Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)

PEG-Intron/REBETOL vs PEG-Intron/ SCH 503034 With and Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 (HCV-1) Peginterferon Alfa/Ribavirin Nonresponders: A SCH 503034 Dose-Finding Phase 2 Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00160251

Enrollment

357

Registered

2005-09-12

Start date

2005-09-30

Completion date

2007-07-31

Last updated

2015-10-14

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

Conditions

Chronic Hepatitis C

Keywords

PEG-Intron, Ribavirin, Protease Inhibitor

Brief summary

The primary objective of this study is to determine the safe and effective dose range of boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin provides an additional benefit when combined with PEG-Intron plus boceprevir.

Interventions

DRUGBoceprevir (BOC)

100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID

BIOLOGICALPegIntron (PEG)

1.5 mcg/kg weekly subcutaneously

DRUGRibavirin (RBV)

200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight \[weight-based dosing {WBD}\])

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Key inclusion criteria: * Documented infection with chronic hepatitis C (CHC), genotype 1. * Documented failure to respond to an adequate course of treatment (minimum 12 weeks) with peginterferon-alfa plus ribavirin (failure defined as \<2 log drop in HCV-RNA after 12 weeks of therapy or those who never become Hepatitis C Virus Ribonucleic Acid (HCV)-RNA negative) * No evidence of cirrhosis on liver biopsy. * Results of physical examination and laboratory tests within specified ranges. * Abstinence from use of abused substances. Key

Exclusion criteria

* Women who are pregnant or nursing a child. * Patients with cirrhosis, co-infection with Hepatitis B or human immunodeficiency virus (HIV), and African-American patients (by protocol amendment 2, African-American patients can enroll). * Previous treatment with any Hepatitis C Virus (HCV) polymerase or protease inhibitor. * Patients who relapsed following response to previous treatment. * Evidence of advanced liver disease, or liver disease from a cause other than CHC. * Pre-existing psychiatric condition.

Design outcomes

Primary

Measure	Time frame	Description
Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)	Baseline up to Week 49	Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.
Percent of Participants Who Achieved Sustained Virologic Response (SVR)	Baseline up to Week 73 [24 weeks after end of treatment (EoT)]	SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.

Secondary

Measure	Time frame	Description
Percent of Participants With Virologic Response Prior to Amendment 2	Week 3, Week 5, Week 13	Virologic response was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) ≤10,000 IU/mL.
Peak Plasma Concentration of Boceprevir (BOC)	All visits during treatment (baseline to Week 49) except Day 1 of Week 1	All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.
Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period	All visits during treatment (baseline to Week 49) except Day 1 of Week 1	All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method. The dosing interval of 8 hours is represented as the hr in the unit of measure.
Trough Plasma Concentration Level	All visits during treatment (baseline to Week 49) except Day 1 of Week 1	All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.
Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA	Baseline up to Week 73 [24 weeks after EoT]	Percentage of participants who became HCV-RNA undetectable within the first 13 weeks and subsequently became HCV-RNA positive were not considered negative for this analysis.
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	From dosing change to end of follow-up (Week 73)(up to 48 weeks)	Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	From dosing change to end of follow-up (Week 73)(up to 48 weeks)	Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	From dosing change to end of follow-up (Week 73) (up to 48 weeks)	Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).
Change in Alanine Aminotransferase (ALT) Levels	Baseline up to dosing change (> 25 weeks)	Change in ALT levels during initial treatment regimen and after rolling into amendment 2 as compared to baseline.
Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Week 1 and Week 49	For each log drop category (\<0, 0 to 0.5, 0.5 to \<1, 1 to \<1.5, ≥1.5, and Missing), the percentage of participants receiving combination therapy who were HCV-RNA negative at EoT (Week 49) was calculated as follows: Number of participants in a log category who were HCV-RNA negative divided by the total number of participants in that log drop category (n). Percentages were NOT derived using treatment arm N values. The sum of the n values for all 6 log drop categories within a treatment arm equals the overall N for that treatment group.

Participant flow

Participants by arm

Arm	Count
Arm 1A: PEG + RBV OR Arm 1B: PEG + RBV + BOC 400 Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks. Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.	49
Arm 2: PEG + BOC 100 (48 Weeks) A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.	48
Arm 3: PEG + BOC 200 (48 Weeks) A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.	49
Arm 5: PEG + RBV + BOC 400 A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.	49
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks) A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.	97
Arm 7: PEG + BOC 800 A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.	65
Total	357

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007
Post-amendment 2	Adverse Event	0	0	0	0	0	0	0	20
Post-amendment 2	Lack of Efficacy	0	0	0	0	0	0	0	24
Post-amendment 2	Lost to follow-up/withdrawal by subject	0	0	0	0	0	0	0	11
Prior to Amendment 2	Adverse Event	2	1	3	1	1	1	1	0
Prior to Amendment 2	Completed Treatment Phase	3	0	0	0	0	23	0	0
Prior to Amendment 2	Lack of Efficacy	0	4	37	35	24	55	0	0
Prior to Amendment 2	Lost to Follow-up	0	0	1	0	1	1	0	0
Prior to Amendment 2	Noncompliance with protocol	1	0	0	0	0	0	0	0
Prior to Amendment 2	Withdrawal by Subject	3	1	3	4	2	3	3	0

Baseline characteristics

Characteristic	Arm 1A: PEG + RBV OR Arm 1B: PEG + RBV + BOC 400	Arm 2: PEG + BOC 100 (48 Weeks)	Arm 3: PEG + BOC 200 (48 Weeks)	Arm 5: PEG + RBV + BOC 400	Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Arm 7: PEG + BOC 800	Total
Age, Continuous	48.9 years STANDARD_DEVIATION 9.7	51.6 years STANDARD_DEVIATION 7	48.6 years STANDARD_DEVIATION 9.4	48.2 years STANDARD_DEVIATION 8.9	49.2 years STANDARD_DEVIATION 8.7	50.4 years STANDARD_DEVIATION 7.3	49.5 years STANDARD_DEVIATION 8.6
Sex: Female, Male Female	17 Participants	21 Participants	14 Participants	21 Participants	37 Participants	24 Participants	134 Participants
Sex: Female, Male Male	32 Participants	27 Participants	35 Participants	28 Participants	60 Participants	41 Participants	223 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	14 / 15	33 / 34	48 / 48	48 / 49	47 / 49	96 / 97	64 / 65	136 / 143
serious Total, serious adverse events	2 / 15	1 / 34	2 / 48	4 / 49	2 / 49	4 / 97	3 / 65	12 / 143

Outcome results

Primary

Percent of Participants Who Achieved Sustained Virologic Response (SVR)

SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.

Time frame: Baseline up to Week 73 [24 weeks after end of treatment (EoT)]

Population: For PEG + RBV + BOC number of participants was number who received at least one dose of BOC. For all others, it was number of randomized participants. The PEG + BOC 800 arm was not randomized.

Arm	Measure	Value (NUMBER)
Arm 1B: PEG + RBV + BOC 400	Percent of Participants Who Achieved Sustained Virologic Response (SVR)	7.5 Percent of participants
Arm 2: PEG + BOC 100 (48 Weeks)	Percent of Participants Who Achieved Sustained Virologic Response (SVR)	2.1 Percent of participants
Arm 3: PEG + BOC 200 (48 Weeks)	Percent of Participants Who Achieved Sustained Virologic Response (SVR)	12.2 Percent of participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Percent of Participants Who Achieved Sustained Virologic Response (SVR)	5.2 Percent of participants
Arm 5: PEG + RBV + BOC 400	Percent of Participants Who Achieved Sustained Virologic Response (SVR)	14.3 Percent of participants
Arm 7: PEG + BOC 800	Percent of Participants Who Achieved Sustained Virologic Response (SVR)	4.6 Percent of participants

Primary

Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)

Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.

Time frame: Baseline up to Week 49

Arm	Measure	Value (NUMBER)
Arm 1B: PEG + RBV + BOC 400	Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)	35.0 Percent of participants
Arm 2: PEG + BOC 100 (48 Weeks)	Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)	6.3 Percent of participants
Arm 3: PEG + BOC 200 (48 Weeks)	Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)	16.3 Percent of participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)	13.4 Percent of participants
Arm 5: PEG + RBV + BOC 400	Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)	20.4 Percent of participants
Arm 7: PEG + BOC 800	Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)	21.5 Percent of participants

Secondary

Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period

All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method. The dosing interval of 8 hours is represented as the hr in the unit of measure.

Time frame: All visits during treatment (baseline to Week 49) except Day 1 of Week 1

Population: Participants were only included in the analysis if the recorded previous dose of boceprevir was taken \< 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.

Arm	Measure	Value (MEAN)	Dispersion
Arm 1B: PEG + RBV + BOC 400	Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period	1042 ng*hr/mL	Standard Error 25
Arm 2: PEG + BOC 100 (48 Weeks)	Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period	2184 ng*hr/mL	Standard Error 181
Arm 3: PEG + BOC 200 (48 Weeks)	Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period	3633 ng*hr/mL	Standard Error 88
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period	6276 ng*hr/mL	Standard Error 337

Secondary

Change in Alanine Aminotransferase (ALT) Levels

Change in ALT levels during initial treatment regimen and after rolling into amendment 2 as compared to baseline.

Time frame: Baseline up to dosing change (> 25 weeks)

Population: Only participants with at least one value for the laboratory test were included.

Arm	Measure	Group	Value (NUMBER)
Arm 1B: PEG + RBV + BOC 400	Change in Alanine Aminotransferase (ALT) Levels	<2.00 x baseline ALT value	14 Participants
Arm 1B: PEG + RBV + BOC 400	Change in Alanine Aminotransferase (ALT) Levels	>10.0 x baseline ALT value	0 Participants
Arm 1B: PEG + RBV + BOC 400	Change in Alanine Aminotransferase (ALT) Levels	5.10-10.0 x baseline ALT value	0 Participants
Arm 1B: PEG + RBV + BOC 400	Change in Alanine Aminotransferase (ALT) Levels	2.10-5.09 x baseline ALT value	0 Participants
Arm 1B: PEG + RBV + BOC 400	Change in Alanine Aminotransferase (ALT) Levels	2.00-2.09 x baseline ALT value	1 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Change in Alanine Aminotransferase (ALT) Levels	2.00-2.09 x baseline ALT value	1 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Change in Alanine Aminotransferase (ALT) Levels	5.10-10.0 x baseline ALT value	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Change in Alanine Aminotransferase (ALT) Levels	>10.0 x baseline ALT value	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Change in Alanine Aminotransferase (ALT) Levels	2.10-5.09 x baseline ALT value	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Change in Alanine Aminotransferase (ALT) Levels	<2.00 x baseline ALT value	33 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Change in Alanine Aminotransferase (ALT) Levels	2.00-2.09 x baseline ALT value	1 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Change in Alanine Aminotransferase (ALT) Levels	>10.0 x baseline ALT value	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Change in Alanine Aminotransferase (ALT) Levels	<2.00 x baseline ALT value	45 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Change in Alanine Aminotransferase (ALT) Levels	5.10-10.0 x baseline ALT value	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Change in Alanine Aminotransferase (ALT) Levels	2.10-5.09 x baseline ALT value	2 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Change in Alanine Aminotransferase (ALT) Levels	2.10-5.09 x baseline ALT value	3 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Change in Alanine Aminotransferase (ALT) Levels	>10.0 x baseline ALT value	0 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Change in Alanine Aminotransferase (ALT) Levels	<2.00 x baseline ALT value	43 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Change in Alanine Aminotransferase (ALT) Levels	2.00-2.09 x baseline ALT value	1 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Change in Alanine Aminotransferase (ALT) Levels	5.10-10.0 x baseline ALT value	0 Participants
Arm 5: PEG + RBV + BOC 400	Change in Alanine Aminotransferase (ALT) Levels	2.10-5.09 x baseline ALT value	1 Participants
Arm 5: PEG + RBV + BOC 400	Change in Alanine Aminotransferase (ALT) Levels	<2.00 x baseline ALT value	47 Participants
Arm 5: PEG + RBV + BOC 400	Change in Alanine Aminotransferase (ALT) Levels	2.00-2.09 x baseline ALT value	0 Participants
Arm 5: PEG + RBV + BOC 400	Change in Alanine Aminotransferase (ALT) Levels	5.10-10.0 x baseline ALT value	0 Participants
Arm 5: PEG + RBV + BOC 400	Change in Alanine Aminotransferase (ALT) Levels	>10.0 x baseline ALT value	0 Participants
Arm 7: PEG + BOC 800	Change in Alanine Aminotransferase (ALT) Levels	2.10-5.09 x baseline ALT value	9 Participants
Arm 7: PEG + BOC 800	Change in Alanine Aminotransferase (ALT) Levels	5.10-10.0 x baseline ALT value	0 Participants
Arm 7: PEG + BOC 800	Change in Alanine Aminotransferase (ALT) Levels	2.00-2.09 x baseline ALT value	4 Participants
Arm 7: PEG + BOC 800	Change in Alanine Aminotransferase (ALT) Levels	<2.00 x baseline ALT value	84 Participants
Arm 7: PEG + BOC 800	Change in Alanine Aminotransferase (ALT) Levels	>10.0 x baseline ALT value	0 Participants
Arm 7: PEG + BOC 800	Change in Alanine Aminotransferase (ALT) Levels	2.10-5.09 x baseline ALT value	3 Participants
Arm 7: PEG + BOC 800	Change in Alanine Aminotransferase (ALT) Levels	<2.00 x baseline ALT value	61 Participants
Arm 7: PEG + BOC 800	Change in Alanine Aminotransferase (ALT) Levels	2.00-2.09 x baseline ALT value	0 Participants
Arm 7: PEG + BOC 800	Change in Alanine Aminotransferase (ALT) Levels	>10.0 x baseline ALT value	0 Participants
Arm 7: PEG + BOC 800	Change in Alanine Aminotransferase (ALT) Levels	5.10-10.0 x baseline ALT value	0 Participants
Arm 8: PEG + RBV + BOC 800	Change in Alanine Aminotransferase (ALT) Levels	>10.0 x baseline ALT value	1 Participants
Arm 8: PEG + RBV + BOC 800	Change in Alanine Aminotransferase (ALT) Levels	5.10-10.0 x baseline ALT value	1 Participants
Arm 8: PEG + RBV + BOC 800	Change in Alanine Aminotransferase (ALT) Levels	<2.00 x baseline ALT value	119 Participants
Arm 8: PEG + RBV + BOC 800	Change in Alanine Aminotransferase (ALT) Levels	2.10-5.09 x baseline ALT value	18 Participants
Arm 8: PEG + RBV + BOC 800	Change in Alanine Aminotransferase (ALT) Levels	2.00-2.09 x baseline ALT value	4 Participants

Secondary

Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])

Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).

Time frame: From dosing change to end of follow-up (Week 73)(up to 48 weeks)

Population: All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV\_RNA ≤ 10,000 IU) switched to continuing triple therapy.

Arm	Measure	Group	Value (NUMBER)
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 8 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 3 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 4 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	End of follow-up after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 9 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 24 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 12 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 18 after dosing change	1 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 12 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 24 after dosing change	1 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 6 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	End of treatment	1 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 24 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	End of treatment	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 8 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 6 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 18 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 12 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 3 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 4 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 24 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 9 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	End of follow-up after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 12 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 24 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 9 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 8 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 12 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	End of follow-up after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 12 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	End of treatment	1 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 4 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 18 after dosing change	1 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 6 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 3 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 24 after dosing change	1 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 4 after dosing change	4 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 3 after dosing change	4 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 6 after dosing change	4 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 9 after dosing change	4 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 12 after dosing change	4 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 18 after dosing change	4 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 24 after dosing change	4 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	End of treatment	4 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 8 after dosing change	4 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 12 after dosing change	4 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 24 after dosing change	4 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	End of follow-up after dosing change	4 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 18 after dosing change	11 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 9 after dosing change	9 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 3 after dosing change	11 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	End of follow-up after dosing change	7 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 24 after dosing change	7 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 12 after dosing change	9 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 6 after dosing change	11 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 8 after dosing change	6 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 12 after dosing change	6 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	End of treatment	11 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 4 after dosing change	8 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 24 after dosing change	12 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 4 after dosing change	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 18 after dosing change	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 8 after dosing change	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 12 after dosing change	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	End of follow-up after dosing change	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 12 after dosing change	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 9 after dosing change	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 6 after dosing change	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Follow-up Week 24 after dosing change	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 3 after dosing change	2 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	End of treatment	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])	Week 24 after dosing change	1 Participants

Secondary

Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)

Time frame: From dosing change to end of follow-up (Week 73) (up to 48 weeks)

Population: All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV\_RNA ≤ 10,000 IU) switched to continuing triple therapy.

Arm	Measure	Group	Value (NUMBER)
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 24 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 24 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 3 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 4 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 12 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 9 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 18 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	End of follow-up after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 12 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 6 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	End of treatment	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 8 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 9 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 24 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	End of follow-up after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 6 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 24 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 12 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 3 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 8 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 12 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 4 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	End of treatment	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 18 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 4 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 24 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 18 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 12 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 3 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 24 after dosing change	1 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 12 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 9 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	End of follow-up after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 8 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	End of treatment	1 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 6 after dosing change	0 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 6 after dosing change	0 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 3 after dosing change	0 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 9 after dosing change	0 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 12 after dosing change	1 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 18 after dosing change	1 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 24 after dosing change	1 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	End of treatment	1 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 4 after dosing change	0 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 8 after dosing change	0 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 12 after dosing change	0 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 24 after dosing change	0 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	End of follow-up after dosing change	0 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 24 after dosing change	1 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 6 after dosing change	3 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 12 after dosing change	1 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 24 after dosing change	4 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 12 after dosing change	4 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 4 after dosing change	1 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 18 after dosing change	5 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 3 after dosing change	5 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 9 after dosing change	5 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	End of follow-up after dosing change	1 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 8 after dosing change	1 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	End of treatment	4 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 18 after dosing change	3 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 8 after dosing change	0 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	End of treatment	3 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 6 after dosing change	5 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	End of follow-up after dosing change	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 4 after dosing change	2 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 12 after dosing change	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 24 after dosing change	3 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 9 after dosing change	7 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 12 after dosing change	5 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 24 after dosing change	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 3 after dosing change	7 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	End of follow-up after dosing change	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 12 after dosing change	4 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	End of treatment	4 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 4 after dosing change	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 9 after dosing change	3 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 8 after dosing change	0 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 6 after dosing change	4 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 12 after dosing change	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 24 after dosing change	1 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 3 after dosing change	4 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 18 after dosing change	4 Participants
Arm 7: PEG + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 24 after dosing change	4 Participants
Arm 8: PEG + RBV + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 8 after dosing change	0 Participants
Arm 8: PEG + RBV + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 4 after dosing change	0 Participants
Arm 8: PEG + RBV + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 9 after dosing change	1 Participants
Arm 8: PEG + RBV + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 24 after dosing change	0 Participants
Arm 8: PEG + RBV + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	End of treatment	1 Participants
Arm 8: PEG + RBV + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 18 after dosing change	2 Participants
Arm 8: PEG + RBV + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 12 after dosing change	2 Participants
Arm 8: PEG + RBV + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	End of follow-up after dosing change	0 Participants
Arm 8: PEG + RBV + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Follow-up Week 12 after dosing change	0 Participants
Arm 8: PEG + RBV + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 6 after dosing change	1 Participants
Arm 8: PEG + RBV + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 3 after dosing change	3 Participants
Arm 8: PEG + RBV + BOC 800	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)	Week 24 after dosing change	1 Participants

Secondary

Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)

Time frame: From dosing change to end of follow-up (Week 73)(up to 48 weeks)

Population: All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV\_RNA ≤ 10,000 IU) switched to continuing triple therapy.

Arm	Measure	Group	Value (NUMBER)
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 24 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 3 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 12 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	End of treatment	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 12 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 24 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	End of follow-up after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 8 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 6 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 18 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 9 after dosing change	0 Participants
Arm 1B: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 4 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	End of follow-up after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	End of treatment	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 24 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 24 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 6 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 3 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 12 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 9 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 8 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 12 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 4 after dosing change	0 Participants
Arm 2: PEG + BOC 100 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 18 after dosing change	0 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 18 after dosing change	2 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 3 after dosing change	3 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 6 after dosing change	3 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 9 after dosing change	3 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 12 after dosing change	3 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 24 after dosing change	3 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	End of treatment	3 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 4 after dosing change	3 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 8 after dosing change	3 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 12 after dosing change	2 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 24 after dosing change	3 Participants
Arm 3: PEG + BOC 200 (48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	End of follow-up after dosing change	3 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 3 after dosing change	12 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 12 after dosing change	5 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 8 after dosing change	4 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 6 after dosing change	10 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 12 after dosing change	9 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	End of follow-up after dosing change	4 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 9 after dosing change	10 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 24 after dosing change	5 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 4 after dosing change	6 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 24 after dosing change	4 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	End of treatment	7 Participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 18 after dosing change	6 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	End of treatment	0 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 12 after dosing change	0 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 24 after dosing change	0 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 4 after dosing change	0 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 9 after dosing change	0 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 8 after dosing change	0 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 6 after dosing change	0 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	End of follow-up after dosing change	0 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Follow-up Week 12 after dosing change	0 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 3 after dosing change	1 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 24 after dosing change	0 Participants
Arm 5: PEG + RBV + BOC 400	Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)	Week 18 after dosing change	0 Participants

Secondary

Peak Plasma Concentration of Boceprevir (BOC)

All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.

Time frame: All visits during treatment (baseline to Week 49) except Day 1 of Week 1

Arm	Measure	Value (MEAN)	Dispersion
Arm 1B: PEG + RBV + BOC 400	Peak Plasma Concentration of Boceprevir (BOC)	203 ng/mL	Standard Error 5
Arm 2: PEG + BOC 100 (48 Weeks)	Peak Plasma Concentration of Boceprevir (BOC)	427 ng/mL	Standard Error 18
Arm 3: PEG + BOC 200 (48 Weeks)	Peak Plasma Concentration of Boceprevir (BOC)	704 ng/mL	Standard Error 16
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Peak Plasma Concentration of Boceprevir (BOC)	1312 ng/mL	Standard Error 45

Secondary

Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop

For each log drop category (\<0, 0 to 0.5, 0.5 to \<1, 1 to \<1.5, ≥1.5, and Missing), the percentage of participants receiving combination therapy who were HCV-RNA negative at EoT (Week 49) was calculated as follows: Number of participants in a log category who were HCV-RNA negative divided by the total number of participants in that log drop category (n). Percentages were NOT derived using treatment arm N values. The sum of the n values for all 6 log drop categories within a treatment arm equals the overall N for that treatment group.

Time frame: Week 1 and Week 49

Population: N=Number of Participants Analyzed, n=number of participants in each log category group. The PEG + BOC 100, 200, or 400 arm combined the following treatment arms: Arm 2 PEG + BOC 100 (48 weeks), Arm 3 PEG + BOC 200 (48 weeks), Arm 4 PEG + BOC 400 (48 weeks), Arm 6 PEG + BOC 400 (24 weeks).

Arm	Measure	Group	Value (NUMBER)
Arm 1B: PEG + RBV + BOC 400	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Log drop <0 (Arm2-4,6 n=21/Arm5 n=6/Arm7 n=3)	9.5 Percent of participants
Arm 1B: PEG + RBV + BOC 400	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Log drop 0-0.5 (Arm2-4,6 n=55/Arm5 n=17/Arm7 n=16)	1.8 Percent of participants
Arm 1B: PEG + RBV + BOC 400	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Log drop 0.5to<1(Arm2-4,6 n=73/Arm5 n=11/Arm7 n=9)	12.3 Percent of participants
Arm 1B: PEG + RBV + BOC 400	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Log drop 1to<1.5(Arm2-4,6 n=31/Arm5 n=9/Arm7 n=18)	25.8 Percent of participants
Arm 1B: PEG + RBV + BOC 400	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Log drop ≥1.5 (Arm2-4,6 n=12/Arm5 n=4/Arm7 n=18)	33.3 Percent of participants
Arm 1B: PEG + RBV + BOC 400	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Missing (Arm2-4,6 n=2/Arm5 n=2/Arm7 n=1)	0 Percent of participants
Arm 2: PEG + BOC 100 (48 Weeks)	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Missing (Arm2-4,6 n=2/Arm5 n=2/Arm7 n=1)	0 Percent of participants
Arm 2: PEG + BOC 100 (48 Weeks)	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Log drop <0 (Arm2-4,6 n=21/Arm5 n=6/Arm7 n=3)	16.7 Percent of participants
Arm 2: PEG + BOC 100 (48 Weeks)	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Log drop 1to<1.5(Arm2-4,6 n=31/Arm5 n=9/Arm7 n=18)	33.3 Percent of participants
Arm 2: PEG + BOC 100 (48 Weeks)	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Log drop ≥1.5 (Arm2-4,6 n=12/Arm5 n=4/Arm7 n=18)	50.0 Percent of participants
Arm 2: PEG + BOC 100 (48 Weeks)	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Log drop 0-0.5 (Arm2-4,6 n=55/Arm5 n=17/Arm7 n=16)	17.6 Percent of participants
Arm 2: PEG + BOC 100 (48 Weeks)	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Log drop 0.5to<1(Arm2-4,6 n=73/Arm5 n=11/Arm7 n=9)	9.1 Percent of participants
Arm 3: PEG + BOC 200 (48 Weeks)	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Log drop 0-0.5 (Arm2-4,6 n=55/Arm5 n=17/Arm7 n=16)	18.8 Percent of participants
Arm 3: PEG + BOC 200 (48 Weeks)	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Log drop 0.5to<1(Arm2-4,6 n=73/Arm5 n=11/Arm7 n=9)	0 Percent of participants
Arm 3: PEG + BOC 200 (48 Weeks)	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Missing (Arm2-4,6 n=2/Arm5 n=2/Arm7 n=1)	0 Percent of participants
Arm 3: PEG + BOC 200 (48 Weeks)	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Log drop 1to<1.5(Arm2-4,6 n=31/Arm5 n=9/Arm7 n=18)	16.7 Percent of participants
Arm 3: PEG + BOC 200 (48 Weeks)	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Log drop <0 (Arm2-4,6 n=21/Arm5 n=6/Arm7 n=3)	1 Percent of participants
Arm 3: PEG + BOC 200 (48 Weeks)	Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop	Log drop ≥1.5 (Arm2-4,6 n=12/Arm5 n=4/Arm7 n=18)	44.4 Percent of participants

Secondary

Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA

Percentage of participants who became HCV-RNA undetectable within the first 13 weeks and subsequently became HCV-RNA positive were not considered negative for this analysis.

Time frame: Baseline up to Week 73 [24 weeks after EoT]

Population: Number of participants across all treatment arms who achieved negative HCV-RNA

Arm	Measure	Value (NUMBER)
Arm 1B: PEG + RBV + BOC 400	Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA	58 Percent of participants
Arm 2: PEG + BOC 100 (48 Weeks)	Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA	33 Percent of participants
Arm 3: PEG + BOC 200 (48 Weeks)	Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA	33 Percent of participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA	0 Percent of participants

Secondary

Percent of Participants With Virologic Response Prior to Amendment 2

Virologic response was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) ≤10,000 IU/mL.

Time frame: Week 3, Week 5, Week 13

Arm	Measure	Group	Value (NUMBER)
Arm 1B: PEG + RBV + BOC 400	Percent of Participants With Virologic Response Prior to Amendment 2	Week 5	4.1 Percent of participants
Arm 1B: PEG + RBV + BOC 400	Percent of Participants With Virologic Response Prior to Amendment 2	Week 3	4.1 Percent of participants
Arm 1B: PEG + RBV + BOC 400	Percent of Participants With Virologic Response Prior to Amendment 2	Week 13	6.1 Percent of participants
Arm 2: PEG + BOC 100 (48 Weeks)	Percent of Participants With Virologic Response Prior to Amendment 2	Week 5	0.0 Percent of participants
Arm 2: PEG + BOC 100 (48 Weeks)	Percent of Participants With Virologic Response Prior to Amendment 2	Week 3	0.0 Percent of participants
Arm 2: PEG + BOC 100 (48 Weeks)	Percent of Participants With Virologic Response Prior to Amendment 2	Week 13	2.1 Percent of participants
Arm 3: PEG + BOC 200 (48 Weeks)	Percent of Participants With Virologic Response Prior to Amendment 2	Week 5	8.2 Percent of participants
Arm 3: PEG + BOC 200 (48 Weeks)	Percent of Participants With Virologic Response Prior to Amendment 2	Week 3	0.0 Percent of participants
Arm 3: PEG + BOC 200 (48 Weeks)	Percent of Participants With Virologic Response Prior to Amendment 2	Week 13	14.3 Percent of participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Percent of Participants With Virologic Response Prior to Amendment 2	Week 5	12.2 Percent of participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Percent of Participants With Virologic Response Prior to Amendment 2	Week 3	0 Percent of participants
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Percent of Participants With Virologic Response Prior to Amendment 2	Week 13	30.6 Percent of participants
Arm 5: PEG + RBV + BOC 400	Percent of Participants With Virologic Response Prior to Amendment 2	Week 5	9.3 Percent of participants
Arm 5: PEG + RBV + BOC 400	Percent of Participants With Virologic Response Prior to Amendment 2	Week 3	5.2 Percent of participants
Arm 5: PEG + RBV + BOC 400	Percent of Participants With Virologic Response Prior to Amendment 2	Week 13	13.4 Percent of participants
Arm 7: PEG + BOC 800	Percent of Participants With Virologic Response Prior to Amendment 2	Week 3	4.6 Percent of participants
Arm 7: PEG + BOC 800	Percent of Participants With Virologic Response Prior to Amendment 2	Week 13	0 Percent of participants
Arm 7: PEG + BOC 800	Percent of Participants With Virologic Response Prior to Amendment 2	Week 5	15.4 Percent of participants

Secondary

Trough Plasma Concentration Level

All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.

Time frame: All visits during treatment (baseline to Week 49) except Day 1 of Week 1

Arm	Measure	Value (MEAN)	Dispersion
Arm 1B: PEG + RBV + BOC 400	Trough Plasma Concentration Level	56.7 ng/mL	Standard Error 3
Arm 2: PEG + BOC 100 (48 Weeks)	Trough Plasma Concentration Level	133.0 ng/mL	Standard Error 27
Arm 3: PEG + BOC 200 (48 Weeks)	Trough Plasma Concentration Level	214.0 ng/mL	Standard Error 10
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	Trough Plasma Concentration Level	355 ng/mL	Standard Error 42

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percent of Participants Who Achieved Sustained Virologic Response (SVR)

Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)

Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period

Change in Alanine Aminotransferase (ALT) Levels

Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])

Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)

Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)

Peak Plasma Concentration of Boceprevir (BOC)

Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop

Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA

Percent of Participants With Virologic Response Prior to Amendment 2

Trough Plasma Concentration Level