Trial Outcomes & Findings for 4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients (NCT NCT00905632)

Last Updated: 2016-04-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

75 participants

Primary outcome timeframe

Baseline and 4 weeks

Results posted on

2016-04-19

Participant Flow

75 patients were screened, however only 57 patients were randomised.

Participant milestones

Participant milestones
Measure	Treatment Naive (TN): Placebo Treatment Naive (TN) patients to receive Placebo (given as a tablet, orally three times daily (tid)) + Peg-IFN (Peginterferon alfa (Peg-IFN) injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days	Treatment Naive (TN): BI 207127 400 mg TN patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days	Treatment Naive (TN): BI 207127 600 mg TN patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days	Treatment Naive (TN): BI 207127 800 mg TN patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days	Treatment Experienced (TE): BI 207127 400 mg Treatment Experienced (TE) patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days	Treatment Experienced (TE): BI 207127 600 mg TE patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days	Treatment Experienced (TE): BI 207127 800 mg TE patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
Overall Study STARTED	8	6	7	6	10	9	11
Overall Study COMPLETED	8	6	7	6	10	8	7
Overall Study NOT COMPLETED	0	0	0	0	0	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Naive (TN): Placebo Treatment Naive (TN) patients to receive Placebo (given as a tablet, orally three times daily (tid)) + Peg-IFN (Peginterferon alfa (Peg-IFN) injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days	Treatment Naive (TN): BI 207127 400 mg TN patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days	Treatment Naive (TN): BI 207127 600 mg TN patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days	Treatment Naive (TN): BI 207127 800 mg TN patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days	Treatment Experienced (TE): BI 207127 400 mg Treatment Experienced (TE) patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days	Treatment Experienced (TE): BI 207127 600 mg TE patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days	Treatment Experienced (TE): BI 207127 800 mg TE patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
Overall Study Adverse Event	0	0	0	0	0	1	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=8 Participants Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=6 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=7 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=6 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=10 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=9 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg n=11 Participants TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Total n=57 Participants Total of all reporting groups
Age, Continuous	51.250 years STANDARD_DEVIATION 7.573 • n=5 Participants	43.833 years STANDARD_DEVIATION 15.459 • n=7 Participants	42.571 years STANDARD_DEVIATION 11.731 • n=5 Participants	46.167 years STANDARD_DEVIATION 13.963 • n=4 Participants	49.200 years STANDARD_DEVIATION 5.996 • n=21 Participants	50.889 years STANDARD_DEVIATION 11.252 • n=10 Participants	53.727 years STANDARD_DEVIATION 10.287 • n=115 Participants	48.930 years STANDARD_DEVIATION 10.863 • n=24 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	2 Participants n=115 Participants	10 Participants n=24 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	10 Participants n=21 Participants	7 Participants n=10 Participants	9 Participants n=115 Participants	47 Participants n=24 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=8 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=6 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=7 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=6 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=10 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=9 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg n=11 Participants TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
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.	1 Participants	5 Participants	7 Participants	6 Participants	4 Participants	5 Participants	6 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=8 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=5 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=7 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=6 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=10 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=9 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg n=11 Participants TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline Day 1 (11:55 hours) (N=8,5,7,6,10,9,11)	-0.10 IU/mL Interval -0.5 to 0.2	-1.50 IU/mL Interval -2.51 to -0.54	-2.38 IU/mL Interval -2.89 to -1.02	-2.40 IU/mL Interval -3.22 to -1.55	-1.11 IU/mL Interval -2.53 to -0.61	-1.66 IU/mL Interval -2.72 to -0.42	-1.01 IU/mL Interval -2.53 to -0.2
Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline Day 1 (15:00 hours) (N=8,5,7,6,8,9,10)	-0.20 IU/mL Interval -0.49 to 0.05	-2.13 IU/mL Interval -3.05 to -0.71	-2.49 IU/mL Interval -3.36 to -1.3	-2.86 IU/mL Interval -3.52 to -2.48	-1.45 IU/mL Interval -3.02 to -0.92	-2.48 IU/mL Interval -3.05 to -0.66	-1.66 IU/mL Interval -2.79 to -0.78
Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline Day 1 (02:00 hours) (N=8,5,7,6,10,9,11)	-0.04 IU/mL Interval -0.27 to 0.14	-0.09 IU/mL Interval -0.13 to 0.03	-0.01 IU/mL Interval -0.26 to 0.37	-0.06 IU/mL Interval -0.19 to 0.08	0.02 IU/mL Interval -0.15 to 0.15	0.04 IU/mL Interval -0.13 to 0.16	0.03 IU/mL Interval -0.25 to 0.25
Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline Day 1 (04:00 hours) (N=8,5,7,6,10,9,11)	-0.05 IU/mL Interval -0.28 to 0.04	-0.27 IU/mL Interval -0.36 to -0.11	-0.28 IU/mL Interval -0.54 to 0.07	-0.29 IU/mL Interval -0.56 to 0.1	-0.10 IU/mL Interval -0.37 to 0.08	-0.09 IU/mL Interval -0.36 to 0.21	-0.01 IU/mL Interval -0.81 to 0.31
Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline Day 1 (05:55 hours) (N=8,5,7,6,10,9,11)	-0.08 IU/mL Interval -0.31 to 0.1	-0.53 IU/mL Interval -0.95 to -0.13	-0.79 IU/mL Interval -1.32 to -0.19	-1.09 IU/mL Interval -1.26 to -0.5	-0.37 IU/mL Interval -0.93 to -0.09	-0.55 IU/mL Interval -0.97 to 0.19	-0.11 IU/mL Interval -1.53 to 0.01
Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline Day 1 (08:00 hours) (N=8,5,7,6,10,9,11)	-0.07 IU/mL Interval -0.51 to 0.18	-1.04 IU/mL Interval -1.52 to -0.49	-1.30 IU/mL Interval -2.09 to -0.54	-1.72 IU/mL Interval -2.12 to -0.51	-0.69 IU/mL Interval -1.66 to -0.16	-1.00 IU/mL Interval -1.77 to -0.03	-0.46 IU/mL Interval -2.07 to -0.01
Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline Day 1 (10:00 hours) (N=8,5,7,6,10,9,11)	-0.06 IU/mL Interval -0.34 to 0.15	-1.15 IU/mL Interval -2.13 to -0.53	-1.70 IU/mL Interval -2.53 to -0.77	-1.99 IU/mL Interval -2.75 to -1.41	-0.80 IU/mL Interval -1.8 to -0.44	-1.18 IU/mL Interval -2.44 to -0.22	-0.79 IU/mL Interval -2.45 to -0.2
Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline Day 2 (N=8,5,7,6,10,8,11)	-0.39 IU/mL Interval -1.02 to 0.24	-1.78 IU/mL Interval -3.86 to -0.6	-2.73 IU/mL Interval -4.07 to -2.18	-3.32 IU/mL Interval -3.9 to -3.17	-1.57 IU/mL Interval -3.54 to -0.46	-2.46 IU/mL Interval -3.55 to -0.87	-1.93 IU/mL Interval -2.98 to -0.62
Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline Day 4 (N=8,5,7,6,10,9,11)	-0.61 IU/mL Interval -0.93 to 0.04	-2.43 IU/mL Interval -4.33 to -1.43	-3.07 IU/mL Interval -5.25 to -2.95	-3.80 IU/mL Interval -4.11 to -3.52	-1.51 IU/mL Interval -4.15 to -0.54	-2.76 IU/mL Interval -3.92 to -0.92	-2.53 IU/mL Interval -3.54 to -1.19
Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline Day 8 (N=8,5,7,6,10,9,9)	-0.32 IU/mL Interval -1.43 to 0.26	-3.19 IU/mL Interval -5.28 to -1.83	-4.13 IU/mL Interval -6.36 to -3.28	-4.31 IU/mL Interval -4.95 to -3.77	-1.58 IU/mL Interval -4.86 to -0.36	-3.04 IU/mL Interval -4.51 to -0.88	-2.68 IU/mL Interval -4.08 to -1.9
Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline Day 15 (N=7,5,7,6,10,8,8)	-0.42 IU/mL Interval -1.5 to -0.11	-3.89 IU/mL Interval -5.74 to -2.96	-5.27 IU/mL Interval -6.36 to -3.86	-4.86 IU/mL Interval -5.2 to -4.45	-2.09 IU/mL Interval -4.96 to -0.7	-4.00 IU/mL Interval -5.6 to -1.37	-3.26 IU/mL Interval -4.68 to -2.11
Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline Day 22 (N=8,5,7,6,10,8 ,8)	-1.06 IU/mL Interval -2.78 to -0.45	-4.53 IU/mL Interval -5.74 to -3.77	-5.55 IU/mL Interval -6.36 to -4.62	-5.27 IU/mL Interval -5.9 to -4.46	-2.63 IU/mL Interval -4.96 to -1.42	-3.83 IU/mL Interval -5.71 to -1.65	-4.13 IU/mL Interval -4.98 to -2.4
Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline Day 28 (N=7,5,6,6,10,8,7)	-1.41 IU/mL Interval -3.75 to -0.73	-5.08 IU/mL Interval -5.74 to -4.32	-5.61 IU/mL Interval -6.22 to -4.84	-5.44 IU/mL Interval -5.9 to -4.93	-2.86 IU/mL Interval -4.96 to -1.32	-4.20 IU/mL Interval -6.14 to -1.2	-4.48 IU/mL Interval -5.41 to -2.99

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=8 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=6 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=7 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=6 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=10 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=9 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg n=11 Participants TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
Viral Load at Each Visit up to Day 28 Baseline (N=8,4,7,6,9,9,11)	3540000 IU/mL Interval 925000.0 to 10900000.0	3260000 IU/mL Interval 572000.0 to 4910000.0	8480000 IU/mL Interval 629000.0 to 20600000.0	3440000 IU/mL Interval 763000.0 to 19000000.0	3620000 IU/mL Interval 1330000.0 to 17400000.0	3560000 IU/mL Interval 684000.0 to 12300000.0	3340000 IU/mL Interval 665000.0 to 45300000.0
Viral Load at Each Visit up to Day 28 Day 8 (N=8,3,6,6,9,9,9)	1520000 IU/mL Interval 34500.0 to 19700000.0	NA IU/mL No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.	320 IU/mL Interval 42.0 to 3200.0	234 IU/mL Interval 28.0 to 913.0	47800 IU/mL Interval 30.0 to 2300000.0	4120 IU/mL Interval 161.0 to 89400.0	8460 IU/mL Interval 108.0 to 566000.0
Viral Load at Each Visit up to Day 28 Day 15 (N=7,2,3,4,8,8,7)	618000 IU/mL Interval 92800.0 to 6470000.0	NA IU/mL No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.	NA IU/mL No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.	107 IU/mL Interval 28.0 to 188.0	18100 IU/mL Interval 367.0 to 626000.0	690 IU/mL Interval 31.0 to 153000.0	NA IU/mL No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.
Viral Load at Each Visit up to Day 28 Day 22 (N=8,1,2,2,8,5,6)	249000 IU/mL Interval 1550.0 to 3870000.0	NA IU/mL No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.	NA IU/mL No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.	NA IU/mL No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.	29600 IU/mL Interval 554.0 to 70400.0	NA IU/mL No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.	NA IU/mL No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.
Viral Load at Each Visit up to Day 28 Day 28 (N=7,1,2,0,7,5,4)	168000 IU/mL Interval 133.0 to 1620000.0	NA IU/mL No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.	NA IU/mL No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.	NA IU/mL No patients with available data at this timepoint.	43100 IU/mL Interval 685.0 to 373000.0	NA IU/mL No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.	NA IU/mL No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.

SECONDARY outcome

Timeframe: day 28

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

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=8 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=6 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=7 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=6 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=10 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=9 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg n=11 Participants TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
Number of Participants With Virologic Response at Day 28	0 Participants	4 Participants	6 Participants	6 Participants	1 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=8 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=6 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=7 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=6 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=10 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=9 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg n=11 Participants TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
Number of Participants With Rapid Virological Response	0 Participants	3 Participants	4 Participants	3 Participants	0 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 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 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)

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=8 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=6 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=7 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=6 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=10 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=9 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg n=11 Participants TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
Number of Participants With Early Virological Response Number of responders	7 Participants	5 Participants	7 Participants	6 Participants	6 Participants	6 Participants	4 Participants
Number of Participants With Early Virological Response Number of failures	1 Participants	1 Participants	0 Participants	0 Participants	4 Participants	3 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=8 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=6 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=7 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=6 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=10 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=9 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg n=11 Participants TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
Number of Participants With End of Treatment Response Number of responders	4 Participants	3 Participants	6 Participants	6 Participants	4 Participants	3 Participants	1 Participants
Number of Participants With End of Treatment Response Number of failures	4 Participants	3 Participants	1 Participants	0 Participants	6 Participants	6 Participants	10 Participants

SECONDARY outcome

Timeframe: 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 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).

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=8 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=6 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=7 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=6 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=10 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=9 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg n=11 Participants TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
Number of Participants With Sustained Virological Response Number of responders	2 Participants	2 Participants	5 Participants	6 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Sustained Virological Response Number of failures	6 Participants	4 Participants	2 Participants	0 Participants	10 Participants	9 Participants	11 Participants

SECONDARY outcome

Timeframe: 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 BI 207127

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=6 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=7 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=6 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=9 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=9 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=11 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
Plasma Concentration Time Profiles of BI 207127 BI 207127 0.5 hours (N=4,6,6,-,8,-)	111 ng/mL Geometric Coefficient of Variation 344	103 ng/mL Geometric Coefficient of Variation 534	230 ng/mL Geometric Coefficient of Variation 391	NA ng/mL Geometric Coefficient of Variation NA Some patients had data below the limit of quantification which is not analysable and per internal rules, descriptive statistics are not calculated unless data from at least 2/3rds of all subjects were available.	422 ng/mL Geometric Coefficient of Variation 265	NA ng/mL Geometric Coefficient of Variation NA Some patients had data below the limit of quantification which is not analysable and per internal rules, descriptive statistics are not calculated unless data from at least 2/3rds of all subjects were available.	—
Plasma Concentration Time Profiles of BI 207127 BI 207127 3 hours (N=6,7,6,9,9,10)	2040 ng/mL Geometric Coefficient of Variation 32.4	2610 ng/mL Geometric Coefficient of Variation 76.0	5730 ng/mL Geometric Coefficient of Variation 52.4	3070 ng/mL Geometric Coefficient of Variation 64.3	4650 ng/mL Geometric Coefficient of Variation 90.4	4460 ng/mL Geometric Coefficient of Variation 59.8	—
Plasma Concentration Time Profiles of BI 207127 BI 207127 8 hours (N=6,7,6,9,9,11)	2590 ng/mL Geometric Coefficient of Variation 29.0	4610 ng/mL Geometric Coefficient of Variation 124	12600 ng/mL Geometric Coefficient of Variation 65.3	4320 ng/mL Geometric Coefficient of Variation 81.1	6070 ng/mL Geometric Coefficient of Variation 67.3	7140 ng/mL Geometric Coefficient of Variation 73.1	—
Plasma Concentration Time Profiles of BI 207127 BI 207127 15 hours (N=6,7,6,8,9,10)	3550 ng/mL Geometric Coefficient of Variation 55.3	6530 ng/mL Geometric Coefficient of Variation 55.9	13500 ng/mL Geometric Coefficient of Variation 62.8	4860 ng/mL Geometric Coefficient of Variation 115	7270 ng/mL Geometric Coefficient of Variation 93.4	13300 ng/mL Geometric Coefficient of Variation 67.2	—
Plasma Concentration Time Profiles of BI 207127 BI 207127 23.917 hours (N=6,7,6,9,8,11)	595 ng/mL Geometric Coefficient of Variation 72.0	1610 ng/mL Geometric Coefficient of Variation 138	4780 ng/mL Geometric Coefficient of Variation 76.4	1170 ng/mL Geometric Coefficient of Variation 201	3450 ng/mL Geometric Coefficient of Variation 173	9350 ng/mL Geometric Coefficient of Variation 71.0	—
Plasma Concentration Time Profiles of BI 207127 BI 207127 503.917 hours (N=6,7,5,9,8,8)	336 ng/mL Geometric Coefficient of Variation 101	1250 ng/mL Geometric Coefficient of Variation 302	1730 ng/mL Geometric Coefficient of Variation 146	330 ng/mL Geometric Coefficient of Variation 104	709 ng/mL Geometric Coefficient of Variation 167	4460 ng/mL Geometric Coefficient of Variation 249	—
Plasma Concentration Time Profiles of BI 207127 BI 207127 649 hours (N=6,7,6,9,8,7)	1210 ng/mL Geometric Coefficient of Variation 91.4	2490 ng/mL Geometric Coefficient of Variation 176	2340 ng/mL Geometric Coefficient of Variation 197	1050 ng/mL Geometric Coefficient of Variation 100	1710 ng/mL Geometric Coefficient of Variation 153	3050 ng/mL Geometric Coefficient of Variation 182	—
Plasma Concentration Time Profiles of BI 207127 BI 207127 652 hours (N=6,7,6,9,8,7)	2520 ng/mL Geometric Coefficient of Variation 86.3	5100 ng/mL Geometric Coefficient of Variation 100	11300 ng/mL Geometric Coefficient of Variation 68.6	2650 ng/mL Geometric Coefficient of Variation 66.3	5340 ng/mL Geometric Coefficient of Variation 60.0	9070 ng/mL Geometric Coefficient of Variation 106	—
Plasma Concentration Time Profiles of BI 207127 BI 207127 656 hours (N=5,7,6,8,8,6)	905 ng/mL Geometric Coefficient of Variation 113	1940 ng/mL Geometric Coefficient of Variation 121	2820 ng/mL Geometric Coefficient of Variation 145	635 ng/mL Geometric Coefficient of Variation 82.7	1380 ng/mL Geometric Coefficient of Variation 97.5	3820 ng/mL Geometric Coefficient of Variation 122	—
Plasma Concentration Time Profiles of BI 207127 BI 207127 672 hours (N=5,7,6,-,8,6)	57.7 ng/mL Geometric Coefficient of Variation 137	80.4 ng/mL Geometric Coefficient of Variation 306	101 ng/mL Geometric Coefficient of Variation 175	NA ng/mL Geometric Coefficient of Variation NA Some patients had data below the limit of quantification which is not analysable and per internal rules, descriptive statistics are not calculated unless data from at least 2/3rds of all subjects were available.	62.4 ng/mL Geometric Coefficient of Variation 105	163 ng/mL Geometric Coefficient of Variation 236	—

SECONDARY outcome

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

Plasma concentration time profiles of CD 6168

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=6 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=7 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=6 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=9 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=9 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=11 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
Plasma Concentration Time Profiles of CD 6168 CD 6168 0.5 hours (N=-,-,-,-,-,-)	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated as all participants results were below the limit of quantification.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated as all participants results were below the limit of quantification.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated as all participants results were below the limit of quantification.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated as all participants results were below the limit of quantification.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated as all participants results were below the limit of quantification.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated as all participants results were below the limit of quantification.	—
Plasma Concentration Time Profiles of CD 6168 CD 6168 3 hours (N=6,7,6,9,8,11)	124 ng/mL Geometric Coefficient of Variation 152	155 ng/mL Geometric Coefficient of Variation 68.1	397 ng/mL Geometric Coefficient of Variation 47.6	142 ng/mL Geometric Coefficient of Variation 63.4	247 ng/mL Geometric Coefficient of Variation 58.1	183 ng/mL Geometric Coefficient of Variation 144	—
Plasma Concentration Time Profiles of CD 6168 CD 6168 8 hours (N=6,7,6,9,9,11)	337 ng/mL Geometric Coefficient of Variation 61.6	636 ng/mL Geometric Coefficient of Variation 97.3	1220 ng/mL Geometric Coefficient of Variation 39.0	307 ng/mL Geometric Coefficient of Variation 79.1	545 ng/mL Geometric Coefficient of Variation 64.1	622 ng/mL Geometric Coefficient of Variation 54.8	—
Plasma Concentration Time Profiles of CD 6168 CD 6168 15 hours (N=6,7,5,8,9,10)	690 ng/mL Geometric Coefficient of Variation 57.8	1320 ng/mL Geometric Coefficient of Variation 55.2	2210 ng/mL Geometric Coefficient of Variation 47.0	570 ng/mL Geometric Coefficient of Variation 122	973 ng/mL Geometric Coefficient of Variation 64.6	1330 ng/mL Geometric Coefficient of Variation 61.9	—
Plasma Concentration Time Profiles of CD 6168 CD 6168 23.917 hours (N=6,7,6,9,8,11)	201 ng/mL Geometric Coefficient of Variation 71.7	617 ng/mL Geometric Coefficient of Variation 136	1530 ng/mL Geometric Coefficient of Variation 57.3	276 ng/mL Geometric Coefficient of Variation 186	827 ng/mL Geometric Coefficient of Variation 143	1920 ng/mL Geometric Coefficient of Variation 55.2	—
Plasma Concentration Time Profiles of CD 6168 CD 6168 503.917 hours (N=6,7,5,9,8,8)	193 ng/mL Geometric Coefficient of Variation 89.4	712 ng/mL Geometric Coefficient of Variation 308	1310 ng/mL Geometric Coefficient of Variation 218	150 ng/mL Geometric Coefficient of Variation 164	385 ng/mL Geometric Coefficient of Variation 123	2730 ng/mL Geometric Coefficient of Variation 285	—
Plasma Concentration Time Profiles of CD 6168 CD 6168 649 hours (N=6,7,6,9,8,7)	394 ng/mL Geometric Coefficient of Variation 89.4	1230 ng/mL Geometric Coefficient of Variation 193	1160 ng/mL Geometric Coefficient of Variation 234	196 ng/mL Geometric Coefficient of Variation 169	473 ng/mL Geometric Coefficient of Variation 132	1470 ng/mL Geometric Coefficient of Variation 249	—
Plasma Concentration Time Profiles of CD 6168 CD 6168 652 hours (N=6,7,6,9,8,7)	699 ng/mL Geometric Coefficient of Variation 53.9	1940 ng/mL Geometric Coefficient of Variation 144	3360 ng/mL Geometric Coefficient of Variation 105	556 ng/mL Geometric Coefficient of Variation 104	1160 ng/mL Geometric Coefficient of Variation 71.8	2570 ng/mL Geometric Coefficient of Variation 207	—
Plasma Concentration Time Profiles of CD 6168 CD 6168 656 hours (N=5,7,6,8,8,6)	418 ng/mL Geometric Coefficient of Variation 81.4	1200 ng/mL Geometric Coefficient of Variation 153	1660 ng/mL Geometric Coefficient of Variation 194	243 ng/mL Geometric Coefficient of Variation 135	566 ng/mL Geometric Coefficient of Variation 106	1770 ng/mL Geometric Coefficient of Variation 178	—
Plasma Concentration Time Profiles of CD 6168 CD 6168 672 hours (N=4,7,5,-,6,6)	61.7 ng/mL Geometric Coefficient of Variation 58.8	84.8 ng/mL Geometric Coefficient of Variation 490	135 ng/mL Geometric Coefficient of Variation 337	NA ng/mL Geometric Coefficient of Variation NA Some patients had data below the limit of quantification which is not analysable and per internal rules, descriptive statistics are not calculated unless data from at least 2/3rds of all subjects were available.	50.8 ng/mL Geometric Coefficient of Variation 90.8	123 ng/mL Geometric Coefficient of Variation 297	—

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=6 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=7 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=6 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=9 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=9 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=11 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) Cmax BI207127 in plasma (N=6,7,6,9,9,11)	2420 ng/mL Geometric Coefficient of Variation 29.1	3490 ng/mL Geometric Coefficient of Variation 61.7	7440 ng/mL Geometric Coefficient of Variation 81.8	3590 ng/mL Geometric Coefficient of Variation 64.1	5910 ng/mL Geometric Coefficient of Variation 54.3	7640 ng/mL Geometric Coefficient of Variation 52.5	—
Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) Cmax CD 6168 in plasma (N=6,7,6,9,8,11)	261 ng/mL Geometric Coefficient of Variation 56.2	412 ng/mL Geometric Coefficient of Variation 64.5	891 ng/mL Geometric Coefficient of Variation 51.0	232 ng/mL Geometric Coefficient of Variation 69.4	426 ng/mL Geometric Coefficient of Variation 75.5	556 ng/mL Geometric Coefficient of Variation 75.7	—
Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) Cmax,ss BI207127 in plasma (N=6,7,6,9,9,7)	3260 ng/mL Geometric Coefficient of Variation 70.1	6020 ng/mL Geometric Coefficient of Variation 91.5	12200 ng/mL Geometric Coefficient of Variation 73.0	3460 ng/mL Geometric Coefficient of Variation 55.2	5750 ng/mL Geometric Coefficient of Variation 67.2	10800 ng/mL Geometric Coefficient of Variation 66.0	—
Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) Cmax,ss CD 6168 in plasma (N=6,7,6,9,8,7)	861 ng/mL Geometric Coefficient of Variation 36.0	2090 ng/mL Geometric Coefficient of Variation 135	3450 ng/mL Geometric Coefficient of Variation 107	584 ng/mL Geometric Coefficient of Variation 105	1170 ng/mL Geometric Coefficient of Variation 74.0	2990 ng/mL Geometric Coefficient of Variation 122	—

SECONDARY outcome

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).

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=6 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=7 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=6 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=9 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=9 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=11 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) tmax BI 207127 (N=6,7,6,9,9,11)	2.96 hour Geometric Coefficient of Variation 27.8	3.87 hour Geometric Coefficient of Variation 24.4	3.91 hour Geometric Coefficient of Variation 24.9	3.11 hour Geometric Coefficient of Variation 29.1	3.19 hour Geometric Coefficient of Variation 31.7	4.10 hour Geometric Coefficient of Variation 83.1	—
Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) tmax CD 6168 (N=6,7,6,9,9,11)	4.79 hour Geometric Coefficient of Variation 27.9	4.80 hour Geometric Coefficient of Variation 28.2	5.56 hour Geometric Coefficient of Variation 16.3	4.82 hour Geometric Coefficient of Variation 26.1	5.69 hour Geometric Coefficient of Variation 13.4	5.37 hour Geometric Coefficient of Variation 23.0	—
Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) tmax,ss BI 207127 (N=6,7,6,9,8,7)	2.57 hour Geometric Coefficient of Variation 108	3.56 hour Geometric Coefficient of Variation 41.0	3.32 hour Geometric Coefficient of Variation 16.5	2.77 hour Geometric Coefficient of Variation 27.4	3.26 hour Geometric Coefficient of Variation 24.5	3.91 hour Geometric Coefficient of Variation 23.3	—
Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) tmax,ss CD 6168(N=6,7,6,9,8,7)	3.24 hour Geometric Coefficient of Variation 68.0	4.34 hour Geometric Coefficient of Variation 32.0	3.91 hour Geometric Coefficient of Variation 24.0	3.85 hour Geometric Coefficient of Variation 27.5	3.63 hour Geometric Coefficient of Variation 24.6	3.49 hour Geometric Coefficient of Variation 62.1	—

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=5 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=5 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=5 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=9 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=9 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=7 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) AUC0-6 BI 207127 (N=5,5,5,9,9,7)	8840 ng*h/mL Geometric Coefficient of Variation 35.0	13500 ng*h/mL Geometric Coefficient of Variation 61.5	23700 ng*h/mL Geometric Coefficient of Variation 62.6	13000 ng*h/mL Geometric Coefficient of Variation 64.8	21900 ng*h/mL Geometric Coefficient of Variation 70.3	NA ng*h/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	—
AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) AUC0-6 CD 6168 (N=-,-,-,-,-,-)	NA ng*h/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng*h/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng*h/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng*h/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng*h/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng*h/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	—
AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) AUC0-6,ss BI 207127 (N=6,7,7,8,8,7)	11300 ng*h/mL Geometric Coefficient of Variation 83.7	24000 ng*h/mL Geometric Coefficient of Variation 112	42500 ng*h/mL Geometric Coefficient of Variation 88.1	12400 ng*h/mL Geometric Coefficient of Variation 56.1	21400 ng*h/mL Geometric Coefficient of Variation 73.7	36600 ng*h/mL Geometric Coefficient of Variation 107	—
AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) AUC0-6,ss CD 6168 (N=6,7,7,9,8,7)	3180 ng*h/mL Geometric Coefficient of Variation 48.7	9610 ng*h/mL Geometric Coefficient of Variation 162	14000 ng*h/mL Geometric Coefficient of Variation 138	2380 ng*h/mL Geometric Coefficient of Variation 115	4920 ng*h/mL Geometric Coefficient of Variation 90.2	12500 ng*h/mL Geometric Coefficient of Variation 191	—

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=6 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=7 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=6 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=9 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=9 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=11 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 CD 6168 Cpre,15 (N=6,7,6,9,8,8)	239 ng/mL Geometric Coefficient of Variation 175	723 ng/mL Geometric Coefficient of Variation 265	1000 ng/mL Geometric Coefficient of Variation 149	169 ng/mL Geometric Coefficient of Variation 172	428 ng/mL Geometric Coefficient of Variation 135	2020 ng/mL Geometric Coefficient of Variation 519	—
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 CD 6168 Cpre,22 (N=6,7,6,9,8,8)	193 ng/mL Geometric Coefficient of Variation 89.4	712 ng/mL Geometric Coefficient of Variation 308	1010 ng/mL Geometric Coefficient of Variation 226	150 ng/mL Geometric Coefficient of Variation 164	385 ng/mL Geometric Coefficient of Variation 123	2730 ng/mL Geometric Coefficient of Variation 285	—
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 CD 6168 Cpre,27 (N=-,5,-,6,-,-)	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	1730 ng/mL Geometric Coefficient of Variation 74.5	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	427 ng/mL Geometric Coefficient of Variation 147	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	—
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 BI 207127 Cpre,1 (N=-,-,-,-,-,-)	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	—
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 BI 207127 Cpre,2 (N=6,7,6,9,8,11)	595 ng/mL Geometric Coefficient of Variation 72.0	1610 ng/mL Geometric Coefficient of Variation 138	4780 ng/mL Geometric Coefficient of Variation 76.4	1170 ng/mL Geometric Coefficient of Variation 201	3450 ng/mL Geometric Coefficient of Variation 173	9350 ng/mL Geometric Coefficient of Variation 71.0	—
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 BI 207127 Cpre,4 (N=5,6,6,9,9,10)	659 ng/mL Geometric Coefficient of Variation 48.4	1530 ng/mL Geometric Coefficient of Variation 267	6200 ng/mL Geometric Coefficient of Variation 160	816 ng/mL Geometric Coefficient of Variation 197	2780 ng/mL Geometric Coefficient of Variation 201	9830 ng/mL Geometric Coefficient of Variation 170	—
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 BI 207127 Cpre,8 (N=6,6,5,9,9,9)	414 ng/mL Geometric Coefficient of Variation 117	607 ng/mL Geometric Coefficient of Variation 131	1770 ng/mL Geometric Coefficient of Variation 310	635 ng/mL Geometric Coefficient of Variation 217	783 ng/mL Geometric Coefficient of Variation 186	4160 ng/mL Geometric Coefficient of Variation 176	—
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 BI 207127 Cpre,15 (N=6,7,6,9,8,8)	399 ng/mL Geometric Coefficient of Variation 135	1170 ng/mL Geometric Coefficient of Variation 188	1560 ng/mL Geometric Coefficient of Variation 139	358 ng/mL Geometric Coefficient of Variation 97.8	944 ng/mL Geometric Coefficient of Variation 163	3530 ng/mL Geometric Coefficient of Variation 349	—
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 BI 207127 Cpre,22 (N=6,7,6,9,8,8)	336 ng/mL Geometric Coefficient of Variation 101	1250 ng/mL Geometric Coefficient of Variation 302	1340 ng/mL Geometric Coefficient of Variation 165	330 ng/mL Geometric Coefficient of Variation 104	709 ng/mL Geometric Coefficient of Variation 167	4460 ng/mL Geometric Coefficient of Variation 249	—
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 BI 207127 Cpre,27 (N=-,5,-,6,-,-)	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	4270 ng/mL Geometric Coefficient of Variation 56.9	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	1280 ng/mL Geometric Coefficient of Variation 80.8	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	—
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 CD 6168 Cpre,1 (N=-,-,-,-,-,-)	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	NA ng/mL Geometric Coefficient of Variation NA No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.	—
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 CD 6168 Cpre,2 (N=6,7,6,9,8,11)	201 ng/mL Geometric Coefficient of Variation 71.7	617 ng/mL Geometric Coefficient of Variation 136	1530 ng/mL Geometric Coefficient of Variation 57.3	276 ng/mL Geometric Coefficient of Variation 186	827 ng/mL Geometric Coefficient of Variation 143	1920 ng/mL Geometric Coefficient of Variation 55.2	—
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 CD 6168 Cpre,4 (N=5,6,6,9,9,10)	236 ng/mL Geometric Coefficient of Variation 56.2	564 ng/mL Geometric Coefficient of Variation 276	2510 ng/mL Geometric Coefficient of Variation 146	250 ng/mL Geometric Coefficient of Variation 257	994 ng/mL Geometric Coefficient of Variation 192	3000 ng/mL Geometric Coefficient of Variation 235	—
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 CD 6168 Cpre,8 (N=6,6,5,9,9,9)	194 ng/mL Geometric Coefficient of Variation 111	368 ng/mL Geometric Coefficient of Variation 138	1140 ng/mL Geometric Coefficient of Variation 177	253 ng/mL Geometric Coefficient of Variation 353	350 ng/mL Geometric Coefficient of Variation 221	2340 ng/mL Geometric Coefficient of Variation 183	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=6 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=7 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=6 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=9 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=8 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=7 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
C6,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose BI 207127 654 hours	1520 ng/mL Geometric Coefficient of Variation 103	4030 ng/mL Geometric Coefficient of Variation 107	5820 ng/mL Geometric Coefficient of Variation 94.4	1380 ng/mL Geometric Coefficient of Variation 71.4	2810 ng/mL Geometric Coefficient of Variation 85.7	5910 ng/mL Geometric Coefficient of Variation 114	—
C6,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose CD 6168 654 hours	556 ng/mL Geometric Coefficient of Variation 63.7	1810 ng/mL Geometric Coefficient of Variation 148	2580 ng/mL Geometric Coefficient of Variation 136	424 ng/mL Geometric Coefficient of Variation 122	893 ng/mL Geometric Coefficient of Variation 89.7	2200 ng/mL Geometric Coefficient of Variation 133	—

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=5 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=7 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=6 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=8 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=8 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=6 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
AUC0-infinity,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose AUC0 to infinity,SS of BI207127	20500 ng*h/mL Geometric Coefficient of Variation 88.4	38600 ng*h/mL Geometric Coefficient of Variation 131	62300 ng*h/mL Geometric Coefficient of Variation 99.2	16900 ng*h/mL Geometric Coefficient of Variation 63.0	31500 ng*h/mL Geometric Coefficient of Variation 79.2	71300 ng*h/mL Geometric Coefficient of Variation 116	—
AUC0-infinity,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose AUC0 to infinity,SS of CD 6168	7170 ng*h/mL Geometric Coefficient of Variation 70.9	19600 ng*h/mL Geometric Coefficient of Variation 201	26800 ng*h/mL Geometric Coefficient of Variation 171	4290 ng*h/mL Geometric Coefficient of Variation 129	9190 ng*h/mL Geometric Coefficient of Variation 97.9	29000 ng*h/mL Geometric Coefficient of Variation 196	—

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=5 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=7 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=6 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=8 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=8 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=6 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
λz Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose λz,ss of BI 207127	0.162 1/h Geometric Coefficient of Variation 17.6	0.182 1/h Geometric Coefficient of Variation 27.8	0.170 1/h Geometric Coefficient of Variation 32.6	0.226 1/h Geometric Coefficient of Variation 20.8	0.163 1/h Geometric Coefficient of Variation 30.9	0.174 1/h Geometric Coefficient of Variation 28.2	—
λz Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose λz,ss of CD 6168	0.157 1/h Geometric Coefficient of Variation 36.4	0.163 1/h Geometric Coefficient of Variation 20.3	0.166 1/h Geometric Coefficient of Variation 43.3	0.185 1/h Geometric Coefficient of Variation 21.4	0.192 1/h Geometric Coefficient of Variation 24.3	0.129 1/h Geometric Coefficient of Variation 56.0	—

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=5 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=7 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=6 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=8 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=8 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=6 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
t1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose t1/2,ss of BI 207127	4.28 hour Geometric Coefficient of Variation 17.6	3.81 hour Geometric Coefficient of Variation 27.8	4.09 hour Geometric Coefficient of Variation 32.6	3.06 hour Geometric Coefficient of Variation 20.8	4.26 hour Geometric Coefficient of Variation 30.9	3.99 hour Geometric Coefficient of Variation 28.2	—
t1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose MRTpo,ss of BI 207127	6.44 hour Geometric Coefficient of Variation 28.3	6.40 hour Geometric Coefficient of Variation 17.7	5.83 hour Geometric Coefficient of Variation 14.5	5.32 hour Geometric Coefficient of Variation 16.8	5.82 hour Geometric Coefficient of Variation 12.9	7.03 hour Geometric Coefficient of Variation 23.8	—
t1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose t1/2,ss of CD 6168	4.42 hour Geometric Coefficient of Variation 36.4	4.25 hour Geometric Coefficient of Variation 20.3	4.18 hour Geometric Coefficient of Variation 43.3	3.75 hour Geometric Coefficient of Variation 21.4	3.61 hour Geometric Coefficient of Variation 24.3	5.36 hour Geometric Coefficient of Variation 56.0	—
t1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose MRTpo,ss of CD 6168	8.98 hour Geometric Coefficient of Variation 26.0	8.61 hour Geometric Coefficient of Variation 24.7	8.07 hour Geometric Coefficient of Variation 22.5	7.51 hour Geometric Coefficient of Variation 14.2	7.75 hour Geometric Coefficient of Variation 16.4	9.38 hour Geometric Coefficient of Variation 30.8	—

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=6 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=7 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=6 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=9 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg n=8 Participants TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg n=7 Participants TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
RA,Cmax Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose RA,Cmax of BI 207127	1.35 ratio Geometric Coefficient of Variation 74.1	1.72 ratio Geometric Coefficient of Variation 95.2	1.64 ratio Geometric Coefficient of Variation 84.4	0.965 ratio Geometric Coefficient of Variation 37.5	1.02 ratio Geometric Coefficient of Variation 40.0	1.44 ratio Geometric Coefficient of Variation 56.2	—
RA,Cmax Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose RA,Cmax of CD 6168	3.30 ratio Geometric Coefficient of Variation 66.5	5.07 ratio Geometric Coefficient of Variation 127	3.87 ratio Geometric Coefficient of Variation 120	2.52 ratio Geometric Coefficient of Variation 84.8	2.77 ratio Geometric Coefficient of Variation 55.9	6.08 ratio Geometric Coefficient of Variation 146	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=8 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=16 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=16 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=17 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
Number of Participants With Clinical Relevant Abnormalities for Vital Signs, Body Temperature, Physical Examination, Blood Chemistry, Haematology, Coagulation, Urinalysis and ECG Weight decreased	0 participants	0 participants	1 participants	3 participants	—	—	—
Number of Participants With Clinical Relevant Abnormalities for Vital Signs, Body Temperature, Physical Examination, Blood Chemistry, Haematology, Coagulation, Urinalysis and ECG Alanine aminotransferase increased	0 participants	1 participants	2 participants	1 participants	—	—	—

SECONDARY outcome

Timeframe: 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 adverse events (AEs) leading to discontinuation of trial drug

Outcome measures

Outcome measures
Measure	Treatment Naive (TN): Placebo n=8 Participants TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 400 mg n=16 Participants TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 600 mg n=16 Participants TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Naive (TN): BI 207127 800 mg n=17 Participants TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 400 mg TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 600 mg TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	Treatment Experienced (TE): BI 207127 800 mg TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
Number of Participants With Discontinuations Due to AEs	0 participants	0 participants	1 participants	4 participants	—	—	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

BI 207127 400 mg

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

BI 207127 600 mg

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

BI 207127 800 mg

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=8 participants at risk patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days	BI 207127 400 mg n=16 participants at risk patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	BI 207127 600 mg n=16 participants at risk patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days	BI 207127 800 mg n=17 participants at risk patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
Gastrointestinal disorders Umbilical hernia	0.00% 0/8 • From drug administration until 2 days after the end of treatment, up to 570 days	6.2% 1/16 • From drug administration until 2 days after the end of treatment, up to 570 days	0.00% 0/16 • From drug administration until 2 days after the end of treatment, up to 570 days	0.00% 0/17 • From drug administration until 2 days after the end of treatment, up to 570 days
Nervous system disorders Syncope	0.00% 0/8 • From drug administration until 2 days after the end of treatment, up to 570 days	6.2% 1/16 • From drug administration until 2 days after the end of treatment, up to 570 days	0.00% 0/16 • From drug administration until 2 days after the end of treatment, up to 570 days	0.00% 0/17 • From drug administration until 2 days after the end of treatment, up to 570 days
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/8 • From drug administration until 2 days after the end of treatment, up to 570 days	0.00% 0/16 • From drug administration until 2 days after the end of treatment, up to 570 days	0.00% 0/16 • From drug administration until 2 days after the end of treatment, up to 570 days	5.9% 1/17 • From drug administration until 2 days after the end of treatment, up to 570 days

Other adverse events

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BIs intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER