Trial Outcomes & Findings for PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b (NCT NCT01066819)
NCT ID: NCT01066819
Last Updated: 2016-08-08
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
1656 participants
Primary outcome timeframe
At 24 weeks (Wk) after EOT
Results posted on
2016-08-08
Participant Flow
A total of 1656 participants were enrolled in this study conducted from January 2008 to August 2011 at 111 centres in United States.
Participant milestones
| Measure |
Genotype 1 (G1)
Eligible participants with serologically proven Chronic hepatitis C (CHC) (Genotype 1) who received Pegylated Interferon (PEG-IFN) alfa-2a (PEGASYS®) or PEG-IFN alfa-2b (PegIntron®) plus ribavirin for up to 48 weeks according to the standard of care and in line with summaries of product characteristics (SPCs)/local labeling were observed.
|
Genotype 2 (G2)
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 4 (G4)
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1006
|
348
|
257
|
25
|
7
|
13
|
|
Overall Study
COMPLETED
|
317
|
177
|
111
|
8
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
689
|
171
|
146
|
17
|
4
|
6
|
Reasons for withdrawal
| Measure |
Genotype 1 (G1)
Eligible participants with serologically proven Chronic hepatitis C (CHC) (Genotype 1) who received Pegylated Interferon (PEG-IFN) alfa-2a (PEGASYS®) or PEG-IFN alfa-2b (PegIntron®) plus ribavirin for up to 48 weeks according to the standard of care and in line with summaries of product characteristics (SPCs)/local labeling were observed.
|
Genotype 2 (G2)
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 4 (G4)
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
18
|
1
|
6
|
0
|
0
|
0
|
|
Overall Study
Death
|
5
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
22
|
1
|
2
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
6
|
2
|
3
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
12
|
6
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
29
|
11
|
6
|
0
|
0
|
0
|
|
Overall Study
Administrative
|
6
|
4
|
2
|
0
|
0
|
0
|
|
Overall Study
Not met inclusion/exclusion criteria
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Early termination
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Failed to return
|
298
|
107
|
68
|
7
|
2
|
3
|
|
Overall Study
Lab test not done
|
9
|
0
|
2
|
1
|
0
|
0
|
|
Overall Study
Miscellaneous
|
28
|
10
|
18
|
1
|
0
|
0
|
|
Overall Study
Non responders
|
123
|
2
|
7
|
2
|
0
|
1
|
|
Overall Study
Not categorised
|
9
|
2
|
6
|
1
|
0
|
0
|
|
Overall Study
Relapse
|
16
|
4
|
3
|
0
|
0
|
0
|
|
Overall Study
Results not available
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Screen failure
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Spontaneous cure
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Treatment never started
|
85
|
19
|
19
|
3
|
2
|
2
|
|
Overall Study
Treatment stopped
|
12
|
1
|
2
|
1
|
0
|
0
|
|
Overall Study
Other
|
5
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b
Baseline characteristics by cohort
| Measure |
Genotype 1 (G1)
n=1006 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=348 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=257 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 4 (G4)
n=25 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=7 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=13 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Total
n=1656 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 9.68 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 9.74 • n=7 Participants
|
46.9 years
STANDARD_DEVIATION 9.41 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 10.59 • n=4 Participants
|
53.3 years
STANDARD_DEVIATION 10.48 • n=21 Participants
|
45.6 years
STANDARD_DEVIATION 10.72 • n=10 Participants
|
48.4 years
STANDARD_DEVIATION 9.71 • n=115 Participants
|
|
Sex: Female, Male
Female
|
419 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
692 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
587 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
964 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: At 24 weeks (Wk) 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 |
Genotype 4 (G4)
n=18 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=674 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=267 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=188 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling 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=568,221,159,16,2,1)
|
31.3 percentage of participants
Interval 11.0 to 58.7
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
30.3 percentage of participants
Interval 26.5 to 34.2
|
55.7 percentage of participants
Interval 48.8 to 62.3
|
43.4 percentage of participants
Interval 35.6 to 51.5
|
|
Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population
Peg IFN Alfa 2b (n=106,46,29,2,1,1)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
23.6 percentage of participants
Interval 15.9 to 32.8
|
50.0 percentage of participants
Interval 34.9 to 65.1
|
37.9 percentage of participants
Interval 20.7 to 57.7
|
PRIMARY outcome
Timeframe: At 24 weeks after EOTPopulation: The per-protocol (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 |
Genotype 4 (G4)
n=16 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=564 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=231 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=151 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population
Peg IFN Alfa 2a (n=476,190,123,14,2,1)
|
35.7 percentage of participants
Interval 12.8 to 64.9
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
31.5 percentage of participants
Interval 27.4 to 35.9
|
57.4 percentage of participants
Interval 50.0 to 64.5
|
48.8 percentage of participants
Interval 39.7 to 58.0
|
|
Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population
Peg IFN Alfa 2b (n=88,41,28,2,1,1)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
26.1 percentage of participants
Interval 17.3 to 36.6
|
48.8 percentage of participants
Interval 32.9 to 64.9
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
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 result \<50 international units per millilitre (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 |
Genotype 4 (G4)
n=18 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=674 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=267 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=188 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Modified Sustained Virological Response Over Time by Type of Peginterferon and Genotype in Modified All Treated Population
Peg IFN Alfa 2a (n=568,221,159,16,2,1)
|
31.3 percentage of participants
Interval 11.0 to 58.7
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
30.6 percentage of participants
Interval 26.9 to 34.6
|
56.1 percentage of participants
Interval 49.3 to 62.8
|
43.4 percentage of participants
Interval 35.6 to 51.5
|
|
Percentage of Participants With Modified Sustained Virological Response Over Time by Type of Peginterferon and Genotype in Modified All Treated Population
Peg IFN Alfa 2b (n=106,46,29, 2,1,1)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
23.6 percentage of participants
Interval 15.9 to 32.8
|
50.0 percentage of participants
Interval 34.9 to 65.1
|
37.9 percentage of participants
Interval 20.7 to 57.7
|
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 |
Genotype 4 (G4)
n=16 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=564 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=231 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=151 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population
Peg IFN Alfa 2b (n=88,41,28,2,1,1)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
26.1 percentage of participants
Interval 17.3 to 36.6
|
48.8 percentage of participants
Interval 32.9 to 64.9
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
|
Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population
Peg IFN Alfa 2a (n=476,190,123,14,2,1)
|
35.7 percentage of participants
Interval 12.8 to 64.9
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
31.9 percentage of participants
Interval 27.8 to 36.3
|
57.9 percentage of participants
Interval 50.5 to 65.0
|
48.8 percentage of participants
Interval 39.7 to 58.0
|
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 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 |
Genotype 4 (G4)
n=18 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=674 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=267 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=188 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk4, PegIFNAlfa2b, PPV (n=106,46,29,2,1,1)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
52.6 percentage of participants
Interval 28.9 to 75.6
|
52.6 percentage of participants
Interval 35.8 to 69.0
|
50.0 percentage of participants
Interval 27.2 to 72.8
|
|
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk12,PegIFNAlfa2a,PPV (n=568,221,159,16,2,1)
|
50.0 percentage of participants
Interval 18.7 to 81.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
48.4 percentage of participants
Interval 42.7 to 54.1
|
59.0 percentage of participants
Interval 52.1 to 65.8
|
51.1 percentage of participants
Interval 42.3 to 59.9
|
|
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk12,PegIFNAlfa2a, NPV(n=568,221,159,16,2,1)
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
91.3 percentage of participants
Interval 87.1 to 94.5
|
100.0 percentage of participants
Interval 71.5 to 100.0
|
95.8 percentage of participants
Interval 78.9 to 99.9
|
|
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk4,PegIFNAlfa2a,PPV (n=568,221,159,16,2,1)
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
53.8 percentage of participants
Interval 44.9 to 62.6
|
62.0 percentage of participants
Interval 54.5 to 69.0
|
56.1 percentage of participants
Interval 46.5 to 65.4
|
|
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk4, PegIFNAlfa2a,NPV (n=568,221,159,16,2,1)
|
60.0 percentage of participants
Interval 26.2 to 87.8
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
76.7 percentage of participants
Interval 72.3 to 80.7
|
78.1 percentage of participants
Interval 60.0 to 90.7
|
88.1 percentage of participants
Interval 74.4 to 96.0
|
|
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk4, PegIFNAlfa2b, NPV (n=106,46,29,2,1,1)
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
81.6 percentage of participants
Interval 71.0 to 89.5
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
|
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk12,PegIFNAlfa2b, PPV (n=106,46,29,2,1,1)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
52.4 percentage of participants
Interval 36.4 to 68.0
|
50.0 percentage of participants
Interval 34.6 to 65.4
|
40.7 percentage of participants
Interval 22.4 to 61.2
|
|
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk12, PegIFNAlfa2b, NPV (n=106, 46,29, 2,1,1)
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
96.6 percentage of participants
Interval 88.3 to 99.6
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
100.0 percentage of participants
Interval 15.8 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 |
Genotype 4 (G4)
n=16 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=564 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=231 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=151 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk12,PegIFNAlfa2b, PPV (n=88,41,28,2,1,1)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
55.6 percentage of participants
Interval 38.1 to 72.1
|
48.7 percentage of participants
Interval 32.4 to 65.2
|
38.5 percentage of participants
Interval 20.2 to 59.4
|
|
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk4,PegIFNAlfa2a,PPV (n=476,190,123,14,2,1)
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
54.1 percentage of participants
Interval 44.3 to 63.7
|
62.4 percentage of participants
Interval 54.6 to 69.8
|
55.0 percentage of participants
Interval 44.7 to 65.0
|
|
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk4, PegIFNAlfa2a,NPV (n=476,190,123,14,2,1)
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
75.4 percentage of participants
Interval 70.5 to 79.8
|
70.8 percentage of participants
Interval 48.9 to 87.4
|
77.3 percentage of participants
Interval 54.6 to 92.2
|
|
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk4, PegIFNAlfa2b, NPV (n=88,41,28,2,1,1)
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
78.1 percentage of participants
Interval 66.0 to 87.5
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
|
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk4, PegIFNAlfa2b, PPV (n=88,41,28,2,1,1)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
50.0 percentage of participants
Interval 24.7 to 75.3
|
51.5 percentage of participants
Interval 33.5 to 69.2
|
47.4 percentage of participants
Interval 24.4 to 71.1
|
|
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk12,PegIFNAlfa2a,PPV (n=476,190,123,14,2,1)
|
50.0 percentage of participants
Interval 18.7 to 81.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
49.6 percentage of participants
Interval 43.4 to 55.8
|
59.1 percentage of participants
Interval 51.7 to 66.3
|
51.3 percentage of participants
Interval 41.8 to 60.7
|
|
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk12,PegIFNAlfa2a, NPV(n=476, 190,123,14,2,1)
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
90.5 percentage of participants
Interval 85.7 to 94.1
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
|
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk12, PegIFNAlfa2b, NPV (n=88,41,28,2,1,1)
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
95.8 percentage of participants
Interval 85.7 to 99.5
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
SECONDARY outcome
Timeframe: At Week 2, Week 4, Week 12, EOT, and 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 baseline 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 COBAS AmpliPrep/COBAS TaqMan (HCV) (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 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. PEOT= Post End of Treatment. EOT= 12, 24, 48 or 72 weeks after initiation of treatment.
Outcome measures
| Measure |
Genotype 4 (G4)
n=18 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=674 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=267 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=188 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
EOT,PegIFNAlfa2a (n=568,221,159,16,2,1)
|
56.3 percentage of participants
Interval 29.9 to 80.2
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
55.3 percentage of participants
Interval 51.1 to 59.4
|
85.5 percentage of participants
Interval 80.2 to 89.9
|
74.2 percentage of participants
Interval 66.7 to 80.8
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
EOT,PegIFNAlfa2b (n=106,46,29,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
38.7 percentage of participants
Interval 29.4 to 48.6
|
84.8 percentage of participants
Interval 71.1 to 93.7
|
72.4 percentage of participants
Interval 52.8 to 87.3
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk4,PegIFNAlfa2a (n=568,221,159,16,2,1)
|
31.3 percentage of participants
Interval 11.0 to 58.7
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
22.9 percentage of participants
Interval 19.5 to 26.6
|
83.3 percentage of participants
Interval 77.7 to 87.9
|
71.7 percentage of participants
Interval 64.0 to 78.5
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk2,PegIFNAlfa2a (n=568,221,159 ,16,2,1)
|
12.5 percentage of participants
Interval 1.6 to 38.3
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
6.5 percentage of participants
Interval 4.6 to 8.9
|
25.8 percentage of participants
Interval 20.2 to 32.1
|
20.8 percentage of participants
Interval 14.7 to 27.9
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk2,PegIFNAlfa2b (n=106,46,29,2,1,1)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
2.8 percentage of participants
Interval 0.6 to 8.0
|
17.4 percentage of participants
Interval 7.8 to 31.4
|
24.1 percentage of participants
Interval 10.3 to 43.5
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk4,PegIFNAlfa2b (n=106,46,29,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
17.9 percentage of participants
Interval 11.2 to 26.6
|
82.6 percentage of participants
Interval 68.6 to 92.2
|
69.0 percentage of participants
Interval 49.2 to 84.7
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk12,PegIFNAlfa2a (n=568,221,159,16,2,1)
|
62.5 percentage of participants
Interval 35.4 to 84.8
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
54.9 percentage of participants
Interval 50.7 to 59.1
|
95.0 percentage of participants
Interval 91.3 to 97.5
|
83.6 percentage of participants
Interval 77.0 to 89.0
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk12,PegIFNAlfa2b (n=106,46,29,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
39.6 percentage of participants
Interval 30.3 to 49.6
|
95.7 percentage of participants
Interval 85.2 to 99.5
|
93.1 percentage of participants
Interval 77.2 to 99.2
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
12Wk PEOT,PegIFNAlfa2a (n=568,221,159,16,2,1)
|
31.3 percentage of participants
Interval 11.0 to 58.7
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
34.5 percentage of participants
Interval 30.6 to 38.6
|
59.7 percentage of participants
Interval 52.9 to 66.3
|
48.4 percentage of participants
Interval 40.4 to 56.5
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
12Wk PEOT,PegIFNAlfa2b (n=106,46,29,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
29.2 percentage of participants
Interval 20.8 to 38.9
|
54.3 percentage of participants
Interval 39.0 to 69.1
|
44.8 percentage of participants
Interval 26.4 to 64.3
|
SECONDARY outcome
Timeframe: At Week 2, Week 4, Week 12, EOT, and 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.
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 |
Genotype 4 (G4)
n=16 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=564 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=231 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=151 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
EOT,PegIFNAlfa2b (n=88,41,28,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
43.2 percentage of participants
Interval 32.7 to 54.2
|
85.4 percentage of participants
Interval 70.8 to 94.4
|
71.4 percentage of participants
Interval 51.3 to 86.8
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk2,PegIFNAlfa2a (n=476,190,123,14,2,1)
|
14.3 percentage of participants
Interval 1.8 to 42.8
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
7.4 percentage of participants
Interval 5.2 to 10.1
|
28.9 percentage of participants
Interval 22.6 to 36.0
|
23.6 percentage of participants
Interval 16.4 to 32.1
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk2,PegIFNAlfa2b (n=88,41,28,2,1,1)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
3.4 percentage of participants
Interval 0.7 to 9.6
|
19.5 percentage of participants
Interval 8.8 to 34.9
|
25.0 percentage of participants
Interval 10.7 to 44.9
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk4,PegIFNAlfa2a (n=476,190,123,14,2,1)
|
35.7 percentage of participants
Interval 12.8 to 64.9
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
22.9 percentage of participants
Interval 19.2 to 26.9
|
86.8 percentage of participants
Interval 81.2 to 91.3
|
81.3 percentage of participants
Interval 73.3 to 87.8
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk4,PegIFNAlfa2b (n=88,41,28,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
18.2 percentage of participants
Interval 10.8 to 27.8
|
80.5 percentage of participants
Interval 65.1 to 91.2
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk12,PegIFNAlfa2a (n=476,190,123,14,2,1)
|
71.4 percentage of participants
Interval 41.9 to 91.6
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
55.5 percentage of participants
Interval 50.9 to 60.0
|
97.9 percentage of participants
Interval 94.7 to 99.4
|
93.5 percentage of participants
Interval 87.6 to 97.2
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk12,PegIFNAlfa2b (n=88,41,28,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
40.9 percentage of participants
Interval 30.5 to 51.9
|
95.1 percentage of participants
Interval 83.5 to 99.4
|
92.9 percentage of participants
Interval 76.5 to 99.1
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
EOT,PegIFNAlfa2a (n=476,190,123,14,2,1)
|
64.3 percentage of participants
Interval 35.1 to 87.2
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
55.5 percentage of participants
Interval 50.9 to 60.0
|
88.9 percentage of participants
Interval 83.6 to 93.0
|
81.3 percentage of participants
Interval 73.3 to 87.8
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk12 PEOT,PegIFNAlfa2a (n=476,190,123,14,2,1)
|
35.7 percentage of participants
Interval 12.8 to 64.9
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
35.5 percentage of participants
Interval 31.2 to 40.0
|
62.1 percentage of participants
Interval 54.8 to 69.0
|
52.8 percentage of participants
Interval 43.6 to 61.9
|
|
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk12 EOT,PegIFNAlfa2b (n=88,41,28,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
30.7 percentage of participants
Interval 21.3 to 41.4
|
51.2 percentage of participants
Interval 35.1 to 67.1
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
SECONDARY outcome
Timeframe: At Week 2, Week 4, Week 12, EOT, and 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 baseline 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 |
Genotype 4 (G4)
n=18 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=674 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=267 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=188 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
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=568,221,159,16,2,1)
|
18.8 percentage of participants
Interval 4.0 to 45.6
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
7.6 percentage of participants
Interval 5.5 to 10.1
|
28.5 percentage of participants
Interval 22.7 to 34.9
|
25.8 percentage of participants
Interval 19.2 to 33.3
|
|
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=106,46,29,2,1,1)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
3.8 percentage of participants
Interval 1.0 to 9.4
|
19.6 percentage of participants
Interval 9.4 to 33.9
|
31.0 percentage of participants
Interval 15.3 to 50.8
|
|
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=106,46,29,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
22.6 percentage of participants
Interval 15.1 to 31.8
|
84.8 percentage of participants
Interval 71.1 to 93.7
|
75.9 percentage of participants
Interval 56.5 to 89.7
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Wk12,Peg IFN Alfa 2b (n=106,46,29,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
43.4 percentage of participants
Interval 33.8 to 53.4
|
95.7 percentage of participants
Interval 85.2 to 99.5
|
93.1 percentage of participants
Interval 77.2 to 99.2
|
|
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=568,221,159,16,2,1)
|
56.3 percentage of participants
Interval 29.9 to 80.2
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
56.2 percentage of participants
Interval 52.0 to 60.3
|
86.9 percentage of participants
Interval 81.7 to 91.0
|
75.5 percentage of participants
Interval 68.0 to 81.9
|
|
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=106,46,29,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
40.6 percentage of participants
Interval 31.1 to 50.5
|
87.0 percentage of participants
Interval 73.7 to 95.1
|
72.4 percentage of participants
Interval 52.8 to 87.3
|
|
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=568,221,159,16,2,1)
|
37.5 percentage of participants
Interval 15.2 to 64.6
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
25.9 percentage of participants
Interval 22.3 to 29.7
|
85.5 percentage of participants
Interval 80.2 to 89.9
|
75.5 percentage of participants
Interval 68.0 to 81.9
|
|
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=568,221,159,16,2,1)
|
62.5 percentage of participants
Interval 35.4 to 84.8
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
58.1 percentage of participants
Interval 53.9 to 62.2
|
95.5 percentage of participants
Interval 91.8 to 97.8
|
85.5 percentage of participants
Interval 79.1 to 90.6
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
12wk PEOT,PegIFNAlfa2a(n=568,221,159,16,2,1)
|
37.5 percentage of participants
Interval 15.2 to 64.6
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
34.9 percentage of participants
Interval 30.9 to 38.9
|
60.6 percentage of participants
Interval 53.9 to 67.1
|
48.4 percentage of participants
Interval 40.4 to 56.5
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
12wk PEOT, PegIFNAlfa2b(n=106,46,29,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
29.2 percentage of participants
Interval 20.8 to 38.9
|
54.3 percentage of participants
Interval 39.0 to 69.1
|
44.8 percentage of participants
Interval 26.4 to 64.3
|
SECONDARY outcome
Timeframe: At Week 2, Week 4, Week 12, EOT, and 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.
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 |
Genotype 4 (G4)
n=16 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=564 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=231 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=151 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk4, Peg IFN Alfa 2a (n=476,190,123,14,2,1)
|
42.9 percentage of participants
Interval 17.7 to 71.1
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
25.4 percentage of participants
Interval 21.6 to 29.6
|
89.5 percentage of participants
Interval 84.2 to 93.5
|
83.7 percentage of participants
Interval 76.0 to 89.8
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
EOT, Peg IFN Alfa 2a (n=476,190,123,14,2,1)
|
64.3 percentage of participants
Interval 35.1 to 87.2
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
56.5 percentage of participants
Interval 51.9 to 61.0
|
90.0 percentage of participants
Interval 84.8 to 93.9
|
81.3 percentage of participants
Interval 73.3 to 87.8
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
EOT, Peg IFN Alfa 2b (n=88,41,28,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
44.3 percentage of participants
Interval 33.7 to 55.3
|
85.4 percentage of participants
Interval 70.8 to 94.4
|
71.4 percentage of participants
Interval 51.3 to 86.8
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk2, Peg IFN Alfa 2a (n=476,190,123,14,2,1)
|
21.4 percentage of participants
Interval 4.7 to 50.8
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
7.8 percentage of participants
Interval 5.5 to 10.6
|
32.1 percentage of participants
Interval 25.5 to 39.2
|
28.5 percentage of participants
Interval 20.7 to 37.3
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk2, Peg IFN Alfa 2b (n=88,41,28,2,1,1)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
3.4 percentage of participants
Interval 0.7 to 9.6
|
19.5 percentage of participants
Interval 8.8 to 34.9
|
32.1 percentage of participants
Interval 15.9 to 52.4
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk4, Peg IFN Alfa 2b (n=88,41,28,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
23.9 percentage of participants
Interval 15.4 to 34.1
|
82.9 percentage of participants
Interval 67.9 to 92.8
|
75.0 percentage of participants
Interval 55.1 to 89.3
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk12, Peg IFN Alfa 2a (n=476,190,123,14,2,1)
|
71.4 percentage of participants
Interval 41.9 to 91.6
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
58.8 percentage of participants
Interval 54.3 to 63.3
|
98.4 percentage of participants
Interval 95.5 to 99.7
|
94.3 percentage of participants
Interval 88.6 to 97.7
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
Wk12,Peg IFN Alfa 2b (n=88,41,28,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
45.5 percentage of participants
Interval 34.8 to 56.4
|
95.1 percentage of participants
Interval 83.5 to 99.4
|
92.9 percentage of participants
Interval 76.5 to 99.1
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
12wk PEOT,PegIFNAlfa2a(n=476,190,123,14,2,1)
|
42.9 percentage of participants
Interval 17.7 to 71.1
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
35.9 percentage of participants
Interval 31.6 to 40.4
|
63.2 percentage of participants
Interval 55.9 to 70.0
|
52.8 percentage of participants
Interval 43.6 to 61.9
|
|
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
12wk PEOT, PegIFNAlfa2b(n=88,41,28,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
30.7 percentage of participants
Interval 21.3 to 41.4
|
51.2 percentage of participants
Interval 35.1 to 67.1
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
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 baseline 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 |
Genotype 4 (G4)
n=18 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=674 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=267 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=188 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 2-log10 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=106,46,29,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
43.4 percentage of participants
Interval 33.8 to 53.4
|
95.7 percentage of participants
Interval 85.2 to 99.5
|
86.2 percentage of participants
Interval 68.3 to 96.1
|
|
Percentage of Participants With at Least a 2-log10 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=568,221,159,16,2,1)
|
62.5 percentage of participants
Interval 35.4 to 84.8
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
78.3 percentage of participants
Interval 74.7 to 81.7
|
99.5 percentage of participants
Interval 97.5 to 100.0
|
94.3 percentage of participants
Interval 89.5 to 97.4
|
|
Percentage of Participants With at Least a 2-log10 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=106,46,29,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
67.9 percentage of participants
Interval 58.2 to 76.7
|
97.8 percentage of participants
Interval 88.5 to 99.9
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
|
Percentage of Participants With at Least a 2-log10 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=568,221,159,16,2,1)
|
25.0 percentage of participants
Interval 7.3 to 52.4
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
19.9 percentage of participants
Interval 16.7 to 23.4
|
53.8 percentage of participants
Interval 47.0 to 60.6
|
48.4 percentage of participants
Interval 40.4 to 56.5
|
|
Percentage of Participants With at Least a 2-log10 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=106,46,29,2,1,1)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
17.0 percentage of participants
Interval 10.4 to 25.5
|
43.5 percentage of participants
Interval 28.9 to 58.9
|
62.1 percentage of participants
Interval 42.3 to 79.3
|
|
Percentage of Participants With at Least a 2-log10 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=568,221,159,16,2,1)
|
50.0 percentage of participants
Interval 24.7 to 75.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
53.7 percentage of participants
Interval 49.5 to 57.9
|
95.9 percentage of participants
Interval 92.4 to 98.1
|
92.5 percentage of participants
Interval 87.2 to 96.0
|
SECONDARY outcome
Timeframe: At Week 2, Week 4 and Week 12Population: Th 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 |
Genotype 4 (G4)
n=16 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=564 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=231 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=151 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 2-log10 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=88,41,28,2,1,1)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
19.3 percentage of participants
Interval 11.7 to 29.1
|
46.3 percentage of participants
Interval 30.7 to 62.6
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
|
Percentage of Participants With at Least a 2-log10 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=476,190,123,14,2,1)
|
71.4 percentage of participants
Interval 41.9 to 91.6
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
79.6 percentage of participants
Interval 75.7 to 83.2
|
100.0 percentage of participants
Interval 98.1 to 100.0
|
98.4 percentage of participants
Interval 94.2 to 99.8
|
|
Percentage of Participants With at Least a 2-log10 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=476,190,123,14,2,1)
|
28.6 percentage of participants
Interval 8.4 to 58.1
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
21.0 percentage of participants
Interval 17.4 to 24.9
|
57.4 percentage of participants
Interval 50.0 to 64.5
|
52.0 percentage of participants
Interval 42.8 to 61.1
|
|
Percentage of Participants With at Least a 2-log10 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=476,190,123,14,2,1)
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
54.6 percentage of participants
Interval 50.0 to 59.2
|
98.4 percentage of participants
Interval 95.5 to 99.7
|
96.7 percentage of participants
Interval 91.9 to 99.1
|
|
Percentage of Participants With at Least a 2-log10 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=88,41,28,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
47.7 percentage of participants
Interval 37.0 to 58.6
|
95.1 percentage of participants
Interval 83.5 to 99.4
|
85.7 percentage of participants
Interval 67.3 to 96.0
|
|
Percentage of Participants With at Least a 2-log10 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=88,41,28,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
72.7 percentage of participants
Interval 62.2 to 81.7
|
97.6 percentage of participants
Interval 87.1 to 99.9
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
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 baseline 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 |
Genotype 4 (G4)
n=18 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=674 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=267 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=188 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 1-log10 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=568,221,159,16,2,1)
|
68.8 percentage of participants
Interval 41.3 to 89.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
73.4 percentage of participants
Interval 69.6 to 77.0
|
97.3 percentage of participants
Interval 94.2 to 99.0
|
95.0 percentage of participants
Interval 90.3 to 97.8
|
|
Percentage of Participants With at Least a 1-log10 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=106,46,29,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
62.3 percentage of participants
Interval 52.3 to 71.5
|
95.7 percentage of participants
Interval 85.2 to 99.5
|
89.7 percentage of participants
Interval 72.6 to 97.8
|
|
Percentage of Participants With at Least a 1-log10 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=568,221,159,16,2,1)
|
31.3 percentage of participants
Interval 11.0 to 58.7
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
29.2 percentage of participants
Interval 25.5 to 33.2
|
56.1 percentage of participants
Interval 49.3 to 62.8
|
50.9 percentage of participants
Interval 42.9 to 58.9
|
|
Percentage of Participants With at Least a 1-log10 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=106,46,29,2,1,1)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
26.4 percentage of participants
Interval 18.3 to 35.9
|
45.7 percentage of participants
Interval 30.9 to 61.0
|
62.1 percentage of participants
Interval 42.3 to 79.3
|
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 |
Genotype 4 (G4)
n=16 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=564 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=231 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=151 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 1-log10 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=476,190,123,14,2,1)
|
35.7 percentage of participants
Interval 12.8 to 64.9
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
31.1 percentage of participants
Interval 27.0 to 35.5
|
59.5 percentage of participants
Interval 52.1 to 66.5
|
53.7 percentage of participants
Interval 44.4 to 62.7
|
|
Percentage of Participants With at Least a 1-log10 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=88,41,28,2,1,1)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
29.5 percentage of participants
Interval 20.3 to 40.2
|
48.8 percentage of participants
Interval 32.9 to 64.9
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
|
Percentage of Participants With at Least a 1-log10 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=476,190,123,14,2,1)
|
78.6 percentage of participants
Interval 49.2 to 95.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
74.6 percentage of participants
Interval 70.4 to 78.4
|
99.5 percentage of participants
Interval 97.1 to 100.0
|
98.4 percentage of participants
Interval 94.2 to 99.8
|
|
Percentage of Participants With at Least a 1-log10 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=88,41,28,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
65.9 percentage of participants
Interval 55.0 to 75.7
|
95.1 percentage of participants
Interval 83.5 to 99.4
|
89.3 percentage of participants
Interval 71.8 to 97.7
|
|
Percentage of Participants With at Least a 1-log10 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=476,190,123,14,2,1)
|
85.7 percentage of participants
Interval 57.2 to 98.2
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
91.6 percentage of participants
Interval 88.7 to 93.9
|
100.0 percentage of participants
Interval 98.1 to 100.0
|
99.2 percentage of participants
Interval 95.6 to 100.0
|
|
Percentage of Participants With at Least a 1-log10 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=88,41,28,2,1,1)
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
83.0 percentage of participants
Interval 73.4 to 90.1
|
97.6 percentage of participants
Interval 87.1 to 99.9
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
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 baseline 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 |
Genotype 4 (G4)
n=18 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=674 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=267 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=188 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling 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 IFNAlfa 2b, NPV (n=106,46,29,2,1,1)
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
78.8 percentage of participants
Interval 65.3 to 88.9
|
50.0 percentage of participants
Interval 23.0 to 77.0
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk2, Peg IFNAlfa2a,PPV (n=568,221,159,16,2,1)
|
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.
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
45.9 percentage of participants
Interval 29.5 to 63.1
|
63.2 percentage of participants
Interval 49.3 to 75.6
|
54.5 percentage of participants
Interval 36.4 to 71.9
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk2,Peg IFNAlfa2a,NPV (n=568,221,159,16,2,1)
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
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.
|
69.5 percentage of participants
Interval 63.5 to 75.1
|
43.1 percentage of participants
Interval 31.4 to 55.3
|
64.9 percentage of participants
Interval 51.1 to 77.1
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Wk2, Peg IFNAlfa 2b, PPV (n=106,46,29,2,1,1)
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
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.
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 |
Genotype 4 (G4)
n=16 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=564 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=231 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=151 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk2, PegIFNAlfa2a, NPV(n=476,190,123,14,2,1)
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
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.
|
67.0 percentage of participants
Interval 60.3 to 73.2
|
33.3 percentage of participants
Interval 21.7 to 46.7
|
56.1 percentage of participants
Interval 39.7 to 71.5
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk2, PegIFNAlfa2b, PPV(n=88,41,28,2,1,1)
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk2, PegIFNAlfa2b, NPV(n=88,41,28,2,1,1)
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
NA percentage of participants
Predictive values could not be determined as the denominator was zero.
|
77.3 percentage of participants
Interval 62.2 to 88.5
|
53.8 percentage of participants
Interval 25.1 to 80.8
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
|
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Wk2, Peg IFNAlfa2a, PPV (n=476,190,123,14,2,1)
|
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.
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
48.6 percentage of participants
Interval 31.4 to 66.0
|
61.8 percentage of participants
Interval 47.7 to 74.6
|
51.7 percentage of participants
Interval 32.5 to 70.6
|
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 ribonucleic acid (RNA) result. Participants with a baseline 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 |
Genotype 4 (G4)
n=18 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=674 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=267 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=188 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
Peg IFN Alfa 2b RVR (n= 106,46,29,2,1,1)
|
2 participants
|
1 participants
|
0 participants
|
19 participants
|
38 participants
|
20 participants
|
|
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
Peg IFN Alfa 2b mRVR(n= 106,46,29,2,1,1)
|
2 participants
|
1 participants
|
0 participants
|
24 participants
|
39 participants
|
22 participants
|
|
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
Peg IFN Alfa 2a RVR(n= 568,221,159,16,2,1)
|
5 participants
|
1 participants
|
1 participants
|
130 participants
|
184 participants
|
114 participants
|
|
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
Peg IFN Alfa 2a mRVR(n= 568,221,159,16,2,1)
|
6 participants
|
2 participants
|
1 participants
|
147 participants
|
189 participants
|
120 participants
|
SECONDARY outcome
Timeframe: During first 12 weeks of treatmentPopulation: 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 |
Genotype 4 (G4)
n=16 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=2 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=564 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=231 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=151 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling 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=476,190,123,14,2,1)
|
5 participants
|
1 participants
|
1 participants
|
109 participants
|
165 participants
|
100 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=88,41,28,2,1,1)
|
2 participants
|
1 participants
|
0 participants
|
16 participants
|
33 participants
|
19 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=88,41,28,2,1,1)
|
2 participants
|
1 participants
|
0 participants
|
21 participants
|
34 participants
|
21 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=476,190,123,14,2,1)
|
5 participants
|
1 participants
|
0 participants
|
155 participants
|
21 participants
|
15 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=476,190,123,14,2,1)
|
6 participants
|
2 participants
|
1 participants
|
121 participants
|
170 participants
|
103 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 baseline 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 |
Genotype 4 (G4)
n=6 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=1 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=1 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=172 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=112 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=72 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling 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,PegIFN Alfa2a (n=153,94,63,4,1,1)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
24.8 Percentage of Participants
|
8.5 Percentage of Participants
|
22.2 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, PegIFN Alfa2b(n=19,18,9,2,0,0)
|
0.0 Percentage of Participants
|
NA Percentage of Participants
There were no participants with an mVR who also had a HCV RNA test at the 12 weeks after EOT follow-up time point for G5/6 and UNK genotype subgroups.
|
NA Percentage of Participants
There were no participants with an mVR who also had a HCV RNA test at the 12 weeks after EOT follow-up time point for G5/6 and UNK genotype subgroups.
|
10.5 Percentage of Participants
|
11.1 Percentage of Participants
|
0.0 Percentage of Participants
|
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 ribonucleic acid (RNA) result. Participants with a baseline 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 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. It was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'.
Outcome measures
| Measure |
Genotype 4 (G4)
n=7 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=264 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=161 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=95 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling 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,PegIFN Alfa2a (n=236,136,84, 6, 2, 0)
|
16.7 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
26.3 Percentage of Participants
|
8.8 Percentage of Participants
|
19.0 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, PegIFN Alfa2b(n=28, 25, 11, 1, 1, 0)
|
0.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
10.7 Percentage of Participants
|
8.0 Percentage of Participants
|
0.0 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 the 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. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment.
Outcome measures
| Measure |
Genotype 4 (G4)
n=6 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=1 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
n=1 Participants
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=144 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=101 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=63 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling 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,PegINFAlfa2a (n=128,86,55,4,1,1)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
23.4 Percentage of Participants
|
8.1 Percentage of Participants
|
21.8 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, PegIFNAlfa2b(n=16,15,8,2,0,0)
|
0.0 Percentage of Participants
|
NA Percentage of Participants
There were no participants with an mVR who also had a HCV RNA test at the 12 weeks after EOT follow-up time point for G5/6 and UNK genotype subgroups.
|
NA Percentage of Participants
There were no participants with an mVR who also had a HCV RNA test at the 12 weeks after EOT follow-up time point for G5/6 and UNK genotype subgroups.
|
12.5 Percentage of Participants
|
13.3 Percentage of Participants
|
0.0 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 the 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. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'.
Outcome measures
| Measure |
Genotype 4 (G4)
n=7 Participants
Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 5/6 (G5/6)
n=3 Participants
Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype Unknown (UNK)
Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 1 (G1)
n=227 Participants
Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 2 (G2)
n=142 Participants
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
Genotype 3 (G3)
n=82 Participants
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling 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, PegIFNAlfa2b(n=26,22,10,1,1, 0)
|
0.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
11.5 Percentage of Participants
|
9.1 Percentage of Participants
|
0.0 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,PegIFNAlfa2a (n=201, 120, 72, 6, 2, 0)
|
16.7 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
24.4 Percentage of Participants
|
8.3 Percentage of Participants
|
18.1 Percentage of Participants
|
Adverse Events
Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b)
Serious events: 130 serious events
Other events: 841 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b)
n=1441 participants at risk
Eligible participants with serologically proven CHC who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.69%
10/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Cellulitis
|
0.21%
3/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Appendicitis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Appendicitis perforated
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Bronchitis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Escherichia sepsis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Gastroenteritis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Gastroenteritis viral
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Infection
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Localised infection
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Lung abscess
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Osteomyelitis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Peritonitis bacterial
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Pyelonephritis acute
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Salmonellosis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Sepsis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Sepsis syndrome
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Staphylococcal infection
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Streptococcal sepsis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Subcutaneous abscess
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Infections and infestations
Urinary tract infection
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Psychiatric disorders
Depression
|
0.35%
5/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Psychiatric disorders
Alcoholism
|
0.21%
3/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Psychiatric disorders
Psychotic disorder
|
0.21%
3/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Psychiatric disorders
Suicidal ideation
|
0.21%
3/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Psychiatric disorders
Suicide attempt
|
0.21%
3/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Psychiatric disorders
Mental status changes
|
0.14%
2/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Psychiatric disorders
Acute psychosis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Psychiatric disorders
Bipolar disorder
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Psychiatric disorders
Confusional state
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Psychiatric disorders
Delirium
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Psychiatric disorders
Depression suicidal
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Psychiatric disorders
Major depression
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Psychiatric disorders
Panic attack
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.69%
10/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.35%
5/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.14%
2/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Gastrointestinal disorders
Nausea
|
0.21%
3/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.14%
2/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Gastrointestinal disorders
Dysphagia
|
0.14%
2/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Gastrointestinal disorders
Haematochezia
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Gastrointestinal disorders
Melaena
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Gastrointestinal disorders
Vomiting
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.21%
3/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Injury, poisoning and procedural complications
Fall
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
General disorders
Chest pain
|
0.35%
5/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
General disorders
Chest discomfort
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
General disorders
Death
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
General disorders
Fatigue
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
General disorders
Impaired healing
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
General disorders
Irritability
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Cardiac disorders
Angina pectoris
|
0.14%
2/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Cardiac disorders
Myocardial infarction
|
0.14%
2/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Cardiac disorders
Cardiac arrest
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Cardiac disorders
Cardiac failure
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.14%
2/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.14%
2/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.21%
3/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.21%
3/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate Control
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.14%
2/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Nervous system disorders
Syncope
|
0.28%
4/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Nervous system disorders
Convulsion
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Vascular disorders
Hypotension
|
0.14%
2/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Vascular disorders
Deep vein thrombosis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Vascular disorders
Orthostatic hypotension
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Vascular disorders
Phlebitis superficial
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Vascular disorders
Thrombosis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Renal and urinary disorders
Renal failure acute
|
0.21%
3/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.14%
2/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Renal and urinary disorders
Renal failure
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.14%
2/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Investigations
Blood glucose increased
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Investigations
Laboratory test interference
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Investigations
Platelet count decreased
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Eye disorders
Cataract
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Eye disorders
Scleritis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Surgical and medical procedures
Drug rehabilitation
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Surgical and medical procedures
Hysterectomy
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Congenital, familial and genetic disorders
Fanconi Syndrome
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Endocrine disorders
Hypothyroidism
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Immune system disorders
Sarcoidosis
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Social circumstances
Substance use
|
0.07%
1/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
Other adverse events
| Measure |
Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b)
n=1441 participants at risk
Eligible participants with serologically proven CHC who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
|
|---|---|
|
Psychiatric disorders
Depression
|
16.2%
234/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Psychiatric disorders
Insomnia
|
15.5%
224/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Psychiatric disorders
Anxiety
|
6.4%
92/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Blood and lymphatic system disorders
Anaemia
|
23.1%
333/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.5%
108/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
General disorders
Fatigue
|
14.3%
206/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
General disorders
Influenza like illness
|
7.2%
104/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
General disorders
Irritability
|
5.1%
74/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.6%
138/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
80/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Gastrointestinal disorders
Nausea
|
11.7%
168/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
78/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
75/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Nervous system disorders
Headache
|
9.4%
136/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.5%
79/1441 • Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
|
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