Hepatitis C, Chronic
Conditions
Brief summary
This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is \<2000.
Interventions
DRUGPeginterferon alfa-2a [Pegasys]
Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.
Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>/= 18 years of age * chronic hepatitis C * informed consent to data collection
Exclusion criteria
* co-infection with HIV or HBV * previous treatment with peginterferon and/or ribavirin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | At 24 weeks after EOT | Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of \<15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection \[LLOD\] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive 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. |
| Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | At 24 weeks after EOT | Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of \<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. |
| Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | At 24 weeks after EOT | Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA \<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT 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. |
| Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | At 24 weeks after EOT | Modified sustained virological response is defined as mVR of HCV RNA \<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. |
| Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | At 24 weeks after EOT | The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. |
| Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | At 24 weeks after EOT | The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | At Week 2, Week 4 and Week 12 | Participants with 1-log drop in HCV RNA including HCV RNA values \<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. |
| Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | At Week 2, Week 4 and Week 12 | Participants with 1-log drop in HCV RNA including HCV RNA values \<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. |
| Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | 24 weeks after EOT | 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. |
| Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | 24 weeks after EOT | 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. |
| Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | At Week 4 and Week 12 | 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. |
| Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT | Virological response (VR) was defined as HCV RNA \<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment |
| Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment | At 12 weeks after EOT | Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The 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. |
| Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment | At 12 weeks after EOT | Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. |
| Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment | At 24 weeks after EOT | Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The 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. |
| Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment | At 24 weeks after EOT | Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. |
| Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | At Week 4 and Week 12 | 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. |
| Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT | 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 |
| Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT | 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 |
| Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT | 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 |
| Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | At Week 2, Week 4 and Week 12 | Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values \<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. |
| Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | At Week 2, Week 4 and Week 12 | Participants with 2-log drop in HCV RNA including HCV RNA values \<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. |
Countries
Belgium, Ireland, Italy, United Kingdom
Participant flow
Recruitment details
A total of 2343 participants were enrolled in this study conducted from October 2007 to May 2011 at 125 centers in Belgium, Italy, United Kingdom, and Ireland.
Participants by arm
| Arm | Count |
|---|---|
| Genotype 1 (G1) Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. | 1,128 |
| Genotype 2 (G2) Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. | 572 |
| Genotype 3 (G3) Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. | 484 |
| Genotype 4 (G4) Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. | 143 |
| Genotype 5/6 (G5/6) Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. | 11 |
| Unknown Genotype (UNK) Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. | 5 |
| Total | 2,343 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Death | 4 | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Early Termination | 3 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lab test not done | 7 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 2 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 180 | 39 | 82 | 16 | 0 | 1 |
| Overall Study | Miscellaneous | 4 | 5 | 6 | 0 | 0 | 0 |
| Overall Study | Non-responders | 104 | 5 | 11 | 25 | 0 | 0 |
| Overall Study | Other | 15 | 5 | 6 | 2 | 0 | 0 |
| Overall Study | Physician Decision | 3 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 3 | 2 | 2 | 0 | 0 | 0 |
| Overall Study | Relapse | 20 | 8 | 2 | 3 | 0 | 0 |
| Overall Study | Result Not Available | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Treatment Interrupted | 1 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Treatment Never Started | 18 | 5 | 4 | 1 | 0 | 0 |
| Overall Study | Treatment Stopped | 2 | 1 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 4 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Genotype 1 (G1) | Genotype 2 (G2) | Genotype 3 (G3) | Genotype 4 (G4) | Genotype 5/6 (G5/6) | Unknown Genotype (UNK) | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 49.1 years STANDARD_DEVIATION 12.52 | 54.2 years STANDARD_DEVIATION 12.52 | 40.6 years STANDARD_DEVIATION 9.2 | 46.6 years STANDARD_DEVIATION 11.56 | 52.7 years STANDARD_DEVIATION 12.82 | 51.4 years STANDARD_DEVIATION 13.24 | 48.5 years STANDARD_DEVIATION 12.71 |
| Sex: Female, Male Female | 532 Participants | 291 Participants | 134 Participants | 53 Participants | 4 Participants | 3 Participants | 1017 Participants |
| Sex: Female, Male Male | 596 Participants | 281 Participants | 350 Participants | 90 Participants | 7 Participants | 2 Participants | 1326 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population
Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA \<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT 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.
Time frame: At 24 weeks after EOT
Population: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2a (n=778, 414, 353,114, 9, 2) | 46.5 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 39.6 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2a (n=778, 414, 353,114, 9, 2) | 78.3 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 82.7 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2a (n=778, 414, 353,114, 9, 2) | 68.6 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 68.9 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2a (n=778, 414, 353,114, 9, 2) | 43.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 35.7 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2a (n=778, 414, 353,114, 9, 2) | 66.7 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2a (n=778, 414, 353,114, 9, 2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 0.0 percentage of participants |
Comparison: The statistical analysis is presented for Gamma-Glutamyl Transferase (Gamma-GT) in log10 international units per liter (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week \[Wk\]12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.021195% CI: [0.306, 0.908]Regression, Logistic
Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.065, 1.092]Regression, Logistic
Comparison: The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, during the first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.005395% CI: [1.061, 1.403]Regression, Logistic
Comparison: The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.007995% CI: [0.264, 0.818]Regression, Logistic
Comparison: The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.180895% CI: [0.471, 1.153]Regression, Logistic
Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.069, 1.095]Regression, Logistic
Comparison: The statistical analysis is presented for Weight per 10 kilogram (kg). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000595% CI: [0.542, 0.844]Regression, Logistic
Comparison: The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.004195% CI: [0.392, 0.838]Regression, Logistic
Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.048, 1.142]Regression, Logistic
Comparison: The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.003195% CI: [2.013, 31.359]Regression, Logistic
Comparison: The statistical analysis is presented for body mass index (BMI) in kilogram per square meter (kg/m\^2). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.001295% CI: [0.844, 0.959]Regression, Logistic
Comparison: The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.008595% CI: [0.433, 0.885]Regression, Logistic
Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.087, 1.174]Regression, Logistic
Comparison: The statistical analysis is presented for Weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.034195% CI: [0.626, 0.982]Regression, Logistic
Comparison: The statistical analysis is presented for aspartate aminotransferase (AST) ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.044395% CI: [0.335, 0.986]Regression, Logistic
Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.057, 1.144]Regression, Logistic
Comparison: The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, during the first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.003995% CI: [2.73, 191.56]Regression, Logistic
Comparison: The statistical analysis is presented for Weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2ap-value: 0.024495% CI: [0.628, 0.968]Regression, Logistic
Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [1.086, 1.172]Regression, Logistic
Comparison: The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.p-value: 0.045395% CI: [0.303, 0.987]Regression, Logistic
Comparison: The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.p-value: 0.018495% CI: [0.025, 0.712]Regression, Logistic
Comparison: The statistical analysis is presented for treatment duration after VR in Weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.p-value: <0.000195% CI: [1.072, 1.134]Regression, Logistic
Comparison: The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.p-value: 0.001995% CI: [0.37, 0.798]Regression, Logistic
Comparison: The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.p-value: 0.001795% CI: [0.189, 0.679]Regression, Logistic
Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.p-value: <0.000195% CI: [1.047, 1.114]Regression, Logistic
Comparison: The statistical analysis is presented for cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.p-value: 0.004295% CI: [1.029, 1.162]Regression, Logistic
Comparison: The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.016895% CI: [0.32, 0.893]Regression, Logistic
Comparison: The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.012895% CI: [0.291, 0.864]Regression, Logistic
Comparison: The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.463495% CI: [0.558, 1.305]Regression, Logistic
Comparison: The statistical analysis is presented for On-treatment response (Rapid Virological Response \[RVR\] vs No RVR/EVR \[Early Virological Response\]). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [9.725, 39.722]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (cEVR \[Complete Early Virological Response\] vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [4.408, 16.658]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (pEVR \[Partial Early Virological Response\] vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.008995% CI: [1.26, 5.034]Regression, Logistic
Comparison: The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.003795% CI: [0.851, 0.969]Regression, Logistic
Comparison: The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.00295% CI: [0.379, 0.805]Regression, Logistic
Comparison: The statistical analysis is presented for On-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2ap-value: 0.000395% CI: [3.654, 74.849]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.073395% CI: [0.87, 22.114]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.347895% CI: [0.394, 14.031]Regression, Logistic
Comparison: The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.026495% CI: [0.552, 0.964]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.009695% CI: [1.586, 27.946]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.042195% CI: [1.057, 21.203]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.600495% CI: [0.09, 4.014]Regression, Logistic
Comparison: The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.p-value: 0.041895% CI: [0.517, 0.988]Regression, Logistic
Comparison: The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.p-value: 0.027995% CI: [0.047, 0.839]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.p-value: <0.000195% CI: [7.474, 223.61]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.p-value: <0.000195% CI: [8.724, 206.02]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.p-value: 0.008795% CI: [1.704, 39.908]Regression, Logistic
Primary
Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population
Modified sustained virological response is defined as mVR of HCV RNA \<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Time frame: At 24 weeks after EOT
Population: The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2a (n=704, 361, 299, 102, 7, 2) | 47.6 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 39.2 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2a (n=704, 361, 299, 102, 7, 2) | 79.5 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 81.6 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2a (n=704, 361, 299, 102, 7, 2) | 69.2 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 69.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2a (n=704, 361, 299, 102, 7, 2) | 40.2 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 35.7 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2a (n=704, 361, 299, 102, 7, 2) | 57.1 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2a (n=704, 361, 299, 102, 7, 2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 0.0 percentage of participants |
Primary
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Time frame: At 24 weeks after EOT
Population: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2b, PPV (n=177,101,71,14,2,2) | 72.4 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2a, NPV (n=733,397,325,104,8,2) | 64.0 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4,PEG-IFN alfa-2a, PPV (n=733,397,325,104,8,2) | 74.9 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2b, NPV (n=177,101,71,14,2,2) | 67.6 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2a,PPV (n=768,412,350,109,9,2) | 64.6 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2a, NPV(n=768,412,350,109,9,2) | 80.1 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2b, PPV (n=181, 104,74,14,2,2) | 68.8 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12, PEG-IFN alfa-2b, NPV (n=181, 104,74,14,2,2) | 81.7 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2b, NPV (n=177,101,71,14,2,2) | 47.8 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12, PEG-IFN alfa-2b, NPV (n=181, 104,74,14,2,2) | 55.6 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4,PEG-IFN alfa-2a, PPV (n=733,397,325,104,8,2) | 84.7 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2b, PPV (n=181, 104,74,14,2,2) | 86.3 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2a, NPV(n=768,412,350,109,9,2) | 59.4 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2b, PPV (n=177,101,71,14,2,2) | 91.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2a, NPV (n=733,397,325,104,8,2) | 51.6 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2a,PPV (n=768,412,350,109,9,2) | 81.8 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2a, NPV (n=733,397,325,104,8,2) | 52.0 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2b, PPV (n=177,101,71,14,2,2) | 80.0 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2b, NPV (n=177,101,71,14,2,2) | 61.9 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12, PEG-IFN alfa-2b, NPV (n=181, 104,74,14,2,2) | 66.7 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2a,PPV (n=768,412,350,109,9,2) | 72.4 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2a, NPV(n=768,412,350,109,9,2) | 74.1 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2b, PPV (n=181, 104,74,14,2,2) | 73.8 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4,PEG-IFN alfa-2a, PPV (n=733,397,325,104,8,2) | 74.8 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2b, PPV (n=181, 104,74,14,2,2) | 71.4 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2a, NPV(n=768,412,350,109,9,2) | 93.9 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2a,PPV (n=768,412,350,109,9,2) | 59.2 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4,PEG-IFN alfa-2a, PPV (n=733,397,325,104,8,2) | 64.3 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2b, PPV (n=177,101,71,14,2,2) | 66.7 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2b, NPV (n=177,101,71,14,2,2) | 87.5 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12, PEG-IFN alfa-2b, NPV (n=181, 104,74,14,2,2) | 100.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2a, NPV (n=733,397,325,104,8,2) | 71.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12, PEG-IFN alfa-2b, NPV (n=181, 104,74,14,2,2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4,PEG-IFN alfa-2a, PPV (n=733,397,325,104,8,2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2a,PPV (n=768,412,350,109,9,2) | 75.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2a, NPV(n=768,412,350,109,9,2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2b, PPV (n=181, 104,74,14,2,2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2a, NPV (n=733,397,325,104,8,2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2b, PPV (n=177,101,71,14,2,2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2b, NPV (n=177,101,71,14,2,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12, PEG-IFN alfa-2b, NPV (n=181, 104,74,14,2,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2a,PPV (n=768,412,350,109,9,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2b, PPV (n=177,101,71,14,2,2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2b, NPV (n=177,101,71,14,2,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2a, NPV(n=768,412,350,109,9,2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4, PEG-IFN alfa-2a, NPV (n=733,397,325,104,8,2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk12,PEG-IFN alfa-2b, PPV (n=181, 104,74,14,2,2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk4,PEG-IFN alfa-2a, PPV (n=733,397,325,104,8,2) | 100.0 percentage of participants |
Primary
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Time frame: At 24 weeks after EOT
Population: The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4, PEG-IFN alfa-2b, PPV (n=155,85,65,14,2,2) | 75.0 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4,PEG-IFN alfa-2a, NPV (n=668,351,275,93,6,2) | 63.5 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4,PEG-IFN alfa-2a, PPV (n=668,351,275,93,6,2) | 75.8 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4, PEG-IFN alfa-2b, NPV (n=155,85,65,14,2,2) | 68.7 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12,PEG-IFN alfa-2a, PPV(n=697,359,296,98,7,2) | 65.2 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12,PEG-IFN alfa-2a, NPV (n=697,359,296,98,7,2) | 79.6 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12, PEG-IFN alfa-2b, PPV (n=158, 87,68,14,2,2) | 68.7 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12, PEG-IFN alfa-2b, NPV (n=158, 87,68,14,2,2) | 82.4 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4, PEG-IFN alfa-2b, NPV (n=155,85,65,14,2,2) | 52.6 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12, PEG-IFN alfa-2b, NPV (n=158, 87,68,14,2,2) | 57.1 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4,PEG-IFN alfa-2a, PPV (n=668,351,275,93,6,2) | 85.6 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12, PEG-IFN alfa-2b, PPV (n=158, 87,68,14,2,2) | 85.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12,PEG-IFN alfa-2a, NPV (n=697,359,296,98,7,2) | 56.5 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4, PEG-IFN alfa-2b, PPV (n=155,85,65,14,2,2) | 90.9 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4,PEG-IFN alfa-2a, NPV (n=668,351,275,93,6,2) | 49.1 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12,PEG-IFN alfa-2a, PPV(n=697,359,296,98,7,2) | 82.4 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4,PEG-IFN alfa-2a, NPV (n=668,351,275,93,6,2) | 45.2 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4, PEG-IFN alfa-2b, PPV (n=155,85,65,14,2,2) | 81.8 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4, PEG-IFN alfa-2b, NPV (n=155,85,65,14,2,2) | 61.9 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12, PEG-IFN alfa-2b, NPV (n=158, 87,68,14,2,2) | 66.7 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12,PEG-IFN alfa-2a, PPV(n=697,359,296,98,7,2) | 72.5 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12,PEG-IFN alfa-2a, NPV (n=697,359,296,98,7,2) | 70.0 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12, PEG-IFN alfa-2b, PPV (n=158, 87,68,14,2,2) | 74.6 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4,PEG-IFN alfa-2a, PPV (n=668,351,275,93,6,2) | 73.7 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12, PEG-IFN alfa-2b, PPV (n=158, 87,68,14,2,2) | 71.4 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12,PEG-IFN alfa-2a, NPV (n=697,359,296,98,7,2) | 96.4 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12,PEG-IFN alfa-2a, PPV(n=697,359,296,98,7,2) | 55.7 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4,PEG-IFN alfa-2a, PPV (n=668,351,275,93,6,2) | 61.5 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4, PEG-IFN alfa-2b, PPV (n=155,85,65,14,2,2) | 66.7 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4, PEG-IFN alfa-2b, NPV (n=155,85,65,14,2,2) | 87.5 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12, PEG-IFN alfa-2b, NPV (n=158, 87,68,14,2,2) | 100.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4,PEG-IFN alfa-2a, NPV (n=668,351,275,93,6,2) | 74.1 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12, PEG-IFN alfa-2b, NPV (n=158, 87,68,14,2,2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4,PEG-IFN alfa-2a, PPV (n=668,351,275,93,6,2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12,PEG-IFN alfa-2a, PPV(n=697,359,296,98,7,2) | 66.7 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12,PEG-IFN alfa-2a, NPV (n=697,359,296,98,7,2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12, PEG-IFN alfa-2b, PPV (n=158, 87,68,14,2,2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4,PEG-IFN alfa-2a, NPV (n=668,351,275,93,6,2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4, PEG-IFN alfa-2b, PPV (n=155,85,65,14,2,2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4, PEG-IFN alfa-2b, NPV (n=155,85,65,14,2,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12, PEG-IFN alfa-2b, NPV (n=158, 87,68,14,2,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12,PEG-IFN alfa-2a, PPV(n=697,359,296,98,7,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4, PEG-IFN alfa-2b, PPV (n=155,85,65,14,2,2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4, PEG-IFN alfa-2b, NPV (n=155,85,65,14,2,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12,PEG-IFN alfa-2a, NPV (n=697,359,296,98,7,2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4,PEG-IFN alfa-2a, NPV (n=668,351,275,93,6,2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk12, PEG-IFN alfa-2b, PPV (n=158, 87,68,14,2,2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk4,PEG-IFN alfa-2a, PPV (n=668,351,275,93,6,2) | 100.0 percentage of participants |
Primary
Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population
Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of \<15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection \[LLOD\] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive 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.
Time frame: At 24 weeks after EOT
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2a (n=778, 414, 353,114, 9, 2) | 46.1 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 39.6 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2a (n=778, 414, 353,114, 9, 2) | 78.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 81.7 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2a (n=778, 414, 353,114, 9, 2) | 68.3 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 68.9 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2a (n=778, 414, 353,114, 9, 2) | 43.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 35.7 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2a (n=778, 414, 353,114, 9, 2) | 55.6 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2a (n=778, 414, 353,114, 9, 2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 0.0 percentage of participants |
Primary
Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population
Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of \<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Time frame: At 24 weeks after EOT
Population: The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2a (n=704, 361, 299, 102, 7, 2) | 47.2 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 39.2 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2a (n=704, 361, 299, 102, 7, 2) | 79.5 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 80.5 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2a (n=704, 361, 299, 102, 7, 2) | 68.9 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 69.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2a (n=704, 361, 299, 102, 7, 2) | 40.2 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 35.7 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2a (n=704, 361, 299, 102, 7, 2) | 57.1 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2a (n=704, 361, 299, 102, 7, 2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 0.0 percentage of participants |
Secondary
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
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.
Time frame: At Week 4 and Week 12
Population: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 192 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 199 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mCEVR, PEG-IFN alfa-2b (n=182,104,74,14,2, 2) | 49 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2b (n=182,104, 74,14,2, 2) | 46 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mRVR,PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 237 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 154 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2b (n=182, 104,74,14, 2, 2) | 38 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 258 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2b (n=182, 104,74,14, 2, 2) | 56 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 48 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 29 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mcEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 258 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 17 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mcEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 35 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 18 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 78 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 47 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2b (n=182, 104,74,14, 2, 2) | 90 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 333 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mCEVR, PEG-IFN alfa-2b (n=182,104,74,14,2, 2) | 8 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 9 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mRVR,PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 354 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2b (n=182,104, 74,14,2, 2) | 5 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2b (n=182, 104,74,14, 2, 2) | 8 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 10 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mRVR,PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 265 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 16 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2b (n=182, 104,74,14, 2, 2) | 55 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2b (n=182,104, 74,14,2, 2) | 3 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2b (n=182, 104,74,14, 2, 2) | 7 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mcEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 64 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mCEVR, PEG-IFN alfa-2b (n=182,104,74,14,2, 2) | 14 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 73 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 250 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 15 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mCEVR, PEG-IFN alfa-2b (n=182,104,74,14,2, 2) | 1 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 42 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 6 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mRVR,PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 47 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2b (n=182, 104,74,14, 2, 2) | 6 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 34 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 1 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mcEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 33 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 12 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2b (n=182, 104,74,14, 2, 2) | 1 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 8 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2b (n=182,104, 74,14,2, 2) | 1 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 4 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mRVR,PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 4 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 4 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2b (n=182,104, 74,14,2, 2) | 1 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 0 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2b (n=182, 104,74,14, 2, 2) | 1 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 1 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 1 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2b (n=182, 104,74,14, 2, 2) | 1 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mcEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 5 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mCEVR, PEG-IFN alfa-2b (n=182,104,74,14,2, 2) | 0 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 0 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mCEVR, PEG-IFN alfa-2b (n=182,104,74,14,2, 2) | 0 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 0 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 1 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2b (n=182, 104,74,14, 2, 2) | 1 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2b (n=182,104, 74,14,2, 2) | 0 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2b (n=182, 104,74,14, 2, 2) | 0 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mRVR,PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 2 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 1 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 0 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 1 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | mcEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 0 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 0 number of participants |
Secondary
Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12
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.
Time frame: At Week 4 and Week 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 175 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 186 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mCEVR, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 43 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 40 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 223 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 139 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 33 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 236 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 49 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 43 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 24 number of participants |
| Genotype 1 (G1) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mcEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 235 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 14 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mcEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 28 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 13 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 66 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 38 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 77 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 298 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mCEVR, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 5 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 6 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 315 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 4 number of participants |
| Genotype 2 (G2) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 6 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 8 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 224 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 13 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 49 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 3 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 7 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mcEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 57 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mCEVR, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 14 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 63 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 44 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 213 number of participants |
| Genotype 3 (G3) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 15 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mCEVR, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 1 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 39 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 6 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 44 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 6 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 31 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 1 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mcEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 29 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 10 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 1 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 7 number of participants |
| Genotype 4 (G4) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 1 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 4 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 2 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 2 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 1 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 0 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 1 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 1 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 1 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 1 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mcEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 5 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mCEVR, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 0 number of participants |
| Genotype 5/6 (G5/6) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 0 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mCEVR, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 0 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 0 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 1 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 1 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 0 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | pEVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 0 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mRVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 2 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 1 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mpEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 0 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | RVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 1 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | mcEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 0 number of participants |
| Unknown Genotype (UNK) | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | cEVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 0 number of participants |
Secondary
Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12
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.
Time frame: At Week 2, Week 4 and Week 12
Population: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 23.7 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 18.7 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 79.6 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 75.8 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 93.6 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 89.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 26.9 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 96.2 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 99.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 37.2 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 93.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 98.1 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 98.6 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 97.2 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 89.2 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 87.8 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 21.8 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 24.3 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 57.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 21.4 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 78.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 78.6 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 86.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 8.8 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 0.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 88.9 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 50.0 percentage of participants |
Secondary
Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12
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.
Time frame: At Week 2, Week 4 and Week 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 24.0 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2,PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 17.1 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 81.3 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 76.6 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 94.9 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 90.5 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2,PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 28.7 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 96.6 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 98.9 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 39.9 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 94.7 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 98.3 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 98.5 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 98.0 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 88.2 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 88.3 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 22.4 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2,PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 26.5 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 57.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2,PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 21.4 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 79.4 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 78.6 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 87.3 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 7.8 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 0.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2,PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 85.7 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2,PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 50.0 percentage of participants |
Secondary
Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12
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.
Time frame: At Week 2, Week 4 and Week 12
Population: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 14.4 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 10.4 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 59.0 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 46.2 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 83.4 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 73.1 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 24.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 94.2 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 99.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 33.8 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 90.8 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 96.1 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 97.3 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 96.0 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 85.1 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 85.0 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 20.1 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 20.3 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 42.9 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 14.3 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 64.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 57.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 77.2 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 5.3 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 0.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 66.7 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 50.0 percentage of participants |
Secondary
Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12
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.
Time frame: At Week 2, Week 4 and Week 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 14.5 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 10.1 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 59.9 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 45.6 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 84.8 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12,PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 73.4 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 26.4 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 95.4 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12,PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 98.9 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 36.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 92.5 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 96.7 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12,PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 97.1 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 96.7 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 83.8 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 84.9 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 20.4 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 22.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 42.9 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 14.3 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 65.7 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12,PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 57.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 78.4 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 4.9 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 0.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 57.1 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12,PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk12,PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 50.0 percentage of participants |
Secondary
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
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
Time frame: At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT
Population: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 20.9 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 30.5 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=182,104, 4,14,2,2) | 40.7 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 50.0 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 57.1 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 73.8 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 3.8 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 4.8 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 47.8 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 63.6 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 10.6 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 24.9 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 85.5 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 86.5 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 94.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 94.2 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 92.8 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 92.3 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 80.2 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=182,104, 4,14,2,2) | 83.7 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 74.3 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 89.2 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 12.7 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 93.2 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 75.1 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 12.2 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 93.2 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 71.4 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=182,104, 4,14,2,2) | 70.3 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 92.4 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 67.5 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 57.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 7.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=182,104, 4,14,2,2) | 35.7 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 46.5 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 3.5 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 70.2 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 42.9 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 41.2 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 88.9 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 0.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=182,104, 4,14,2,2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 66.7 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 44.4 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=182,104, 4,14,2,2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 100.0 percentage of participants |
Secondary
Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time
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
Time frame: At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT
Population: The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2a (n=704, 361,299,102,7,2) | 31.7 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 56.3 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 20.9 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 4.7 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 51.1 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=158,87,68,14,2,2) | 39.9 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 65.1 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12,PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 48.1 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 74.9 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 3.2 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 81.4 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12,PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 94.3 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2a (n=704, 361,299,102,7,2) | 87.3 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=158,87,68,14,2,2) | 82.8 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 88.5 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 12.6 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 26.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 92.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 95.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 93.6 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 12.7 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 72.1 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=158,87,68,14,2,2) | 70.6 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 92.6 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 94.0 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 71.9 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 13.2 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12,PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 92.6 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2a (n=704, 361,299,102,7,2) | 74.9 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 89.7 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 66.7 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 44.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=158,87,68,14,2,2) | 35.7 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 2.9 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 7.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2a (n=704, 361,299,102,7,2) | 43.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 42.9 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 71.6 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12,PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 50.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 57.1 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 57.1 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2a (n=704, 361,299,102,7,2) | 28.6 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12,PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 0.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 85.7 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=158,87,68,14,2,2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=158,87,68,14,2,2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2a (n=704, 361,299,102,7,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12,PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 50.0 percentage of participants |
Secondary
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
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.
Time frame: 24 weeks after EOT
Population: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2a, PPV (n=267,174,98,16,0, 1) | 84.4 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2a,NPV (n=267, 174,98,16, 0, 1) | 51.9 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2b, PPV (n=54, 29, 19,7,1,1) | 57.1 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2b, NPV (n=54,29,19,7,1, 1) | 59.6 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2b, PPV (n=54, 29, 19,7,1,1) | 71.4 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2a,NPV (n=267, 174,98,16, 0, 1) | 22.6 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2a, PPV (n=267,174,98,16,0, 1) | 92.2 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2b, NPV (n=54,29,19,7,1, 1) | 13.6 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2b, NPV (n=54,29,19,7,1, 1) | 28.6 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2b, PPV (n=54, 29, 19,7,1,1) | 60.0 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2a,NPV (n=267, 174,98,16, 0, 1) | 28.6 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2a, PPV (n=267,174,98,16,0, 1) | 77.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2a, PPV (n=267,174,98,16,0, 1) | 33.3 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2b, NPV (n=54,29,19,7,1, 1) | 50.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2a,NPV (n=267, 174,98,16, 0, 1) | 69.2 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2b, PPV (n=54, 29, 19,7,1,1) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2b, PPV (n=54, 29, 19,7,1,1) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2b, NPV (n=54,29,19,7,1, 1) | NA percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2a,NPV (n=267, 174,98,16, 0, 1) | NA percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2a, PPV (n=267,174,98,16,0, 1) | NA percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2a,NPV (n=267, 174,98,16, 0, 1) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2b, PPV (n=54, 29, 19,7,1,1) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2b, NPV (n=54,29,19,7,1, 1) | NA percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | Wk2, PEG-IFN alfa-2a, PPV (n=267,174,98,16,0, 1) | NA percentage of participants |
Secondary
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
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.
Time frame: 24 weeks after EOT
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2a, PPV (n=246, 63,87,14,0,1) | 82.1 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2b, NPV (n=43, 26,19,7,1,1) | 55.3 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2b, PPV (n=43, 26,19,7,1,1) | 60.0 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2a, NPV (n=246, 163,87,14,0,1) | 51.8 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2b, NPV (n=43, 26,19,7,1,1) | 15.8 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2a, NPV (n=246, 163,87,14,0,1) | 21.5 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2a, PPV (n=246, 63,87,14,0,1) | 92.9 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2b, PPV (n=43, 26,19,7,1,1) | 71.4 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2b, PPV (n=43, 26,19,7,1,1) | 60.0 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2a, NPV (n=246, 163,87,14,0,1) | 28.6 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2a, PPV (n=246, 63,87,14,0,1) | 74.2 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2b, NPV (n=43, 26,19,7,1,1) | 28.6 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2b, PPV (n=43, 26,19,7,1,1) | 100.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2a, NPV (n=246, 163,87,14,0,1) | 75.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2a, PPV (n=246, 63,87,14,0,1) | 0.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2b, NPV (n=43, 26,19,7,1,1) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2b, NPV (n=43, 26,19,7,1,1) | NA percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2a, NPV (n=246, 163,87,14,0,1) | NA percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2a, PPV (n=246, 63,87,14,0,1) | NA percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2b, PPV (n=43, 26,19,7,1,1) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2a, NPV (n=246, 163,87,14,0,1) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2a, PPV (n=246, 63,87,14,0,1) | NA percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2b, NPV (n=43, 26,19,7,1,1) | NA percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | Wk2, PEG-IFN alfa-2b, PPV (n=43, 26,19,7,1,1) | 0.0 percentage of participants |
Secondary
Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment
Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The 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.
Time frame: At 12 weeks after EOT
Population: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2a (n=257,193,109,14,0,0) | 30.0 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2b (n=36,50,27,3,0,0) | 22.2 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2a (n=257,193,109,14,0,0) | 10.9 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2b (n=36,50,27,3,0,0) | 4.0 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2a (n=257,193,109,14,0,0) | 14.7 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2b (n=36,50,27,3,0,0) | 7.4 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2a (n=257,193,109,14,0,0) | 21.4 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2b (n=36,50,27,3,0,0) | 33.3 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2a (n=257,193,109,14,0,0) | 0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2b (n=36,50,27,3,0,0) | 0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2a (n=257,193,109,14,0,0) | 0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2b (n=36,50,27,3,0,0) | 0 percentage of participants |
Secondary
Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment
Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The 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.
Time frame: At 24 weeks after EOT
Population: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment | 24Wk PEOT, PEG-IFN alfa-2a (n=508,364,282,69,8,2) | 28.7 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment | 24wk PEOT, PEG-IFN alfa-2b (n=91,93,57,7,2,0) | 20.9 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment | 24Wk PEOT, PEG-IFN alfa-2a (n=508,364,282,69,8,2) | 11.3 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment | 24wk PEOT, PEG-IFN alfa-2b (n=91,93,57,7,2,0) | 7.5 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment | 24Wk PEOT, PEG-IFN alfa-2a (n=508,364,282,69,8,2) | 14.2 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment | 24wk PEOT, PEG-IFN alfa-2b (n=91,93,57,7,2,0) | 10.5 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment | 24Wk PEOT, PEG-IFN alfa-2a (n=508,364,282,69,8,2) | 29.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment | 24wk PEOT, PEG-IFN alfa-2b (n=91,93,57,7,2,0) | 28.6 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment | 24Wk PEOT, PEG-IFN alfa-2a (n=508,364,282,69,8,2) | 25.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment | 24wk PEOT, PEG-IFN alfa-2b (n=91,93,57,7,2,0) | 15.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment | 24Wk PEOT, PEG-IFN alfa-2a (n=508,364,282,69,8,2) | 0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment | 24wk PEOT, PEG-IFN alfa-2b (n=91,93,57,7,2,0) | 0 percentage of participants |
Comparison: The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000295% CI: [1.383, 2.77]Regression, Logistic
Comparison: The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000795% CI: [1.661, 6.705]Regression, Logistic
Comparison: The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.361195% CI: [0.737, 2.312]Regression, Logistic
Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [0.929, 0.958]Regression, Logistic
Comparison: The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, during the first 12 weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.00295% CI: [0.615, 0.897]Regression, Logistic
Comparison: The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000495% CI: [1.322, 2.628]Regression, Logistic
Comparison: The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.038695% CI: [1.04, 4.338]Regression, Logistic
Comparison: The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000495% CI: [1.722, 6.706]Regression, Logistic
Comparison: The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.276995% CI: [0.776, 2.428]Regression, Logistic
Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [0.931, 0.96]Regression, Logistic
Comparison: The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000195% CI: [1.078, 1.256]Regression, Logistic
Comparison: The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.021395% CI: [1.091, 2.932]Regression, Logistic
Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000295% CI: [0.856, 0.953]Regression, Logistic
Comparison: The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.030695% CI: [0.538, 0.97]Regression, Logistic
Comparison: The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000595% CI: [1.061, 1.236]Regression, Logistic
Comparison: The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.012295% CI: [1.151, 3.158]Regression, Logistic
Comparison: The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.095695% CI: [0.872, 5.424]Regression, Logistic
Comparison: The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.084695% CI: [0.06, 1.197]Regression, Logistic
Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [0.852, 0.945]Regression, Logistic
Comparison: The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.003395% CI: [1.259, 3.165]Regression, Logistic
Comparison: The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.009595% CI: [1.035, 1.277]Regression, Logistic
Comparison: The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.003195% CI: [0.045, 0.533]Regression, Logistic
Comparison: The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.064595% CI: [0.125, 1.063]Regression, Logistic
Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000195% CI: [0.846, 0.948]Regression, Logistic
Comparison: The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.003395% CI: [1.259, 3.165]Regression, Logistic
Comparison: The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.009595% CI: [1.035, 1.277]Regression, Logistic
Comparison: The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.003195% CI: [0.045, 0.533]Regression, Logistic
Comparison: The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.064595% CI: [0.125, 1.063]Regression, Logistic
Comparison: The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000195% CI: [0.846, 0.948]Regression, Logistic
Comparison: The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.018295% CI: [1.041, 1.541]Regression, Logistic
Comparison: The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.009295% CI: [1.122, 2.254]Regression, Logistic
Comparison: The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.00295% CI: [1.488, 5.942]Regression, Logistic
Comparison: The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.652495% CI: [0.641, 2.035]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: <0.000195% CI: [0.037, 0.311]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.042995% CI: [0.156, 0.97]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.54995% CI: [0.523, 3.38]Regression, Logistic
Comparison: The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.000895% CI: [1.054, 1.224]Regression, Logistic
Comparison: The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.01495% CI: [1.133, 3.037]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.057595% CI: [0.015, 1.068]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.712895% CI: [0.072, 6.025]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.59695% CI: [0.04, 6.318]Regression, Logistic
Comparison: The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.003395% CI: [1.27, 3.311]Regression, Logistic
Comparison: The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.045295% CI: [1.002, 1.236]Regression, Logistic
Comparison: The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.00495% CI: [0.043, 0.551]Regression, Logistic
Comparison: The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2ap-value: 0.083395% CI: [0.137, 1.131]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.143995% CI: [0.01, 1.951]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.445795% CI: [0.024, 5.194]Regression, Logistic
Comparison: The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.p-value: 0.625895% CI: [0.1, 45.801]Regression, Logistic
Secondary
Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment
Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Time frame: At 12 weeks after EOT
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment | 12Wk PEOT, PEG-IFN alfa-2a (n=239,175,98,12,0,0) | 29.3 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2b (n=28,43,25,3,0,0) | 25.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment | 12Wk PEOT, PEG-IFN alfa-2a (n=239,175,98,12,0,0) | 10.3 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2b (n=28,43,25,3,0,0) | 4.7 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment | 12Wk PEOT, PEG-IFN alfa-2a (n=239,175,98,12,0,0) | 14.3 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2b (n=28,43,25,3,0,0) | 8.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment | 12Wk PEOT, PEG-IFN alfa-2a (n=239,175,98,12,0,0) | 25.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2b (n=28,43,25,3,0,0) | 33.3 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment | 12Wk PEOT, PEG-IFN alfa-2a (n=239,175,98,12,0,0) | 0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2b (n=28,43,25,3,0,0) | 0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment | 12Wk PEOT, PEG-IFN alfa-2a (n=239,175,98,12,0,0) | 0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment | 12wk PEOT, PEG-IFN alfa-2b (n=28,43,25,3,0,0) | 0 percentage of participants |
Secondary
Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment
Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Time frame: At 24 weeks after EOT
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment | 24Wk PEOT, PEG-IFN alfa-2a (n=468,323,240,60,6,2) | 28.4 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment | 24wk PEOT, PEG-IFN alfa-2b (n=79,77,53,7,2,0) | 21.5 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment | 24Wk PEOT, PEG-IFN alfa-2a (n=468,323,240,60,6,2) | 11.5 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment | 24wk PEOT, PEG-IFN alfa-2b (n=79,77,53,7,2,0) | 7.8 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment | 24Wk PEOT, PEG-IFN alfa-2a (n=468,323,240,60,6,2) | 13.8 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment | 24wk PEOT, PEG-IFN alfa-2b (n=79,77,53,7,2,0) | 11.3 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment | 24Wk PEOT, PEG-IFN alfa-2a (n=468,323,240,60,6,2) | 31.7 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment | 24wk PEOT, PEG-IFN alfa-2b (n=79,77,53,7,2,0) | 28.6 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment | 24Wk PEOT, PEG-IFN alfa-2a (n=468,323,240,60,6,2) | 33.3 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment | 24wk PEOT, PEG-IFN alfa-2b (n=79,77,53,7,2,0) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment | 24Wk PEOT, PEG-IFN alfa-2a (n=468,323,240,60,6,2) | 0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment | 24wk PEOT, PEG-IFN alfa-2b (n=79,77,53,7,2,0) | 0 percentage of participants |
Secondary
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
Virological response (VR) was defined as HCV RNA \<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment
Time frame: At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT
Population: The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 15.9 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 25.6 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=182,104, 4,14,2,2) | 40.7 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT,PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 49.2 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 53.8 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 71.5 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 3.8 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 4.1 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12,PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 42.3 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 58.7 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 6.7 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 21.7 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 80.4 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 75.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 91.8 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12,PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 91.3 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 91.3 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 90.4 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT,PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 80.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=182,104, 4,14,2,2) | 81.7 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 67.6 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 89.2 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 9.9 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 91.5 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 70.8 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 6.8 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12,PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 87.8 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT,PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 70.8 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=182,104, 4,14,2,2) | 70.3 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 91.8 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 66.7 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 57.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 7.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=182,104, 4,14,2,2) | 35.7 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT,PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 46.5 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 2.6 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12,PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 66.7 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 42.9 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 36.8 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 88.9 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 88.9 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12,PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 0.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=182,104, 4,14,2,2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT,PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 55.6 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 44.4 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12,PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=182,104, 4,14,2,2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | EOT, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | 12wk PEOT,PEG-IFN alfa-2a (n=778,414,353,114,9,2) | 100.0 percentage of participants |
Secondary
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
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
Time frame: At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT
Population: The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 15.2 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 26.4 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=158, 87, 68,14,2,2) | 39.9 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT,PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 50.3 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 52.5 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2a (n=704,361,299,102, 7, 2) | 72.9 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 3.2 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 4.0 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 42.4 percentage of participants |
| Genotype 1 (G1) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 59.9 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 8.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 23.3 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 82.5 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 75.9 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 93.1 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 92.0 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2a (n=704,361,299,102, 7, 2) | 92.2 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 89.7 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT,PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 81.4 percentage of participants |
| Genotype 2 (G2) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=158, 87, 68,14,2,2) | 80.5 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 64.7 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 89.7 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 10.4 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 92.3 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 71.2 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 7.4 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 86.8 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT,PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 71.2 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=158, 87, 68,14,2,2) | 70.6 percentage of participants |
| Genotype 3 (G3) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2a (n=704,361,299,102, 7, 2) | 92.3 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2a (n=704,361,299,102, 7, 2) | 65.7 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 57.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 7.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=158, 87, 68,14,2,2) | 35.7 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT,PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 44.1 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 2.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 68.6 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 42.9 percentage of participants |
| Genotype 4 (G4) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 38.2 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2a (n=704,361,299,102, 7, 2) | 85.7 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 85.7 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 0.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 100.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=158, 87, 68,14,2,2) | 50.0 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT,PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 57.1 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 28.6 percentage of participants |
| Genotype 5/6 (G5/6) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT, PEG-IFN alfa-2b (n=158, 87, 68,14,2,2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2a (n=704,361,299,102, 7, 2) | 100.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2) | 50.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | EOT, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 0.0 percentage of participants |
| Unknown Genotype (UNK) | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | 12wk PEOT,PEG-IFN alfa-2a (n=704,361,299,102,7,2) | 100.0 percentage of participants |