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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)

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ClinicalTrials.gov Identifier: NCT01070550
Recruitment Status : Completed
First Posted : February 18, 2010
Results First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hepatitis C, Chronic
Intervention Drug: Peginterferon alfa-2a (Pegasys®)
Enrollment 4680
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.
Pre-assignment Details  
Arm/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description Eligible participants infected with hepatitis C virus (HCV) of Genotype 1 who received PEGASYS® (Pegylated Interferon [PEG-IFN]) alfa-2a plus ribavirin according to the standard of care and in line with summary of product characteristics (SPCs)/local labelling were observed for up to 72 weeks. 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 labelling were observed for up to 72 weeks. Eligible participants infected with HCV of Genotype 3 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling were observed for up to 72 weeks. Eligible participants infected with HCV of Genotype 4 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling were observed for up to 72 weeks. Eligible participants infected with HCV of Genotype 5/6 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. Eligible participants infected with HCV of Genotype unknown 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.
Period Title: Overall Study
Started 3356 316 744 201 21 42
Completed 2071 254 528 124 20 35
Not Completed 1285 62 216 77 1 7
Reason Not Completed
Adverse Event             43             1             3             0             0             0
Death             20             4             3             0             0             0
Not meeting inclusion/exclusion criteria             2             1             1             0             0             0
Early termination             3             0             0             0             0             0
Failed to return             450             33             144             40             1             2
Incomplete treatment             2             0             0             0             0             0
Lab test not done             22             3             4             1             0             1
Lack of Efficacy             65             1             5             5             0             1
Miscellaneous             12             2             3             1             0             0
New treatment started             3             1             0             2             0             0
Non-responders             493             4             21             20             0             2
Not categorized             33             2             6             1             0             1
Protocol Violation             15             1             1             1             0             0
Relapse             44             5             14             4             0             0
Result not available             3             1             3             0             0             0
Screen failure             1             0             0             0             0             0
Sponsor decision             1             0             0             0             0             0
Treatment duration shortened             1             0             0             0             0             0
Treatment interrupted             7             0             1             1             0             0
Treatment not started             14             2             4             0             0             0
Treatment restarted             0             1             0             0             0             0
Treatment stopped             3             0             0             0             0             0
Treatment unavailable             1             0             0             0             0             0
Treatment was stopped early             7             0             0             0             0             0
Other             5             0             0             1             0             0
Withdrawal by Subject             35             0             3             0             0             0
Arm/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown Total
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 3356 316 744 201 21 42 4680
Hide Baseline Analysis Population Description
All enrolled population included every participant for whom there was any data available in the PROPHESYS 1 database.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3356 participants 316 participants 744 participants 201 participants 21 participants 42 participants 4680 participants
47.1  (11.87) 52.0  (11.74) 40.8  (10.25) 43.1  (9.87) 52.5  (11.81) 44.9  (10.62) 46.3  (11.86)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3356 participants 316 participants 744 participants 201 participants 21 participants 42 participants 4680 participants
Female 1610 155 243 54 4 16 2082
Male 1746 161 501 147 17 25 2597
Unknown 0 0 0 0 0 1 1
1.Primary Outcome
Title Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
Eligible participants infected with HCV of Genotype 1 who received Peginterferon (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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2981 275 665 175 14 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
40.6
(38.8 to 42.4)
60.4
(54.3 to 66.2)
55.0
(51.2 to 58.9)
36.0
(28.9 to 43.6)
57.1
(28.9 to 82.3)
44.4
(13.7 to 78.8)
2.Primary Outcome
Title Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who met the inclusion/exclusion criteria.
Arm/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2554 234 597 152 12 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
41.7
(39.8 to 43.7)
62.0
(55.4 to 68.2)
57.1
(53.0 to 61.1)
38.8
(31.0 to 47.0)
66.7
(34.9 to 90.1)
42.9
(9.9 to 81.6)
3.Primary Outcome
Title Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2981 275 665 175 14 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
43.2
(41.4 to 45.0)
72.4
(66.7 to 77.6)
60.5
(56.6 to 64.2)
40.6
(33.2 to 48.2)
71.4
(41.9 to 91.6)
44.4
(13.7 to 78.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0126
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.903
Confidence Interval (2-Sided) 95%
0.833 to 0.978
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0042
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.966
Confidence Interval (2-Sided) 95%
0.944 to 0.989
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.732
Confidence Interval (2-Sided) 95%
0.656 to 0.816
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.686
Confidence Interval (2-Sided) 95%
1.347 to 2.109
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4759
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.103
Confidence Interval (2-Sided) 95%
0.843 to 1.442
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0180
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.656
Confidence Interval (2-Sided) 95%
0.462 to 0.930
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0262
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.742
Confidence Interval (2-Sided) 95%
0.570 to 0.965
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0069
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.717
Confidence Interval (2-Sided) 95%
0.563 to 0.913
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.062
Confidence Interval (2-Sided) 95%
1.056 to 1.067
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0062
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.107
Confidence Interval (2-Sided) 95%
1.029 to 1.191
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Genotype 2
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0295
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.739
Confidence Interval (2-Sided) 95%
0.563 to 0.970
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Genotype 2
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.166
Confidence Interval (2-Sided) 95%
0.083 to 0.329
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Genotype 2
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.049
Confidence Interval (2-Sided) 95%
1.015 to 1.084
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Genotype 2
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.797
Confidence Interval (2-Sided) 95%
2.136 to 28.458
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0255
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.638
Confidence Interval (2-Sided) 95%
0.431 to 0.946
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0059
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.755
Confidence Interval (2-Sided) 95%
0.618 to 0.922
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.521
Confidence Interval (2-Sided) 95%
1.501 to 4.236
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.602
Confidence Interval (2-Sided) 95%
1.463 to 4.627
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0034
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.727
Confidence Interval (2-Sided) 95%
1.198 to 2.491
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.545
Confidence Interval (2-Sided) 95%
0.376 to 0.792
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.047
Confidence Interval (2-Sided) 95%
1.029 to 1.065
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0074
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.896
Confidence Interval (2-Sided) 95%
0.827 to 0.971
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0088
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.971
Confidence Interval (2-Sided) 95%
0.950 to 0.993
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.719
Confidence Interval (2-Sided) 95%
0.643 to 0.803
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.683
Confidence Interval (2-Sided) 95%
1.346 to 2.106
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4479
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.110
Confidence Interval (2-Sided) 95%
0.848 to 1.453
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0123
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.640
Confidence Interval (2-Sided) 95%
0.451 to 0.908
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0147
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.720
Confidence Interval (2-Sided) 95%
0.553 to 0.937
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0071
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.718
Confidence Interval (2-Sided) 95%
0.564 to 0.914
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.058
Confidence Interval (2-Sided) 95%
1.052 to 1.064
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.014
Confidence Interval (2-Sided) 95%
1.005 to 1.023
Estimation Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Genotype 2
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0083
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.701
Confidence Interval (2-Sided) 95%
0.539 to 0.913
Estimation Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Genotype 2
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.174
Confidence Interval (2-Sided) 95%
0.090 to 0.338
Estimation Comments [Not Specified]
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Genotype 2
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.057
Confidence Interval (2-Sided) 95%
1.023 to 1.091
Estimation Comments [Not Specified]
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0255
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.638
Confidence Interval (2-Sided) 95%
0.431 to 0.946
Estimation Comments [Not Specified]
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0059
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.755
Confidence Interval (2-Sided) 95%
0.618 to 0.922
Estimation Comments [Not Specified]
Show Statistical Analysis 37 Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.521
Confidence Interval (2-Sided) 95%
1.501 to 4.236
Estimation Comments [Not Specified]
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.602
Confidence Interval (2-Sided) 95%
1.463 to 4.627
Estimation Comments [Not Specified]
Show Statistical Analysis 39 Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0034
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.727
Confidence Interval (2-Sided) 95%
1.198 to 2.491
Estimation Comments [Not Specified]
Show Statistical Analysis 40 Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.545
Confidence Interval (2-Sided) 95%
0.376 to 0.792
Estimation Comments [Not Specified]
Show Statistical Analysis 41 Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0042
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.890
Confidence Interval (2-Sided) 95%
0.822 to 0.964
Estimation Comments [Not Specified]
Show Statistical Analysis 42 Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0363
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.824
Confidence Interval (2-Sided) 95%
0.687 to 0.988
Estimation Comments [Not Specified]
Show Statistical Analysis 43 Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0033
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.842
Confidence Interval (2-Sided) 95%
0.751 to 0.944
Estimation Comments [Not Specified]
Show Statistical Analysis 44 Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.477
Confidence Interval (2-Sided) 95%
1.183 to 1.844
Estimation Comments [Not Specified]
Show Statistical Analysis 45 Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3810
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.128
Confidence Interval (2-Sided) 95%
0.862 to 1.477
Estimation Comments [Not Specified]
Show Statistical Analysis 46 Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0279
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.812
Confidence Interval (2-Sided) 95%
0.674 to 0.978
Estimation Comments [Not Specified]
Show Statistical Analysis 47 Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 45.894
Confidence Interval (2-Sided) 95%
27.972 to 75.299
Estimation Comments [Not Specified]
Show Statistical Analysis 48 Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 32.176
Confidence Interval (2-Sided) 95%
20.129 to 51.434
Estimation Comments [Not Specified]
Show Statistical Analysis 49 Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.928
Confidence Interval (2-Sided) 95%
4.291 to 11.188
Estimation Comments [Not Specified]
Show Statistical Analysis 50 Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Genotype 2
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0204
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.733
Confidence Interval (2-Sided) 95%
0.564 to 0.953
Estimation Comments [Not Specified]
Show Statistical Analysis 51 Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Genotype 2
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.170
Confidence Interval (2-Sided) 95%
0.087 to 0.331
Estimation Comments [Not Specified]
Show Statistical Analysis 52 Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Genotype 2
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.806
Confidence Interval (2-Sided) 95%
1.514 to 5.201
Estimation Comments [Not Specified]
Show Statistical Analysis 53 Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0459
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.663
Confidence Interval (2-Sided) 95%
0.443 to 0.993
Estimation Comments [Not Specified]
Show Statistical Analysis 54 Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0087
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.758
Confidence Interval (2-Sided) 95%
0.616 to 0.932
Estimation Comments [Not Specified]
Show Statistical Analysis 55 Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0064
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.054
Confidence Interval (2-Sided) 95%
1.224 to 3.447
Estimation Comments [Not Specified]
Show Statistical Analysis 56 Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0271
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.931
Confidence Interval (2-Sided) 95%
1.077 to 3.461
Estimation Comments [Not Specified]
Show Statistical Analysis 57 Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0039
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.738
Confidence Interval (2-Sided) 95%
1.194 to 2.528
Estimation Comments [Not Specified]
Show Statistical Analysis 58 Hide Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0035
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.565
Confidence Interval (2-Sided) 95%
0.386 to 0.829
Estimation Comments [Not Specified]
Show Statistical Analysis 59 Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0071
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.533
Confidence Interval (2-Sided) 95%
1.593 to 19.219
Estimation Comments [Not Specified]
Show Statistical Analysis 60 Hide Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3042
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.964
Confidence Interval (2-Sided) 95%
0.542 to 7.114
Estimation Comments [Not Specified]
Show Statistical Analysis 61 Hide Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4100
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.726
Confidence Interval (2-Sided) 95%
0.471 to 6.318
Estimation Comments [Not Specified]
4.Primary Outcome
Title Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who met the inclusion/exclusion criteria.
Arm/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2554 234 597 152 12 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
44.4
(42.5 to 46.4)
74.4
(68.3 to 79.8)
62.3
(58.3 to 66.2)
44.1
(36.0 to 52.4)
83.3
(51.6 to 97.9)
42.9
(9.9 to 81.6)
5.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2957 272 652 173 14 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 4, PPV (n=2802, 263, 618, 159, 12, 8)
71.4
(67.6 to 75.0)
77.3
(70.3 to 83.4)
71.1
(66.4 to 75.6)
68.6
(54.1 to 80.9)
75.0
(19.4 to 99.4)
100.0
(15.8 to 100.0)
Week 4, NPV (n=2802, 263, 618, 159, 12, 8)
64.1
(62.1 to 66.1)
34.1
(24.5 to 44.7)
55.6
(48.8 to 62.2)
70.4
(60.8 to 78.8)
37.5
(8.5 to 75.5)
66.7
(22.3 to 95.7)
Week12, PPV (n=2957, 272, 652, 173, 14, 8)
65.3
(62.9 to 67.7)
74.5
(68.1 to 80.2)
65.8
(61.5 to 69.9)
52.7
(43.0 to 62.3)
80.0
(44.4 to 97.5)
100.0
(39.8 to 100.0)
Week 12, NPV (n=2957, 272, 652, 173, 14, 8)
82.4
(80.3 to 84.4)
33.3
(21.7 to 46.7)
58.0
(49.3 to 66.3)
81.0
(69.1 to 89.8)
50.0
(6.8 to 93.2)
100.0
(39.8 to 100.0)
6.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who met the inclusion/exclusion criteria. n = the number of participants analyzed at a given time point.
Arm/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2535 231 586 150 12 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 4, PPV (n=2408, 222, 556, 139, 10, 6)
72.2
(68.0 to 76.1)
79.2
(71.8 to 85.4)
73.2
(68.3 to 77.7)
67.3
(52.5 to 80.1)
75.0
(19.4 to 99.4)
100.0
(15.8 to 100.0)
Week 4, NPV (n=2408, 222, 556, 139, 10, 6)
63.0
(60.8 to 65.2)
31.5
(21.1 to 43.4)
55.1
(47.8 to 62.1)
66.7
(55.9 to 76.3)
16.7
(0.4 to 64.1)
75.0
(19.4 to 99.4)
Week 12, PPV (n=2535, 231, 586, 150, 12, 6)
66.9
(64.4 to 69.4)
76.7
(69.8 to 82.6)
67.3
(62.9 to 71.5)
56.1
(45.7 to 66.1)
88.9
(51.8 to 99.7)
100.0
(29.2 to 100.0)
Week 12, NPV (n=2535, 231, 586, 150, 12, 6)
81.6
(79.3 to 83.8)
31.4
(19.1 to 45.9)
55.9
(46.5 to 65.1)
78.8
(65.3 to 88.9)
33.3
(0.8 to 90.6)
100.0
(29.2 to 100.0)
7.Secondary Outcome
Title Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2981 275 665 175 14 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
At Week 2
4.8
(4.1 to 5.6)
24.7
(19.7 to 30.3)
16.2
(13.5 to 19.3)
8.6
(4.9 to 13.7)
14.3
(1.8 to 42.8)
11.1
(0.3 to 48.2)
At Week 4
19.7
(18.3 to 21.2)
62.5
(56.5 to 68.3)
59.4
(55.6 to 63.2)
29.1
(22.5 to 36.5)
28.6
(8.4 to 58.1)
22.2
(2.8 to 60.0)
At Week 12
53.2
(51.4 to 55.0)
77.1
(71.7 to 81.9)
77.3
(73.9 to 80.4)
62.9
(55.2 to 70.0)
71.4
(41.9 to 91.6)
44.4
(13.7 to 78.8)
At EOT
62.1
(60.4 to 63.9)
75.6
(70.1 to 80.6)
78.0
(74.7 to 81.1)
59.4
(51.8 to 66.8)
71.4
(41.9 to 91.6)
44.4
(13.7 to 78.8)
At 12 Weeks after EOT
43.2
(41.5 to 45.0)
64.0
(58.0 to 69.7)
59.5
(55.7 to 63.3)
40.6
(33.2 to 48.2)
57.1
(28.9 to 82.3)
44.4
(13.7 to 78.8)
8.Secondary Outcome
Title Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who met the inclusion/exclusion criteria.
Arm/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2554 234 597 152 12 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
At Week 2
4.8
(4.0 to 5.7)
26.1
(20.6 to 32.2)
16.8
(13.8 to 20.0)
8.6
(4.6 to 14.2)
16.7
(2.1 to 48.4)
14.3
(0.4 to 57.9)
At Week 4
19.6
(18.1 to 21.2)
63.7
(57.2 to 69.8)
60.0
(55.9 to 63.9)
32.2
(24.9 to 40.3)
33.3
(9.9 to 65.1)
28.6
(3.7 to 71.0)
At Week 12
53.2
(51.2 to 55.1)
76.9
(71.0 to 82.2)
78.4
(74.9 to 81.6)
64.5
(56.3 to 72.1)
75.0
(42.8 to 94.5)
42.9
(9.9 to 81.6)
At EOT
62.5
(60.6 to 64.4)
76.1
(70.1 to 81.4)
79.6
(76.1 to 82.7)
61.8
(53.6 to 69.6)
75.0
(42.8 to 94.5)
42.9
(9.9 to 81.6)
At 12 weeks after EOT
44.2
(42.3 to 46.2)
65.8
(59.3 to 71.9)
61.8
(57.8 to 65.7)
43.4
(35.4 to 51.7)
66.7
(34.9 to 90.1)
42.9
(9.9 to 81.6)
9.Secondary Outcome
Title Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2981 275 665 175 14 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
At Week 2
6.7
(5.8 to 7.6)
31.3
(25.8 to 37.1)
23.0
(19.9 to 26.4)
13.7
(9.0 to 19.7)
28.6
(8.4 to 58.1)
11.1
(0.3 to 48.2)
At Week 4
25.9
(24.4 to 27.5)
82.5
(77.5 to 86.8)
73.2
(69.7 to 76.6)
39.4
(32.1 to 47.1)
50.0
(23.0 to 77.0)
33.3
(7.5 to 70.1)
At Week 12
62.3
(60.6 to 64.1)
96.0
(93.0 to 98.0)
93.1
(90.9 to 94.9)
73.1
(65.9 to 79.6)
100.0
(76.8 to 100.0)
44.4
(13.7 to 78.8)
At EOT
67.7
(65.9 to 69.3)
92.4
(88.6 to 95.2)
88.7
(86.1 to 91.0)
68.6
(61.1 to 75.4)
92.9
(66.1 to 99.8)
55.6
(21.2 to 86.3)
At 12 weeks after EOT
46.2
(44.4 to 48.0)
76.4
(70.9 to 81.3)
65.0
(61.2 to 68.6)
46.3
(38.7 to 54.0)
85.7
(57.2 to 98.2)
44.4
(13.7 to 78.8)
10.Secondary Outcome
Title Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who met the inclusion/exclusion criteria.
Arm/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2554 234 597 152 12 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
At Week 2
6.6
(5.7 to 7.7)
32.5
(26.5 to 38.9)
23.6
(20.3 to 27.2)
13.8
(8.8 to 20.3)
33.3
(9.9 to 65.1)
14.3
(0.4 to 57.9)
At Week 4
25.7
(24.0 to 27.5)
81.6
(76.1 to 86.4)
73.4
(69.6 to 76.9)
42.1
(34.2 to 50.4)
58.3
(27.7 to 84.8)
42.9
(9.9 to 81.6)
At Week 12
62.5
(60.5 to 64.3)
95.3
(91.7 to 97.6)
93.8
(91.6 to 95.6)
74.3
(66.6 to 81.1)
100.0
(73.5 to 100.0)
42.9
(9.9 to 81.6)
At EOT
68.0
(66.2 to 69.8)
92.7
(88.6 to 95.7)
89.4
(86.7 to 91.8)
71.7
(63.8 to 78.7)
91.7
(61.5 to 99.8)
42.9
(9.9 to 81.6)
At 12 week after EOT
47.3
(45.3 to 49.2)
78.6
(72.8 to 83.7)
67.0
(63.1 to 70.8)
49.3
(41.1 to 57.6)
91.7
(61.5 to 99.8)
42.9
(9.9 to 81.6)
11.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2981 275 665 175 14 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
>=2-log10 drop at Week 2
21.5
(20.0 to 23.0)
49.1
(43.0 to 55.2)
40.6
(36.8 to 44.4)
22.3
(16.4 to 29.2)
42.9
(17.7 to 71.1)
11.1
(0.3 to 48.2)
>=2-log10 drop at Week 4
55.2
(53.4 to 57.0)
92.4
(88.6 to 95.2)
87.8
(85.1 to 90.2)
56.0
(48.3 to 63.5)
85.7
(57.2 to 98.2)
44.4
(13.7 to 78.8)
>=2-log10 drop at Week 12
81.8
(80.4 to 83.2)
98.2
(95.8 to 99.4)
95.6
(93.8 to 97.1)
82.9
(76.4 to 88.1)
100.0
(76.8 to 100.0)
44.4
(13.7 to 78.8)
12.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who met the inclusion/exclusion criteria.
Arm/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2554 234 597 152 12 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
>=2-log 10 drop by Week 2
21.3
(19.7 to 22.9)
49.1
(42.6 to 55.7)
40.5
(36.6 to 44.6)
22.4
(16.0 to 29.8)
41.7
(15.2 to 72.3)
14.3
(0.4 to 57.9)
>=2-log 10 drop by Week 4
55.6
(53.6 to 57.5)
91.0
(86.6 to 94.4)
88.1
(85.2 to 90.6)
59.9
(51.6 to 67.7)
83.3
(51.6 to 97.9)
42.9
(9.9 to 81.6)
>=2-log 10 drop by Week 12
82.5
(81.0 to 84.0)
97.9
(95.1 to 99.3)
96.0
(94.1 to 97.4)
84.2
(77.4 to 89.6)
100.0
(73.5 to 100.0)
42.9
(9.9 to 81.6)
13.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2981 275 665 175 14 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
>=1-log10 drop by Week 2
33.6
(31.9 to 35.3)
51.6
(45.6 to 57.7)
46.0
(42.2 to 49.9)
35.4
(28.4 to 43.0)
42.9
(17.7 to 71.1)
11.1
(0.3 to 48.2)
>=1-log10 drop by Week 4
75.0
(73.4 to 76.6)
93.8
(90.3 to 96.4)
90.2
(87.7 to 92.4)
72.6
(65.3 to 79.0)
85.7
(57.2 to 98.2)
55.6
(21.2 to 86.3)
>=1-log10 drop by Week 12
90.5
(89.4 to 91.5)
98.5
(96.3 to 99.6)
96.5
(94.9 to 97.8)
90.9
(85.6 to 94.7)
100.0
(76.8 to 100.0)
66.7
(29.9 to 92.5)
14.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Week 2, Week 4, and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who met the inclusion/exclusion criteria.
Arm/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2554 234 597 152 12 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
>=1-log10 drop by Week 2
33.5
(31.7 to 35.4)
51.7
(45.1 to 58.3)
46.1
(42.0 to 50.2)
35.5
(27.9 to 43.7)
41.7
(15.2 to 72.3)
14.3
(0.4 to 57.9)
>=1-log10 drop by Week 4
76.3
(74.6 to 77.9)
92.7
(88.6 to 95.7)
90.6
(88.0 to 92.8)
76.3
(68.7 to 82.8)
83.3
(51.6 to 97.9)
57.1
(18.4 to 90.1)
>=1-log10 drop by Week 12
91.6
(90.5 to 92.7)
98.3
(95.7 to 99.5)
96.8
(95.1 to 98.1)
92.1
(86.6 to 95.9)
100.0
(73.5 to 100.0)
71.4
(29.0 to 96.3)
15.Secondary Outcome
Title Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2981 275 665 175 14 9
Measure Type: Number
Unit of Measure: Participants
RVR at Week 4 588 172 395 51 4 2
mRVR at Week 4 773 227 487 69 7 3
cEVR at Week 12 998 40 119 59 6 2
mcEVR at Week 12 1085 37 132 59 7 1
pEVR at Week 12 853 58 122 35 4 0
mpEVR at Week 12 581 6 17 17 0 0
16.Secondary Outcome
Title Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who met the inclusion/exclusion criteria.
Arm/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2554 234 597 152 12 7
Measure Type: Number
Unit of Measure: Participants
RVR at Week 4 500 149 358 49 4 2
mRVR at Week 4 657 191 438 64 7 3
cEVR at Week 12 858 31 110 49 5 1
mcEVR at Week 12 938 32 122 49 5 0
pEVR at Week 12 749 49 105 30 3 0
mpEVR at Week 12 512 6 13 15 0 0
17.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 775 127 247 54 6 1
Measure Type: Number
Unit of Measure: Percentage of participants
26.5 10.2 19.4 29.6 0.0 0.0
18.Secondary Outcome
Title Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who met the inclusion/exclusion criteria.
Arm/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 671 116 234 49 5 1
Measure Type: Number
Unit of Measure: Percentage of Participants
24.4 10.3 18.4 28.6 0.0 0.0
19.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5/6 Genotype Unknown
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 1751 227 487 95 11 4
Measure Type: Number
Unit of Measure: Percentage of participants
27.1 12.3 17.9 25.3 9.1 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.379
Confidence Interval (2-Sided) 95%
1.236 to 1.538
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0251
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.033
Confidence Interval (2-Sided) 95%
1.004 to 1.063
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.585
Confidence Interval (2-Sided) 95%
1.358 to 1.849
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0317
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.501
Confidence Interval (2-Sided) 95%
1.036 to 2.174
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0129
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.493
Confidence Interval (2-Sided) 95%
1.089 to 2.048
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0128
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.616
Confidence Interval (2-Sided) 95%
1.107 to 2.357
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7809
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.046
Confidence Interval (2-Sided) 95%
0.763 to 1.432
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.969
Confidence Interval (2-Sided) 95%
0.962 to 0.976
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0189
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.298
Confidence Interval (2-Sided) 95%
1.273 to 14.512
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Genotype 2
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0316
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.567
Confidence Interval (2-Sided) 95%
1.040 to 2.359
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Genotype 2
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.495
Confidence Interval (2-Sided) 95%
1.701 to 11.879
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Genotype 2
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0247
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.112
Confidence Interval (2-Sided) 95%
1.014 to 1.219
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Genotype 2
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0258
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.844
Confidence Interval (2-Sided) 95%
1.077 to 3.158
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.677
Confidence Interval (2-Sided) 95%
1.243 to 2.263
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.384
Confidence Interval (2-Sided) 95%
1.166 to 1.641
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.090
Confidence Interval (2-Sided) 95%
1.421 to 3.074
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.288
Confidence Interval (2-Sided) 95%
0.141 to 0.588
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.247
Confidence Interval (2-Sided) 95%
0.106 to 0.579
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0062
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.959
Confidence Interval (2-Sided) 95%
0.931 to 0.988
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Genotype 3
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.708
Confidence Interval (2-Sided) 95%
0.568 to 0.881
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.434
Confidence Interval (2-Sided) 95%
1.288 to 1.596
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.475
Confidence Interval (2-Sided) 95%
1.260 to 1.726
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.963
Confidence Interval (2-Sided) 95%
0.956 to 0.970
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Genotype 1
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.195
Confidence Interval (2-Sided) 95%
1.120 to 1.275
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Genotype 2
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0316
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.567
Confidence Interval (2-Sided) 95%
1.040 to 2.359
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Geno