N=2)	18 U/L	Standard Deviation 4
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, wk8 (N=75, N=76)	-70 U/L	Standard Deviation 143
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, EoT (n=67, N=73)	5 U/L	Standard Deviation 16
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, wk36 (N=4, N=2)	-37 U/L	Standard Deviation 22
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, day1 (N=77, N=75)	-5 U/L	Standard Deviation 88
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, wk12 (N=75, N=76)	-69 U/L	Standard Deviation 150
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, wk2 (N=76, N=78)	-38 U/L	Standard Deviation 117
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, wk28 (N=5, N=3)	0 U/L	Standard Deviation 11
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, wk4 (N=76, N=77)	-60 U/L	Standard Deviation 135
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, EoT (N=66, N=71)	-21 U/L	Standard Deviation 331
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, wk18 (N=68, N=70)	-64 U/L	Standard Deviation 146
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, day1 (N=77, N=75)	26 U/L	Standard Deviation 239
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, wk12 (N=75, N=75)	-4 U/L	Standard Deviation 33
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, EoT (N=67, N=73)	-5 U/L	Standard Deviation 27
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, wk24 (N=12, N=4)	-131 U/L	Standard Deviation 50
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, day1 (N=77, N=75)	7 U/L	Standard Deviation 68
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, wk2 (N=76, N=78)	9 U/L	Standard Deviation 30
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, wk2 (N=76, N=78)	3 U/L	Standard Deviation 23
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, wk18 (N=68, N=70)	-7 U/L	Standard Deviation 28
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, wk28 (N=5, N=3)	-113 U/L	Standard Deviation 42
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, wk24 (N=12, N=4)	-16 U/L	Standard Deviation 23
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, wk36 (N=4, N=2)	-15 U/L	Standard Deviation 0
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, Day 1(N=74, N=75)	-5 U/L	Standard Deviation 29
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, wk36 (N=4, N=2)	-14 U/L	Standard Deviation 73
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, wk2 (N=75, N=78)	-29 U/L	Standard Deviation 43
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, wk4 (N=76, N=76)	6 U/L	Standard Deviation 36
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, wk4 (N=74, N=76)	-29 U/L	Standard Deviation 49
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, wk12 (N=74, N=76)	-27 U/L	Standard Deviation 44
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	GGT (U/L), CFB, EoT (N=67, N=73)	-59 U/L	Standard Deviation 148
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, wk18 (N=67, N=70)	-30 U/L	Standard Deviation 50
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, EoT (N=67, N=73)	-4 U/L	Standard Deviation 27
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, wk24 (N=12, N=4)	-10 U/L	Standard Deviation 15
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, day1 (N=76, N=75)	30 U/L	Standard Deviation 308
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, wk28 (N=5, N=3)	-16 U/L	Standard Deviation 24
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, wk8 (N=75, N=76)	2 U/L	Standard Deviation 57
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, wk36 (N=4, N=2)	11 U/L	Standard Deviation 4
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, wk2 (N=75, N=78)	-41 U/L	Standard Deviation 118
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	AST/GOT (U/L), CFB, EoT (N=66, N=71)	-27 U/L	Standard Deviation 49
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, wk4 (N=74, N=77)	-34 U/L	Standard Deviation 50
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, wk4 (N=76, N=77)	5 U/L	Standard Deviation 27
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, wk12 (N=74, N=76)	-36 U/L	Standard Deviation 48
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, wk4 (N=74, N=77)	-62 U/L	Standard Deviation 134
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, wk18 (N=67, N=70)	-42 U/L	Standard Deviation 52
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, wk12 (N=75, N=75)	4 U/L	Standard Deviation 90
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, wk24 (N=12, N=4)	-24 U/L	Standard Deviation 22
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, wk8 (N=74, N=76)	-75 U/L	Standard Deviation 131
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, wk28 (N=5, N=3)	-22 U/L	Standard Deviation 15
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Amylase (U/L), CFB, wk36 (N=4, N=2)	-19 U/L	Standard Deviation 9
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, wk36 (N=4, N=2)	-6 U/L	Standard Deviation 4
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, wk12 (N=74, N=75)	-84 U/L	Standard Deviation 132
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	ALT/GPT (U/L), CFB, EoT (N=66, N=71)	-42 U/L	Standard Deviation 45
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Lipase (U/L). CFB, wk18 (N=68, N=70)	-4 U/L	Standard Deviation 32
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, day1 (n=77, N=75)	1 U/L	Standard Deviation 13
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, wk4 (n=76, N=77)	10 U/L	Standard Deviation 13
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Creatine kinase (U/L), CFB, wk18 (N=67, N=70)	-60 U/L	Standard Deviation 216
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)	Alka. phosphatase (U/L), CFB, wk8 (n=75, N=76)	9 U/L	Standard Deviation 15

Secondary

Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)

Change from baseline (CFB) in PT-INR (ratio).

Time frame: baseline and 48 weeks

Population: TS

Arm	Measure	Group	Value (MEAN)	Dispersion
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, wk4(N=74, N=76)	0.0 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, wk2 (N=76, N=78)	0.0 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, wk24(N=12, N=4)	0.0 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, wk8(N=73, N=75)	0.0 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, wk28(N=5, N=3)	-0.1 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, Day 1(N=77, N=72)	0.0 ratio	Standard Deviation 0.2
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, wk36(N=4, N=2)	0.0 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, wk12(N=74, N=72)	0.0 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, EoT(N=68, N=73)	0.0 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (12 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, wk18(N=69, N=70)	0.0 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, EoT(N=68, N=73)	0.0 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, Day 1(N=77, N=72)	0.0 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, wk2 (N=76, N=78)	0.0 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, wk4(N=74, N=76)	0.0 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, wk8(N=73, N=75)	0.0 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, wk12(N=74, N=72)	0.0 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, wk18(N=69, N=70)	0.0 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, wk24(N=12, N=4)	0.1 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, wk28(N=5, N=3)	0.0 ratio	Standard Deviation 0.1
Faldaprevir 120 mg (24 Weeks)	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	PT-INR (ratio), CFB, wk36(N=4, N=2)	-0.1 ratio	Standard Deviation 0.1

Secondary

Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination

No number of participants with clinically relevant abnormalities in vital signs and physical examination.

Time frame: 48 weeks

Population: TS

Arm	Measure	Value (NUMBER)
Faldaprevir 120 mg (12 Weeks)	Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination	0 participants with abnormality
Faldaprevir 120 mg (24 Weeks)	Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination	0 participants with abnormality

Secondary

Rapid Virological Response at Week 4 (RVR)

Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4.

Time frame: 4 weeks

Population: PPS

Arm	Measure	Value (NUMBER)
Faldaprevir 120 mg (12 Weeks)	Rapid Virological Response at Week 4 (RVR)	48 participants
Faldaprevir 120 mg (24 Weeks)	Rapid Virological Response at Week 4 (RVR)	56 participants

p-value: 0.22995% CI: [-5.3, 23.3]Cochran-Mantel-Haenszel

Secondary

Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy

Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy.

Time frame: 72 weeks

Population: PPS

Arm	Measure	Value (NUMBER)
Faldaprevir 120 mg (12 Weeks)	Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy	54 participants
Faldaprevir 120 mg (24 Weeks)	Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy	58 participants

p-value: 0.51295% CI: [-9, 18.6]Cochran-Mantel-Haenszel

Secondary

Time to Reach a Plasma HCV RNA Level BLD While on Treatment

Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment

Time frame: 48 weeks

Population: PPS

Arm	Measure	Value (MEDIAN)
Faldaprevir 120 mg (12 Weeks)	Time to Reach a Plasma HCV RNA Level BLD While on Treatment	4.1 week
Faldaprevir 120 mg (24 Weeks)	Time to Reach a Plasma HCV RNA Level BLD While on Treatment	4.1 week

p-value: 0.1397Log Rank

Secondary

Viral Load (HCV RNA) at All Visits During Treatment and Follow-up

Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits.

Time frame: From baseline to 72 weeks

Population: PPS

Arm	Measure	Group	Value (MEAN)	Dispersion
Faldaprevir 120 mg (12 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 4, change from baseline (N=76, N=77)	-4.993 IU/mL	Standard Deviation 1.1168
Faldaprevir 120 mg (12 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 20, change from baseline (N=52, N=57)	-5.056 IU/mL	Standard Deviation 1.0894
Faldaprevir 120 mg (12 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	12 wks after TRT, change from baseline (N=75,N=75)	-4.154 IU/mL	Standard Deviation 2.3356
Faldaprevir 120 mg (12 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 24, change from baseline (N=12, N=8)	-4.176 IU/mL	Standard Deviation 2.1635
Faldaprevir 120 mg (12 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 8, change from baseline (N=75, N=76)	-5.128 IU/mL	Standard Deviation 1.1159
Faldaprevir 120 mg (12 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 36, change from baseline (N=4, N=2)	-5.624 IU/mL	Standard Deviation 0.7059
Faldaprevir 120 mg (12 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 2, change from baseline (N=76, N=78)	-4.724 IU/mL	Standard Deviation 0.9059
Faldaprevir 120 mg (12 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	End of TRT, change from baseline (N=80, N=78)	-4.910 IU/mL	Standard Deviation 1.469
Faldaprevir 120 mg (12 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 12, change from baseline (N=76, N=76)	-5.117 IU/mL	Standard Deviation 1.1495
Faldaprevir 120 mg (12 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	4 wks after TRT, change from baseline (N=75, N=77)	-4.296 IU/mL	Standard Deviation 2.2499
Faldaprevir 120 mg (12 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 28, change from baseline (N=4, N=4)	-5.723 IU/mL	Standard Deviation 0.6795
Faldaprevir 120 mg (12 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	24 wks after TRT, change from baseline (N=73,N=75)	-4.103 IU/mL	Standard Deviation 2.3673
Faldaprevir 120 mg (12 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 16, change from baseline (N=18, N=13)	-5.363 IU/mL	Standard Deviation 1.2341
Faldaprevir 120 mg (24 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	24 wks after TRT, change from baseline (N=73,N=75)	-4.250 IU/mL	Standard Deviation 2.2439
Faldaprevir 120 mg (24 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	4 wks after TRT, change from baseline (N=75, N=77)	-4.367 IU/mL	Standard Deviation 2.1849
Faldaprevir 120 mg (24 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 2, change from baseline (N=76, N=78)	-4.866 IU/mL	Standard Deviation 0.8664
Faldaprevir 120 mg (24 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 4, change from baseline (N=76, N=77)	-5.081 IU/mL	Standard Deviation 1.1195
Faldaprevir 120 mg (24 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 8, change from baseline (N=75, N=76)	-5.088 IU/mL	Standard Deviation 1.315
Faldaprevir 120 mg (24 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 12, change from baseline (N=76, N=76)	-5.107 IU/mL	Standard Deviation 1.2852
Faldaprevir 120 mg (24 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 16, change from baseline (N=18, N=13)	-5.262 IU/mL	Standard Deviation 0.582
Faldaprevir 120 mg (24 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 20, change from baseline (N=52, N=57)	-5.366 IU/mL	Standard Deviation 0.7319
Faldaprevir 120 mg (24 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 28, change from baseline (N=4, N=4)	-4.369 IU/mL	Standard Deviation 2.2917
Faldaprevir 120 mg (24 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 36, change from baseline (N=4, N=2)	-5.958 IU/mL	Standard Deviation 0.1909
Faldaprevir 120 mg (24 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	End of TRT, change from baseline (N=80, N=78)	-5.017 IU/mL	Standard Deviation 1.4434
Faldaprevir 120 mg (24 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	12 wks after TRT, change from baseline (N=75,N=75)	-4.353 IU/mL	Standard Deviation 2.1588
Faldaprevir 120 mg (24 Weeks)	Viral Load (HCV RNA) at All Visits During Treatment and Follow-up	week 24, change from baseline (N=12, N=8)	-4.740 IU/mL	Standard Deviation 1.6576

Secondary

Virological Response at Week 24 (W24VR)

virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24.

Time frame: 24 weeks

Population: PPS

Arm	Measure	Value (NUMBER)
Faldaprevir 120 mg (12 Weeks)	Virological Response at Week 24 (W24VR)	59 participants
Faldaprevir 120 mg (24 Weeks)	Virological Response at Week 24 (W24VR)	63 participants

p-value: 0.41795% CI: [-7.3, 18.3]Cochran-Mantel-Haenszel

Secondary

Virological Response at Week 36 (W36VR)

Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36.

Time frame: 36 weeks

Population: PPS

Arm	Measure	Value (NUMBER)
Faldaprevir 120 mg (12 Weeks)	Virological Response at Week 36 (W36VR)	55 participants
Faldaprevir 120 mg (24 Weeks)	Virological Response at Week 36 (W36VR)	58 participants

p-value: 0.67695% CI: [-10.6, 16.6]Cochran-Mantel-Haenszel

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026

Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Virological Response at Week 28 (W28VR)

End of Treatment Response (ETR)

Laboratory Test Abnormalities and Study Medication Tolerabilities

Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)

Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)

Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)

Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)

Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)

Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)

Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination

Rapid Virological Response at Week 4 (RVR)

Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy

Time to Reach a Plasma HCV RNA Level BLD While on Treatment

Viral Load (HCV RNA) at All Visits During Treatment and Follow-up

Virological Response at Week 24 (W24VR)

Virological Response at Week 36 (W36VR)