Trial Outcomes & Findings for A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C (NCT NCT01591460)

Last Updated: 2016-11-02

Results Overview

SVR at 12 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 12 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower limit of detection (LOD) of 10 to 15 international units per milliliter (IU/mL). The percentage of participants with SVR was calculated as \[number of participants with undetectable HCV RNA at 12 weeks after EOT divided by the number of participants analyzed\] multiplied by 100.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

165 participants

Primary outcome timeframe

At 12 weeks after EOT (up to 60 weeks)

Results posted on

2016-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Total Population Treatment-naive participants with chronic hepatitis C (CHC) received treatment with peginterferon alfa-2a (PEG-IFN) 180 micrograms (mcg) subcutaneous (SC) once weekly, weight-based ribavirin (RBV) 1000 to 1200 milligrams (mg) orally (PO) daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a less than (\<) 1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
Overall Study STARTED	165
Overall Study COMPLETED	139
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Total Population Treatment-naive participants with chronic hepatitis C (CHC) received treatment with peginterferon alfa-2a (PEG-IFN) 180 micrograms (mcg) subcutaneous (SC) once weekly, weight-based ribavirin (RBV) 1000 to 1200 milligrams (mg) orally (PO) daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a less than (\<) 1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
Overall Study Adverse Event or Intercurrent Illness	5
Overall Study Futility Rule (Week 12)	7
Overall Study Futility Rule (Week 24)	3
Overall Study Rebound or Breakthrough	3
Overall Study Treatment Discontinued by Error	1
Overall Study Lost to Follow-up	1
Overall Study Noncompliance	1
Overall Study Participant Refusal	3
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	1

Baseline Characteristics

A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Population n=165 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
Age, Continuous	45.8 years STANDARD_DEVIATION 12.53 • n=5 Participants
Gender Female	83 Participants n=5 Participants
Gender Male	82 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 12 weeks after EOT (up to 60 weeks)

Population: All-Treated Population. Arms were not mutually exclusive.

Outcome measures

Outcome measures
Measure	Total Population n=165 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics n=20 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders n=78 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others n=19 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT)	81 percentage of participants Interval 74.0 to 86.0	70 percentage of participants Interval 46.0 to 88.0	75 percentage of participants Interval 53.0 to 90.0	88 percentage of participants Interval 68.0 to 97.0	95 percentage of participants Interval 87.0 to 99.0	32 percentage of participants Interval 13.0 to 57.0

SECONDARY outcome

Timeframe: At 24 weeks after EOT (up to 72 weeks)

Population: All-Treated Population. Arms were not mutually exclusive.

SVR at 24 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 24 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with SVR was calculated as \[number of participants with undetectable HCV RNA at 24 weeks after EOT divided by the number of participants analyzed\] multiplied by 100.

Outcome measures

Outcome measures
Measure	Total Population n=165 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics n=20 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders n=78 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others n=19 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
Percentage of Participants With SVR at 24 Weeks After EOT	80 percentage of participants Interval 73.0 to 86.0	70 percentage of participants Interval 46.0 to 88.0	71 percentage of participants Interval 49.0 to 87.0	88 percentage of participants Interval 68.0 to 97.0	95 percentage of participants Interval 87.0 to 99.0	32 percentage of participants Interval 13.0 to 57.0

SECONDARY outcome

Timeframe: At Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; EOT; and 12 and 24 weeks after EOT (up to 72 weeks)

Population: All-Treated Population; number (n) = number of participants who provided evaluable data at the respective visit. Arms were not mutually exclusive.

HCV RNA levels were obtained routinely during and after treatment. Mean HCV RNA levels were calculated by averaging the HCV RNA levels among all participants analyzed at each collection timepoint and expressed in log10 IU/mL.

Outcome measures

Outcome measures
Measure	Total Population n=165 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics n=20 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders n=78 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others n=19 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
HCV RNA Levels Week 28 (n=143,15,19,23,76,10)	1.23 log10 IU/mL Standard Deviation 0.480	1.18 log10 IU/mL Standard Deviation 0.000	1.45 log10 IU/mL Standard Deviation 1.173	1.18 log10 IU/mL Standard Deviation 0.000	1.18 log10 IU/mL Standard Deviation 0.025	1.48 log10 IU/mL Standard Deviation 0.822
HCV RNA Levels Week 36 (n=71,16,21,24,3,7)	1.69 log10 IU/mL Standard Deviation 1.563	1.54 log10 IU/mL Standard Deviation 1.412	2.00 log10 IU/mL Standard Deviation 2.069	1.33 log10 IU/mL Standard Deviation 0.745	2.60 log10 IU/mL Standard Deviation 2.466	1.91 log10 IU/mL Standard Deviation 1.930
HCV RNA Levels EOT (n=162,20,24,23,78,17)	1.52 log10 IU/mL Standard Deviation 1.120	1.58 log10 IU/mL Standard Deviation 1.167	1.87 log10 IU/mL Standard Deviation 1.563	1.38 log10 IU/mL Standard Deviation 0.996	1.18 log10 IU/mL Standard Deviation 0.025	2.73 log10 IU/mL Standard Deviation 1.943
HCV RNA Levels Week 4 (n=158,20,24,22,75,17)	4.06 log10 IU/mL Standard Deviation 1.525	4.30 log10 IU/mL Standard Deviation 1.533	5.78 log10 IU/mL Standard Deviation 0.550	4.60 log10 IU/mL Standard Deviation 0.874	3.25 log10 IU/mL Standard Deviation 1.289	4.24 log10 IU/mL Standard Deviation 1.689
HCV RNA Levels Week 6 (n=151,18,24,21,73,15)	1.75 log10 IU/mL Standard Deviation 0.882	2.01 log10 IU/mL Standard Deviation 1.002	2.70 log10 IU/mL Standard Deviation 0.972	1.91 log10 IU/mL Standard Deviation 0.570	1.25 log10 IU/mL Standard Deviation 0.154	2.18 log10 IU/mL Standard Deviation 1.337
HCV RNA Levels Week 8 (n=160,20,24,24,77,15)	1.47 log10 IU/mL Standard Deviation 0.638	1.69 log10 IU/mL Standard Deviation 0.650	1.95 log10 IU/mL Standard Deviation 0.874	1.52 log10 IU/mL Standard Deviation 0.329	1.18 log10 IU/mL Standard Deviation 0.000	1.84 log10 IU/mL Standard Deviation 1.236
HCV RNA Levels Baseline (n=165,20,24,24,78,19)	6.29 log10 IU/mL Standard Deviation 0.722	6.34 log10 IU/mL Standard Deviation 0.710	6.40 log10 IU/mL Standard Deviation 0.592	6.46 log10 IU/mL Standard Deviation 0.530	6.18 log10 IU/mL Standard Deviation 0.796	6.34 log10 IU/mL Standard Deviation 0.762
HCV RNA Levels Week 2 (n=159,18,24,23,76,18)	4.86 log10 IU/mL Standard Deviation 1.418	5.06 log10 IU/mL Standard Deviation 1.288	6.07 log10 IU/mL Standard Deviation 0.610	5.38 log10 IU/mL Standard Deviation 0.767	4.27 log10 IU/mL Standard Deviation 1.441	4.90 log10 IU/mL Standard Deviation 1.597
HCV RNA Levels Week 12 (n=160,20,24,24,77,15)	1.35 log10 IU/mL Standard Deviation 0.682	1.41 log10 IU/mL Standard Deviation 0.393	1.69 log10 IU/mL Standard Deviation 1.316	1.25 log10 IU/mL Standard Deviation 0.107	1.18 log10 IU/mL Standard Deviation 0.000	1.74 log10 IU/mL Standard Deviation 1.292
HCV RNA Levels Week 16 (n=156,19,22,24,78,13)	1.25 log10 IU/mL Standard Deviation 0.405	1.34 log10 IU/mL Standard Deviation 0.459	1.46 log10 IU/mL Standard Deviation 0.906	1.19 log10 IU/mL Standard Deviation 0.045	1.18 log10 IU/mL Standard Deviation 0.000	1.32 log10 IU/mL Standard Deviation 0.458
HCV RNA Levels Week 24 (n=152,17,23,24,78,10)	1.41 log10 IU/mL Standard Deviation 1.042	1.80 log10 IU/mL Standard Deviation 1.753	1.83 log10 IU/mL Standard Deviation 1.696	1.18 log10 IU/mL Standard Deviation 0.000	1.18 log10 IU/mL Standard Deviation 0.000	2.21 log10 IU/mL Standard Deviation 1.916
HCV RNA Levels 12 weeks after EOT (n=152,19,24,23,74,12)	1.92 log10 IU/mL Standard Deviation 1.792	2.53 log10 IU/mL Standard Deviation 2.340	2.48 log10 IU/mL Standard Deviation 2.345	1.48 log10 IU/mL Standard Deviation 1.087	1.40 log10 IU/mL Standard Deviation 0.946	3.83 log10 IU/mL Standard Deviation 2.789
HCV RNA Levels 24 weeks after EOT (n=159,20,23,24,78,14)	2.00 log10 IU/mL Standard Deviation 1.874	2.66 log10 IU/mL Standard Deviation 2.351	2.39 log10 IU/mL Standard Deviation 2.327	1.77 log10 IU/mL Standard Deviation 1.605	1.42 log10 IU/mL Standard Deviation 1.053	4.05 log10 IU/mL Standard Deviation 2.592

SECONDARY outcome

Timeframe: At Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT (up to 48 weeks)

Population: All-Treated Population. Arms were not mutually exclusive.

HCV RNA levels were obtained routinely during and after treatment. The percentage of participants with undetectable HCV RNA viral load (ie, virological response) was calculated as \[number of participants with undetectable HCV RNA at each timepoint divided by the number of participants analyzed\] multiplied by 100.

Outcome measures

Outcome measures
Measure	Total Population n=165 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics n=20 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders n=78 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others n=19 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
Percentage of Participants With Virological Response Week 2	4 percentage of participants Interval 1.0 to 8.0	0 percentage of participants Interval 0.0 to 17.0	0 percentage of participants Interval 0.0 to 14.0	0 percentage of participants Interval 0.0 to 14.0	6 percentage of participants Interval 2.0 to 14.0	5 percentage of participants Interval 0.0 to 26.0
Percentage of Participants With Virological Response Week 8	61 percentage of participants Interval 53.0 to 68.0	45 percentage of participants Interval 23.0 to 68.0	13 percentage of participants Interval 3.0 to 32.0	0 percentage of participants Interval 0.0 to 14.0	100 percentage of participants Interval 95.0 to 100.0	53 percentage of participants Interval 29.0 to 76.0
Percentage of Participants With Virological Response Week 12	82 percentage of participants Interval 75.0 to 87.0	65 percentage of participants Interval 41.0 to 85.0	75 percentage of participants Interval 53.0 to 90.0	67 percentage of participants Interval 45.0 to 84.0	100 percentage of participants Interval 95.0 to 100.0	53 percentage of participants Interval 29.0 to 76.0
Percentage of Participants With Virological Response EOT	87 percentage of participants Interval 81.0 to 92.0	80 percentage of participants Interval 56.0 to 94.0	79 percentage of participants Interval 58.0 to 93.0	96 percentage of participants Interval 79.0 to 100.0	99 percentage of participants Interval 93.0 to 100.0	47 percentage of participants Interval 24.0 to 71.0
Percentage of Participants With Virological Response Week 4	7 percentage of participants Interval 4.0 to 12.0	0 percentage of participants Interval 0.0 to 17.0	0 percentage of participants Interval 0.0 to 14.0	0 percentage of participants Interval 0.0 to 14.0	14 percentage of participants Interval 7.0 to 24.0	5 percentage of participants Interval 0.0 to 26.0
Percentage of Participants With Virological Response Week 6	41 percentage of participants Interval 34.0 to 49.0	35 percentage of participants Interval 15.0 to 59.0	0 percentage of participants Interval 0.0 to 14.0	4 percentage of participants Interval 0.0 to 21.0	71 percentage of participants Interval 59.0 to 80.0	26 percentage of participants Interval 9.0 to 51.0
Percentage of Participants With Virological Response Week 16	87 percentage of participants Interval 81.0 to 91.0	70 percentage of participants Interval 46.0 to 88.0	71 percentage of participants Interval 49.0 to 87.0	96 percentage of participants Interval 79.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	58 percentage of participants Interval 33.0 to 80.0
Percentage of Participants With Virological Response Week 24	88 percentage of participants Interval 82.0 to 92.0	80 percentage of participants Interval 56.0 to 94.0	79 percentage of participants Interval 58.0 to 93.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	42 percentage of participants Interval 20.0 to 67.0
Percentage of Participants With Virological Response Week 28	87 percentage of participants Interval 81.0 to 91.0	80 percentage of participants Interval 56.0 to 94.0	79 percentage of participants Interval 58.0 to 93.0	96 percentage of participants Interval 79.0 to 100.0	99 percentage of participants Interval 93.0 to 100.0	42 percentage of participants Interval 20.0 to 67.0
Percentage of Participants With Virological Response Week 36	83 percentage of participants Interval 76.0 to 88.0	75 percentage of participants Interval 51.0 to 91.0	75 percentage of participants Interval 53.0 to 90.0	96 percentage of participants Interval 79.0 to 100.0	95 percentage of participants Interval 87.0 to 99.0	37 percentage of participants Interval 16.0 to 62.0

SECONDARY outcome

Timeframe: At Weeks 2, 4, 6, 8, 12, 16, 24, and 28

Population: All-Treated Population. Arms were not mutually exclusive.

HCV RNA levels were obtained routinely during and after treatment. Reductions in HCV RNA viral load by 1-log, 2-log, or 3-log increments were determined relative to Baseline HCV RNA. Each increment represents a reduction greater than or equal to (≥) the specified log value, including results for which HCV RNA was below the limit of quantification (25 IU/mL). The percentage of participants with each log reduction in HCV RNA was calculated as \[number of participants with log reduction divided by the number of participants analyzed\] multiplied by 100.

Outcome measures

Outcome measures
Measure	Total Population n=165 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics n=20 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders n=78 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others n=19 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 3-log, Week 4	29 percentage of participants Interval 22.0 to 37.0	20 percentage of participants Interval 6.0 to 44.0	0 percentage of participants Interval 0.0 to 14.0	8 percentage of participants Interval 1.0 to 27.0	47 percentage of participants Interval 36.0 to 59.0	26 percentage of participants Interval 9.0 to 51.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 3-log, Week 6	88 percentage of participants Interval 82.0 to 92.0	85 percentage of participants Interval 62.0 to 97.0	75 percentage of participants Interval 53.0 to 90.0	92 percentage of participants Interval 73.0 to 99.0	97 percentage of participants Interval 91.0 to 100.0	63 percentage of participants Interval 38.0 to 84.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 3-log, Week 8	93 percentage of participants Interval 88.0 to 97.0	95 percentage of participants Interval 75.0 to 100.0	83 percentage of participants Interval 63.0 to 95.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	68 percentage of participants Interval 43.0 to 87.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 3-log, Week 12	95 percentage of participants Interval 91.0 to 98.0	100 percentage of participants Interval 83.0 to 100.0	88 percentage of participants Interval 68.0 to 97.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	74 percentage of participants Interval 49.0 to 91.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 3-log, Week 16	94 percentage of participants Interval 89.0 to 97.0	95 percentage of participants Interval 75.0 to 100.0	88 percentage of participants Interval 68.0 to 97.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	68 percentage of participants Interval 43.0 to 87.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 3-log, Week 28	88 percentage of participants Interval 83.0 to 93.0	80 percentage of participants Interval 56.0 to 94.0	79 percentage of participants Interval 58.0 to 93.0	96 percentage of participants Interval 79.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	53 percentage of participants Interval 29.0 to 76.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 2-log, Week 4	51 percentage of participants Interval 43.0 to 59.0	50 percentage of participants Interval 27.0 to 73.0	0 percentage of participants Interval 0.0 to 14.0	33 percentage of participants Interval 16.0 to 55.0	76 percentage of participants Interval 65.0 to 85.0	37 percentage of participants Interval 16.0 to 62.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 2-log, Week 6	95 percentage of participants Interval 90.0 to 97.0	95 percentage of participants Interval 75.0 to 100.0	96 percentage of participants Interval 79.0 to 100.0	96 percentage of participants Interval 79.0 to 100.0	99 percentage of participants Interval 93.0 to 100.0	74 percentage of participants Interval 49.0 to 91.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 2-log, Week 8	97 percentage of participants Interval 93.0 to 99.0	100 percentage of participants Interval 83.0 to 100.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	74 percentage of participants Interval 49.0 to 91.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 2-log, Week 12	95 percentage of participants Interval 91.0 to 98.0	100 percentage of participants Interval 83.0 to 100.0	88 percentage of participants Interval 68.0 to 97.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	74 percentage of participants Interval 49.0 to 91.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 2-log, Week 16	94 percentage of participants Interval 89.0 to 97.0	95 percentage of participants Interval 75.0 to 100.0	88 percentage of participants Interval 68.0 to 97.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	68 percentage of participants Interval 43.0 to 87.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 2-log, Week 24	90 percentage of participants Interval 84.0 to 94.0	80 percentage of participants Interval 56.0 to 94.0	83 percentage of participants Interval 63.0 to 95.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	53 percentage of participants Interval 29.0 to 76.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 2-log, Week 28	88 percentage of participants Interval 83.0 to 93.0	80 percentage of participants Interval 56.0 to 94.0	79 percentage of participants Interval 58.0 to 93.0	96 percentage of participants Interval 79.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	53 percentage of participants Interval 29.0 to 76.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 1-log, Week 2	55 percentage of participants Interval 47.0 to 62.0	60 percentage of participants Interval 36.0 to 81.0	0 percentage of participants Interval 0.0 to 14.0	54 percentage of participants Interval 33.0 to 74.0	73 percentage of participants Interval 62.0 to 82.0	42 percentage of participants Interval 20.0 to 67.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 1-log, Week 4	81 percentage of participants Interval 74.0 to 86.0	75 percentage of participants Interval 51.0 to 91.0	0 percentage of participants Interval 0.0 to 14.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	84 percentage of participants Interval 60.0 to 97.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 1-log, Week 6	98 percentage of participants Interval 94.0 to 99.0	95 percentage of participants Interval 75.0 to 100.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	84 percentage of participants Interval 60.0 to 97.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 1-log, Week 12	96 percentage of participants Interval 92.0 to 99.0	100 percentage of participants Interval 83.0 to 100.0	96 percentage of participants Interval 79.0 to 100.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	74 percentage of participants Interval 49.0 to 91.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 1-log, Week 28	88 percentage of participants Interval 83.0 to 93.0	80 percentage of participants Interval 56.0 to 94.0	79 percentage of participants Interval 58.0 to 93.0	96 percentage of participants Interval 79.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	53 percentage of participants Interval 29.0 to 76.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 1-log, Week 16	94 percentage of participants Interval 89.0 to 97.0	95 percentage of participants Interval 75.0 to 100.0	88 percentage of participants Interval 68.0 to 97.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	68 percentage of participants Interval 43.0 to 87.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 1-log, Week 24	91 percentage of participants Interval 85.0 to 95.0	80 percentage of participants Interval 56.0 to 94.0	88 percentage of participants Interval 68.0 to 97.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	58 percentage of participants Interval 33.0 to 80.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 3-log, Week 2	12 percentage of participants Interval 7.0 to 17.0	5 percentage of participants Interval 0.0 to 25.0	0 percentage of participants Interval 0.0 to 14.0	0 percentage of participants Interval 0.0 to 14.0	19 percentage of participants Interval 11.0 to 30.0	16 percentage of participants Interval 3.0 to 40.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 3-log, Week 24	90 percentage of participants Interval 84.0 to 94.0	80 percentage of participants Interval 56.0 to 94.0	83 percentage of participants Interval 63.0 to 95.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	53 percentage of participants Interval 29.0 to 76.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 2-log, Week 2	27 percentage of participants Interval 20.0 to 34.0	20 percentage of participants Interval 6.0 to 44.0	0 percentage of participants Interval 0.0 to 14.0	8 percentage of participants Interval 1.0 to 27.0	42 percentage of participants Interval 31.0 to 54.0	26 percentage of participants Interval 9.0 to 51.0
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA 1-log, Week 8	98 percentage of participants Interval 95.0 to 100.0	100 percentage of participants Interval 83.0 to 100.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 86.0 to 100.0	100 percentage of participants Interval 95.0 to 100.0	84 percentage of participants Interval 60.0 to 97.0

SECONDARY outcome

Timeframe: Up to 72 weeks (at 12 and 24 weeks after EOT)

Population: All-Treated Population; only participants with a previous EOT virological response were included in the analysis. Arms were not mutually exclusive.

Virological relapse was defined as a detectable post-treatment HCV RNA viral load following a previously undetectable EOT level (ie, virological response). The percentage of participants with virological relapse was calculated as \[number of participants meeting the above criteria divided by the number of participants analyzed\] multiplied by 100.

Outcome measures

Outcome measures
Measure	Total Population n=143 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics n=16 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders n=19 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders n=23 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders n=77 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others n=8 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
Percentage of Participants With Virological Relapse Following EOT Response	7 percentage of participants Interval 3.0 to 12.0	13 percentage of participants Interval 2.0 to 38.0	5 percentage of participants Interval 0.0 to 26.0	9 percentage of participants Interval 1.0 to 28.0	4 percentage of participants Interval 1.0 to 11.0	25 percentage of participants Interval 3.0 to 65.0

SECONDARY outcome

Timeframe: Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)

Population: All-Treated Population; only participants with a previous on-treatment virological response were included in the analysis. Arms were not mutually exclusive.

Virological breakthrough was defined as an HCV RNA viral load greater than (\>) 1000 IU/mL following a previously undetectable level at any time during treatment (ie, virological response). Participants who ultimately achieved an EOT response were not considered for virological breakthrough. The percentage of participants with virological breakthrough was calculated as \[number of participants meeting the above criteria divided by the number of participants analyzed\] multiplied by 100.

Outcome measures

Outcome measures
Measure	Total Population n=151 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics n=17 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders n=19 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders n=78 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others n=13 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
Percentage of Participants With Virological Breakthrough Following On-Treatment Response	3 percentage of participants Interval 1.0 to 7.0	0 percentage of participants Interval 0.0 to 20.0	0 percentage of participants Interval 0.0 to 18.0	4 percentage of participants Interval 0.0 to 21.0	0 percentage of participants Interval 0.0 to 5.0	23 percentage of participants Interval 5.0 to 54.0

SECONDARY outcome

Timeframe: Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)

Population: All-Treated Population; only participants with a previous on-treatment decline in HCV RNA were included in the analysis. Arms were not mutually exclusive.

Virological rebound was defined as an HCV RNA viral load \>1000 IU/mL and a ≥1-log increase from nadir following a decline in HCV RNA from Baseline at any time during treatment (ie, on-treatment decline). Participants who ultimately achieved an EOT response were not considered for virological rebound. The percentage of participants with virological rebound was calculated as \[number of participants meeting the above criteria divided by the number of participants analyzed\] multiplied by 100.

Outcome measures

Outcome measures
Measure	Total Population n=164 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics n=20 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders n=78 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others n=18 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA	6 percentage of participants Interval 3.0 to 11.0	5 percentage of participants Interval 0.0 to 25.0	17 percentage of participants Interval 5.0 to 37.0	4 percentage of participants Interval 0.0 to 21.0	0 percentage of participants Interval 0.0 to 5.0	22 percentage of participants Interval 6.0 to 48.0

SECONDARY outcome

Timeframe: At 12 and 24 weeks

Population: All-Treated Population. Arms were not mutually exclusive.

Treatment was to be discontinued for participants who met prespecified criteria, termed the futility rule, after 12 or 24 weeks of treatment. Participants were discontinued from treatment for one of the following reasons: HCV RNA viral load ≥100 IU/mL (Week 12) or a detectable HCV RNA viral load (Week 24). HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with treatment discontinued for each reason was calculated as \[number of participants meeting one of the above criteria divided by the number of participants analyzed\] multiplied by 100.

Outcome measures

Outcome measures
Measure	Total Population n=165 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics n=20 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders n=78 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others n=19 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA Week 12	4 percentage of participants	10 percentage of participants	13 percentage of participants	0 percentage of participants	0 percentage of participants	11 percentage of participants
Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA Week 24	3 percentage of participants	5 percentage of participants	8 percentage of participants	0 percentage of participants	0 percentage of participants	11 percentage of participants

SECONDARY outcome

Timeframe: Up to 48 weeks (from Baseline until EOT)

Population: Safety Population: All participants who received at least one dose of study medication and had at least one post-baseline safety assessment; n = number of participants who received the respective study medication. Arms were not mutually exclusive.

The duration of treatment with each study drug was determined as the time from treatment start until the last dose of PEG-IFN, RBV, or boceprevir. Median duration of treatment was determined using the actual duration of treatment among individual participants and expressed in weeks.

Outcome measures

Outcome measures
Measure	Total Population n=165 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics n=20 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders n=78 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others n=19 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
Duration of Treatment With PEG-IFN, RBV, and Boceprevir PEG-IFN (n=165,20,24,24,78,19)	28.0 weeks Interval 1.0 to 49.0	48.0 weeks Interval 14.0 to 48.0	48.0 weeks Interval 13.0 to 49.0	48.0 weeks Interval 32.0 to 48.0	28.0 weeks Interval 24.0 to 32.0	26.0 weeks Interval 1.0 to 48.0
Duration of Treatment With PEG-IFN, RBV, and Boceprevir RBV (n=165,20,24,24,78,19)	28.0 weeks Interval 1.0 to 49.0	48.0 weeks Interval 13.0 to 48.0	48.0 weeks Interval 14.0 to 49.0	48.0 weeks Interval 30.0 to 49.0	28.0 weeks Interval 10.0 to 33.0	27.0 weeks Interval 1.0 to 48.0
Duration of Treatment With PEG-IFN, RBV, and Boceprevir Boceprevir (n=164,20,24,24,78,18)	24.0 weeks Interval 1.0 to 45.0	44.0 weeks Interval 8.0 to 44.0	44.0 weeks Interval 10.0 to 45.0	32.0 weeks Interval 2.0 to 33.0	24.0 weeks Interval 6.0 to 25.0	10.0 weeks Interval 1.0 to 44.0

SECONDARY outcome

Timeframe: Up to 48 weeks (from Baseline until EOT)

Population: Safety Population; n = number of participants who received the respective study medication. Arms were not mutually exclusive.

Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Adverse event (AE)-related reasons were documented, as well as reasons related to insufficient efficacy ('Poor efficacy') or other safety-related reasons ('Safety/other'). The percentage of participants with a dose modification documented for each reason was calculated as \[number of participants with dose modification divided by the number of participants analyzed\] multiplied by 100.

Outcome measures

Outcome measures
Measure	Total Population n=165 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics n=20 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders n=78 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others n=19 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason PEG-IFN, Any reason (n=165,20,24,24,78,19)	52 percentage of participants	60 percentage of participants	54 percentage of participants	46 percentage of participants	42 percentage of participants	84 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason PEG-IFN, Anemia (n=165,20,24,24,78,19)	1 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	1 percentage of participants	5 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason PEG-IFN, Nausea/vomiting (n=165,20,24,24,78,19)	0.6 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	1 percentage of participants	0 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason PEG-IFN, Neutropenia (n=165,20,24,24,78,19)	36 percentage of participants	30 percentage of participants	38 percentage of participants	33 percentage of participants	36 percentage of participants	47 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason PEG-IFN, Thrombocytopenia (n=165,20,24,24,78,19)	5 percentage of participants	35 percentage of participants	4 percentage of participants	0 percentage of participants	1 percentage of participants	0 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason PEG-IFN, Safety/other (n=165,20,24,24,78,19)	4 percentage of participants	10 percentage of participants	4 percentage of participants	13 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason PEG-IFN, Poor efficacy (n=165,20,24,24,78,19)	8 percentage of participants	15 percentage of participants	21 percentage of participants	4 percentage of participants	0 percentage of participants	21 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason PEG-IFN, Not specified (n=165,20,24,24,78,19)	12 percentage of participants	0 percentage of participants	8 percentage of participants	13 percentage of participants	8 percentage of participants	42 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason RBV, Any reason (n=165,20,24,24,78,19)	64 percentage of participants	65 percentage of participants	67 percentage of participants	46 percentage of participants	62 percentage of participants	89 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason RBV, Asthenia (n=165,20,24,24,78,19)	0.6 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	1 percentage of participants	0 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason RBV, Nausea/vomiting (n=165,20,24,24,78,19)	1 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	11 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason RBV, Neutropenia (n=165,20,24,24,78,19)	3 percentage of participants	0 percentage of participants	0 percentage of participants	4 percentage of participants	0 percentage of participants	21 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason RBV, Rash (n=165,20,24,24,78,19)	1 percentage of participants	5 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	5 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason RBV, Safety/other (n=165,20,24,24,78,19)	8 percentage of participants	15 percentage of participants	8 percentage of participants	13 percentage of participants	3 percentage of participants	16 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason RBV, Poor efficacy (n=165,20,24,24,78,19)	8 percentage of participants	15 percentage of participants	21 percentage of participants	4 percentage of participants	0 percentage of participants	21 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason RBV, Not specified (n=165,20,24,24,78,19)	11 percentage of participants	0 percentage of participants	8 percentage of participants	8 percentage of participants	8 percentage of participants	42 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason Boceprevir, Any reason (n=164,20,24,24,78,18)	28 percentage of participants	45 percentage of participants	29 percentage of participants	21 percentage of participants	12 percentage of participants	89 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason Boceprevir, Anemia (n=164,20,24,24,78,18)	2 percentage of participants	10 percentage of participants	0 percentage of participants	4 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason Boceprevir, Asthenia (n=164,20,24,24,78,18)	0.6 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	1 percentage of participants	0 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason Boceprevir, Nausea/vomiting (n=164,20,24,24,78,18)	1 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	11 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason Boceprevir, Neutropenia (n=164,20,24,24,78,18)	4 percentage of participants	0 percentage of participants	0 percentage of participants	4 percentage of participants	0 percentage of participants	28 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason Boceprevir, Rash (n=164,20,24,24,78,18)	1 percentage of participants	5 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	6 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason Boceprevir, Safety/other (n=164,20,24,24,78,18)	4 percentage of participants	10 percentage of participants	0 percentage of participants	4 percentage of participants	0 percentage of participants	17 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason Boceprevir, Poor efficacy (n=164,20,24,24,78,18)	7 percentage of participants	15 percentage of participants	21 percentage of participants	0 percentage of participants	0 percentage of participants	17 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason Boceprevir, Not specified (n=164,20,24,24,78,18)	12 percentage of participants	10 percentage of participants	8 percentage of participants	8 percentage of participants	10 percentage of participants	28 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason PEG-IFN, Asthenia (n=165,20,24,24,78,19)	1 percentage of participants	0 percentage of participants	4 percentage of participants	4 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason PEG-IFN, Rash (n=165,20,24,24,78,19)	0.6 percentage of participants	5 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason RBV, Anemia (n=165,20,24,24,78,19)	46 percentage of participants	50 percentage of participants	46 percentage of participants	38 percentage of participants	53 percentage of participants	26 percentage of participants

SECONDARY outcome

Timeframe: Up to 48 weeks (from Baseline until EOT)

Population: Safety Population; only participants providing evaluable data were included in the analysis. Arms were not mutually exclusive.

The frequency of missed treatments was examined using the number of administrations received as a percentage of target administrations for each study drug. The maximum number of possible administrations was considered in terms of once-weekly injections with PEG-IFN and in terms of treatment days with RBV and boceprevir. The percentage of target administrations each participant received was separated into ranges of \<60%, 60 to \<80%, 80 to \<95%, and ≥95% for each study drug. The percentage of participants who received each range of target administrations was calculated as \[number of participants in each range divided by the number of participants analyzed\] multiplied by 100.

Outcome measures

Outcome measures
Measure	Total Population n=146 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics n=20 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders n=24 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders n=78 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir PEG-IFN, <60%	8 percentage of participants	25 percentage of participants	25 percentage of participants	0 percentage of participants	0 percentage of participants	—
Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir PEG-IFN, 60 to <80%	0.7 percentage of participants	0 percentage of participants	0 percentage of participants	4 percentage of participants	0 percentage of participants	—
Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir PEG-IFN, 80 to <95%	5 percentage of participants	5 percentage of participants	0 percentage of participants	17 percentage of participants	4 percentage of participants	—
Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir PEG-IFN, 95% or more	86 percentage of participants	70 percentage of participants	75 percentage of participants	79 percentage of participants	96 percentage of participants	—
Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir RBV, <60%	9 percentage of participants	25 percentage of participants	25 percentage of participants	4 percentage of participants	1 percentage of participants	—
Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir RBV, 60 to <80%	0.7 percentage of participants	0 percentage of participants	0 percentage of participants	4 percentage of participants	0 percentage of participants	—
Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir Boceprevir, 80 to <95%	3 percentage of participants	5 percentage of participants	0 percentage of participants	4 percentage of participants	3 percentage of participants	—
Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir RBV, 80 to <95%	5 percentage of participants	10 percentage of participants	0 percentage of participants	8 percentage of participants	4 percentage of participants	—
Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir RBV, 95% or more	86 percentage of participants	65 percentage of participants	75 percentage of participants	83 percentage of participants	95 percentage of participants	—
Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir Boceprevir, <60%	10 percentage of participants	30 percentage of participants	25 percentage of participants	8 percentage of participants	1 percentage of participants	—
Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir Boceprevir, 60 to <80%	0.7 percentage of participants	5 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—
Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir Boceprevir, 95% or more	86 percentage of participants	60 percentage of participants	75 percentage of participants	88 percentage of participants	96 percentage of participants	—

SECONDARY outcome

Timeframe: Up to 48 weeks (from Baseline until EOT)

Population: Safety Population.

Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. The percentage of participants with a safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was calculated as \[number of participants with dose modification divided by the number of participants analyzed\] multiplied by 100.

Outcome measures

Outcome measures
Measure	Total Population n=165 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
Number of Participants With a Safety-Related Dose Modification	113 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 48 weeks (from Baseline until EOT)

Population: Safety Population.

Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Median time to safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was estimated using Kaplan-Meier and expressed in weeks.

Outcome measures

Outcome measures
Measure	Total Population n=165 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
Time to Safety-Related Dose Modification	12.1 weeks Interval 10.3 to 16.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks (from Baseline until 24 weeks after EOT)

Population: Safety Population.

Use of concomitant hematopoietic stimulants (such as epoetin) during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant hematopoietic stimulants was calculated as \[number of participants reporting concomitant use divided by the number of participants analyzed\] multiplied by 100.

Outcome measures

Outcome measures
Measure	Total Population n=165 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up	6 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 76 weeks (from Screening until 24 weeks after EOT)

Population: Safety Population.

The prevalence of concomitant disease at any time from Screening through the end of follow-up was documented. The percentage of participants with a concomitant disease was calculated as \[number of participants reporting or diagnosed with concomitant disease divided by the number of participants analyzed\] multiplied by 100. Diseases documented for ≥5% of participants included hypertension, diabetes mellitus, hypothyroidism, and vitamin D deficiency as reported here.

Outcome measures

Outcome measures
Measure	Total Population n=165 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
Percentage of Participants With a Concomitant Disease Prior to or During the Study Any disease	53 percentage of participants	—	—	—	—	—
Percentage of Participants With a Concomitant Disease Prior to or During the Study Hypertension	18 percentage of participants	—	—	—	—	—
Percentage of Participants With a Concomitant Disease Prior to or During the Study Diabetes mellitus	8 percentage of participants	—	—	—	—	—
Percentage of Participants With a Concomitant Disease Prior to or During the Study Hypothyroidism	6 percentage of participants	—	—	—	—	—
Percentage of Participants With a Concomitant Disease Prior to or During the Study Vitamin D deficiency	5 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks (from Baseline until 24 weeks after EOT)

Population: Safety Population.

Use of concomitant prescription or nonprescription medications during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant medications was calculated as \[number of participants reporting concomitant use divided by the number of participants analyzed\] multiplied by 100. Medication classes reported by \>10% of participants included analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, corticosteroids, proton pump inhibitors, vitamins and minerals, and beta-adrenoceptor blocking agents as reported here.

Outcome measures

Outcome measures
Measure	Total Population n=165 Participants Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.	Cirrhotics Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.	Poor Responders Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a \<1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.	Late Responders Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.	Early Responders Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.	Others Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up Any medication	79 percentage of participants	—	—	—	—	—
Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up Analgesics	29 percentage of participants	—	—	—	—	—
Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up NSAIDs	22 percentage of participants	—	—	—	—	—
Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up Antihistamines	19 percentage of participants	—	—	—	—	—
Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up Corticosteroids	19 percentage of participants	—	—	—	—	—
Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up Proton pump inhibitors	17 percentage of participants	—	—	—	—	—
Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up Vitamins and minerals	12 percentage of participants	—	—	—	—	—
Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up Beta-adrenoceptor blocking agents	11 percentage of participants	—	—	—	—	—

Adverse Events

Cirrhotics (Safety)

Serious events: 7 serious events

Other events: 21 other events

Deaths: 0 deaths

Noncirrhotics (Safety)

Serious events: 8 serious events

Other events: 135 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cirrhotics (Safety) n=21 participants at risk Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants with liver cirrhosis were grouped separately in the safety analysis.	Noncirrhotics (Safety) n=144 participants at risk Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants without liver cirrhosis, including those with transition to cirrhosis, were grouped separately in the safety analysis.
Blood and lymphatic system disorders Anaemia	9.5% 2/21 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.	1.4% 2/144 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.
Blood and lymphatic system disorders Granulocytopenia	0.00% 0/21 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.	0.69% 1/144 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.
Blood and lymphatic system disorders Neutropenia	0.00% 0/21 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.	0.69% 1/144 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.
Blood and lymphatic system disorders Thrombocytopenia	4.8% 1/21 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.	0.00% 0/144 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.
General disorders Fatigue	0.00% 0/21 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.	0.69% 1/144 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.
Hepatobiliary disorders Hepatic failure	9.5% 2/21 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.	0.00% 0/144 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.
Injury, poisoning and procedural complications Overdose	0.00% 0/21 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.	0.69% 1/144 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/21 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.	0.69% 1/144 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	4.8% 1/21 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.	0.00% 0/144 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	4.8% 1/21 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.	0.00% 0/144 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.
Immune system disorders Drug hypersensitivity	0.00% 0/21 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.	0.69% 1/144 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.
Infections and infestations Epididymitis	0.00% 0/21 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.	0.69% 1/144 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.
Psychiatric disorders Depression	0.00% 0/21 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.	0.69% 1/144 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.
Skin and subcutaneous tissue disorders Psoriasis	4.8% 1/21 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.	0.00% 0/144 • Up to 72 weeks (from Baseline until 24 weeks after EOT) Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.

Other adverse events

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER