PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Virus (HCV)Treated With Pegasys (Peginterferon Alfa-2a)

Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in a Cohort of Treatment naïve HCV-infected Patients Treated With Pegylated Interferons.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01070550

Enrollment

4680

Registered

2010-02-18

Start date

2007-06-30

Completion date

2011-07-31

Last updated

2016-06-15

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

Conditions

Hepatitis C, Chronic

Brief summary

This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is \<5000.

Interventions

DRUGPeginterferon alfa-2a (Pegasys®)

Peginterferon (PEG-IFN) alfa-2a Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* adult patients, \>/= 18 years of age * chronic hepatitis C * informed consent to data collection

Exclusion criteria

* co-infection with HIV or Hepatitis B Virus (HBV) * previous treatment with peginterferon and/or ribavirin

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population	At 24 weeks after EOT	Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of \<15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection \[LLOD\] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive hepatitis C virus (HCV) mono-infected modified all-treated (mTRT) who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population	At 24 weeks after EOT	Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of \<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population	At 24 weeks after EOT	Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA \<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population	At 24 weeks after EOT	Modified sustained virological response is defined as mVR of HCV RNA \<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	At 24 weeks after EOT	The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	At 24 weeks after EOT	The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Secondary

Measure	Time frame	Description
Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	Week 2, Week 4, and Week 12	Participants with 1-log drop in HCV RNA including HCV RNA values \<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a.
Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	Week 2, Week 4, and Week 12	Participants with 1-log drop in HCV RNA including HCV RNA values \<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.
Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	Week 4 and Week 12	Rapid virological response (RVR) was defined as VR by Week 4, Modified rapid virological response (mRVR) was defined as mVR by Week 4, Complete early virological response (cEVR) was defined as VR by Week 12, but no RVR, Modified complete early virological response (mcEVR) was defined as mVR by Week 12, but no mRVR, Partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values \<50 IU/mL) by, Week 12, but no RVR and no cEVR, Modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Week 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a.
Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	At Week 4 and Week 12	RVR defined was as VR by Week 4, mRVR was defined as mVR by Week 4, cEVR was defined as VR by Week 12, but no RVR, mcEVR was defined as mVR by Week 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values \<50 IU/mL) by Week 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Week 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.
Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment	At 12 Weeks after EOT	Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 2, Week 4, and Week 12, EOT, and 12 weeks after EOT	Virological response was defined as HCV RNA \<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment	At 24 weeks after EOT	Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment	At 24 weeks after EOT	Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	At 24 weeks after EOT	The probability that a participant who developed VR by Wk 2 also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 2 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	At 24 weeks after EOT	The probability that a participant who developed VR by Wk 2 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 2 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment	At 12 weeks after EOT	Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT	Virological response was defined as HCV RNA \<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT	Modified virological response was defined as HCV RNA \<50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT	Modified virological response is defined as HCV RNA \<50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	At Week 2, Week 4, and Week 12	Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values \<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a.
Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	Week 2, Week 4, and Week 12	Participants with 2-log drop in HCV RNA including HCV RNA values \<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.

Countries

Austria, Brazil, Canada, Croatia, France, Hungary, Mexico, Morocco, North Macedonia, Poland, Romania, Serbia, Slovenia, Sweden

Participant flow

Recruitment details

A total of 4680 participants were enrolled into the study conducted from June 2007 to July 2011 at 332 centers in 14 countries.

Participants by arm

Arm	Count
Genotype 1 Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.	3,356
Genotype 2 Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.	316
Genotype 3 Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.	744
Genotype 4 Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.	201
Genotype 5/6 Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.	21
Genotype Unknown Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.	42
Total	4,680

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Overall Study	Adverse Event	43	1	3	0	0	0
Overall Study	Death	20	4	3	0	0	0
Overall Study	Early termination	3	0	0	0	0	0
Overall Study	Failed to return	450	33	144	40	1	2
Overall Study	Incomplete treatment	2	0	0	0	0	0
Overall Study	Lab test not done	22	3	4	1	0	1
Overall Study	Lack of Efficacy	65	1	5	5	0	1
Overall Study	Miscellaneous	12	2	3	1	0	0
Overall Study	New treatment started	3	1	0	2	0	0
Overall Study	Non-responders	493	4	21	20	0	2
Overall Study	Not categorized	33	2	6	1	0	1
Overall Study	Not meeting inclusion/exclusion criteria	2	1	1	0	0	0
Overall Study	Other	5	0	0	1	0	0
Overall Study	Protocol Violation	15	1	1	1	0	0
Overall Study	Relapse	44	5	14	4	0	0
Overall Study	Result not available	3	1	3	0	0	0
Overall Study	Screen failure	1	0	0	0	0	0
Overall Study	Sponsor decision	1	0	0	0	0	0
Overall Study	Treatment duration shortened	1	0	0	0	0	0
Overall Study	Treatment interrupted	7	0	1	1	0	0
Overall Study	Treatment not started	14	2	4	0	0	0
Overall Study	Treatment restarted	0	1	0	0	0	0
Overall Study	Treatment stopped	3	0	0	0	0	0
Overall Study	Treatment unavailable	1	0	0	0	0	0
Overall Study	Treatment was stopped early	7	0	0	0	0	0
Overall Study	Withdrawal by Subject	35	0	3	0	0	0

Baseline characteristics

Characteristic	Genotype 1	Genotype 2	Genotype 3	Genotype 4	Genotype 5/6	Genotype Unknown	Total
Age, Continuous	47.1 Years STANDARD_DEVIATION 11.87	52.0 Years STANDARD_DEVIATION 11.74	40.8 Years STANDARD_DEVIATION 10.25	43.1 Years STANDARD_DEVIATION 9.87	52.5 Years STANDARD_DEVIATION 11.81	44.9 Years STANDARD_DEVIATION 10.62	46.3 Years STANDARD_DEVIATION 11.86
Sex/Gender, Customized Female	1610 Participants	155 Participants	243 Participants	54 Participants	4 Participants	16 Participants	2082 Participants
Sex/Gender, Customized Male	1746 Participants	161 Participants	501 Participants	147 Participants	17 Participants	25 Participants	2597 Participants
Sex/Gender, Customized Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 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
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Outcome results

Primary

Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population

Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA \<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Time frame: At 24 weeks after EOT

Population: The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of \<50 IU/mL were excluded from the mTRT population.

Arm	Measure	Value (NUMBER)
Genotype 1	Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population	43.2 Percentage of participants
Genotype 2	Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population	72.4 Percentage of participants
Genotype 3	Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population	60.5 Percentage of participants
Genotype 4	Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population	40.6 Percentage of participants
Genotype 5/6	Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population	71.4 Percentage of participants
Genotype Unknown	Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population	44.4 Percentage of participants

Comparison: The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.012695% CI: [0.833, 0.978]Regression, Logistic

Comparison: The statistical analysis is presented for Body Mass Index (BMI) in kilogram per square meter (kg/m\^2). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.004295% CI: [0.944, 0.989]Regression, Logistic

Comparison: The statistical analysis is presented for HCV RNA at Baseline (BL) in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [0.656, 0.816]Regression, Logistic

Comparison: The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.347, 2.109]Regression, Logistic

Comparison: The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.475995% CI: [0.843, 1.442]Regression, Logistic

Comparison: The statistical analysis is presented for Alanine transaminase (ALT) ratio at BL (\<=1 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.01895% CI: [0.462, 0.93]Regression, Logistic

Comparison: The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.026295% CI: [0.57, 0.965]Regression, Logistic

Comparison: The statistical analysis is presented for aspartate aminotransferase (AST) ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.006995% CI: [0.563, 0.913]Regression, Logistic

Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.056, 1.067]Regression, Logistic

Comparison: The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.006295% CI: [1.029, 1.191]Regression, Logistic

Comparison: The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [0.083, 0.329]Regression, Logistic

Comparison: The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.001995% CI: [2.136, 28.458]Regression, Logistic

Comparison: The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.005995% CI: [0.618, 0.922]Regression, Logistic

Comparison: The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.003495% CI: [1.198, 2.491]Regression, Logistic

Comparison: The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.001495% CI: [0.376, 0.792]Regression, Logistic

Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.029, 1.065]Regression, Logistic

Comparison: The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.007495% CI: [0.827, 0.971]Regression, Logistic

Comparison: The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.008895% CI: [0.95, 0.993]Regression, Logistic

Comparison: The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [0.643, 0.803]Regression, Logistic

Comparison: The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.346, 2.106]Regression, Logistic

Comparison: The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.447995% CI: [0.848, 1.453]Regression, Logistic

Comparison: The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.012395% CI: [0.451, 0.908]Regression, Logistic

Comparison: The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.014795% CI: [0.553, 0.937]Regression, Logistic

Comparison: The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.007195% CI: [0.564, 0.914]Regression, Logistic

Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.052, 1.064]Regression, Logistic

Comparison: The statistical analysis is presented for cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.001995% CI: [1.005, 1.023]Regression, Logistic

Comparison: The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.008395% CI: [0.539, 0.913]Regression, Logistic

Comparison: The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [0.09, 0.338]Regression, Logistic

Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000895% CI: [1.023, 1.091]Regression, Logistic

Comparison: The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.025595% CI: [0.431, 0.946]Regression, Logistic

Comparison: The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.005995% CI: [0.618, 0.922]Regression, Logistic

Comparison: The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000595% CI: [1.501, 4.236]Regression, Logistic

Comparison: The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.003495% CI: [1.198, 2.491]Regression, Logistic

Comparison: The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.001495% CI: [0.376, 0.792]Regression, Logistic

Comparison: The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.004295% CI: [0.822, 0.964]Regression, Logistic

Comparison: The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.036395% CI: [0.687, 0.988]Regression, Logistic

Comparison: The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.003395% CI: [0.751, 0.944]Regression, Logistic

Comparison: The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000695% CI: [1.183, 1.844]Regression, Logistic

Comparison: The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.38195% CI: [0.862, 1.477]Regression, Logistic

Comparison: The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.027995% CI: [0.674, 0.978]Regression, Logistic

Comparison: The statistical analysis is presented for On-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [27.972, 75.299]Regression, Logistic

Comparison: The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [20.129, 51.434]Regression, Logistic

Comparison: The statistical analysis is presented for on-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [4.291, 11.188]Regression, Logistic

Comparison: The statistical analysis is presented for on-treatment response, combined (RVR vs no RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.00195% CI: [1.514, 5.201]Regression, Logistic

Comparison: The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.006495% CI: [1.224, 3.447]Regression, Logistic

Comparison: The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.027195% CI: [1.077, 3.461]Regression, Logistic

Comparison: The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.003995% CI: [1.194, 2.528]Regression, Logistic

Comparison: The statistical analysis is presented for on-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.007195% CI: [1.593, 19.219]Regression, Logistic

Comparison: The statistical analysis is presented for on-treatment response (pEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.4195% CI: [0.471, 6.318]Regression, Logistic

Primary

Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population

Modified sustained virological response is defined as mVR of HCV RNA \<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Time frame: At 24 weeks after EOT

Population: The PP population included all participants who met the inclusion/exclusion criteria.

Arm	Measure	Value (NUMBER)
Genotype 1	Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population	44.4 Percentage of participants
Genotype 2	Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population	74.4 Percentage of participants
Genotype 3	Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population	62.3 Percentage of participants
Genotype 4	Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population	44.1 Percentage of participants
Genotype 5/6	Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population	83.3 Percentage of participants
Genotype Unknown	Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population	42.9 Percentage of participants

Primary

Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population

The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Time frame: At 24 weeks after EOT

Population: The PP population included all participants who met the inclusion/exclusion criteria. n = the number of participants analyzed at a given time point.

Arm	Measure	Group	Value (NUMBER)
Genotype 1	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 4, PPV (n=2408, 222, 556, 139, 10, 6)	72.2 Percentage of participants
Genotype 1	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 12, PPV (n=2535, 231, 586, 150, 12, 6)	66.9 Percentage of participants
Genotype 1	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 4, NPV (n=2408, 222, 556, 139, 10, 6)	63.0 Percentage of participants
Genotype 1	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 12, NPV (n=2535, 231, 586, 150, 12, 6)	81.6 Percentage of participants
Genotype 2	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 4, NPV (n=2408, 222, 556, 139, 10, 6)	31.5 Percentage of participants
Genotype 2	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 12, NPV (n=2535, 231, 586, 150, 12, 6)	31.4 Percentage of participants
Genotype 2	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 4, PPV (n=2408, 222, 556, 139, 10, 6)	79.2 Percentage of participants
Genotype 2	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 12, PPV (n=2535, 231, 586, 150, 12, 6)	76.7 Percentage of participants
Genotype 3	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 12, NPV (n=2535, 231, 586, 150, 12, 6)	55.9 Percentage of participants
Genotype 3	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 4, PPV (n=2408, 222, 556, 139, 10, 6)	73.2 Percentage of participants
Genotype 3	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 4, NPV (n=2408, 222, 556, 139, 10, 6)	55.1 Percentage of participants
Genotype 3	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 12, PPV (n=2535, 231, 586, 150, 12, 6)	67.3 Percentage of participants
Genotype 4	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 12, NPV (n=2535, 231, 586, 150, 12, 6)	78.8 Percentage of participants
Genotype 4	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 4, PPV (n=2408, 222, 556, 139, 10, 6)	67.3 Percentage of participants
Genotype 4	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 12, PPV (n=2535, 231, 586, 150, 12, 6)	56.1 Percentage of participants
Genotype 4	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 4, NPV (n=2408, 222, 556, 139, 10, 6)	66.7 Percentage of participants
Genotype 5/6	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 4, NPV (n=2408, 222, 556, 139, 10, 6)	16.7 Percentage of participants
Genotype 5/6	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 4, PPV (n=2408, 222, 556, 139, 10, 6)	75.0 Percentage of participants
Genotype 5/6	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 12, PPV (n=2535, 231, 586, 150, 12, 6)	88.9 Percentage of participants
Genotype 5/6	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 12, NPV (n=2535, 231, 586, 150, 12, 6)	33.3 Percentage of participants
Genotype Unknown	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 12, NPV (n=2535, 231, 586, 150, 12, 6)	100.0 Percentage of participants
Genotype Unknown	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 4, NPV (n=2408, 222, 556, 139, 10, 6)	75.0 Percentage of participants
Genotype Unknown	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 12, PPV (n=2535, 231, 586, 150, 12, 6)	100.0 Percentage of participants
Genotype Unknown	Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	Week 4, PPV (n=2408, 222, 556, 139, 10, 6)	100.0 Percentage of participants

Primary

Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population

The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Time frame: At 24 weeks after EOT

Population: The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result \<50 IU/mL were excluded from the mTRT population. n = the number of participants analyzed at a given time point.

Arm	Measure	Group	Value (NUMBER)
Genotype 1	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 4, NPV (n=2802, 263, 618, 159, 12, 8)	64.1 Percentage of participants
Genotype 1	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 12, NPV (n=2957, 272, 652, 173, 14, 8)	82.4 Percentage of participants
Genotype 1	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week12, PPV (n=2957, 272, 652, 173, 14, 8)	65.3 Percentage of participants
Genotype 1	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 4, PPV (n=2802, 263, 618, 159, 12, 8)	71.4 Percentage of participants
Genotype 2	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 4, NPV (n=2802, 263, 618, 159, 12, 8)	34.1 Percentage of participants
Genotype 2	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 4, PPV (n=2802, 263, 618, 159, 12, 8)	77.3 Percentage of participants
Genotype 2	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week12, PPV (n=2957, 272, 652, 173, 14, 8)	74.5 Percentage of participants
Genotype 2	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 12, NPV (n=2957, 272, 652, 173, 14, 8)	33.3 Percentage of participants
Genotype 3	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 12, NPV (n=2957, 272, 652, 173, 14, 8)	58.0 Percentage of participants
Genotype 3	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 4, NPV (n=2802, 263, 618, 159, 12, 8)	55.6 Percentage of participants
Genotype 3	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week12, PPV (n=2957, 272, 652, 173, 14, 8)	65.8 Percentage of participants
Genotype 3	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 4, PPV (n=2802, 263, 618, 159, 12, 8)	71.1 Percentage of participants
Genotype 4	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week12, PPV (n=2957, 272, 652, 173, 14, 8)	52.7 Percentage of participants
Genotype 4	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 4, PPV (n=2802, 263, 618, 159, 12, 8)	68.6 Percentage of participants
Genotype 4	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 4, NPV (n=2802, 263, 618, 159, 12, 8)	70.4 Percentage of participants
Genotype 4	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 12, NPV (n=2957, 272, 652, 173, 14, 8)	81.0 Percentage of participants
Genotype 5/6	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 4, NPV (n=2802, 263, 618, 159, 12, 8)	37.5 Percentage of participants
Genotype 5/6	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 12, NPV (n=2957, 272, 652, 173, 14, 8)	50.0 Percentage of participants
Genotype 5/6	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week12, PPV (n=2957, 272, 652, 173, 14, 8)	80.0 Percentage of participants
Genotype 5/6	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 4, PPV (n=2802, 263, 618, 159, 12, 8)	75.0 Percentage of participants
Genotype Unknown	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 12, NPV (n=2957, 272, 652, 173, 14, 8)	100.0 Percentage of participants
Genotype Unknown	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 4, PPV (n=2802, 263, 618, 159, 12, 8)	100.0 Percentage of participants
Genotype Unknown	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week 4, NPV (n=2802, 263, 618, 159, 12, 8)	66.7 Percentage of participants
Genotype Unknown	Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	Week12, PPV (n=2957, 272, 652, 173, 14, 8)	100.0 Percentage of participants

Primary

Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population

Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of \<15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection \[LLOD\] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive hepatitis C virus (HCV) mono-infected modified all-treated (mTRT) who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Time frame: At 24 weeks after EOT

Population: The mTRT population included all participants who received at least one dose of peginterferon alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result \<50 IU/mL were excluded from the mTRT population.

Arm	Measure	Value (NUMBER)
Genotype 1	Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population	40.6 Percentage of participants
Genotype 2	Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population	60.4 Percentage of participants
Genotype 3	Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population	55.0 Percentage of participants
Genotype 4	Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population	36.0 Percentage of participants
Genotype 5/6	Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population	57.1 Percentage of participants
Genotype Unknown	Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population	44.4 Percentage of participants

Primary

Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population

Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of \<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Time frame: At 24 weeks after EOT

Population: The PP population included all participants who met the inclusion/exclusion criteria.

Arm	Measure	Value (NUMBER)
Genotype 1	Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population	41.7 Percentage of participants
Genotype 2	Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population	62.0 Percentage of participants
Genotype 3	Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population	57.1 Percentage of participants
Genotype 4	Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population	38.8 Percentage of participants
Genotype 5/6	Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population	66.7 Percentage of participants
Genotype Unknown	Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population	42.9 Percentage of participants

Secondary

Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12

Rapid virological response (RVR) was defined as VR by Week 4, Modified rapid virological response (mRVR) was defined as mVR by Week 4, Complete early virological response (cEVR) was defined as VR by Week 12, but no RVR, Modified complete early virological response (mcEVR) was defined as mVR by Week 12, but no mRVR, Partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values \<50 IU/mL) by, Week 12, but no RVR and no cEVR, Modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Week 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a.

Time frame: Week 4 and Week 12

Arm	Measure	Group	Value (NUMBER)
Genotype 1	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mpEVR at Week 12	581 Participants
Genotype 1	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	pEVR at Week 12	853 Participants
Genotype 1	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	cEVR at Week 12	998 Participants
Genotype 1	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mRVR at Week 4	773 Participants
Genotype 1	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	RVR at Week 4	588 Participants
Genotype 1	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mcEVR at Week 12	1085 Participants
Genotype 2	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	RVR at Week 4	172 Participants
Genotype 2	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mcEVR at Week 12	37 Participants
Genotype 2	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	pEVR at Week 12	58 Participants
Genotype 2	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mpEVR at Week 12	6 Participants
Genotype 2	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	cEVR at Week 12	40 Participants
Genotype 2	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mRVR at Week 4	227 Participants
Genotype 3	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mpEVR at Week 12	17 Participants
Genotype 3	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	pEVR at Week 12	122 Participants
Genotype 3	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	cEVR at Week 12	119 Participants
Genotype 3	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mcEVR at Week 12	132 Participants
Genotype 3	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	RVR at Week 4	395 Participants
Genotype 3	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mRVR at Week 4	487 Participants
Genotype 4	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mcEVR at Week 12	59 Participants
Genotype 4	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	pEVR at Week 12	35 Participants
Genotype 4	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mRVR at Week 4	69 Participants
Genotype 4	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	RVR at Week 4	51 Participants
Genotype 4	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	cEVR at Week 12	59 Participants
Genotype 4	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mpEVR at Week 12	17 Participants
Genotype 5/6	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	cEVR at Week 12	6 Participants
Genotype 5/6	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	RVR at Week 4	4 Participants
Genotype 5/6	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mRVR at Week 4	7 Participants
Genotype 5/6	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mcEVR at Week 12	7 Participants
Genotype 5/6	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	pEVR at Week 12	4 Participants
Genotype 5/6	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mpEVR at Week 12	0 Participants
Genotype Unknown	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mcEVR at Week 12	1 Participants
Genotype Unknown	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mpEVR at Week 12	0 Participants
Genotype Unknown	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	mRVR at Week 4	3 Participants
Genotype Unknown	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	RVR at Week 4	2 Participants
Genotype Unknown	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	pEVR at Week 12	0 Participants
Genotype Unknown	Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	cEVR at Week 12	2 Participants

Secondary

Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12

RVR defined was as VR by Week 4, mRVR was defined as mVR by Week 4, cEVR was defined as VR by Week 12, but no RVR, mcEVR was defined as mVR by Week 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values \<50 IU/mL) by Week 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Week 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.

Time frame: At Week 4 and Week 12

Population: The PP population included all participants who met the inclusion/exclusion criteria.

Arm	Measure	Group	Value (NUMBER)
Genotype 1	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mcEVR at Week 12	938 Participants
Genotype 1	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mpEVR at Week 12	512 Participants
Genotype 1	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	cEVR at Week 12	858 Participants
Genotype 1	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	pEVR at Week 12	749 Participants
Genotype 1	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mRVR at Week 4	657 Participants
Genotype 1	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	RVR at Week 4	500 Participants
Genotype 2	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	pEVR at Week 12	49 Participants
Genotype 2	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	cEVR at Week 12	31 Participants
Genotype 2	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	RVR at Week 4	149 Participants
Genotype 2	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mcEVR at Week 12	32 Participants
Genotype 2	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mpEVR at Week 12	6 Participants
Genotype 2	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mRVR at Week 4	191 Participants
Genotype 3	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mcEVR at Week 12	122 Participants
Genotype 3	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	cEVR at Week 12	110 Participants
Genotype 3	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mpEVR at Week 12	13 Participants
Genotype 3	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	pEVR at Week 12	105 Participants
Genotype 3	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mRVR at Week 4	438 Participants
Genotype 3	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	RVR at Week 4	358 Participants
Genotype 4	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	cEVR at Week 12	49 Participants
Genotype 4	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mcEVR at Week 12	49 Participants
Genotype 4	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mpEVR at Week 12	15 Participants
Genotype 4	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	RVR at Week 4	49 Participants
Genotype 4	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mRVR at Week 4	64 Participants
Genotype 4	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	pEVR at Week 12	30 Participants
Genotype 5/6	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mRVR at Week 4	7 Participants
Genotype 5/6	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	pEVR at Week 12	3 Participants
Genotype 5/6	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mpEVR at Week 12	0 Participants
Genotype 5/6	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	RVR at Week 4	4 Participants
Genotype 5/6	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	cEVR at Week 12	5 Participants
Genotype 5/6	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mcEVR at Week 12	5 Participants
Genotype Unknown	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mcEVR at Week 12	0 Participants
Genotype Unknown	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mRVR at Week 4	3 Participants
Genotype Unknown	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	RVR at Week 4	2 Participants
Genotype Unknown	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	pEVR at Week 12	0 Participants
Genotype Unknown	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	cEVR at Week 12	1 Participants
Genotype Unknown	Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	mpEVR at Week 12	0 Participants

Secondary

Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12

Participants with 1-log drop in HCV RNA including HCV RNA values \<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a.

Time frame: Week 2, Week 4, and Week 12

Arm	Measure	Group	Value (NUMBER)
Genotype 1	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 4	75.0 Percentage of participants
Genotype 1	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 12	90.5 Percentage of participants
Genotype 1	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 2	33.6 Percentage of participants
Genotype 2	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 12	98.5 Percentage of participants
Genotype 2	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 4	93.8 Percentage of participants
Genotype 2	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 2	51.6 Percentage of participants
Genotype 3	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 4	90.2 Percentage of participants
Genotype 3	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 12	96.5 Percentage of participants
Genotype 3	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 2	46.0 Percentage of participants
Genotype 4	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 12	90.9 Percentage of participants
Genotype 4	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 2	35.4 Percentage of participants
Genotype 4	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 4	72.6 Percentage of participants
Genotype 5/6	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 12	100.0 Percentage of participants
Genotype 5/6	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 2	42.9 Percentage of participants
Genotype 5/6	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 4	85.7 Percentage of participants
Genotype Unknown	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 12	66.7 Percentage of participants
Genotype Unknown	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 4	55.6 Percentage of participants
Genotype Unknown	Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 2	11.1 Percentage of participants

Secondary

Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12

Time frame: Week 2, Week 4, and Week 12

Population: The PP population included all participants who met the inclusion/exclusion criteria.

Arm	Measure	Group	Value (NUMBER)
Genotype 1	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 12	91.6 Percentage of participants
Genotype 1	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 4	76.3 Percentage of participants
Genotype 1	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 2	33.5 Percentage of participants
Genotype 2	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 2	51.7 Percentage of participants
Genotype 2	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 12	98.3 Percentage of participants
Genotype 2	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 4	92.7 Percentage of participants
Genotype 3	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 4	90.6 Percentage of participants
Genotype 3	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 12	96.8 Percentage of participants
Genotype 3	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 2	46.1 Percentage of participants
Genotype 4	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 2	35.5 Percentage of participants
Genotype 4	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 12	92.1 Percentage of participants
Genotype 4	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 4	76.3 Percentage of participants
Genotype 5/6	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 12	100.0 Percentage of participants
Genotype 5/6	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 4	83.3 Percentage of participants
Genotype 5/6	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 2	41.7 Percentage of participants
Genotype Unknown	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 12	71.4 Percentage of participants
Genotype Unknown	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 2	14.3 Percentage of participants
Genotype Unknown	Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=1-log10 drop by Week 4	57.1 Percentage of participants

Secondary

Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12

Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values \<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a.

Time frame: At Week 2, Week 4, and Week 12

Arm	Measure	Group	Value (NUMBER)
Genotype 1	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 12	81.8 Percentage of participants
Genotype 1	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 4	55.2 Percentage of participants
Genotype 1	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 2	21.5 Percentage of participants
Genotype 2	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 12	98.2 Percentage of participants
Genotype 2	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 2	49.1 Percentage of participants
Genotype 2	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 4	92.4 Percentage of participants
Genotype 3	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 2	40.6 Percentage of participants
Genotype 3	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 12	95.6 Percentage of participants
Genotype 3	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 4	87.8 Percentage of participants
Genotype 4	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 2	22.3 Percentage of participants
Genotype 4	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 12	82.9 Percentage of participants
Genotype 4	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 4	56.0 Percentage of participants
Genotype 5/6	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 4	85.7 Percentage of participants
Genotype 5/6	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 2	42.9 Percentage of participants
Genotype 5/6	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 12	100.0 Percentage of participants
Genotype Unknown	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 12	44.4 Percentage of participants
Genotype Unknown	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 2	11.1 Percentage of participants
Genotype Unknown	Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12	>=2-log10 drop at Week 4	44.4 Percentage of participants

Secondary

Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12

Participants with 2-log drop in HCV RNA including HCV RNA values \<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.

Time frame: Week 2, Week 4, and Week 12

Population: The PP population included all participants who met the inclusion/exclusion criteria.

Arm	Measure	Group	Value (NUMBER)
Genotype 1	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 4	55.6 Percentage of participants
Genotype 1	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 12	82.5 Percentage of participants
Genotype 1	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 2	21.3 Percentage of participants
Genotype 2	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 4	91.0 Percentage of participants
Genotype 2	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 12	97.9 Percentage of participants
Genotype 2	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 2	49.1 Percentage of participants
Genotype 3	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 12	96.0 Percentage of participants
Genotype 3	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 2	40.5 Percentage of participants
Genotype 3	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 4	88.1 Percentage of participants
Genotype 4	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 2	22.4 Percentage of participants
Genotype 4	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 4	59.9 Percentage of participants
Genotype 4	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 12	84.2 Percentage of participants
Genotype 5/6	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 12	100.0 Percentage of participants
Genotype 5/6	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 2	41.7 Percentage of participants
Genotype 5/6	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 4	83.3 Percentage of participants
Genotype Unknown	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 4	42.9 Percentage of participants
Genotype Unknown	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 2	14.3 Percentage of participants
Genotype Unknown	Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12	>=2-log 10 drop by Week 12	42.9 Percentage of participants

Secondary

Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time

Modified virological response was defined as HCV RNA \<50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Time frame: At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT

Arm	Measure	Group	Value (NUMBER)
Genotype 1	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At EOT	67.7 Percentage of participants
Genotype 1	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 4	25.9 Percentage of participants
Genotype 1	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 2	6.7 Percentage of participants
Genotype 1	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At 12 weeks after EOT	46.2 Percentage of participants
Genotype 1	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 12	62.3 Percentage of participants
Genotype 2	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At EOT	92.4 Percentage of participants
Genotype 2	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 2	31.3 Percentage of participants
Genotype 2	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 12	96.0 Percentage of participants
Genotype 2	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 4	82.5 Percentage of participants
Genotype 2	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At 12 weeks after EOT	76.4 Percentage of participants
Genotype 3	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At EOT	88.7 Percentage of participants
Genotype 3	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 12	93.1 Percentage of participants
Genotype 3	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At 12 weeks after EOT	65.0 Percentage of participants
Genotype 3	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 4	73.2 Percentage of participants
Genotype 3	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 2	23.0 Percentage of participants
Genotype 4	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At 12 weeks after EOT	46.3 Percentage of participants
Genotype 4	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 2	13.7 Percentage of participants
Genotype 4	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 12	73.1 Percentage of participants
Genotype 4	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 4	39.4 Percentage of participants
Genotype 4	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At EOT	68.6 Percentage of participants
Genotype 5/6	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 4	50.0 Percentage of participants
Genotype 5/6	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At EOT	92.9 Percentage of participants
Genotype 5/6	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 12	100.0 Percentage of participants
Genotype 5/6	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At 12 weeks after EOT	85.7 Percentage of participants
Genotype 5/6	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 2	28.6 Percentage of participants
Genotype Unknown	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At 12 weeks after EOT	44.4 Percentage of participants
Genotype Unknown	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 12	44.4 Percentage of participants
Genotype Unknown	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 2	11.1 Percentage of participants
Genotype Unknown	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At EOT	55.6 Percentage of participants
Genotype Unknown	Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 4	33.3 Percentage of participants

Secondary

Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time

Modified virological response is defined as HCV RNA \<50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Time frame: At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT

Population: The PP population included all participants who met the inclusion/exclusion criteria.

Arm	Measure	Group	Value (NUMBER)
Genotype 1	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At 12 week after EOT	47.3 Percentage of participants
Genotype 1	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 2	6.6 Percentage of participants
Genotype 1	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 4	25.7 Percentage of participants
Genotype 1	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 12	62.5 Percentage of participants
Genotype 1	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At EOT	68.0 Percentage of participants
Genotype 2	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 2	32.5 Percentage of participants
Genotype 2	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 4	81.6 Percentage of participants
Genotype 2	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At 12 week after EOT	78.6 Percentage of participants
Genotype 2	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 12	95.3 Percentage of participants
Genotype 2	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At EOT	92.7 Percentage of participants
Genotype 3	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At EOT	89.4 Percentage of participants
Genotype 3	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 4	73.4 Percentage of participants
Genotype 3	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At 12 week after EOT	67.0 Percentage of participants
Genotype 3	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 2	23.6 Percentage of participants
Genotype 3	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 12	93.8 Percentage of participants
Genotype 4	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 12	74.3 Percentage of participants
Genotype 4	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 4	42.1 Percentage of participants
Genotype 4	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At EOT	71.7 Percentage of participants
Genotype 4	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 2	13.8 Percentage of participants
Genotype 4	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At 12 week after EOT	49.3 Percentage of participants
Genotype 5/6	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 12	100.0 Percentage of participants
Genotype 5/6	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At 12 week after EOT	91.7 Percentage of participants
Genotype 5/6	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 2	33.3 Percentage of participants
Genotype 5/6	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At EOT	91.7 Percentage of participants
Genotype 5/6	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 4	58.3 Percentage of participants
Genotype Unknown	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 4	42.9 Percentage of participants
Genotype Unknown	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 2	14.3 Percentage of participants
Genotype Unknown	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At 12 week after EOT	42.9 Percentage of participants
Genotype Unknown	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At Week 12	42.9 Percentage of participants
Genotype Unknown	Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	At EOT	42.9 Percentage of participants

Secondary

Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population

The probability that a participant who developed VR by Wk 2 also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 2 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Time frame: At 24 weeks after EOT

Arm	Measure	Group	Value (NUMBER)
Genotype 1	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	At Week 2, PPV	65.7 Percentage of participants
Genotype 1	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	At Week 2, NPV	61.0 Percentage of participants
Genotype 2	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	At Week 2, NPV	35.7 Percentage of participants
Genotype 2	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	At Week 2, PPV	89.7 Percentage of participants
Genotype 3	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	At Week 2, PPV	71.3 Percentage of participants
Genotype 3	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	At Week 2, NPV	47.6 Percentage of participants
Genotype 4	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	At Week 2, PPV	73.3 Percentage of participants
Genotype 4	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	At Week 2, NPV	65.7 Percentage of participants
Genotype 5/6	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	At Week 2, PPV	50.0 Percentage of participants
Genotype 5/6	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	At Week 2, NPV	25.0 Percentage of participants
Genotype Unknown	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	At Week 2, NPV	50.0 Percentage of participants
Genotype Unknown	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	At Week 2, PPV	100.0 Percentage of participants

Secondary

Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population

The probability that a participant who developed VR by Wk 2 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 2 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Time frame: At 24 weeks after EOT

Population: The PP population included all participants who met the inclusion/exclusion criteria.

Arm	Measure	Group	Value (NUMBER)
Genotype 1	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	At Week 2, PPV	68.3 Percentage of participants
Genotype 1	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	At Week 2, NPV	60.0 Percentage of participants
Genotype 2	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	At Week 2, PPV	91.8 Percentage of participants
Genotype 2	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	At Week 2, NPV	32.9 Percentage of participants
Genotype 3	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	At Week 2, PPV	72.0 Percentage of participants
Genotype 3	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	At Week 2, NPV	46.0 Percentage of participants
Genotype 4	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	At Week 2, PPV	69.2 Percentage of participants
Genotype 4	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	At Week 2, NPV	63.2 Percentage of participants
Genotype 5/6	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	At Week 2, PPV	50.0 Percentage of participants
Genotype 5/6	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	At Week 2, NPV	0.0 Percentage of participants
Genotype Unknown	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	At Week 2, PPV	100.0 Percentage of participants
Genotype Unknown	Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	At Week 2, NPV	0 Percentage of participants

Secondary

Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment

Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Time frame: At 12 Weeks after EOT

Arm	Measure	Value (NUMBER)
Genotype 1	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment	26.5 Percentage of participants
Genotype 2	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment	10.2 Percentage of participants
Genotype 3	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment	19.4 Percentage of participants
Genotype 4	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment	29.6 Percentage of participants
Genotype 5/6	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment	0.0 Percentage of participants
Genotype Unknown	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment	0.0 Percentage of participants

Secondary

Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment

Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Time frame: At 24 weeks after EOT

Arm	Measure	Value (NUMBER)
Genotype 1	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment	27.1 Percentage of participants
Genotype 2	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment	12.3 Percentage of participants
Genotype 3	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment	17.9 Percentage of participants
Genotype 4	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment	25.3 Percentage of participants
Genotype 5/6	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment	9.1 Percentage of participants
Genotype Unknown	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment	0.0 Percentage of participants

Comparison: The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.236, 1.538]Regression, Logistic

Comparison: The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.025195% CI: [1.004, 1.063]Regression, Logistic

Comparison: The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.358, 1.849]Regression, Logistic

Comparison: The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.031795% CI: [1.036, 2.174]Regression, Logistic

Comparison: The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.012995% CI: [1.089, 2.048]Regression, Logistic

Comparison: The statistical analysis is presented for Platelets x 10\^9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.012895% CI: [1.107, 2.357]Regression, Logistic

Comparison: The statistical analysis is presented for Platelets x 10\^9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.780995% CI: [0.763, 1.432]Regression, Logistic

Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [0.962, 0.976]Regression, Logistic

Comparison: The statistical analysis is presented for Cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.018995% CI: [1.273, 14.512]Regression, Logistic

Comparison: The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.002495% CI: [1.701, 11.879]Regression, Logistic

Comparison: The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.024795% CI: [1.014, 1.219]Regression, Logistic

Comparison: The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.025895% CI: [1.077, 3.158]Regression, Logistic

Comparison: The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000295% CI: [1.166, 1.641]Regression, Logistic

Comparison: The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000295% CI: [1.421, 3.074]Regression, Logistic

Comparison: The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000695% CI: [0.141, 0.588]Regression, Logistic

Comparison: The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.001395% CI: [0.106, 0.579]Regression, Logistic

Comparison: The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.00295% CI: [0.568, 0.881]Regression, Logistic

Comparison: The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.288, 1.596]Regression, Logistic

Comparison: The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.26, 1.726]Regression, Logistic

Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [0.956, 0.97]Regression, Logistic

Comparison: The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.12, 1.275]Regression, Logistic

Comparison: The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.031695% CI: [1.04, 2.359]Regression, Logistic

Comparison: The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.002495% CI: [1.701, 11.879]Regression, Logistic

Comparison: The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.024795% CI: [1.014, 1.219]Regression, Logistic

Comparison: The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.025895% CI: [1.077, 3.158]Regression, Logistic

Comparison: The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000995% CI: [1.232, 2.235]Regression, Logistic

Comparison: The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.004595% CI: [1.073, 1.467]Regression, Logistic

Comparison: The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000195% CI: [1.434, 3.034]Regression, Logistic

Comparison: The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.00195% CI: [0.16, 0.63]Regression, Logistic

Comparison: The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.002195% CI: [0.121, 0.626]Regression, Logistic

Comparison: The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.245, 1.553]Regression, Logistic

Comparison: The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.002995% CI: [1.092, 1.535]Regression, Logistic

Comparison: The statistical analysis is presented for On-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [0.05, 0.236]Regression, Logistic

Comparison: The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.001495% CI: [0.159, 0.645]Regression, Logistic

Comparison: The statistical analysis is presented for on-treatment response (pEVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.53995% CI: [0.616, 2.528]Regression, Logistic

Comparison: The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.005695% CI: [1.547, 12.766]Regression, Logistic

Comparison: The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.026795% CI: [1.04, 1.892]Regression, Logistic

Comparison: The statistical analysis is presented for on-treatment response, combined (RVR vs no RVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.001895% CI: [0.089, 0.575]Regression, Logistic

Comparison: The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000295% CI: [1.401, 3.032]Regression, Logistic

Comparison: The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.001995% CI: [0.162, 0.662]Regression, Logistic

Comparison: The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.008695% CI: [0.137, 0.749]Regression, Logistic

Comparison: The statistical analysis is presented for on-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [0.138, 0.441]Regression, Logistic

Secondary

Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment

Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Time frame: At 12 weeks after EOT

Population: The PP population included all participants who met the inclusion/exclusion criteria.

Arm	Measure	Value (NUMBER)
Genotype 1	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment	24.4 Percentage of Participants
Genotype 2	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment	10.3 Percentage of Participants
Genotype 3	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment	18.4 Percentage of Participants
Genotype 4	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment	28.6 Percentage of Participants
Genotype 5/6	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment	0.0 Percentage of Participants
Genotype Unknown	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment	0.0 Percentage of Participants

Secondary

Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment

Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Time frame: At 24 weeks after EOT

Population: The PP population included all participants who met the inclusion/exclusion criteria.

Arm	Measure	Value (NUMBER)
Genotype 1	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment	26.6 Percentage of participants
Genotype 2	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment	10.8 Percentage of participants
Genotype 3	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment	16.6 Percentage of participants
Genotype 4	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment	24.7 Percentage of participants
Genotype 5/6	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment	0.0 Percentage of participants
Genotype Unknown	Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment	0.0 Percentage of participants

Secondary

Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time

Virological response was defined as HCV RNA \<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Time frame: At Week 2, Week 4, and Week 12, EOT, and 12 weeks after EOT

Arm	Measure	Group	Value (NUMBER)
Genotype 1	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 12	53.2 Percentage of participants
Genotype 1	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 2	4.8 Percentage of participants
Genotype 1	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At EOT	62.1 Percentage of participants
Genotype 1	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At 12 Weeks after EOT	43.2 Percentage of participants
Genotype 1	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 4	19.7 Percentage of participants
Genotype 2	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 12	77.1 Percentage of participants
Genotype 2	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At 12 Weeks after EOT	64.0 Percentage of participants
Genotype 2	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 2	24.7 Percentage of participants
Genotype 2	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 4	62.5 Percentage of participants
Genotype 2	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At EOT	75.6 Percentage of participants
Genotype 3	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At 12 Weeks after EOT	59.5 Percentage of participants
Genotype 3	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 12	77.3 Percentage of participants
Genotype 3	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 4	59.4 Percentage of participants
Genotype 3	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At EOT	78.0 Percentage of participants
Genotype 3	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 2	16.2 Percentage of participants
Genotype 4	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 12	62.9 Percentage of participants
Genotype 4	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At 12 Weeks after EOT	40.6 Percentage of participants
Genotype 4	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 2	8.6 Percentage of participants
Genotype 4	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 4	29.1 Percentage of participants
Genotype 4	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At EOT	59.4 Percentage of participants
Genotype 5/6	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 12	71.4 Percentage of participants
Genotype 5/6	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 4	28.6 Percentage of participants
Genotype 5/6	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At 12 Weeks after EOT	57.1 Percentage of participants
Genotype 5/6	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At EOT	71.4 Percentage of participants
Genotype 5/6	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 2	14.3 Percentage of participants
Genotype Unknown	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At EOT	44.4 Percentage of participants
Genotype Unknown	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 12	44.4 Percentage of participants
Genotype Unknown	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 4	22.2 Percentage of participants
Genotype Unknown	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At Week 2	11.1 Percentage of participants
Genotype Unknown	Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time	At 12 Weeks after EOT	44.4 Percentage of participants

Secondary

Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time

Virological response was defined as HCV RNA \<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

Time frame: At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT

Population: The PP population included all participants who met the inclusion/exclusion criteria.

Arm	Measure	Group	Value (NUMBER)
Genotype 1	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At EOT	62.5 Percentage of participants
Genotype 1	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 4	19.6 Percentage of participants
Genotype 1	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 2	4.8 Percentage of participants
Genotype 1	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 12	53.2 Percentage of participants
Genotype 1	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At 12 weeks after EOT	44.2 Percentage of participants
Genotype 2	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 12	76.9 Percentage of participants
Genotype 2	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 4	63.7 Percentage of participants
Genotype 2	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 2	26.1 Percentage of participants
Genotype 2	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At EOT	76.1 Percentage of participants
Genotype 2	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At 12 weeks after EOT	65.8 Percentage of participants
Genotype 3	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At EOT	79.6 Percentage of participants
Genotype 3	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 4	60.0 Percentage of participants
Genotype 3	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 12	78.4 Percentage of participants
Genotype 3	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At 12 weeks after EOT	61.8 Percentage of participants
Genotype 3	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 2	16.8 Percentage of participants
Genotype 4	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At 12 weeks after EOT	43.4 Percentage of participants
Genotype 4	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 2	8.6 Percentage of participants
Genotype 4	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At EOT	61.8 Percentage of participants
Genotype 4	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 4	32.2 Percentage of participants
Genotype 4	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 12	64.5 Percentage of participants
Genotype 5/6	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At 12 weeks after EOT	66.7 Percentage of participants
Genotype 5/6	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 12	75.0 Percentage of participants
Genotype 5/6	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 4	33.3 Percentage of participants
Genotype 5/6	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At EOT	75.0 Percentage of participants
Genotype 5/6	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 2	16.7 Percentage of participants
Genotype Unknown	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 2	14.3 Percentage of participants
Genotype Unknown	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At EOT	42.9 Percentage of participants
Genotype Unknown	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 12	42.9 Percentage of participants
Genotype Unknown	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At 12 weeks after EOT	42.9 Percentage of participants
Genotype Unknown	Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	At Week 4	28.6 Percentage of participants

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

PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Virus (HCV)Treated With Pegasys (Peginterferon Alfa-2a)

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population

Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population

Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population

Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population

Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population

Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population

Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12

Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12

Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12

Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12

Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12

Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12

Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time

Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time

Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population

Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population

Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment

Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment

Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment

Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment

Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time

Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time