Trial Outcomes & Findings for PROPHESYS 2: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b (NCT NCT01066793)
NCT ID: NCT01066793
Last Updated: 2016-05-09
Results Overview
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 HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Recruitment status
COMPLETED
Target enrollment
2343 participants
Primary outcome timeframe
At 24 weeks after EOT
Results posted on
2016-05-09
Participant Flow
A total of 2343 participants were enrolled in this study conducted from October 2007 to May 2011 at 125 centers in Belgium, Italy, United Kingdom, and Ireland.
Participant milestones
| Measure |
Genotype 1 (G1)
Eligible participants infected with hepatitis C virus (HCV) of Genotype 1 who received Pegasys® (Pegylated Interferon \[PEG-IFN\] alfa-2a) or PegIntron® (PEG-IFN alfa-2b) plus ribavirin dose according to the standard of care and in line with summary of product characteristics (SPCs)/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Unknown Genotype (UNK)
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1128
|
572
|
484
|
143
|
11
|
5
|
|
Overall Study
COMPLETED
|
754
|
495
|
369
|
94
|
11
|
4
|
|
Overall Study
NOT COMPLETED
|
374
|
77
|
115
|
49
|
0
|
1
|
Reasons for withdrawal
| Measure |
Genotype 1 (G1)
Eligible participants infected with hepatitis C virus (HCV) of Genotype 1 who received Pegasys® (Pegylated Interferon \[PEG-IFN\] alfa-2a) or PegIntron® (PEG-IFN alfa-2b) plus ribavirin dose according to the standard of care and in line with summary of product characteristics (SPCs)/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Unknown Genotype (UNK)
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
4
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
180
|
39
|
82
|
16
|
0
|
1
|
|
Overall Study
Physician Decision
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
3
|
2
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
1
|
0
|
0
|
0
|
|
Overall Study
Early Termination
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lab test not done
|
7
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Miscellaneous
|
4
|
5
|
6
|
0
|
0
|
0
|
|
Overall Study
Non-responders
|
104
|
5
|
11
|
25
|
0
|
0
|
|
Overall Study
Other
|
15
|
5
|
6
|
2
|
0
|
0
|
|
Overall Study
Relapse
|
20
|
8
|
2
|
3
|
0
|
0
|
|
Overall Study
Result Not Available
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Treatment Interrupted
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Treatment Never Started
|
18
|
5
|
4
|
1
|
0
|
0
|
|
Overall Study
Treatment Stopped
|
2
|
1
|
0
|
1
|
0
|
0
|
Baseline Characteristics
PROPHESYS 2: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b
Baseline characteristics by cohort
| Measure |
Genotype 1 (G1)
n=1128 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=572 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=484 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=143 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=11 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Unknown Genotype (UNK)
n=5 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Total
n=2343 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 12.52 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 12.52 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 9.20 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 11.56 • n=4 Participants
|
52.7 years
STANDARD_DEVIATION 12.82 • n=21 Participants
|
51.4 years
STANDARD_DEVIATION 13.24 • n=10 Participants
|
48.5 years
STANDARD_DEVIATION 12.71 • n=115 Participants
|
|
Sex: Female, Male
Female
|
532 Participants
n=5 Participants
|
291 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1017 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
596 Participants
n=5 Participants
|
281 Participants
n=7 Participants
|
350 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1326 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: At 24 weeks after EOTPopulation: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline (BL) result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
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 HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=960 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=518 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=427 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=128 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=11 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population
PEG-IFN alfa-2a (n=778, 414, 353,114, 9, 2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
46.1 percentage of participants
Interval 42.6 to 49.7
|
78.0 percentage of participants
Interval 73.7 to 81.9
|
68.3 percentage of participants
Interval 63.1 to 73.1
|
43.0 percentage of participants
Interval 33.7 to 52.6
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
|
Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population
PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
39.6 percentage of participants
Interval 32.4 to 47.1
|
81.7 percentage of participants
Interval 72.9 to 88.6
|
68.9 percentage of participants
Interval 57.1 to 79.2
|
35.7 percentage of participants
Interval 12.8 to 64.9
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
PRIMARY outcome
Timeframe: At 24 weeks after EOTPopulation: The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.
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 and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=862 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=448 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=367 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=116 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=9 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population
PEG-IFN alfa-2a (n=704, 361, 299, 102, 7, 2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
47.2 percentage of participants
Interval 43.4 to 50.9
|
79.5 percentage of participants
Interval 75.0 to 83.5
|
68.9 percentage of participants
Interval 63.3 to 74.1
|
40.2 percentage of participants
Interval 30.6 to 50.4
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
|
Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population
PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
39.2 percentage of participants
Interval 31.6 to 47.3
|
80.5 percentage of participants
Interval 70.6 to 88.2
|
69.1 percentage of participants
Interval 56.7 to 79.8
|
35.7 percentage of participants
Interval 12.8 to 64.9
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
PRIMARY outcome
Timeframe: At 24 weeks after EOTPopulation: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
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 population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=960 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=518 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=427 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=128 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=11 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population
PEG-IFN alfa-2a (n=778, 414, 353,114, 9, 2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
46.5 percentage of participants
Interval 43.0 to 50.1
|
78.3 percentage of participants
Interval 74.0 to 82.1
|
68.6 percentage of participants
Interval 63.4 to 73.4
|
43.0 percentage of participants
Interval 33.7 to 52.6
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
|
Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population
PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
39.6 percentage of participants
Interval 32.4 to 47.1
|
82.7 percentage of participants
Interval 74.0 to 89.4
|
68.9 percentage of participants
Interval 57.1 to 79.2
|
35.7 percentage of participants
Interval 12.8 to 64.9
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
PRIMARY outcome
Timeframe: At 24 weeks after EOTPopulation: The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.
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 and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=862 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=448 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=367 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=116 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=9 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population
PEG-IFN alfa-2a (n=704, 361, 299, 102, 7, 2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
47.6 percentage of participants
Interval 43.8 to 51.3
|
79.5 percentage of participants
Interval 75.0 to 83.5
|
69.2 percentage of participants
Interval 63.7 to 74.4
|
40.2 percentage of participants
Interval 30.6 to 50.4
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
|
Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population
PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
39.2 percentage of participants
Interval 31.6 to 47.3
|
81.6 percentage of participants
Interval 71.9 to 89.1
|
69.1 percentage of participants
Interval 56.7 to 79.8
|
35.7 percentage of participants
Interval 12.8 to 64.9
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
PRIMARY outcome
Timeframe: At 24 weeks after EOTPopulation: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
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 and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=960 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=518 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=427 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=128 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=11 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk12,PEG-IFN alfa-2a, NPV(n=768,412,350,109,9,2)
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
80.1 percentage of participants
Interval 75.2 to 84.4
|
59.4 percentage of participants
Interval 40.6 to 76.3
|
74.1 percentage of participants
Interval 53.7 to 88.9
|
93.9 percentage of participants
Interval 79.8 to 99.3
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk4,PEG-IFN alfa-2a, PPV (n=733,397,325,104,8,2)
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
74.9 percentage of participants
Interval 68.3 to 80.7
|
84.7 percentage of participants
Interval 80.4 to 88.4
|
74.8 percentage of participants
Interval 68.9 to 80.1
|
64.3 percentage of participants
Interval 48.0 to 78.4
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk4, PEG-IFN alfa-2a, NPV (n=733,397,325,104,8,2)
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
64.0 percentage of participants
Interval 59.8 to 68.1
|
51.6 percentage of participants
Interval 38.7 to 64.2
|
52.0 percentage of participants
Interval 40.2 to 63.7
|
71.0 percentage of participants
Interval 58.1 to 81.8
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk4, PEG-IFN alfa-2b, PPV (n=177,101,71,14,2,2)
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
72.4 percentage of participants
Interval 52.8 to 87.3
|
91.0 percentage of participants
Interval 82.4 to 96.3
|
80.0 percentage of participants
Interval 66.3 to 90.0
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk4, PEG-IFN alfa-2b, NPV (n=177,101,71,14,2,2)
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
67.6 percentage of participants
Interval 59.4 to 75.0
|
47.8 percentage of participants
Interval 26.8 to 69.4
|
61.9 percentage of participants
Interval 38.4 to 81.9
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk12,PEG-IFN alfa-2a,PPV (n=768,412,350,109,9,2)
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
64.6 percentage of participants
Interval 60.0 to 68.9
|
81.8 percentage of participants
Interval 77.6 to 85.6
|
72.4 percentage of participants
Interval 67.2 to 77.2
|
59.2 percentage of participants
Interval 47.3 to 70.4
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk12,PEG-IFN alfa-2b, PPV (n=181, 104,74,14,2,2)
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
68.8 percentage of participants
Interval 57.3 to 78.9
|
86.3 percentage of participants
Interval 77.7 to 92.5
|
73.8 percentage of participants
Interval 61.5 to 84.0
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk12, PEG-IFN alfa-2b, NPV (n=181, 104,74,14,2,2)
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
81.7 percentage of participants
Interval 72.9 to 88.6
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
PRIMARY outcome
Timeframe: At 24 weeks after EOTPopulation: The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.
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 and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=862 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=448 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=367 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=116 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=9 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk4,PEG-IFN alfa-2a, PPV (n=668,351,275,93,6,2)
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
75.8 percentage of participants
Interval 69.0 to 81.8
|
85.6 percentage of participants
Interval 81.1 to 89.4
|
73.7 percentage of participants
Interval 67.3 to 79.5
|
61.5 percentage of participants
Interval 44.6 to 76.6
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk4,PEG-IFN alfa-2a, NPV (n=668,351,275,93,6,2)
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
63.5 percentage of participants
Interval 59.0 to 67.8
|
49.1 percentage of participants
Interval 35.1 to 63.2
|
45.2 percentage of participants
Interval 32.5 to 58.3
|
74.1 percentage of participants
Interval 60.3 to 85.0
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk4, PEG-IFN alfa-2b, PPV (n=155,85,65,14,2,2)
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
75.0 percentage of participants
Interval 53.3 to 90.2
|
90.9 percentage of participants
Interval 81.3 to 96.6
|
81.8 percentage of participants
Interval 67.3 to 91.8
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk4, PEG-IFN alfa-2b, NPV (n=155,85,65,14,2,2)
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
68.7 percentage of participants
Interval 60.0 to 76.5
|
52.6 percentage of participants
Interval 28.9 to 75.6
|
61.9 percentage of participants
Interval 38.4 to 81.9
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk12,PEG-IFN alfa-2a, PPV(n=697,359,296,98,7,2)
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
65.2 percentage of participants
Interval 60.4 to 69.7
|
82.4 percentage of participants
Interval 77.9 to 86.4
|
72.5 percentage of participants
Interval 66.8 to 77.6
|
55.7 percentage of participants
Interval 43.3 to 67.6
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk12,PEG-IFN alfa-2a, NPV (n=697,359,296,98,7,2)
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
79.6 percentage of participants
Interval 74.4 to 84.2
|
56.5 percentage of participants
Interval 34.5 to 76.8
|
70.0 percentage of participants
Interval 45.7 to 88.1
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk12, PEG-IFN alfa-2b, PPV (n=158, 87,68,14,2,2)
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
68.7 percentage of participants
Interval 56.2 to 79.4
|
85.0 percentage of participants
Interval 75.3 to 92.0
|
74.6 percentage of participants
Interval 61.6 to 85.0
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk12, PEG-IFN alfa-2b, NPV (n=158, 87,68,14,2,2)
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
82.4 percentage of participants
Interval 73.0 to 89.6
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
SECONDARY outcome
Timeframe: At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOTPopulation: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
Virological response (VR) 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 and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=960 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=518 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=427 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=128 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=11 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
4.1 percentage of participants
Interval 2.8 to 5.8
|
21.7 percentage of participants
Interval 17.9 to 26.0
|
9.9 percentage of participants
Interval 7.0 to 13.5
|
2.6 percentage of participants
Interval 0.5 to 7.5
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
3.8 percentage of participants
Interval 1.6 to 7.8
|
6.7 percentage of participants
Interval 2.7 to 13.4
|
6.8 percentage of participants
Interval 2.2 to 15.1
|
7.1 percentage of participants
Interval 0.2 to 33.9
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
25.6 percentage of participants
Interval 22.5 to 28.8
|
80.4 percentage of participants
Interval 76.3 to 84.1
|
70.8 percentage of participants
Interval 65.8 to 75.5
|
36.8 percentage of participants
Interval 28.0 to 46.4
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
15.9 percentage of participants
Interval 10.9 to 22.1
|
75.0 percentage of participants
Interval 65.6 to 83.0
|
67.6 percentage of participants
Interval 55.7 to 78.0
|
42.9 percentage of participants
Interval 17.7 to 71.1
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk12,PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
42.3 percentage of participants
Interval 35.0 to 49.8
|
91.3 percentage of participants
Interval 84.2 to 96.0
|
87.8 percentage of participants
Interval 78.2 to 94.3
|
50.0 percentage of participants
Interval 23.0 to 77.0
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
EOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
71.5 percentage of participants
Interval 68.2 to 74.6
|
91.3 percentage of participants
Interval 88.2 to 93.8
|
91.8 percentage of participants
Interval 88.4 to 94.4
|
66.7 percentage of participants
Interval 57.2 to 75.2
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
EOT, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
53.8 percentage of participants
Interval 46.3 to 61.2
|
90.4 percentage of participants
Interval 83.0 to 95.3
|
89.2 percentage of participants
Interval 79.8 to 95.2
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
12wk PEOT, PEG-IFN alfa-2b (n=182,104, 4,14,2,2)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
40.7 percentage of participants
Interval 33.5 to 48.2
|
81.7 percentage of participants
Interval 72.9 to 88.6
|
70.3 percentage of participants
Interval 58.5 to 80.3
|
35.7 percentage of participants
Interval 12.8 to 64.9
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
58.7 percentage of participants
Interval 55.2 to 62.2
|
91.8 percentage of participants
Interval 88.7 to 94.2
|
91.5 percentage of participants
Interval 88.1 to 94.2
|
66.7 percentage of participants
Interval 57.2 to 75.2
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
12wk PEOT,PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
49.2 percentage of participants
Interval 45.7 to 52.8
|
80.0 percentage of participants
Interval 75.8 to 83.7
|
70.8 percentage of participants
Interval 65.8 to 75.5
|
46.5 percentage of participants
Interval 37.1 to 56.1
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
SECONDARY outcome
Timeframe: At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOTPopulation: The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.
Virological response (VR) 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 and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=862 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=448 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=367 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=116 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=9 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
4.0 percentage of participants
Interval 2.7 to 5.7
|
23.3 percentage of participants
Interval 19.0 to 28.0
|
10.4 percentage of participants
Interval 7.2 to 14.4
|
2.0 percentage of participants
Interval 0.2 to 6.9
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
12wk PEOT, PEG-IFN alfa-2b (n=158, 87, 68,14,2,2)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
39.9 percentage of participants
Interval 32.2 to 48.0
|
80.5 percentage of participants
Interval 70.6 to 88.2
|
70.6 percentage of participants
Interval 58.3 to 81.0
|
35.7 percentage of participants
Interval 12.8 to 64.9
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
3.2 percentage of participants
Interval 1.0 to 7.2
|
8.0 percentage of participants
Interval 3.3 to 15.9
|
7.4 percentage of participants
Interval 2.4 to 16.3
|
7.1 percentage of participants
Interval 0.2 to 33.9
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
26.4 percentage of participants
Interval 23.2 to 29.8
|
82.5 percentage of participants
Interval 78.2 to 86.3
|
71.2 percentage of participants
Interval 65.7 to 76.3
|
38.2 percentage of participants
Interval 28.8 to 48.4
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
15.2 percentage of participants
Interval 10.0 to 21.8
|
75.9 percentage of participants
Interval 65.5 to 84.4
|
64.7 percentage of participants
Interval 52.2 to 75.9
|
42.9 percentage of participants
Interval 17.7 to 71.1
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
59.9 percentage of participants
Interval 56.2 to 63.6
|
93.1 percentage of participants
Interval 89.9 to 95.5
|
92.3 percentage of participants
Interval 88.7 to 95.1
|
68.6 percentage of participants
Interval 58.7 to 77.5
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk12, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
42.4 percentage of participants
Interval 34.6 to 50.5
|
92.0 percentage of participants
Interval 84.1 to 96.7
|
86.8 percentage of participants
Interval 76.4 to 93.8
|
50.0 percentage of participants
Interval 23.0 to 77.0
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
EOT, PEG-IFN alfa-2a (n=704,361,299,102, 7, 2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
72.9 percentage of participants
Interval 69.4 to 76.1
|
92.2 percentage of participants
Interval 89.0 to 94.8
|
92.3 percentage of participants
Interval 88.7 to 95.1
|
65.7 percentage of participants
Interval 55.6 to 74.8
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
EOT, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
52.5 percentage of participants
Interval 44.4 to 60.5
|
89.7 percentage of participants
Interval 81.3 to 95.2
|
89.7 percentage of participants
Interval 79.9 to 95.8
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
12wk PEOT,PEG-IFN alfa-2a (n=704,361,299,102,7,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
50.3 percentage of participants
Interval 46.5 to 54.0
|
81.4 percentage of participants
Interval 77.0 to 85.3
|
71.2 percentage of participants
Interval 65.7 to 76.3
|
44.1 percentage of participants
Interval 34.3 to 54.3
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
SECONDARY outcome
Timeframe: At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOTPopulation: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
Modified virological response (mVR) 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 and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=960 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=518 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=427 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=128 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=11 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
EOT, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
57.1 percentage of participants
Interval 49.6 to 64.4
|
92.3 percentage of participants
Interval 85.4 to 96.6
|
89.2 percentage of participants
Interval 79.8 to 95.2
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
4.8 percentage of participants
Interval 3.4 to 6.5
|
24.9 percentage of participants
Interval 20.8 to 29.3
|
12.7 percentage of participants
Interval 9.5 to 16.7
|
3.5 percentage of participants
Interval 1.0 to 8.7
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
20.9 percentage of participants
Interval 15.2 to 27.5
|
86.5 percentage of participants
Interval 78.4 to 92.4
|
74.3 percentage of participants
Interval 62.8 to 83.8
|
42.9 percentage of participants
Interval 17.7 to 71.1
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
63.6 percentage of participants
Interval 60.1 to 67.0
|
94.0 percentage of participants
Interval 91.2 to 96.1
|
93.2 percentage of participants
Interval 90.1 to 95.6
|
70.2 percentage of participants
Interval 60.9 to 78.4
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
EOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
73.8 percentage of participants
Interval 70.5 to 76.8
|
92.8 percentage of participants
Interval 89.8 to 95.1
|
92.4 percentage of participants
Interval 89.1 to 94.9
|
67.5 percentage of participants
Interval 58.1 to 76.0
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
12wk PEOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
50.0 percentage of participants
Interval 46.4 to 53.6
|
80.2 percentage of participants
Interval 76.0 to 83.9
|
71.4 percentage of participants
Interval 66.4 to 76.0
|
46.5 percentage of participants
Interval 37.1 to 56.1
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
12wk PEOT, PEG-IFN alfa-2b (n=182,104, 4,14,2,2)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
40.7 percentage of participants
Interval 33.5 to 48.2
|
83.7 percentage of participants
Interval 75.1 to 90.2
|
70.3 percentage of participants
Interval 58.5 to 80.3
|
35.7 percentage of participants
Interval 12.8 to 64.9
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
3.8 percentage of participants
Interval 1.6 to 7.8
|
10.6 percentage of participants
Interval 5.4 to 18.1
|
12.2 percentage of participants
Interval 5.7 to 21.8
|
7.1 percentage of participants
Interval 0.2 to 33.9
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
30.5 percentage of participants
Interval 27.2 to 33.8
|
85.5 percentage of participants
Interval 81.7 to 88.8
|
75.1 percentage of participants
Interval 70.2 to 79.5
|
41.2 percentage of participants
Interval 32.1 to 50.8
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
47.8 percentage of participants
Interval 40.4 to 55.3
|
94.2 percentage of participants
Interval 87.9 to 97.9
|
93.2 percentage of participants
Interval 84.9 to 97.8
|
50.0 percentage of participants
Interval 23.0 to 77.0
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
SECONDARY outcome
Timeframe: At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOTPopulation: The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.
Modified virological response (mVR) 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 and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=862 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=448 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=367 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=116 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=9 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
4.7 percentage of participants
Interval 3.2 to 6.5
|
26.0 percentage of participants
Interval 21.6 to 30.9
|
12.7 percentage of participants
Interval 9.2 to 17.0
|
2.9 percentage of participants
Interval 0.6 to 8.4
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
3.2 percentage of participants
Interval 1.0 to 7.2
|
12.6 percentage of participants
Interval 6.5 to 21.5
|
13.2 percentage of participants
Interval 6.2 to 23.6
|
7.1 percentage of participants
Interval 0.2 to 33.9
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
20.9 percentage of participants
Interval 14.8 to 28.1
|
88.5 percentage of participants
Interval 79.9 to 94.3
|
72.1 percentage of participants
Interval 59.9 to 82.3
|
42.9 percentage of participants
Interval 17.7 to 71.1
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time
EOT, PEG-IFN alfa-2a (n=704,361,299,102,7,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
74.9 percentage of participants
Interval 71.5 to 78.0
|
93.6 percentage of participants
Interval 90.6 to 95.9
|
92.6 percentage of participants
Interval 89.1 to 95.3
|
66.7 percentage of participants
Interval 56.6 to 75.7
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
|
Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time
EOT, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
56.3 percentage of participants
Interval 48.2 to 64.2
|
92.0 percentage of participants
Interval 84.1 to 96.7
|
89.7 percentage of participants
Interval 79.9 to 95.8
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
|
Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time
12wk PEOT, PEG-IFN alfa-2a (n=704,361,299,102,7,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
51.1 percentage of participants
Interval 47.4 to 54.9
|
81.4 percentage of participants
Interval 77.0 to 85.3
|
71.9 percentage of participants
Interval 66.4 to 76.9
|
44.1 percentage of participants
Interval 34.3 to 54.3
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
|
Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time
12wk PEOT, PEG-IFN alfa-2b (n=158,87,68,14,2,2)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
39.9 percentage of participants
Interval 32.2 to 48.0
|
82.8 percentage of participants
Interval 73.2 to 90.0
|
70.6 percentage of participants
Interval 58.3 to 81.0
|
35.7 percentage of participants
Interval 12.8 to 64.9
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk4, PEG-IFN alfa-2a (n=704, 361,299,102,7,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
31.7 percentage of participants
Interval 28.3 to 35.3
|
87.3 percentage of participants
Interval 83.4 to 90.5
|
74.9 percentage of participants
Interval 69.6 to 79.7
|
43.1 percentage of participants
Interval 33.4 to 53.3
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
|
Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
65.1 percentage of participants
Interval 61.4 to 68.6
|
95.0 percentage of participants
Interval 92.2 to 97.0
|
94.0 percentage of participants
Interval 90.7 to 96.4
|
71.6 percentage of participants
Interval 61.8 to 80.1
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
|
Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk12,PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
48.1 percentage of participants
Interval 40.1 to 56.2
|
94.3 percentage of participants
Interval 87.1 to 98.1
|
92.6 percentage of participants
Interval 83.7 to 97.6
|
50.0 percentage of participants
Interval 23.0 to 77.0
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
SECONDARY outcome
Timeframe: At Week 2, Week 4 and Week 12Population: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
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 and PEG-IFN alfa-2b.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=960 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=518 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=427 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=128 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=11 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12
Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
14.4 percentage of participants
Interval 12.0 to 17.1
|
33.8 percentage of participants
Interval 29.3 to 38.6
|
20.1 percentage of participants
Interval 16.1 to 24.7
|
5.3 percentage of participants
Interval 2.0 to 11.1
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
|
Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12
Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
10.4 percentage of participants
Interval 6.4 to 15.8
|
24.0 percentage of participants
Interval 16.2 to 33.4
|
20.3 percentage of participants
Interval 11.8 to 31.2
|
14.3 percentage of participants
Interval 1.8 to 42.8
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12
Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
59.0 percentage of participants
Interval 55.4 to 62.5
|
90.8 percentage of participants
Interval 87.6 to 93.4
|
85.0 percentage of participants
Interval 80.8 to 88.5
|
64.0 percentage of participants
Interval 54.5 to 72.8
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
|
Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12
Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
83.4 percentage of participants
Interval 80.6 to 86.0
|
96.1 percentage of participants
Interval 93.8 to 97.8
|
96.0 percentage of participants
Interval 93.4 to 97.8
|
77.2 percentage of participants
Interval 68.4 to 84.5
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
|
Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12
Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
46.2 percentage of participants
Interval 38.8 to 53.7
|
94.2 percentage of participants
Interval 87.9 to 97.9
|
85.1 percentage of participants
Interval 75.0 to 92.3
|
42.9 percentage of participants
Interval 17.7 to 71.1
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
|
Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12
Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
73.1 percentage of participants
Interval 66.0 to 79.4
|
99.0 percentage of participants
Interval 94.8 to 100.0
|
97.3 percentage of participants
Interval 90.6 to 99.7
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
SECONDARY outcome
Timeframe: At Week 2, Week 4 and Week 12Population: The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.
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 and PEG-IFN alfa-2b.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=862 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=448 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=367 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=116 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=9 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12
Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
14.5 percentage of participants
Interval 12.0 to 17.3
|
36.0 percentage of participants
Interval 31.1 to 41.2
|
20.4 percentage of participants
Interval 16.0 to 25.4
|
4.9 percentage of participants
Interval 1.6 to 11.1
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12
Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
10.1 percentage of participants
Interval 5.9 to 15.9
|
26.4 percentage of participants
Interval 17.6 to 37.0
|
22.1 percentage of participants
Interval 12.9 to 33.8
|
14.3 percentage of participants
Interval 1.8 to 42.8
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12
Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
59.9 percentage of participants
Interval 56.2 to 63.6
|
92.5 percentage of participants
Interval 89.3 to 95.0
|
84.9 percentage of participants
Interval 80.4 to 88.8
|
65.7 percentage of participants
Interval 55.6 to 74.8
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
|
Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12
Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
45.6 percentage of participants
Interval 37.6 to 53.7
|
95.4 percentage of participants
Interval 88.6 to 98.7
|
83.8 percentage of participants
Interval 72.9 to 91.6
|
42.9 percentage of participants
Interval 17.7 to 71.1
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
|
Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12
Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
84.8 percentage of participants
Interval 81.9 to 87.4
|
96.7 percentage of participants
Interval 94.3 to 98.3
|
96.7 percentage of participants
Interval 93.9 to 98.4
|
78.4 percentage of participants
Interval 69.2 to 86.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
|
Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12
Wk12,PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
73.4 percentage of participants
Interval 65.8 to 80.1
|
98.9 percentage of participants
Interval 93.8 to 100.0
|
97.1 percentage of participants
Interval 89.8 to 99.6
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
SECONDARY outcome
Timeframe: At Week 2, Week 4 and Week 12Population: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
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 and PEG-IFN alfa-2b.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=960 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=518 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=427 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=128 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=11 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12
Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
75.8 percentage of participants
Interval 68.9 to 81.9
|
96.2 percentage of participants
Interval 90.4 to 98.9
|
89.2 percentage of participants
Interval 79.8 to 95.2
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
|
Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12
Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
23.7 percentage of participants
Interval 20.7 to 26.8
|
37.2 percentage of participants
Interval 32.5 to 42.1
|
21.8 percentage of participants
Interval 17.6 to 26.5
|
8.8 percentage of participants
Interval 4.3 to 15.5
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
|
Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12
Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
18.7 percentage of participants
Interval 13.3 to 25.1
|
26.9 percentage of participants
Interval 18.7 to 36.5
|
24.3 percentage of participants
Interval 15.1 to 35.7
|
21.4 percentage of participants
Interval 4.7 to 50.8
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12
Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
79.6 percentage of participants
Interval 76.6 to 82.3
|
93.0 percentage of participants
Interval 90.1 to 95.3
|
87.8 percentage of participants
Interval 83.9 to 91.0
|
78.1 percentage of participants
Interval 69.4 to 85.3
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
|
Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12
Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
93.6 percentage of participants
Interval 91.6 to 95.2
|
98.1 percentage of participants
Interval 96.2 to 99.2
|
97.2 percentage of participants
Interval 94.9 to 98.6
|
86.0 percentage of participants
Interval 78.2 to 91.8
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
|
Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12
Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
89.0 percentage of participants
Interval 83.5 to 93.2
|
99.0 percentage of participants
Interval 94.8 to 100.0
|
98.6 percentage of participants
Interval 92.7 to 100.0
|
78.6 percentage of participants
Interval 49.2 to 95.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
SECONDARY outcome
Timeframe: At Week 2, Week 4 and Week 12Population: The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.
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 and PEG-IFN alfa-2b.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=862 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=448 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=367 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=116 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=9 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12
Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
76.6 percentage of participants
Interval 69.2 to 82.9
|
96.6 percentage of participants
Interval 90.3 to 99.3
|
88.2 percentage of participants
Interval 78.1 to 94.8
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
|
Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12
Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
94.9 percentage of participants
Interval 93.0 to 96.4
|
98.3 percentage of participants
Interval 96.4 to 99.4
|
98.0 percentage of participants
Interval 95.7 to 99.3
|
87.3 percentage of participants
Interval 79.2 to 93.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
|
Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12
Wk12, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
90.5 percentage of participants
Interval 84.8 to 94.6
|
98.9 percentage of participants
Interval 93.8 to 100.0
|
98.5 percentage of participants
Interval 92.1 to 100.0
|
78.6 percentage of participants
Interval 49.2 to 95.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
|
Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12
Wk2,PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
17.1 percentage of participants
Interval 11.6 to 23.9
|
28.7 percentage of participants
Interval 19.5 to 39.4
|
26.5 percentage of participants
Interval 16.5 to 38.6
|
21.4 percentage of participants
Interval 4.7 to 50.8
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
|
Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12
Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7, 2)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
81.3 percentage of participants
Interval 78.2 to 84.1
|
94.7 percentage of participants
Interval 91.9 to 96.8
|
88.3 percentage of participants
Interval 84.1 to 91.7
|
79.4 percentage of participants
Interval 70.3 to 86.8
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
|
Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12
Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
24.0 percentage of participants
Interval 20.9 to 27.3
|
39.9 percentage of participants
Interval 34.8 to 45.1
|
22.4 percentage of participants
Interval 17.8 to 27.6
|
7.8 percentage of participants
Interval 3.4 to 14.9
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
SECONDARY outcome
Timeframe: 24 weeks after EOTPopulation: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
The probability that a participant who developed VR by Wk 2 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 was reported in treatment naive HCV mono-infected mTRT population participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=960 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=518 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=427 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=128 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=11 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk2, PEG-IFN alfa-2a, PPV (n=267,174,98,16,0, 1)
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
84.4 percentage of participants
Interval 67.2 to 94.7
|
92.2 percentage of participants
Interval 84.6 to 96.8
|
77.1 percentage of participants
Interval 59.9 to 89.6
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk2, PEG-IFN alfa-2b, PPV (n=54, 29, 19,7,1,1)
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
60.0 percentage of participants
Interval 14.7 to 94.7
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk2, PEG-IFN alfa-2b, NPV (n=54,29,19,7,1, 1)
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
59.6 percentage of participants
Interval 44.3 to 73.6
|
13.6 percentage of participants
Interval 2.9 to 34.9
|
28.6 percentage of participants
Interval 8.4 to 58.1
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk2, PEG-IFN alfa-2a,NPV (n=267, 174,98,16, 0, 1)
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
51.9 percentage of participants
Interval 45.3 to 58.5
|
22.6 percentage of participants
Interval 14.2 to 33.0
|
28.6 percentage of participants
Interval 17.9 to 41.3
|
69.2 percentage of participants
Interval 38.6 to 90.9
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
SECONDARY outcome
Timeframe: 24 weeks after EOTPopulation: The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.
The probability that a participant who developed VR by Wk 2 and 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 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=862 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=448 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=367 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=116 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=9 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk2, PEG-IFN alfa-2b, PPV (n=43, 26,19,7,1,1)
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
60.0 percentage of participants
Interval 14.7 to 94.7
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
60.0 percentage of participants
Interval 14.7 to 94.7
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk2, PEG-IFN alfa-2a, NPV (n=246, 163,87,14,0,1)
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
51.8 percentage of participants
Interval 45.0 to 58.6
|
21.5 percentage of participants
Interval 13.1 to 32.2
|
28.6 percentage of participants
Interval 17.3 to 42.2
|
75.0 percentage of participants
Interval 42.8 to 94.5
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk2, PEG-IFN alfa-2a, PPV (n=246, 63,87,14,0,1)
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
82.1 percentage of participants
Interval 63.1 to 93.9
|
92.9 percentage of participants
Interval 85.1 to 97.3
|
74.2 percentage of participants
Interval 55.4 to 88.1
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk2, PEG-IFN alfa-2b, NPV (n=43, 26,19,7,1,1)
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
55.3 percentage of participants
Interval 38.3 to 71.4
|
15.8 percentage of participants
Interval 3.4 to 39.6
|
28.6 percentage of participants
Interval 8.4 to 58.1
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
SECONDARY outcome
Timeframe: At Week 4 and Week 12Population: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
Rapid virological response (RVR) was defined as VR by Wk 4, Modified rapid virological response (mRVR) was defined as mVR by Wk 4, complete early virological response (cEVR) was defined as VR by Wk 12, but no RVR, modified complete early virological response (mcEVR) was defined as mVR by Wk 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, Wk 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 Wk 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 and PEG-IFN alfa-2b.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=960 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=518 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=427 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=128 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=11 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
RVR, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
1 number of participants
|
29 number of participants
|
78 number of participants
|
50 number of participants
|
6 number of participants
|
1 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
mRVR, PEG-IFN alfa-2b (n=182, 104,74,14, 2, 2)
|
1 number of participants
|
38 number of participants
|
90 number of participants
|
55 number of participants
|
6 number of participants
|
1 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
cEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
0 number of participants
|
258 number of participants
|
47 number of participants
|
73 number of participants
|
34 number of participants
|
4 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
RVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
1 number of participants
|
199 number of participants
|
333 number of participants
|
250 number of participants
|
42 number of participants
|
4 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
mRVR,PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
2 number of participants
|
237 number of participants
|
354 number of participants
|
265 number of participants
|
47 number of participants
|
4 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
cEVR, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)
|
0 number of participants
|
48 number of participants
|
17 number of participants
|
15 number of participants
|
1 number of participants
|
0 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
mcEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
0 number of participants
|
258 number of participants
|
35 number of participants
|
64 number of participants
|
33 number of participants
|
5 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
mCEVR, PEG-IFN alfa-2b (n=182,104,74,14,2, 2)
|
0 number of participants
|
49 number of participants
|
8 number of participants
|
14 number of participants
|
1 number of participants
|
0 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
pEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
1 number of participants
|
192 number of participants
|
18 number of participants
|
16 number of participants
|
12 number of participants
|
1 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
pEVR, PEG-IFN alfa-2b (n=182, 104,74,14, 2, 2)
|
0 number of participants
|
56 number of participants
|
8 number of participants
|
7 number of participants
|
1 number of participants
|
1 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
mpEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2)
|
0 number of participants
|
154 number of participants
|
9 number of participants
|
10 number of participants
|
8 number of participants
|
0 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
mpEVR, PEG-IFN alfa-2b (n=182,104, 74,14,2, 2)
|
0 number of participants
|
46 number of participants
|
5 number of participants
|
3 number of participants
|
1 number of participants
|
1 number of participants
|
SECONDARY outcome
Timeframe: At Week 4 and Week 12Population: The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.
RVR was defined as as VR by Wk 4, mRVR was defined as mVR by Wk 4, cEVR was defined as VR by Wk 12, but no RVR, mcEVR was defined as mVR by Wk 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 Wk 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 Wk 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 and PEG-IFN alfa-2b.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=862 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=448 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=367 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=116 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=9 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12
RVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2)
|
1 number of participants
|
186 number of participants
|
298 number of participants
|
213 number of participants
|
39 number of participants
|
2 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12
RVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
1 number of participants
|
24 number of participants
|
66 number of participants
|
44 number of participants
|
6 number of participants
|
1 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12
mRVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2)
|
2 number of participants
|
223 number of participants
|
315 number of participants
|
224 number of participants
|
44 number of participants
|
2 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12
mRVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
1 number of participants
|
33 number of participants
|
77 number of participants
|
49 number of participants
|
6 number of participants
|
1 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12
cEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2)
|
0 number of participants
|
236 number of participants
|
38 number of participants
|
63 number of participants
|
31 number of participants
|
4 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12
cEVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
0 number of participants
|
43 number of participants
|
14 number of participants
|
15 number of participants
|
1 number of participants
|
0 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12
mcEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2)
|
0 number of participants
|
235 number of participants
|
28 number of participants
|
57 number of participants
|
29 number of participants
|
5 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12
mCEVR, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2)
|
0 number of participants
|
43 number of participants
|
5 number of participants
|
14 number of participants
|
1 number of participants
|
0 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12
pEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2)
|
1 number of participants
|
175 number of participants
|
13 number of participants
|
13 number of participants
|
10 number of participants
|
1 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12
pEVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)
|
0 number of participants
|
49 number of participants
|
6 number of participants
|
7 number of participants
|
1 number of participants
|
1 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12
mpEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2)
|
0 number of participants
|
139 number of participants
|
6 number of participants
|
8 number of participants
|
7 number of participants
|
0 number of participants
|
|
Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12
mpEVR, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2)
|
0 number of participants
|
40 number of participants
|
4 number of participants
|
3 number of participants
|
1 number of participants
|
1 number of participants
|
SECONDARY outcome
Timeframe: At 12 weeks after EOTPopulation: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
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 number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=960 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=518 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=427 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=128 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=11 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
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
12wk PEOT, PEG-IFN alfa-2a (n=257,193,109,14,0,0)
|
0 percentage of participants
|
30.0 percentage of participants
|
10.9 percentage of participants
|
14.7 percentage of participants
|
21.4 percentage of participants
|
0 percentage of participants
|
|
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
12wk PEOT, PEG-IFN alfa-2b (n=36,50,27,3,0,0)
|
0 percentage of participants
|
22.2 percentage of participants
|
4.0 percentage of participants
|
7.4 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: At 12 weeks after EOTPopulation: The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.
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 number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=862 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=448 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=367 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=116 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=9 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment
12wk PEOT, PEG-IFN alfa-2b (n=28,43,25,3,0,0)
|
0 percentage of participants
|
25.0 percentage of participants
|
4.7 percentage of participants
|
8.0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment
12Wk PEOT, PEG-IFN alfa-2a (n=239,175,98,12,0,0)
|
0 percentage of participants
|
29.3 percentage of participants
|
10.3 percentage of participants
|
14.3 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: At 24 weeks after EOTPopulation: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
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 number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=960 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=518 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=427 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=128 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=11 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
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
24wk PEOT, PEG-IFN alfa-2b (n=91,93,57,7,2,0)
|
0 percentage of participants
|
20.9 percentage of participants
|
7.5 percentage of participants
|
10.5 percentage of participants
|
28.6 percentage of participants
|
15.0 percentage of participants
|
|
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
24Wk PEOT, PEG-IFN alfa-2a (n=508,364,282,69,8,2)
|
0 percentage of participants
|
28.7 percentage of participants
|
11.3 percentage of participants
|
14.2 percentage of participants
|
29.0 percentage of participants
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: At 24 weeks after EOTPopulation: The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.
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 number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Outcome measures
| Measure |
Unknown Genotype (UNK)
n=4 Participants
Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 1 (G1)
n=862 Participants
Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 2 (G2)
n=448 Participants
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 3 (G3)
n=367 Participants
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 4 (G4)
n=116 Participants
Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
Genotype 5/6 (G5/6)
n=9 Participants
Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment
24Wk PEOT, PEG-IFN alfa-2a (n=468,323,240,60,6,2)
|
0 percentage of participants
|
28.4 percentage of participants
|
11.5 percentage of participants
|
13.8 percentage of participants
|
31.7 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment
24wk PEOT, PEG-IFN alfa-2b (n=79,77,53,7,2,0)
|
0 percentage of participants
|
21.5 percentage of participants
|
7.8 percentage of participants
|
11.3 percentage of participants
|
28.6 percentage of participants
|
50.0 percentage of participants
|
Adverse Events
Genotype 1 (G1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Genotype 2 (G2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Genotype 3 (G3)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Genotype 4 (G4)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Genotype 5/6 (G5/6)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unknown Genotype (UNK)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 61 6878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER