Trial Outcomes & Findings for Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3) (NCT NCT01358864)

Last Updated: 2016-08-29

Results Overview

Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

678 participants

Primary outcome timeframe

12 weeks post treatment, up to 60 weeks

Results posted on

2016-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	Relapser:Faldaprevir 24 Weeks Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Relapser:Placebo Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Relapser:Faldaprevir 12 Weeks Patients who had had a prior relapse, received Faldaprevir (BI 201335) 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Partial:Placebo Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Partial:Faldaprevir 12 Weeks Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Partial:Faldaprevir 24 Weeks Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 12 Weeks Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Overall Study STARTED	103	49	99	29	57	55	146	140
Overall Study COMPLETED	87	18	86	10	46	42	81	85
Overall Study NOT COMPLETED	16	31	13	19	11	13	65	55

Reasons for withdrawal

Reasons for withdrawal
Measure	Relapser:Faldaprevir 24 Weeks Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Relapser:Placebo Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Relapser:Faldaprevir 12 Weeks Patients who had had a prior relapse, received Faldaprevir (BI 201335) 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Partial:Placebo Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Partial:Faldaprevir 12 Weeks Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Partial:Faldaprevir 24 Weeks Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 12 Weeks Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Overall Study Adverse Event	9	0	6	0	4	8	12	7
Overall Study Lack of Efficacy	4	26	3	19	7	4	49	44
Overall Study Lost to Follow-up	1	0	0	0	0	0	0	1
Overall Study Withdrawal by Subject	2	3	4	0	0	1	1	3
Overall Study Other reason not defined above	0	2	0	0	0	0	2	0
Overall Study Not treated	0	0	0	0	0	0	1	0

Baseline Characteristics

Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Relapser:Placebo n=49 Participants Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Relapser:Faldaprevir 12 Weeks n=99 Participants Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Relapser:Faldaprevir 24 Weeks n=103 Participants Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Partial:Placebo n=29 Participants Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Partial:Faldaprevir 12 Weeks n=57 Participants Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Partial:Faldaprevir 24 Weeks n=55 Participants Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 12 Weeks n=145 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=140 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Total n=677 Participants Total of all reporting groups
Age, Continuous	53.4 years STANDARD_DEVIATION 8.29 • n=93 Participants	53.5 years STANDARD_DEVIATION 8.57 • n=4 Participants	53.7 years STANDARD_DEVIATION 8.14 • n=27 Participants	55.7 years STANDARD_DEVIATION 7.50 • n=483 Participants	52.7 years STANDARD_DEVIATION 7.90 • n=36 Participants	52.0 years STANDARD_DEVIATION 10.32 • n=10 Participants	53.2 years STANDARD_DEVIATION 8.76 • n=115 Participants	53.6 years STANDARD_DEVIATION 8.13 • n=40 Participants	53.4 years STANDARD_DEVIATION 8.48 • n=8 Participants
Sex: Female, Male Female	20 Participants n=93 Participants	44 Participants n=4 Participants	43 Participants n=27 Participants	10 Participants n=483 Participants	20 Participants n=36 Participants	20 Participants n=10 Participants	54 Participants n=115 Participants	63 Participants n=40 Participants	274 Participants n=8 Participants
Sex: Female, Male Male	29 Participants n=93 Participants	55 Participants n=4 Participants	60 Participants n=27 Participants	19 Participants n=483 Participants	37 Participants n=36 Participants	35 Participants n=10 Participants	91 Participants n=115 Participants	77 Participants n=40 Participants	403 Participants n=8 Participants

PRIMARY outcome

Timeframe: 12 weeks post treatment, up to 60 weeks

Population: FAS

Outcome measures

Outcome measures
Measure	Relapser & Partial: Placebo n=78 Participants Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Relapser & Partial: Faldaprevir 12 Weeks n=156 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Relapser & Partial: Faldaprevir 24 Weeks n=158 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Null:Faldaprevir 12 Weeks n=145 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=140 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Partial:Faldaprevir 24 Weeks Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 12 Weeks Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Sustained Virological Response 12 Weeks Post Treatment (SVR12)	10.3 percentage of participants Interval 3.5 to 17.0	65.4 percentage of participants Interval 57.9 to 72.9	61.4 percentage of participants Interval 53.8 to 69.0	33.8 percentage of participants Interval 26.1 to 41.5	32.9 percentage of participants Interval 25.1 to 40.6	—	—	—

SECONDARY outcome

Timeframe: 24 weeks post treatment, up to 72 weeks

Population: FAS

Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.

Outcome measures

Outcome measures
Measure	Relapser & Partial: Placebo n=78 Participants Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Relapser & Partial: Faldaprevir 12 Weeks n=156 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Relapser & Partial: Faldaprevir 24 Weeks n=158 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Null:Faldaprevir 12 Weeks n=145 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=140 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Partial:Faldaprevir 24 Weeks Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 12 Weeks Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)	10.3 percentage of participants Interval 3.5 to 17.0	63.5 percentage of participants Interval 55.9 to 71.0	59.5 percentage of participants Interval 51.8 to 67.1	33.8 percentage of participants Interval 26.1 to 41.5	32.9 percentage of participants Interval 25.1 to 40.6	—	—	—

SECONDARY outcome

Timeframe: Week 4 and Week 8

Population: FAS

Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level \<25 IU/mL (undetected or detected) at Week 4 and \<25 IU/mL (undetected) at Week 8.

Outcome measures

Outcome measures
Measure	Relapser & Partial: Placebo n=49 Participants Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Relapser & Partial: Faldaprevir 12 Weeks n=99 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Relapser & Partial: Faldaprevir 24 Weeks n=103 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Null:Faldaprevir 12 Weeks n=29 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=57 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Partial:Faldaprevir 24 Weeks n=55 Participants Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 12 Weeks n=145 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=140 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Early Treatment Success (ETS)	4.1 percentage of participants	85.9 percentage of participants	87.4 percentage of participants	3.4 percentage of participants	66.7 percentage of participants	76.4 percentage of participants	58.6 percentage of participants	51.4 percentage of participants

SECONDARY outcome

Timeframe: End of treatment, up to 48 weeks

Population: FAS

The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline

Outcome measures

Outcome measures
Measure	Relapser & Partial: Placebo n=49 Participants Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Relapser & Partial: Faldaprevir 12 Weeks n=99 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Relapser & Partial: Faldaprevir 24 Weeks n=103 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Null:Faldaprevir 12 Weeks n=29 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=57 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Partial:Faldaprevir 24 Weeks n=55 Participants Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 12 Weeks n=145 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=140 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO SVR12=NO	42 participants	30 participants	31 participants	28 participants	24 participants	30 participants	96 participants	94 participants
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO BL normal to EoT normal	9 participants	9 participants	6 participants	3 participants	4 participants	4 participants	15 participants	14 participants
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO BL elevated to EoT normal	15 participants	10 participants	14 participants	9 participants	14 participants	6 participants	34 participants	38 participants
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO No EoT data available for ALT	1 participants	0 participants	0 participants	0 participants	0 participants	1 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: End of treatment, up to 48 weeks

Population: FAS

The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline

Outcome measures

Outcome measures
Measure	Relapser & Partial: Placebo n=49 Participants Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Relapser & Partial: Faldaprevir 12 Weeks n=99 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Relapser & Partial: Faldaprevir 24 Weeks n=103 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Null:Faldaprevir 12 Weeks n=29 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=57 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Partial:Faldaprevir 24 Weeks n=55 Participants Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 12 Weeks n=145 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=140 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES SVR12=YES	7 participants	69 participants	72 participants	1 participants	33 participants	25 participants	49 participants	46 participants
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES BL normal to EoT normal	3 participants	30 participants	30 participants	0 participants	10 participants	8 participants	12 participants	9 participants
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES BL elevated to EoT normal	4 participants	29 participants	26 participants	1 participants	14 participants	8 participants	23 participants	27 participants

SECONDARY outcome

Timeframe: End of treatment, up to 48 weeks

Population: FAS

The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline

Outcome measures

Outcome measures
Measure	Relapser & Partial: Placebo n=49 Participants Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Relapser & Partial: Faldaprevir 12 Weeks n=99 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Relapser & Partial: Faldaprevir 24 Weeks n=103 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Null:Faldaprevir 12 Weeks n=29 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=57 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Partial:Faldaprevir 24 Weeks n=55 Participants Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 12 Weeks n=145 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=140 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO SVR12=NO	42 participants	30 participants	31 participants	28 participants	24 participants	30 participants	96 participants	94 participants
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO BL normal to EoT normal	19 participants	16 participants	12 participants	4 participants	3 participants	5 participants	18 participants	21 participants
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO BL elevated to EoT normal	5 participants	5 participants	9 participants	9 participants	14 participants	6 participants	24 participants	28 participants

SECONDARY outcome

Timeframe: End of treatment, up to 48 weeks

Population: FAS

The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline

Outcome measures

Outcome measures
Measure	Relapser & Partial: Placebo n=49 Participants Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Relapser & Partial: Faldaprevir 12 Weeks n=99 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Relapser & Partial: Faldaprevir 24 Weeks n=103 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Null:Faldaprevir 12 Weeks n=29 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=57 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Partial:Faldaprevir 24 Weeks n=55 Participants Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 12 Weeks n=145 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=140 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES SVR12=YES	7 participants	69 participants	72 participants	1 participants	33 participants	25 participants	49 participants	46 participants
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES BL normal to EoT normal	2 participants	35 participants	39 participants	0 participants	13 participants	10 participants	15 participants	16 participants
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES BL elevated to EoT normal	4 participants	24 participants	22 participants	1 participants	10 participants	9 participants	21 participants	20 participants
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES No EoT data available for AST	1 participants	0 participants	0 participants	0 participants	0 participants	1 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: 12 weeks post treatment, up to 60 weeks

Population: FAS

The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline

Outcome measures

Outcome measures
Measure	Relapser & Partial: Placebo n=49 Participants Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Relapser & Partial: Faldaprevir 12 Weeks n=99 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Relapser & Partial: Faldaprevir 24 Weeks n=103 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Null:Faldaprevir 12 Weeks n=29 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=57 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Partial:Faldaprevir 24 Weeks n=55 Participants Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 12 Weeks n=145 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=140 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO SVR12=NO	42 participants	30 participants	31 participants	28 participants	24 participants	30 participants	96 participants	94 participants
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO BL normal to SVR12 normal	0 participants	9 participants	6 participants	0 participants	2 participants	4 participants	11 participants	6 participants
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO BL elevated to SVR12 normal	1 participants	6 participants	6 participants	0 participants	4 participants	3 participants	7 participants	9 participants
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO No ALT data available at SVR12 visit	33 participants	7 participants	3 participants	23 participants	6 participants	5 participants	27 participants	30 participants

SECONDARY outcome

Timeframe: 12 weeks post treatment, up to 60 weeks

Population: FAS

The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline

Outcome measures

Outcome measures
Measure	Relapser & Partial: Placebo n=49 Participants Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Relapser & Partial: Faldaprevir 12 Weeks n=99 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Relapser & Partial: Faldaprevir 24 Weeks n=103 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Null:Faldaprevir 12 Weeks n=29 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=57 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Partial:Faldaprevir 24 Weeks n=55 Participants Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 12 Weeks n=145 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=140 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES SVR12=YES	7 participants	69 participants	72 participants	1 participants	33 participants	25 participants	49 participants	46 participants
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES BL normal to SVR12 normal	3 participants	31 participants	31 participants	0 participants	13 participants	10 participants	13 participants	10 participants
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES BL elevated to SVR12 normal	3 participants	35 participants	38 participants	1 participants	20 participants	11 participants	32 participants	35 participants
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES No ALT data available at SVR12 visit	1 participants	1 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: 12 weeks post treatment, up to 60 weeks

Population: FAS

The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline

Outcome measures

Outcome measures
Measure	Relapser & Partial: Placebo n=49 Participants Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Relapser & Partial: Faldaprevir 12 Weeks n=99 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Relapser & Partial: Faldaprevir 24 Weeks n=103 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Null:Faldaprevir 12 Weeks n=29 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=57 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Partial:Faldaprevir 24 Weeks n=55 Participants Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 12 Weeks n=145 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=140 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO SVR12=NO	42 participants	30 participants	31 participants	28 participants	24 participants	30 participants	96 participants	94 participants
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO BL normal to SVR12 normal	0 participants	14 participants	10 participants	0 participants	3 participants	3 participants	13 participants	14 participants
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO BL elevated to SVR12 normal	2 participants	2 participants	6 participants	0 participants	6 participants	3 participants	6 participants	3 participants
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO No AST data available at SVR12 visit	33 participants	7 participants	3 participants	23 participants	6 participants	6 participants	27 participants	30 participants

SECONDARY outcome

Timeframe: 12 weeks post treatment, up to 60 weeks

Population: FAS

The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline

Outcome measures

Outcome measures
Measure	Relapser & Partial: Placebo n=49 Participants Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Relapser & Partial: Faldaprevir 12 Weeks n=99 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Relapser & Partial: Faldaprevir 24 Weeks n=103 Participants Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Null:Faldaprevir 12 Weeks n=29 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=57 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Partial:Faldaprevir 24 Weeks n=55 Participants Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 12 Weeks n=145 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=140 Participants Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES SVR12=YES	7 participants	69 participants	72 participants	1 participants	33 participants	25 participants	49 participants	46 participants
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES BL normal to SVR12 normal	2 participants	36 participants	41 participants	0 participants	16 participants	13 participants	16 participants	17 participants
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES BL elevated to SVR12 normal	4 participants	29 participants	28 participants	1 participants	16 participants	8 participants	28 participants	25 participants
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES No AST data available at SVR12 visit	1 participants	1 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants

Adverse Events

Relapser & Partial: Placebo

Serious events: 1 serious events

Other events: 74 other events

Deaths: 0 deaths

Relapser & Partial: Faldaprevir 12 Weeks

Serious events: 14 serious events

Other events: 148 other events

Deaths: 0 deaths

Relapser & Partial: Faldaprevir 24 Weeks

Serious events: 13 serious events

Other events: 156 other events

Deaths: 0 deaths

Null:Faldaprevir 12 Weeks

Serious events: 16 serious events

Other events: 142 other events

Deaths: 0 deaths

Null:Faldaprevir 24 Weeks

Serious events: 11 serious events

Other events: 139 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Relapser & Partial: Placebo n=78 participants at risk Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Relapser & Partial: Faldaprevir 12 Weeks n=156 participants at risk Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Relapser & Partial: Faldaprevir 24 Weeks n=158 participants at risk Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Null:Faldaprevir 12 Weeks n=145 participants at risk Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=140 participants at risk Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Vascular disorders Venous thrombosis	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.71% 1/140 • During the course of the study (48 weeks)
Respiratory, thoracic and mediastinal disorders Traumatic haemothorax	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Blood and lymphatic system disorders Anaemia	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	1.4% 2/145 • During the course of the study (48 weeks)	0.71% 1/140 • During the course of the study (48 weeks)
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Blood and lymphatic system disorders Leukopenia	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	1.9% 3/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Cardiac disorders Atrial fibrillation	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.71% 1/140 • During the course of the study (48 weeks)
Cardiac disorders Bradycardia	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Cardiac disorders Cardiac failure congestive	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.71% 1/140 • During the course of the study (48 weeks)
Cardiac disorders Cardio-respiratory arrest	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Congenital, familial and genetic disorders Keratosis follicular	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.71% 1/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Abdominal pain	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Ascites	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	1.4% 2/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Diarrhoea	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	1.4% 2/145 • During the course of the study (48 weeks)	1.4% 2/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Haematochezia	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Nausea	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Oral lichen planus	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Pancreatitis	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Pancreatitis acute	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Peritoneal haemorrhage	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Salivary gland calculus	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Vomiting	0.00% 0/78 • During the course of the study (48 weeks)	1.3% 2/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
General disorders Asthenia	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.71% 1/140 • During the course of the study (48 weeks)
General disorders Chest pain	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
General disorders Fatigue	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
General disorders Malaise	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.71% 1/140 • During the course of the study (48 weeks)
General disorders Pyrexia	0.00% 0/78 • During the course of the study (48 weeks)	1.9% 3/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	2.1% 3/145 • During the course of the study (48 weeks)	0.71% 1/140 • During the course of the study (48 weeks)
Hepatobiliary disorders Biliary colic	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Hepatobiliary disorders Cholelithiasis	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Hepatobiliary disorders Hepatic failure	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Hepatobiliary disorders Hepatorenal failure	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Hepatobiliary disorders Jaundice	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Infections and infestations Appendicitis	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.71% 1/140 • During the course of the study (48 weeks)
Infections and infestations Cellulitis	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Infections and infestations Gastroenteritis	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.71% 1/140 • During the course of the study (48 weeks)
Infections and infestations Gastroenteritis viral	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.71% 1/140 • During the course of the study (48 weeks)
Infections and infestations Peritonitis bacterial	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Infections and infestations Pneumonia	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Infections and infestations Sepsis	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Infections and infestations Streptococcal infection	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Infections and infestations Viral infection	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Injury, poisoning and procedural complications Fall	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Investigations Blood lactate dehydrogenase increased	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Investigations International normalised ratio abnormal	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.71% 1/140 • During the course of the study (48 weeks)
Metabolism and nutrition disorders Dehydration	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Musculoskeletal and connective tissue disorders Fasciitis	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Musculoskeletal and connective tissue disorders Joint instability	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.71% 1/140 • During the course of the study (48 weeks)
Nervous system disorders Coma	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Nervous system disorders Headache	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Nervous system disorders Presyncope	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Psychiatric disorders Anxiety	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Psychiatric disorders Depression	1.3% 1/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Psychiatric disorders Psychiatric decompensation	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Renal and urinary disorders Renal colic	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.71% 1/140 • During the course of the study (48 weeks)
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.3% 1/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Vascular disorders Hypertensive crisis	0.00% 0/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	0.00% 0/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)
Vascular disorders Hypotension	0.00% 0/78 • During the course of the study (48 weeks)	0.00% 0/156 • During the course of the study (48 weeks)	0.63% 1/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	0.00% 0/140 • During the course of the study (48 weeks)

Other adverse events

Other adverse events
Measure	Relapser & Partial: Placebo n=78 participants at risk Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Relapser & Partial: Faldaprevir 12 Weeks n=156 participants at risk Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Relapser & Partial: Faldaprevir 24 Weeks n=158 participants at risk Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Null:Faldaprevir 12 Weeks n=145 participants at risk Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Null:Faldaprevir 24 Weeks n=140 participants at risk Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Blood and lymphatic system disorders Anaemia	10.3% 8/78 • During the course of the study (48 weeks)	19.2% 30/156 • During the course of the study (48 weeks)	17.1% 27/158 • During the course of the study (48 weeks)	15.2% 22/145 • During the course of the study (48 weeks)	13.6% 19/140 • During the course of the study (48 weeks)
Blood and lymphatic system disorders Neutropenia	15.4% 12/78 • During the course of the study (48 weeks)	11.5% 18/156 • During the course of the study (48 weeks)	11.4% 18/158 • During the course of the study (48 weeks)	11.0% 16/145 • During the course of the study (48 weeks)	9.3% 13/140 • During the course of the study (48 weeks)
Blood and lymphatic system disorders Thrombocytopenia	3.8% 3/78 • During the course of the study (48 weeks)	2.6% 4/156 • During the course of the study (48 weeks)	3.8% 6/158 • During the course of the study (48 weeks)	9.0% 13/145 • During the course of the study (48 weeks)	2.1% 3/140 • During the course of the study (48 weeks)
Ear and labyrinth disorders Vertigo	3.8% 3/78 • During the course of the study (48 weeks)	2.6% 4/156 • During the course of the study (48 weeks)	2.5% 4/158 • During the course of the study (48 weeks)	4.1% 6/145 • During the course of the study (48 weeks)	6.4% 9/140 • During the course of the study (48 weeks)
Eye disorders Dry eye	6.4% 5/78 • During the course of the study (48 weeks)	3.8% 6/156 • During the course of the study (48 weeks)	4.4% 7/158 • During the course of the study (48 weeks)	2.8% 4/145 • During the course of the study (48 weeks)	3.6% 5/140 • During the course of the study (48 weeks)
Eye disorders Ocular icterus	0.00% 0/78 • During the course of the study (48 weeks)	5.1% 8/156 • During the course of the study (48 weeks)	3.8% 6/158 • During the course of the study (48 weeks)	4.1% 6/145 • During the course of the study (48 weeks)	1.4% 2/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Abdominal pain	2.6% 2/78 • During the course of the study (48 weeks)	5.1% 8/156 • During the course of the study (48 weeks)	8.9% 14/158 • During the course of the study (48 weeks)	4.8% 7/145 • During the course of the study (48 weeks)	9.3% 13/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Abdominal pain upper	5.1% 4/78 • During the course of the study (48 weeks)	10.3% 16/156 • During the course of the study (48 weeks)	9.5% 15/158 • During the course of the study (48 weeks)	7.6% 11/145 • During the course of the study (48 weeks)	10.7% 15/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Constipation	3.8% 3/78 • During the course of the study (48 weeks)	9.0% 14/156 • During the course of the study (48 weeks)	5.1% 8/158 • During the course of the study (48 weeks)	4.8% 7/145 • During the course of the study (48 weeks)	5.0% 7/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Diarrhoea	12.8% 10/78 • During the course of the study (48 weeks)	28.8% 45/156 • During the course of the study (48 weeks)	37.3% 59/158 • During the course of the study (48 weeks)	26.9% 39/145 • During the course of the study (48 weeks)	33.6% 47/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Dyspepsia	7.7% 6/78 • During the course of the study (48 weeks)	8.3% 13/156 • During the course of the study (48 weeks)	8.2% 13/158 • During the course of the study (48 weeks)	8.3% 12/145 • During the course of the study (48 weeks)	6.4% 9/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Gastrooesophageal reflux disease	6.4% 5/78 • During the course of the study (48 weeks)	1.9% 3/156 • During the course of the study (48 weeks)	0.00% 0/158 • During the course of the study (48 weeks)	2.1% 3/145 • During the course of the study (48 weeks)	4.3% 6/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Nausea	23.1% 18/78 • During the course of the study (48 weeks)	50.0% 78/156 • During the course of the study (48 weeks)	55.7% 88/158 • During the course of the study (48 weeks)	53.1% 77/145 • During the course of the study (48 weeks)	53.6% 75/140 • During the course of the study (48 weeks)
Gastrointestinal disorders Vomiting	6.4% 5/78 • During the course of the study (48 weeks)	26.3% 41/156 • During the course of the study (48 weeks)	29.7% 47/158 • During the course of the study (48 weeks)	31.7% 46/145 • During the course of the study (48 weeks)	26.4% 37/140 • During the course of the study (48 weeks)
General disorders Asthenia	26.9% 21/78 • During the course of the study (48 weeks)	17.9% 28/156 • During the course of the study (48 weeks)	17.7% 28/158 • During the course of the study (48 weeks)	16.6% 24/145 • During the course of the study (48 weeks)	20.0% 28/140 • During the course of the study (48 weeks)
General disorders Chills	6.4% 5/78 • During the course of the study (48 weeks)	5.8% 9/156 • During the course of the study (48 weeks)	8.9% 14/158 • During the course of the study (48 weeks)	0.69% 1/145 • During the course of the study (48 weeks)	5.7% 8/140 • During the course of the study (48 weeks)
General disorders Fatigue	20.5% 16/78 • During the course of the study (48 weeks)	34.0% 53/156 • During the course of the study (48 weeks)	37.3% 59/158 • During the course of the study (48 weeks)	31.0% 45/145 • During the course of the study (48 weeks)	33.6% 47/140 • During the course of the study (48 weeks)
General disorders Influenza like illness	19.2% 15/78 • During the course of the study (48 weeks)	17.9% 28/156 • During the course of the study (48 weeks)	18.4% 29/158 • During the course of the study (48 weeks)	18.6% 27/145 • During the course of the study (48 weeks)	16.4% 23/140 • During the course of the study (48 weeks)
General disorders Injection site erythema	5.1% 4/78 • During the course of the study (48 weeks)	0.64% 1/156 • During the course of the study (48 weeks)	1.9% 3/158 • During the course of the study (48 weeks)	2.8% 4/145 • During the course of the study (48 weeks)	2.9% 4/140 • During the course of the study (48 weeks)
General disorders Malaise	5.1% 4/78 • During the course of the study (48 weeks)	3.2% 5/156 • During the course of the study (48 weeks)	6.3% 10/158 • During the course of the study (48 weeks)	2.8% 4/145 • During the course of the study (48 weeks)	7.9% 11/140 • During the course of the study (48 weeks)
General disorders Pain	5.1% 4/78 • During the course of the study (48 weeks)	3.2% 5/156 • During the course of the study (48 weeks)	4.4% 7/158 • During the course of the study (48 weeks)	2.8% 4/145 • During the course of the study (48 weeks)	2.9% 4/140 • During the course of the study (48 weeks)
General disorders Pyrexia	17.9% 14/78 • During the course of the study (48 weeks)	15.4% 24/156 • During the course of the study (48 weeks)	15.8% 25/158 • During the course of the study (48 weeks)	17.9% 26/145 • During the course of the study (48 weeks)	27.1% 38/140 • During the course of the study (48 weeks)
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/78 • During the course of the study (48 weeks)	7.1% 11/156 • During the course of the study (48 weeks)	7.0% 11/158 • During the course of the study (48 weeks)	6.9% 10/145 • During the course of the study (48 weeks)	6.4% 9/140 • During the course of the study (48 weeks)
Hepatobiliary disorders Jaundice	1.3% 1/78 • During the course of the study (48 weeks)	18.6% 29/156 • During the course of the study (48 weeks)	17.1% 27/158 • During the course of the study (48 weeks)	11.0% 16/145 • During the course of the study (48 weeks)	11.4% 16/140 • During the course of the study (48 weeks)
Infections and infestations Influenza	5.1% 4/78 • During the course of the study (48 weeks)	2.6% 4/156 • During the course of the study (48 weeks)	3.8% 6/158 • During the course of the study (48 weeks)	2.8% 4/145 • During the course of the study (48 weeks)	0.71% 1/140 • During the course of the study (48 weeks)
Infections and infestations Nasopharyngitis	9.0% 7/78 • During the course of the study (48 weeks)	9.0% 14/156 • During the course of the study (48 weeks)	8.2% 13/158 • During the course of the study (48 weeks)	4.1% 6/145 • During the course of the study (48 weeks)	7.1% 10/140 • During the course of the study (48 weeks)
Investigations Haemoglobin decreased	2.6% 2/78 • During the course of the study (48 weeks)	3.8% 6/156 • During the course of the study (48 weeks)	2.5% 4/158 • During the course of the study (48 weeks)	6.2% 9/145 • During the course of the study (48 weeks)	7.1% 10/140 • During the course of the study (48 weeks)
Investigations Weight decreased	3.8% 3/78 • During the course of the study (48 weeks)	4.5% 7/156 • During the course of the study (48 weeks)	1.3% 2/158 • During the course of the study (48 weeks)	5.5% 8/145 • During the course of the study (48 weeks)	5.7% 8/140 • During the course of the study (48 weeks)
Metabolism and nutrition disorders Decreased appetite	12.8% 10/78 • During the course of the study (48 weeks)	21.2% 33/156 • During the course of the study (48 weeks)	20.3% 32/158 • During the course of the study (48 weeks)	18.6% 27/145 • During the course of the study (48 weeks)	25.7% 36/140 • During the course of the study (48 weeks)
Musculoskeletal and connective tissue disorders Arthralgia	9.0% 7/78 • During the course of the study (48 weeks)	9.0% 14/156 • During the course of the study (48 weeks)	13.3% 21/158 • During the course of the study (48 weeks)	6.9% 10/145 • During the course of the study (48 weeks)	10.7% 15/140 • During the course of the study (48 weeks)
Musculoskeletal and connective tissue disorders Back pain	10.3% 8/78 • During the course of the study (48 weeks)	9.0% 14/156 • During the course of the study (48 weeks)	7.6% 12/158 • During the course of the study (48 weeks)	3.4% 5/145 • During the course of the study (48 weeks)	5.0% 7/140 • During the course of the study (48 weeks)
Musculoskeletal and connective tissue disorders Muscle spasms	2.6% 2/78 • During the course of the study (48 weeks)	4.5% 7/156 • During the course of the study (48 weeks)	5.1% 8/158 • During the course of the study (48 weeks)	2.8% 4/145 • During the course of the study (48 weeks)	5.7% 8/140 • During the course of the study (48 weeks)
Musculoskeletal and connective tissue disorders Myalgia	10.3% 8/78 • During the course of the study (48 weeks)	12.8% 20/156 • During the course of the study (48 weeks)	12.0% 19/158 • During the course of the study (48 weeks)	10.3% 15/145 • During the course of the study (48 weeks)	12.9% 18/140 • During the course of the study (48 weeks)
Nervous system disorders Disturbance in attention	1.3% 1/78 • During the course of the study (48 weeks)	2.6% 4/156 • During the course of the study (48 weeks)	5.7% 9/158 • During the course of the study (48 weeks)	1.4% 2/145 • During the course of the study (48 weeks)	2.9% 4/140 • During the course of the study (48 weeks)
Nervous system disorders Dizziness	7.7% 6/78 • During the course of the study (48 weeks)	7.7% 12/156 • During the course of the study (48 weeks)	7.0% 11/158 • During the course of the study (48 weeks)	6.2% 9/145 • During the course of the study (48 weeks)	3.6% 5/140 • During the course of the study (48 weeks)
Nervous system disorders Dysgeusia	5.1% 4/78 • During the course of the study (48 weeks)	5.1% 8/156 • During the course of the study (48 weeks)	7.6% 12/158 • During the course of the study (48 weeks)	4.8% 7/145 • During the course of the study (48 weeks)	8.6% 12/140 • During the course of the study (48 weeks)
Nervous system disorders Headache	28.2% 22/78 • During the course of the study (48 weeks)	25.0% 39/156 • During the course of the study (48 weeks)	29.1% 46/158 • During the course of the study (48 weeks)	35.9% 52/145 • During the course of the study (48 weeks)	32.1% 45/140 • During the course of the study (48 weeks)
Psychiatric disorders Anxiety	3.8% 3/78 • During the course of the study (48 weeks)	5.8% 9/156 • During the course of the study (48 weeks)	7.6% 12/158 • During the course of the study (48 weeks)	3.4% 5/145 • During the course of the study (48 weeks)	7.9% 11/140 • During the course of the study (48 weeks)
Psychiatric disorders Depression	12.8% 10/78 • During the course of the study (48 weeks)	7.1% 11/156 • During the course of the study (48 weeks)	7.6% 12/158 • During the course of the study (48 weeks)	9.7% 14/145 • During the course of the study (48 weeks)	10.7% 15/140 • During the course of the study (48 weeks)
Psychiatric disorders Insomnia	16.7% 13/78 • During the course of the study (48 weeks)	23.1% 36/156 • During the course of the study (48 weeks)	22.2% 35/158 • During the course of the study (48 weeks)	12.4% 18/145 • During the course of the study (48 weeks)	20.7% 29/140 • During the course of the study (48 weeks)
Psychiatric disorders Sleep disorder	3.8% 3/78 • During the course of the study (48 weeks)	2.6% 4/156 • During the course of the study (48 weeks)	3.2% 5/158 • During the course of the study (48 weeks)	5.5% 8/145 • During the course of the study (48 weeks)	7.1% 10/140 • During the course of the study (48 weeks)
Respiratory, thoracic and mediastinal disorders Cough	20.5% 16/78 • During the course of the study (48 weeks)	16.0% 25/156 • During the course of the study (48 weeks)	17.1% 27/158 • During the course of the study (48 weeks)	15.9% 23/145 • During the course of the study (48 weeks)	17.1% 24/140 • During the course of the study (48 weeks)
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.0% 7/78 • During the course of the study (48 weeks)	10.3% 16/156 • During the course of the study (48 weeks)	10.1% 16/158 • During the course of the study (48 weeks)	5.5% 8/145 • During the course of the study (48 weeks)	5.0% 7/140 • During the course of the study (48 weeks)
Respiratory, thoracic and mediastinal disorders Epistaxis	5.1% 4/78 • During the course of the study (48 weeks)	3.2% 5/156 • During the course of the study (48 weeks)	1.9% 3/158 • During the course of the study (48 weeks)	2.8% 4/145 • During the course of the study (48 weeks)	2.1% 3/140 • During the course of the study (48 weeks)
Skin and subcutaneous tissue disorders Alopecia	5.1% 4/78 • During the course of the study (48 weeks)	10.3% 16/156 • During the course of the study (48 weeks)	10.1% 16/158 • During the course of the study (48 weeks)	5.5% 8/145 • During the course of the study (48 weeks)	9.3% 13/140 • During the course of the study (48 weeks)
Skin and subcutaneous tissue disorders Dry skin	15.4% 12/78 • During the course of the study (48 weeks)	18.6% 29/156 • During the course of the study (48 weeks)	18.4% 29/158 • During the course of the study (48 weeks)	13.1% 19/145 • During the course of the study (48 weeks)	22.1% 31/140 • During the course of the study (48 weeks)
Skin and subcutaneous tissue disorders Erythema	5.1% 4/78 • During the course of the study (48 weeks)	5.1% 8/156 • During the course of the study (48 weeks)	5.7% 9/158 • During the course of the study (48 weeks)	7.6% 11/145 • During the course of the study (48 weeks)	8.6% 12/140 • During the course of the study (48 weeks)
Skin and subcutaneous tissue disorders Pruritus	29.5% 23/78 • During the course of the study (48 weeks)	34.6% 54/156 • During the course of the study (48 weeks)	38.6% 61/158 • During the course of the study (48 weeks)	32.4% 47/145 • During the course of the study (48 weeks)	45.0% 63/140 • During the course of the study (48 weeks)
Skin and subcutaneous tissue disorders Rash	20.5% 16/78 • During the course of the study (48 weeks)	23.7% 37/156 • During the course of the study (48 weeks)	27.8% 44/158 • During the course of the study (48 weeks)	26.2% 38/145 • During the course of the study (48 weeks)	29.3% 41/140 • During the course of the study (48 weeks)
Psychiatric disorders Irritability	14.1% 11/78 • During the course of the study (48 weeks)	6.4% 10/156 • During the course of the study (48 weeks)	10.1% 16/158 • During the course of the study (48 weeks)	6.9% 10/145 • During the course of the study (48 weeks)	9.3% 13/140 • During the course of the study (48 weeks)

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

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 BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER