Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced

Safety, Antiviral Activity, and Pharmacokinetics of Multiple Rising Oral Doses of BI 201335 NA in Treatment-naïve Patients With Chronic Hepatitis C Infection for 14 Days Monotherapy Followed by Combination With Pegylated Interferon and Ribavirin for an Additional 14 Days (Double-blind, Placebo Controlled), and in Treatment-experienced Patients With Chronic Hepatitis C Infection for 28 Days as Combination Therapy With Pegylated Interferon and Ribavirin (Open-label)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00793793

Enrollment

Registered

2008-11-19

Start date

2007-09-30

Completion date

2011-01-25

Last updated

2018-09-05

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

Conditions

Hepatitis C, Chronic

Brief summary

This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients. A secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.

Interventions

DRUGBI201335

patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1a. For treatment-naïve patients: no prior therapy with interferon, peginterferon, or ribavirin for acute or chronic hepatitis C infection 1b. For treatment-experienced patients: confirmed virological failure during or after combination treatment with an approved dose of alfa-2a or alfa-2b peginterferon combined with ribavirin; such patients must have received at least 12 weeks of therapy with a 90 day washout period prior to screening and must have documentation of medical history prior to enrolment in 1220.2 2. Age 18 years or older 3. Signed informed consent form prior to trial participation 4. Male or female with documented hysterectomy or menopausal female with last menstrual period at least 6 months prior to screening 5. Chronic hepatitis C infection of genotype 1, diagnosed by positive HCV serology test (HCV Ab positive) or detectable HCV RNA at least 6 months prior to screening 6. HCV viral load \>= 100,000 IU/mL at screening 7. TSH and T4 within normal limits or adequately controlled thyroid function 8. Histological evidence within 36 months prior to study enrolment of any degree of chronic necroinflammatory activity or the presence of fibrosis (Ishak Grade 1-4 or Metavir Grade 1-3)

Exclusion criteria

1. Patients who have been previously treated with at least one dose of any protease inhibitor for acute or chronic hepatitis C infection 2. Evidence of liver disease due to causes other than chronic HCV infection 3. Positive ELISA for HIV-1 or HIV-2 4. Hepatitis B virus (HBV) infection based on presence of Hbs Ag or HBV DNA 5. Any previous liver biopsy consistent with cirrhosis 6. Decompensated liver diseases as evidenced by ascites, portal hypertension, jaundice or hepatic encephalopathy 7. Haemophilia 8. Hemoglobinopathy (e.g., thalassemia major or sickle cell anemia) 9. Severe pre-existing psychiatric disease 10. Poorly controlled diabetes mellitus 11. Ischaemic heart disease 12. Chronic obstructive airway disease 13. Autoimmune disease; including autoimmune hepatitis 14. History of alcohol abuse within the past 12 months 15. Hyperbilirubinemia (conjugated bilirubin) \>1.5x ULN 16. Alkaline phosphatase \>1.5x ULN 17. ALT and AST levels \>= 5 x ULN 18. Hemoglobin \< 12.0 g/dL for women and \< 13.0 g/dL for men 19. White blood cell count \< 2000 cells/mm3 20. Absolute Neutrophil Count \< 1500 cells/mm3 21. Platelet count \< 100,000 cells/mm3 22. Prothrombin time INR (Institutional Normalized Ratio) prolonged to \> 1.5 x ULN 23. Usage of any investigational drug within 30 days prior to enrolment; or the planned usage of an investigational drug during the course of the current study 24. Known hypersensitivity to study drugs

Design outcomes

Primary

Measure	Time frame	Description
Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)	Baseline and up to 4 weeks	Efficacy endpoint: VR (virologic response) of \>=2 log10 reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) from baseline at any time up to Day 14 (naïve patients) or Day 28 (experienced patients).
Occurrence of Adverse Events (AEs) During BI201335 + Washout Period	from day 1 and up to 4 weeks + 4 days washout	Occurrence of Adverse Events (AEs) during BI201335 + washout period. For placebo patients include all AEs through 30 days after trial discontinuation.
Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period	from day 1 and up to 4 weeks + 4 days washout	Occurrence of Serious Adverse Events (SAEs)during BI201335 or BI201335+ washout period. For placebo patients include all SAEs through 30 days after trial discontinuation.
Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Baseline and up to 4 weeks	Occurrence of laboratory test abnormalities and with respect to Division of AIDS (DAIDS) classification and laboratory test values change over time. ALT=Alanine transaminase (SGPT), AST=Aspartate transaminase (SGOT).

Secondary

Measure	Time frame	Description
Complete EVR1 (cEVR1)	week 4 and week 12	VL (Viral load) below the limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) at 4 weeks and below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at 12 weeks
Complete EVR2 (cEVR2)	week 4 and week 12	VL below the limit of detection at both 4 weeks and 12 weeks
End of Treatment Response (ETR)	week 48	End of Treatment Response (ETR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 48 (Day 336).
Sustained Virologic Response (SVR)	week 72	Sustained Virologic Response (SVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 72 (Day 504).
Achievement of an HCV RNA Level Below the Limit of Detection Over Time	from day 1 and up to 4 weeks	Achievement of an HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) over time
Achievement of an HCV RNA Level Below the Limit of Quantification Over Time	from day 1 and up to 4 weeks	Achievement of an HCV RNA Level Below the Limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) Over Time
Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time	from day 1 and up to 4 weeks	Achievement of a \>= 2 log10 reduction in plasma HCV RNA level from baseline over time.
Occurrence of AEs, by Action Taken With Regard to Study Medication	from day 1 and up to 4 weeks	Occurrence of AEs, by action taken with regard to study medication.
Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period	from day 1 and up to 4 weeks	Occurrence of discontinuations due to AEs during BI201335 or BI201335+PegIFN/RBV combination treatment period.
PK (Pharmacokinetic) Parameter After the First Dose: Cmax ( Maximum Measured Concentration of the Analyte in Plasma)	Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)	PK (pharmacokinetic) parameter after the first dose: Cmax ( Maximum measured concentration of the analyte in plasma ). .
PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)	Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)	PK parameter after the first dose: tmax (Time from (last) dosing to the maximum measured concentration of the analyte in plasma).
PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)	Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)	PK parameter after the first dose: AUCτ,1 (Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ on day 1).
Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients	Baseline and up to 4 weeks	Maximum viral load reduction from baseline up to Day 14 for treatment-naïve patients and Day 28 treatment for treatment-experienced patients.
PK Parameter at Steady State After the Last Dose: Tmax,ss (Time From Last Dosing to the Maximum Measured Concentration of the Analyte in Plasma at Steady State )	Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)	PK parameter at steady state after the last dose: tmax,ss (Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state ).
PK Parameter at Steady State After the Last Dose: Cmin,ss (Minimum Measured Concentration of the Analyte in Plasma)	Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)	PK parameter at steady state after the last dose: Cmin,ss (Minimum measured concentration of the analyte in plasma).
PK Parameter at Steady State After the Last Dose: AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)	Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)	PK parameter at steady state after the last dose: AUCτ,ss ((Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ).
PK Parameter at Steady State After the Last Dose: t1/2,ss (Terminal Half-life of the Analyte in Plasma at Steady State )	Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)	PK parameter at steady state after the last dose: t1/2,ss (Terminal half-life of the analyte in plasma at steady state \[h\] )
PK Parameter at Steady State After the Last Dose: MRTpo,ss (Mean Residence Time of the Analyte in the Body at Steady State After Oral Administration)	Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)	PK parameter at steady state after the last dose: MRTpo,ss (Mean residence time of the analyte in the body at steady state after oral administration \[h\] )
PK Parameter at Steady State After the Last Dose: CL/F,ss (Apparent Clearance of the Analyte in Plasma at Steady State Following Multiple Oral Dose Administration )	Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)	PK parameter at steady state after the last dose (if applicable): CL/F,ss (ss Apparent clearance of the analyte in plasma at steady state following multiple oral dose administration \[mL/min\] )
PK Parameter at Steady State After the Last Dose: Vz/F,ss (Apparent Volume of Distribution During the Terminal Phase z at Steady State Following an Oral Administration )	Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)	PK parameter at steady state after the last dose: Vz/F,ss (Apparent volume of distribution during the terminal phase z at steady state following an oral administration \[L\] )
PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ )	Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)	PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): AUCτ,ss ( Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ ).
PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmax,ss	Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)	PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmax,ss.
PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmin, ss	Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)	PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmin, ss.
Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax	Day 1, Day 14, and Day 28	For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.
Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc	Day 1, Day 14, and Day 28	For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.
PK Parameter at Steady State After the Last Dose: Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)	Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)	PK parameter at steady state after the last dose: Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ).
Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients	Baseline and up to 4 weeks	Change from baseline in viral load on Day 14 for treatment-naïve patients and on Day 28 treatment for treatment-experienced patients.
Rapid Virologic Response (RVR)	week 4	Rapid virologic response (RVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) on Day 28 for all patients.
Early Virologic Response (EVR)	week 12	Early Virologic Response (EVR): \>=2 log10 reduction in plasma HCV RNA level from baseline at week 12 (day 84)

Countries

France, Germany, Spain, United States

Participant flow

Participants by arm

Arm	Count
Treatment Naive (TN): Placebo TN patient to receive Placebo + PegIFN/RBV for 28 days	8
TN: 20mg QD TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days	6
TN: 48mg QD TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days	7
TN: 120mg QD TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days	7
TN: 240mg QD TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days	6
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days	6
TE Non-cirrhotic: 120 mg QD TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days	7
TE Non-cirrhotic: 240 mg QD TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days	6
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days	15
TE Non-cirrhotic: 240 mg BID SGC TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days	15
TE With Cirrhosis: 240 mg QD SGC TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days	6
TE With Cirrhosis: 240 mg BID SGC TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days	7
Total	96

Withdrawals & dropouts

Period	Reason	FG001	FG002	FG003	FG004	FG005	FG006	FG008	FG009	FG010	FG011
Overall Study	Adverse Event	0	1	1	0	1	2	0	0	0	2
Overall Study	Lost to Follow-up	0	1	0	0	0	0	1	3	1	0
Overall Study	Protocol Violation	0	0	1	0	0	0	0	0	0	0
Overall Study	reason not specified	1	0	1	1	1	2	7	6	2	4
Overall Study	Withdrawal by Subject	0	0	0	1	0	0	1	0	0	0

Baseline characteristics

Characteristic	Treatment Naive (TN): Placebo	TN: 20mg QD	TN: 48mg QD	TN: 120mg QD	TN: 240mg QD	Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	TE Non-cirrhotic: 120 mg QD	TE Non-cirrhotic: 240 mg QD	TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	TE Non-cirrhotic: 240 mg BID SGC	TE With Cirrhosis: 240 mg QD SGC	TE With Cirrhosis: 240 mg BID SGC	Total
Age, Continuous	49.88 years STANDARD_DEVIATION 8.36	51.00 years STANDARD_DEVIATION 7.97	47.14 years STANDARD_DEVIATION 13.84	48.57 years STANDARD_DEVIATION 16.31	47.83 years STANDARD_DEVIATION 9.26	46.83 years STANDARD_DEVIATION 11.82	46.71 years STANDARD_DEVIATION 4.79	49.33 years STANDARD_DEVIATION 10.11	50.93 years STANDARD_DEVIATION 8.13	48.93 years STANDARD_DEVIATION 13.1	53.67 years STANDARD_DEVIATION 5.32	53.57 years STANDARD_DEVIATION 8.36	49.59 years STANDARD_DEVIATION 10.08
Sex: Female, Male Female	2 Participants	0 Participants	2 Participants	2 Participants	1 Participants	2 Participants	3 Participants	3 Participants	5 Participants	7 Participants	1 Participants	2 Participants	30 Participants
Sex: Female, Male Male	6 Participants	6 Participants	5 Participants	5 Participants	5 Participants	4 Participants	4 Participants	3 Participants	10 Participants	8 Participants	5 Participants	5 Participants	66 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	5 / 8	6 / 6	7 / 7	4 / 7	6 / 6	6 / 6	7 / 7	6 / 6	15 / 15	15 / 15	6 / 6	7 / 7
serious Total, serious adverse events	0 / 8	1 / 6	1 / 7	0 / 7	0 / 6	0 / 6	0 / 7	0 / 6	0 / 15	0 / 15	0 / 6	2 / 7

Outcome results

Primary

Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)

Efficacy endpoint: VR (virologic response) of \>=2 log10 reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) from baseline at any time up to Day 14 (naïve patients) or Day 28 (experienced patients).

Time frame: Baseline and up to 4 weeks

Population: Full Analysis Set (FAS): All randomized TN patients and treatment experienced patients who were dispensed trial medication and were documented to have taken at least 1 dose of trial medication.

Arm	Measure	Value (NUMBER)
TN: Placebo	Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)	0.00 percentage of responders
Treatment Naive(TN): 20mg QD	Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)	83.33 percentage of responders
TN: 48mg QD	Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)	100.00 percentage of responders
TN: 120mg QD	Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)	100.00 percentage of responders
TN: 240mg QD	Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)	100.00 percentage of responders
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)	100.00 percentage of responders
TE Non-cirrhotic: 120 mg QD	Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)	100.00 percentage of responders
TE Non-cirrhotic: 240 mg QD	Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)	100.00 percentage of responders
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)	100.00 percentage of responders
TE Non-cirrhotic: 240 mg BID SGC	Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)	100.00 percentage of responders
TE With Cirrhosis: 240 mg QD SGC	Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)	100.00 percentage of responders
TE With Cirrhosis: 240 mg BID SGC	Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)	100.00 percentage of responders

Primary

Occurrence of Adverse Events (AEs) During BI201335 + Washout Period

Occurrence of Adverse Events (AEs) during BI201335 + washout period. For placebo patients include all AEs through 30 days after trial discontinuation.

Time frame: from day 1 and up to 4 weeks + 4 days washout

Population: Treated Set (TS): This patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment regardless of randomization.

Arm	Measure	Value (NUMBER)
TN: Placebo	Occurrence of Adverse Events (AEs) During BI201335 + Washout Period	62.5 percentage of participants with AEs
Treatment Naive(TN): 20mg QD	Occurrence of Adverse Events (AEs) During BI201335 + Washout Period	100.0 percentage of participants with AEs
TN: 48mg QD	Occurrence of Adverse Events (AEs) During BI201335 + Washout Period	100.0 percentage of participants with AEs
TN: 120mg QD	Occurrence of Adverse Events (AEs) During BI201335 + Washout Period	57.1 percentage of participants with AEs
TN: 240mg QD	Occurrence of Adverse Events (AEs) During BI201335 + Washout Period	100.0 percentage of participants with AEs
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Occurrence of Adverse Events (AEs) During BI201335 + Washout Period	100.0 percentage of participants with AEs
TE Non-cirrhotic: 120 mg QD	Occurrence of Adverse Events (AEs) During BI201335 + Washout Period	100.0 percentage of participants with AEs
TE Non-cirrhotic: 240 mg QD	Occurrence of Adverse Events (AEs) During BI201335 + Washout Period	100.0 percentage of participants with AEs
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Occurrence of Adverse Events (AEs) During BI201335 + Washout Period	100.0 percentage of participants with AEs
TE Non-cirrhotic: 240 mg BID SGC	Occurrence of Adverse Events (AEs) During BI201335 + Washout Period	100.0 percentage of participants with AEs
TE With Cirrhosis: 240 mg QD SGC	Occurrence of Adverse Events (AEs) During BI201335 + Washout Period	100.0 percentage of participants with AEs
TE With Cirrhosis: 240 mg BID SGC	Occurrence of Adverse Events (AEs) During BI201335 + Washout Period	100.0 percentage of participants with AEs

Primary

Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time

Occurrence of laboratory test abnormalities and with respect to Division of AIDS (DAIDS) classification and laboratory test values change over time. ALT=Alanine transaminase (SGPT), AST=Aspartate transaminase (SGOT).

Time frame: Baseline and up to 4 weeks

Population: TS

Arm	Measure	Group	Value (NUMBER)
TN: Placebo	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Bilirubin total increa, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: Placebo	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	ALT/GPT SGPT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: Placebo	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Triglyceride increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: Placebo	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Uric acid increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: Placebo	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	AST/GOT SGOT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: Placebo	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Lipase increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
Treatment Naive(TN): 20mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Triglyceride increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
Treatment Naive(TN): 20mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Uric acid increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
Treatment Naive(TN): 20mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	ALT/GPT SGPT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
Treatment Naive(TN): 20mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Lipase increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
Treatment Naive(TN): 20mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	AST/GOT SGOT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
Treatment Naive(TN): 20mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Bilirubin total increa, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: 48mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Lipase increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: 48mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Uric acid increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: 48mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	AST/GOT SGOT increase, with grade 3 or 4 abnormal	1 participants with grade 3 or 4 abnormal
TN: 48mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	ALT/GPT SGPT increase, with grade 3 or 4 abnormal	1 participants with grade 3 or 4 abnormal
TN: 48mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Triglyceride increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: 48mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Bilirubin total increa, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: 120mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	ALT/GPT SGPT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: 120mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Triglyceride increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: 120mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	AST/GOT SGOT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: 120mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Uric acid increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: 120mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Lipase increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: 120mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Bilirubin total increa, with grade 3 or 4 abnormal	1 participants with grade 3 or 4 abnormal
TN: 240mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	AST/GOT SGOT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: 240mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Triglyceride increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: 240mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	ALT/GPT SGPT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: 240mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Lipase increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: 240mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Uric acid increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TN: 240mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Bilirubin total increa, with grade 3 or 4 abnormal	2 participants with grade 3 or 4 abnormal
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Uric acid increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	ALT/GPT SGPT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	AST/GOT SGOT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Lipase increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Bilirubin total increa, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Triglyceride increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 120 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	ALT/GPT SGPT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 120 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	AST/GOT SGOT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 120 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Uric acid increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 120 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Bilirubin total increa, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 120 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Lipase increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 120 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Triglyceride increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Uric acid increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Lipase increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Triglyceride increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	AST/GOT SGOT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Bilirubin total increa, with grade 3 or 4 abnormal	1 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg QD	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	ALT/GPT SGPT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	ALT/GPT SGPT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Uric acid increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Triglyceride increase, with grade 3 or 4 abnormal	1 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Bilirubin total increa, with grade 3 or 4 abnormal	8 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Lipase increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	AST/GOT SGOT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg BID SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Lipase increase, with grade 3 or 4 abnormal	1 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg BID SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Bilirubin total increa, with grade 3 or 4 abnormal	12 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg BID SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	AST/GOT SGOT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg BID SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Uric acid increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg BID SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	ALT/GPT SGPT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE Non-cirrhotic: 240 mg BID SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Triglyceride increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE With Cirrhosis: 240 mg QD SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	ALT/GPT SGPT increase, with grade 3 or 4 abnormal	1 participants with grade 3 or 4 abnormal
TE With Cirrhosis: 240 mg QD SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Lipase increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE With Cirrhosis: 240 mg QD SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	AST/GOT SGOT increase, with grade 3 or 4 abnormal	2 participants with grade 3 or 4 abnormal
TE With Cirrhosis: 240 mg QD SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Bilirubin total increa, with grade 3 or 4 abnormal	5 participants with grade 3 or 4 abnormal
TE With Cirrhosis: 240 mg QD SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Triglyceride increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE With Cirrhosis: 240 mg QD SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Uric acid increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE With Cirrhosis: 240 mg BID SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Lipase increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE With Cirrhosis: 240 mg BID SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Uric acid increase, with grade 3 or 4 abnormal	1 participants with grade 3 or 4 abnormal
TE With Cirrhosis: 240 mg BID SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	ALT/GPT SGPT increase, with grade 3 or 4 abnormal	0 participants with grade 3 or 4 abnormal
TE With Cirrhosis: 240 mg BID SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	AST/GOT SGOT increase, with grade 3 or 4 abnormal	1 participants with grade 3 or 4 abnormal
TE With Cirrhosis: 240 mg BID SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Bilirubin total increa, with grade 3 or 4 abnormal	5 participants with grade 3 or 4 abnormal
TE With Cirrhosis: 240 mg BID SGC	Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time	Triglyceride increase, with grade 3 or 4 abnormal	1 participants with grade 3 or 4 abnormal

Primary

Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period

Occurrence of Serious Adverse Events (SAEs)during BI201335 or BI201335+ washout period. For placebo patients include all SAEs through 30 days after trial discontinuation.

Time frame: from day 1 and up to 4 weeks + 4 days washout

Population: TS

Arm	Measure	Value (NUMBER)
TN: Placebo	Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period	0.0 percentage of participants with SAEs
Treatment Naive(TN): 20mg QD	Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period	16.7 percentage of participants with SAEs
TN: 48mg QD	Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period	14.3 percentage of participants with SAEs
TN: 120mg QD	Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period	0.0 percentage of participants with SAEs
TN: 240mg QD	Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period	0.0 percentage of participants with SAEs
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period	0.0 percentage of participants with SAEs
TE Non-cirrhotic: 120 mg QD	Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period	0.0 percentage of participants with SAEs
TE Non-cirrhotic: 240 mg QD	Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period	0.0 percentage of participants with SAEs
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period	0.0 percentage of participants with SAEs
TE Non-cirrhotic: 240 mg BID SGC	Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period	0.0 percentage of participants with SAEs
TE With Cirrhosis: 240 mg QD SGC	Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period	0.0 percentage of participants with SAEs
TE With Cirrhosis: 240 mg BID SGC	Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period	28.6 percentage of participants with SAEs

Secondary

Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc

For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.

Time frame: Day 1, Day 14, and Day 28

Population: TS including patients with available RAauc data

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
TN: Placebo	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc	2.68 ratio	Geometric Coefficient of Variation 19.6
Treatment Naive(TN): 20mg QD	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc	3.30 ratio	Geometric Coefficient of Variation 49.9
TN: 48mg QD	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc	3.61 ratio	Geometric Coefficient of Variation 42
TN: 120mg QD	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc	5.03 ratio	Geometric Coefficient of Variation 45.3
TN: 240mg QD	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc	2.68 ratio	Geometric Coefficient of Variation 36.2
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc	3.52 ratio	Geometric Coefficient of Variation 34
TE Non-cirrhotic: 120 mg QD	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc	5.90 ratio	Geometric Coefficient of Variation 56.6
TE Non-cirrhotic: 240 mg QD	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc	2.05 ratio	Geometric Coefficient of Variation 88.8
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc	6.62 ratio	Geometric Coefficient of Variation 88.8
TE Non-cirrhotic: 240 mg BID SGC	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc	3.11 ratio	Geometric Coefficient of Variation 96.6
TE With Cirrhosis: 240 mg QD SGC	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc	10.0 ratio	Geometric Coefficient of Variation 111

Secondary

Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax

For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.

Time frame: Day 1, Day 14, and Day 28

Population: TS including patients with available RAcmax data

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
TN: Placebo	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax	2.34 ratio	Geometric Coefficient of Variation 29.1
Treatment Naive(TN): 20mg QD	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax	4.08 ratio	Geometric Coefficient of Variation 66.6
TN: 48mg QD	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax	3.74 ratio	Geometric Coefficient of Variation 32.5
TN: 120mg QD	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax	4.49 ratio	Geometric Coefficient of Variation 36.2
TN: 240mg QD	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax	2.91 ratio	Geometric Coefficient of Variation 58.7
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax	4.37 ratio	Geometric Coefficient of Variation 50.6
TE Non-cirrhotic: 120 mg QD	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax	6.53 ratio	Geometric Coefficient of Variation 75.7
TE Non-cirrhotic: 240 mg QD	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax	2.45 ratio	Geometric Coefficient of Variation 89.4
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax	4.53 ratio	Geometric Coefficient of Variation 96
TE Non-cirrhotic: 240 mg BID SGC	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax	2.74 ratio	Geometric Coefficient of Variation 90.5
TE With Cirrhosis: 240 mg QD SGC	Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax	6.81 ratio	Geometric Coefficient of Variation 154

Secondary

Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time

Achievement of a \>= 2 log10 reduction in plasma HCV RNA level from baseline over time.

Time frame: from day 1 and up to 4 weeks

Population: FAS

Arm	Measure	Value (NUMBER)
TN: Placebo	Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time	0.0 percentage of participants
Treatment Naive(TN): 20mg QD	Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time	83.3 percentage of participants
TN: 48mg QD	Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time	100.0 percentage of participants
TN: 120mg QD	Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time	100.0 percentage of participants
TN: 240mg QD	Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time	100.0 percentage of participants
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time	100.0 percentage of participants
TE Non-cirrhotic: 120 mg QD	Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time	100.0 percentage of participants
TE Non-cirrhotic: 240 mg QD	Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time	100.0 percentage of participants
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time	100.0 percentage of participants
TE Non-cirrhotic: 240 mg BID SGC	Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time	100.0 percentage of participants
TE With Cirrhosis: 240 mg QD SGC	Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time	100.0 percentage of participants
TE With Cirrhosis: 240 mg BID SGC	Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time	100.0 percentage of participants

Secondary

Achievement of an HCV RNA Level Below the Limit of Detection Over Time

Achievement of an HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) over time

Time frame: from day 1 and up to 4 weeks

Population: FAS

Arm	Measure	Value (NUMBER)
TN: Placebo	Achievement of an HCV RNA Level Below the Limit of Detection Over Time	0.0 percentage of participants
Treatment Naive(TN): 20mg QD	Achievement of an HCV RNA Level Below the Limit of Detection Over Time	0.0 percentage of participants
TN: 48mg QD	Achievement of an HCV RNA Level Below the Limit of Detection Over Time	28.6 percentage of participants
TN: 120mg QD	Achievement of an HCV RNA Level Below the Limit of Detection Over Time	14.3 percentage of participants
TN: 240mg QD	Achievement of an HCV RNA Level Below the Limit of Detection Over Time	16.7 percentage of participants
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Achievement of an HCV RNA Level Below the Limit of Detection Over Time	33.3 percentage of participants
TE Non-cirrhotic: 120 mg QD	Achievement of an HCV RNA Level Below the Limit of Detection Over Time	14.3 percentage of participants
TE Non-cirrhotic: 240 mg QD	Achievement of an HCV RNA Level Below the Limit of Detection Over Time	16.7 percentage of participants
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Achievement of an HCV RNA Level Below the Limit of Detection Over Time	26.7 percentage of participants
TE Non-cirrhotic: 240 mg BID SGC	Achievement of an HCV RNA Level Below the Limit of Detection Over Time	26.7 percentage of participants
TE With Cirrhosis: 240 mg QD SGC	Achievement of an HCV RNA Level Below the Limit of Detection Over Time	66.7 percentage of participants
TE With Cirrhosis: 240 mg BID SGC	Achievement of an HCV RNA Level Below the Limit of Detection Over Time	14.3 percentage of participants

Secondary

Achievement of an HCV RNA Level Below the Limit of Quantification Over Time

Achievement of an HCV RNA Level Below the Limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) Over Time

Time frame: from day 1 and up to 4 weeks

Population: FAS

Arm	Measure	Value (NUMBER)
TN: Placebo	Achievement of an HCV RNA Level Below the Limit of Quantification Over Time	0.0 percentage of participants
Treatment Naive(TN): 20mg QD	Achievement of an HCV RNA Level Below the Limit of Quantification Over Time	16.7 percentage of participants
TN: 48mg QD	Achievement of an HCV RNA Level Below the Limit of Quantification Over Time	28.6 percentage of participants
TN: 120mg QD	Achievement of an HCV RNA Level Below the Limit of Quantification Over Time	28.6 percentage of participants
TN: 240mg QD	Achievement of an HCV RNA Level Below the Limit of Quantification Over Time	50.0 percentage of participants
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Achievement of an HCV RNA Level Below the Limit of Quantification Over Time	50.0 percentage of participants
TE Non-cirrhotic: 120 mg QD	Achievement of an HCV RNA Level Below the Limit of Quantification Over Time	57.1 percentage of participants
TE Non-cirrhotic: 240 mg QD	Achievement of an HCV RNA Level Below the Limit of Quantification Over Time	83.3 percentage of participants
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Achievement of an HCV RNA Level Below the Limit of Quantification Over Time	66.7 percentage of participants
TE Non-cirrhotic: 240 mg BID SGC	Achievement of an HCV RNA Level Below the Limit of Quantification Over Time	60.0 percentage of participants
TE With Cirrhosis: 240 mg QD SGC	Achievement of an HCV RNA Level Below the Limit of Quantification Over Time	83.3 percentage of participants
TE With Cirrhosis: 240 mg BID SGC	Achievement of an HCV RNA Level Below the Limit of Quantification Over Time	85.7 percentage of participants

Secondary

Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients

Change from baseline in viral load on Day 14 for treatment-naïve patients and on Day 28 treatment for treatment-experienced patients.

Time frame: Baseline and up to 4 weeks

Population: FAS (as randomised) including patients with available viral load data.

Arm	Measure	Value (MEDIAN)
TN: Placebo	Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients	0.209 Log10 IU/mL
Treatment Naive(TN): 20mg QD	Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients	-1.226 Log10 IU/mL
TN: 48mg QD	Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients	-1.539 Log10 IU/mL
TN: 120mg QD	Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients	-0.781 Log10 IU/mL
TN: 240mg QD	Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients	-2.449 Log10 IU/mL
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients	-5.023 Log10 IU/mL
TE Non-cirrhotic: 120 mg QD	Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients	-5.244 Log10 IU/mL
TE Non-cirrhotic: 240 mg QD	Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients	-5.386 Log10 IU/mL
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients	-5.246 Log10 IU/mL
TE Non-cirrhotic: 240 mg BID SGC	Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients	-5.404 Log10 IU/mL
TE With Cirrhosis: 240 mg QD SGC	Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients	-4.782 Log10 IU/mL
TE With Cirrhosis: 240 mg BID SGC	Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients	-5.497 Log10 IU/mL

Secondary

Complete EVR1 (cEVR1)

VL (Viral load) below the limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) at 4 weeks and below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at 12 weeks

Time frame: week 4 and week 12

Population: FAS

Arm	Measure	Value (NUMBER)
TN: Placebo	Complete EVR1 (cEVR1)	0.0 percentage of responders
Treatment Naive(TN): 20mg QD	Complete EVR1 (cEVR1)	16.7 percentage of responders
TN: 48mg QD	Complete EVR1 (cEVR1)	28.6 percentage of responders
TN: 120mg QD	Complete EVR1 (cEVR1)	28.6 percentage of responders
TN: 240mg QD	Complete EVR1 (cEVR1)	50.0 percentage of responders
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Complete EVR1 (cEVR1)	50.0 percentage of responders
TE Non-cirrhotic: 120 mg QD	Complete EVR1 (cEVR1)	57.1 percentage of responders
TE Non-cirrhotic: 240 mg QD	Complete EVR1 (cEVR1)	83.3 percentage of responders
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Complete EVR1 (cEVR1)	53.3 percentage of responders
TE Non-cirrhotic: 240 mg BID SGC	Complete EVR1 (cEVR1)	60.0 percentage of responders
TE With Cirrhosis: 240 mg QD SGC	Complete EVR1 (cEVR1)	83.3 percentage of responders
TE With Cirrhosis: 240 mg BID SGC	Complete EVR1 (cEVR1)	57.1 percentage of responders

Secondary

Complete EVR2 (cEVR2)

VL below the limit of detection at both 4 weeks and 12 weeks

Time frame: week 4 and week 12

Population: FAS

Arm	Measure	Value (NUMBER)
TN: Placebo	Complete EVR2 (cEVR2)	0.0 percentage of responders
Treatment Naive(TN): 20mg QD	Complete EVR2 (cEVR2)	0.0 percentage of responders
TN: 48mg QD	Complete EVR2 (cEVR2)	28.6 percentage of responders
TN: 120mg QD	Complete EVR2 (cEVR2)	14.3 percentage of responders
TN: 240mg QD	Complete EVR2 (cEVR2)	33.3 percentage of responders
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Complete EVR2 (cEVR2)	50.0 percentage of responders
TE Non-cirrhotic: 120 mg QD	Complete EVR2 (cEVR2)	14.3 percentage of responders
TE Non-cirrhotic: 240 mg QD	Complete EVR2 (cEVR2)	16.7 percentage of responders
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Complete EVR2 (cEVR2)	33.3 percentage of responders
TE Non-cirrhotic: 240 mg BID SGC	Complete EVR2 (cEVR2)	20.0 percentage of responders
TE With Cirrhosis: 240 mg QD SGC	Complete EVR2 (cEVR2)	33.3 percentage of responders
TE With Cirrhosis: 240 mg BID SGC	Complete EVR2 (cEVR2)	28.6 percentage of responders

Secondary

Early Virologic Response (EVR)

Early Virologic Response (EVR): \>=2 log10 reduction in plasma HCV RNA level from baseline at week 12 (day 84)

Time frame: week 12

Population: FAS

Arm	Measure	Value (NUMBER)
TN: Placebo	Early Virologic Response (EVR)	0.0 percentage of responders
Treatment Naive(TN): 20mg QD	Early Virologic Response (EVR)	100.0 percentage of responders
TN: 48mg QD	Early Virologic Response (EVR)	100.0 percentage of responders
TN: 120mg QD	Early Virologic Response (EVR)	85.7 percentage of responders
TN: 240mg QD	Early Virologic Response (EVR)	83.3 percentage of responders
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Early Virologic Response (EVR)	83.3 percentage of responders
TE Non-cirrhotic: 120 mg QD	Early Virologic Response (EVR)	71.4 percentage of responders
TE Non-cirrhotic: 240 mg QD	Early Virologic Response (EVR)	100.0 percentage of responders
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Early Virologic Response (EVR)	86.7 percentage of responders
TE Non-cirrhotic: 240 mg BID SGC	Early Virologic Response (EVR)	86.7 percentage of responders
TE With Cirrhosis: 240 mg QD SGC	Early Virologic Response (EVR)	100.0 percentage of responders
TE With Cirrhosis: 240 mg BID SGC	Early Virologic Response (EVR)	71.4 percentage of responders

Secondary

End of Treatment Response (ETR)

End of Treatment Response (ETR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 48 (Day 336).

Time frame: week 48

Population: FAS

Arm	Measure	Value (NUMBER)
TN: Placebo	End of Treatment Response (ETR)	0.0 percentage of responders
Treatment Naive(TN): 20mg QD	End of Treatment Response (ETR)	83.3 percentage of responders
TN: 48mg QD	End of Treatment Response (ETR)	57.1 percentage of responders
TN: 120mg QD	End of Treatment Response (ETR)	57.1 percentage of responders
TN: 240mg QD	End of Treatment Response (ETR)	66.7 percentage of responders
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	End of Treatment Response (ETR)	33.3 percentage of responders
TE Non-cirrhotic: 120 mg QD	End of Treatment Response (ETR)	57.1 percentage of responders
TE Non-cirrhotic: 240 mg QD	End of Treatment Response (ETR)	66.7 percentage of responders
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	End of Treatment Response (ETR)	53.3 percentage of responders
TE Non-cirrhotic: 240 mg BID SGC	End of Treatment Response (ETR)	40.0 percentage of responders
TE With Cirrhosis: 240 mg QD SGC	End of Treatment Response (ETR)	50.0 percentage of responders
TE With Cirrhosis: 240 mg BID SGC	End of Treatment Response (ETR)	14.3 percentage of responders

Secondary

Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients

Maximum viral load reduction from baseline up to Day 14 for treatment-naïve patients and Day 28 treatment for treatment-experienced patients.

Time frame: Baseline and up to 4 weeks

Population: FAS (as randomised)

Arm	Measure	Value (MEDIAN)
TN: Placebo	Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients	-0.060 log10 IU/mL
Treatment Naive(TN): 20mg QD	Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients	-3.049 log10 IU/mL
TN: 48mg QD	Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients	-3.624 log10 IU/mL
TN: 120mg QD	Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients	-3.740 log10 IU/mL
TN: 240mg QD	Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients	-4.413 log10 IU/mL
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients	-5.023 log10 IU/mL
TE Non-cirrhotic: 120 mg QD	Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients	-5.244 log10 IU/mL
TE Non-cirrhotic: 240 mg QD	Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients	-5.334 log10 IU/mL
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients	-5.246 log10 IU/mL
TE Non-cirrhotic: 240 mg BID SGC	Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients	-5.404 log10 IU/mL
TE With Cirrhosis: 240 mg QD SGC	Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients	-4.841 log10 IU/mL
TE With Cirrhosis: 240 mg BID SGC	Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients	-5.476 log10 IU/mL

Secondary

Occurrence of AEs, by Action Taken With Regard to Study Medication

Occurrence of AEs, by action taken with regard to study medication.

Time frame: from day 1 and up to 4 weeks

Population: TS

Arm	Measure	Group	Value (NUMBER)
TN: Placebo	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: decreasing dose	0.0 percentage of participants
TN: Placebo	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: stop trial medication	0.0 percentage of participants
Treatment Naive(TN): 20mg QD	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: decreasing dose	0.0 percentage of participants
Treatment Naive(TN): 20mg QD	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: stop trial medication	0.0 percentage of participants
TN: 48mg QD	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: decreasing dose	0.0 percentage of participants
TN: 48mg QD	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: stop trial medication	0.0 percentage of participants
TN: 120mg QD	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: decreasing dose	0.0 percentage of participants
TN: 120mg QD	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: stop trial medication	0.0 percentage of participants
TN: 240mg QD	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: stop trial medication	0.0 percentage of participants
TN: 240mg QD	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: decreasing dose	0.0 percentage of participants
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: decreasing dose	0.0 percentage of participants
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: stop trial medication	0.0 percentage of participants
TE Non-cirrhotic: 120 mg QD	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: stop trial medication	0.0 percentage of participants
TE Non-cirrhotic: 120 mg QD	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: decreasing dose	0.0 percentage of participants
TE Non-cirrhotic: 240 mg QD	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: decreasing dose	0.0 percentage of participants
TE Non-cirrhotic: 240 mg QD	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: stop trial medication	0.0 percentage of participants
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: decreasing dose	0.0 percentage of participants
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: stop trial medication	0.0 percentage of participants
TE Non-cirrhotic: 240 mg BID SGC	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: decreasing dose	6.7 percentage of participants
TE Non-cirrhotic: 240 mg BID SGC	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: stop trial medication	0.0 percentage of participants
TE With Cirrhosis: 240 mg QD SGC	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: stop trial medication	0.0 percentage of participants
TE With Cirrhosis: 240 mg QD SGC	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: decreasing dose	16.7 percentage of participants
TE With Cirrhosis: 240 mg BID SGC	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: stop trial medication	28.6 percentage of participants
TE With Cirrhosis: 240 mg BID SGC	Occurrence of AEs, by Action Taken With Regard to Study Medication	Action taken: decreasing dose	0.0 percentage of participants

Secondary

Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period

Occurrence of discontinuations due to AEs during BI201335 or BI201335+PegIFN/RBV combination treatment period.

Time frame: from day 1 and up to 4 weeks

Population: TS

Arm	Measure	Value (NUMBER)
TN: Placebo	Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period	0.0 percentage of participants discontinued
Treatment Naive(TN): 20mg QD	Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period	0.0 percentage of participants discontinued
TN: 48mg QD	Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period	0.0 percentage of participants discontinued
TN: 120mg QD	Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period	0.0 percentage of participants discontinued
TN: 240mg QD	Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period	0.0 percentage of participants discontinued
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period	0.0 percentage of participants discontinued
TE Non-cirrhotic: 120 mg QD	Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period	0.0 percentage of participants discontinued
TE Non-cirrhotic: 240 mg QD	Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period	0.0 percentage of participants discontinued
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period	0.0 percentage of participants discontinued
TE Non-cirrhotic: 240 mg BID SGC	Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period	0.0 percentage of participants discontinued
TE With Cirrhosis: 240 mg QD SGC	Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period	0.0 percentage of participants discontinued
TE With Cirrhosis: 240 mg BID SGC	Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period	28.6 percentage of participants discontinued

Secondary

PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)

PK parameter after the first dose: AUCτ,1 (Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ on day 1).

Time frame: Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)

Population: TS

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
TN: Placebo	PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)	736 ng*h/mL	Geometric Coefficient of Variation 57
Treatment Naive(TN): 20mg QD	PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)	2650 ng*h/mL	Geometric Coefficient of Variation 16.5
TN: 48mg QD	PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)	11600 ng*h/mL	Geometric Coefficient of Variation 52.9
TN: 120mg QD	PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)	35700 ng*h/mL	Geometric Coefficient of Variation 48.2
TN: 240mg QD	PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)	2550 ng*h/mL	Geometric Coefficient of Variation 48.3
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)	12300 ng*h/mL	Geometric Coefficient of Variation 47.5
TE Non-cirrhotic: 120 mg QD	PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)	27700 ng*h/mL	Geometric Coefficient of Variation 59.9
TE Non-cirrhotic: 240 mg QD	PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)	108000 ng*h/mL	Geometric Coefficient of Variation 55.5
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)	52800 ng*h/mL	Geometric Coefficient of Variation 82.6
TE Non-cirrhotic: 240 mg BID SGC	PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)	78400 ng*h/mL	Geometric Coefficient of Variation 157
TE With Cirrhosis: 240 mg QD SGC	PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)	56800 ng*h/mL	Geometric Coefficient of Variation 55.7

Secondary

PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)

PK parameter after the first dose: tmax (Time from (last) dosing to the maximum measured concentration of the analyte in plasma).

Time frame: Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)

Population: TS

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
TN: Placebo	PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)	7.07 h	Geometric Coefficient of Variation 29
Treatment Naive(TN): 20mg QD	PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)	2.48 h	Geometric Coefficient of Variation 149
TN: 48mg QD	PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)	2.12 h	Geometric Coefficient of Variation 56.6
TN: 120mg QD	PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)	3.89 h	Geometric Coefficient of Variation 44.1
TN: 240mg QD	PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)	3.89 h	Geometric Coefficient of Variation 162
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD	PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)	2.25 h	Geometric Coefficient of Variation 59.1
TE Non-cirrhotic: 120 mg QD	PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)	3.23 h	Geometric Coefficient of Variation 27.9
TE Non-cirrhotic: 240 mg QD	PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)	5.24 h	Geometric Coefficient of Variation 49.2
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)	PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)	5.30 h	Geometric Coefficient of Variation 34.6
TE Non-cirrhotic: 240 mg BID SGC	PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)	6.61 h	Geometric Coefficient of Variation 14.9
TE With Cirrhosis: 240 mg QD SGC	PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)	5.63 h	Geometric Coefficient of Variation 87.4

Secondary

PK Parameter at Steady State After the Last Dose: AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)

PK parameter at steady state after the last dose: AUCτ,ss ((Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ).