4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients

The primary efficacy endpoint is the number of participants with virologic response defined as \>= 3 log drop in viral load from baseline at day 28 with no evidence of virologic rebound during these 28 days. Virologic rebound is defined as \>= 1 log increase in viral load from nadir.

Time frame: Baseline and 4 weeks

Population: Full Analysis Set (FAS): The subset of patients in the treated set (TS) that had at least one measurement of efficacy.

Area under the concentration-time curve of the analyte in plasma (AUC) after first dose on day 1 (AUC0-6) and after last dose on day 28 (AUC0-6,ss) of BI 207127 and CD 6168

Time frame: 30min, 1 hour (h), 2h, 3h, 4h and 5h 55min after drug administration on day 1: 30min, 1h, 2h, 3h, 4h and 6h after admin on day 28

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.

Area under the concentration time curve of the analyte in plasma over the time interval of 0 to infinity at steady state (AUC0-infinity,ss): Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State (SS) After the Last Dose

Time frame: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.

C6,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. C6,ss is the concentration 6 hours after dosing at steady-state (reported as 654 h).

Time frame: 654 hours after drug administration on day 28

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.

Maximum measured concentration of the analyte in plasma (Cmax) after first dose on day 1 (Cmax) and after last dose (steady state) on day 28 (Cmax,ss) of BI 207127 and CD 6168

Time frame: 5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.

Cpre,N \[ng/mL\] - Predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered for BI 207127 and CD 6168. Descriptive statistics were calculated only if at least 2/3 plasma concentrations were available. All values for Cpre,1 were not available, therefore no results are presented below.

Time frame: 5 minutes before drug administration on days 1, 2, 4, 8, 15, 22 and 27

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.

Number of participants with clinically relevant abnormalities for vital signs, blood chemistry, body temperature, physical examination, haematology, coagulation, urinalysis and electrocardiography (ECG). New abnormal findings or worsening of baseline conditions were reported as adverse events.

Time frame: From the start of the study to Day 30 (2 days after last dose)

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.

Number of participants with adverse events (AEs) leading to discontinuation of trial drug

Time frame: 4 weeks

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.

Number of participants with early virological response (EVR) defined as at least 2log10 reduction in HCV Ribonucleic acid (RNA) from baseline at Week 12. Number of responders\* - Response = At least a 2 log10 reduction in viral load from baseline at Week 12 (Day 84)

Time frame: Baseline and week 12

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.

Number of participants with end of treatment response (ETR) - defined as serum HCV RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at end of treatment (including 5-day washout). Number of responders\* - Response = Viral load below the limit of detection at end of all treatment.

Time frame: Week 12

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.

Number of participants with rapid virological response - defined as serum Hepatitis C virus (HCV) RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/High Pure System (HPS) for extraction assay (10 IU/mL) on Day 28.

Time frame: 4 weeks

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.

Number of participants with sustained virological response. Sustained virological response was defined as serum HCV RNA below the limit of detection (\<10 IU/mL) at least 85 days after stopping standard care (SOC).

Time frame: Until end of treatment, up to 570 days

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.

Number of participants with virologic response at day 28, defined as achieving viral load below the limit of quantification (BLQ), \<10 IU/mL, at day 28

Time frame: day 28

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.

Plasma concentration time profiles of BI 207127

Time frame: 0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.

Plasma concentration time profiles of CD 6168

Time frame: 0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.

Accumulation ratio of maximum measured concentration of the analyte in plasma (RA,Cmax): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. Ratio was calculated as Cmax,ss divided by Cmax.

Time frame: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.

Terminal half-life of the analyte in plasma at steady state (t1/2,ss) and mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose

Time frame: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.

tmax \[h\] Time from (last) dosing to the maximum measured concentration of the analyte in plasma after first dose on day 1 and after last dose on day 28 (steady state).

Time frame: 5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.

Viral load (VL) (original values) at each visit up to day 28.

Time frame: Baseline and days 8, 15, 22 and 28

Population: Pharmacodynamic (PD) set which included patients in the treated set but excluded VL values after recorded treatment stop time and values after subjects took wrong or additional doses of treatment. Also one patient was excluded from all descriptive PD summaries due to a protocol violation and another excluded as they did not have a predose VL value.

Reductions of viral load (Log10) at each visit up to day 28, change from baseline. Change from baseline was calculated as the value at baseline minus the value at each later visit. A negative value represents an increase in viral load, a positive value represents a decrease in viral load.

Time frame: Baseline and days 1, 2, 4, 8, 15, 22 and 28

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available viral load data at baseline and day 28.

Terminal rate constant in plasma (λz): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose

Time frame: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28

Population: Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.