Hepatitis C, Chronic
Conditions
Brief summary
The purpose of this open-label, non-randomized, single-arm, multicentre observational study is to investigate the influence of the cumulative dose (total administered dose/ planned dose) of ribavirin on the sustained virologic response (SVR) in participants who have been receiving combination therapy with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus).
Interventions
BIOLOGICALPeginterferon alfa-2a
Participants received pegylated interferon subcutaneous injection in accordance with current guidelines and SPCs.P
DRUGRibavirin
Participants received ribavirin 200 mg film-coated tablet in accordance with current guidelines and SPCs.
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
* Participants with serologically confirmed chronic hepatitis C * Participants using and accepting a double method of contraception
Exclusion criteria
* Participants not approved by the national treatment guideline or the Interferon Committee for combined pegylated interferon-ribavirin treatment * Contraindications in the summary of product characteristics of pegylated interferon alpha-2a and ribavirin * Participants previously treated with pegylated interferon and/or ribavirin * Hepatitis B and Human Immunodeficiency Virus co-infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin | 24 weeks after EOT (maximum up to 96 Weeks) | Determination of hepatitis C virus (HCV) titers was performed using COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C, at Weeks 4, 12 and 24 of the treatment period (and, optionally, at the end of treatment \[EOT\] visit), and at the end of the 24-week follow-up period. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin | Up to EOT (maximum up to 72 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose group is presented. |
| Percentage of Participants With SVR According to Starting Dose of Ribavirin | 24 weeks after EOT (maximum up to 96 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose group is presented. |
| Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin | Up to EOT (maximum up to 72 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each body weight-normalized (measured in milligram per kilogram per day \[mg/kg/day\]) dose group is presented. |
| Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin | 24 weeks after EOT (maximum up to 96 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each body weight-normalized dose group is presented. |
| Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin | Up to EOT (maximum up to 72 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented. |
| Percentage of Participants With SVR According to Dose Reduction of Ribavirin | 24 weeks after EOT (maximum up to 96 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented. |
| Percentage of Participants With Virologic Response | Week 4, 12, 24 and at EOT (maximum up to 72 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. |
| Percentage of Participants With SVR According to IL-28B Polymorphism | 24 weeks after EOT (maximum up to 96 Weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR for each IL-28B allele (CC allele, CT allele, TT allele) is presented. |
| Percentage of Participants With Viral Relapse or Breakthrough | Up to 24 weeks after EOT (maximum up to 96 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough is reported. |
| Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Up to 24 weeks after EOT (maximum up to 96 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with viral relapse or breakthrough in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each cumulative dose group (\<60%, 60-69%, 70-79%, 80-89%, and \>90%) is reported. |
| Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Week 4, 12, 24, at EOT Visit, 24 weeks after EOT (maximum up to 96 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose group (600 mg, 800 mg, 1000 mg, 1200 mg, and 1400 mg) is presented. |
| Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Up to 24 weeks after EOT (maximum up to 96 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each body weight-normalized dose group (\<5mg/kg/day, 5-10 mg/kg/day, 10-15 mg/kg/day, 15-20 mg/kg/day, and \>20 mg/kg/day) is presented. |
| Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin | Up to 24 weeks after EOT (maximum up to 96 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented. |
| Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism | Up to EOT (maximum up to 72 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response for each IL-28B allele (CC allele, CT allele, TT allele) is presented. |
Countries
Hungary
Participant flow
Recruitment details
Out of 697 participants enrolled in the study, only 693 participants provided evaluable data. One participant did not receive peginterferon alfa-2a/ribavirin combination therapy, while 3 participants received combination therapy only for a very short time.
Participants by arm
| Arm | Count |
|---|---|
| Peginterferon Alfa-2a + Ribavirin Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period. | 693 |
| Total | 693 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 40 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 186 |
| Overall Study | Lost to Follow-up | 17 |
| Overall Study | Other | 14 |
| Overall Study | Withdrawal by Subject | 18 |
Baseline characteristics
| Characteristic | Peginterferon Alfa-2a + Ribavirin |
|---|---|
| Age, Continuous | 50.35 years STANDARD_DEVIATION 10.76 |
| Sex: Female, Male Female | 382 Participants |
| Sex: Female, Male Male | 311 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 353 / 697 |
| serious Total, serious adverse events | 52 / 697 |
Outcome results
Primary
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin
Determination of hepatitis C virus (HCV) titers was performed using COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C, at Weeks 4, 12 and 24 of the treatment period (and, optionally, at the end of treatment \[EOT\] visit), and at the end of the 24-week follow-up period. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100.
Time frame: 24 weeks after EOT (maximum up to 96 Weeks)
Population: ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin | Cumulative dose of ribavirin <60% (n=35) | 54.29 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin | Cumulative dose of ribavirin = 60-69% (n=23) | 60.87 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin | Cumulative dose of ribavirin = 70-79% (n=32) | 53.13 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin | Cumulative dose of ribavirin = 80-89% (n=52) | 50.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin | Cumulative dose of ribavirin >90% (n=264) | 68.56 percentage of participants |
Comparison: Cumulative dose of ribavirin \>90%: the relationship between cumulative dose and SVR response in participants in whom the cumulative dose of ribavirin exceeded 90% was analyzed using Chi-square test.p-value: 0.0437Chi-squared
Secondary
Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each body weight-normalized dose group is presented.
Time frame: 24 weeks after EOT (maximum up to 96 weeks)
Population: ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose <5mg/kg/day (n=5) | 0.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose = 5-10 mg/kg/day (n=31) | 54.84 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose = 10-15 mg/kg/day (n=368) | 41.03 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose = 15-20 mg/kg/day (n=239) | 48.54 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose >20mg/kg/day (n=18) | 55.56 percentage of participants |
Comparison: The relationship between the body weight-normalized dose of ribavirin and sustained virological (SVR) response was analyzed using Chi-square test.p-value: 0.0475Chi-squared
Secondary
Percentage of Participants With SVR According to Dose Reduction of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.
Time frame: 24 weeks after EOT (maximum up to 96 weeks)
Population: ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to Dose Reduction of Ribavirin | None (n=280) | 70.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to Dose Reduction of Ribavirin | Not Specified (n =19) | 68.42 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to Dose Reduction of Ribavirin | Within 12 weeks (n = 87) | 57.47 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to Dose Reduction of Ribavirin | After 12 weeks (n = 57) | 63.16 percentage of participants |
Secondary
Percentage of Participants With SVR According to IL-28B Polymorphism
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR for each IL-28B allele (CC allele, CT allele, TT allele) is presented.
Time frame: 24 weeks after EOT (maximum up to 96 Weeks)
Population: ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to IL-28B Polymorphism | CC Allele (n = 25) | 64.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to IL-28B Polymorphism | CT Allele (n = 51) | 39.22 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to IL-28B Polymorphism | TT Allele (n = 18) | 33.33 percentage of participants |
Secondary
Percentage of Participants With SVR According to Starting Dose of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose group is presented.
Time frame: 24 weeks after EOT (maximum up to 96 weeks)
Population: ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to Starting Dose of Ribavirin | Starting dose of ribavirin = 200mg (n=1) | 0.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to Starting Dose of Ribavirin | Starting dose of ribavirin = 400mg (n=1) | 0.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to Starting Dose of Ribavirin | Starting dose of ribavirin = 600mg (n=3) | 66.67 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to Starting Dose of Ribavirin | Starting dose of ribavirin = 800mg (n=33) | 60.61 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to Starting Dose of Ribavirin | Starting dose of ribavirin = 1000mg (n=262) | 43.13 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to Starting Dose of Ribavirin | Starting dose of ribavirin = 1200mg (n=321) | 44.86 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With SVR According to Starting Dose of Ribavirin | Starting dose of ribavirin = 1400mg (n=39) | 38.46 percentage of participants |
Comparison: The relationship between the starting dose ribavirin and sustained virological response (SVR) was analyzed using Chi-square test.p-value: 0.374Chi-squared
Secondary
Percentage of Participants With Viral Relapse or Breakthrough
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough is reported.
Time frame: Up to 24 weeks after EOT (maximum up to 96 weeks)
Population: ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough | None | 66.5 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough | Relapse | 27.3 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough | Breakthrough | 6.0 percentage of participants |
Secondary
Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each body weight-normalized dose group (\<5mg/kg/day, 5-10 mg/kg/day, 10-15 mg/kg/day, 15-20 mg/kg/day, and \>20 mg/kg/day) is presented.
Time frame: Up to 24 weeks after EOT (maximum up to 96 weeks)
Population: ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose <5mg/kg/day: None (n=2) | 0.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose <5mg/kg/day: Relapse (n=2) | 100.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose <5mg/kg/day: Breakthrough (n=2) | 0.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose = 5-10 mg/kg/day: None (n=28) | 60.71 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose = 5-10 mg/kg/day: Relapse (n=28) | 35.71 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose = 5-10mg/kg/day: Breakthrough(n=28) | 3.57 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose = 10-15 mg/kg/day: None (n=249) | 60.64 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose =10-15mg/kg/day:Breakthrough(n=249) | 8.84 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose = 15-20 mg/kg/day: None (n=151) | 76.82 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose = 15-20 mg/kg/day: Relapse (n=151) | 20.53 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose=15-20mg/kg/day: Breakthrough(n=151) | 2.65 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose >20 mg/kg/day: None (n=12) | 83.33 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose >20 mg/kg/day: Breakthrough (n=12) | 0.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose = 10-15 mg/kg/day: Relapse (n=249) | 30.52 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose >20 mg/kg/day: Relapse (n=12) | 16.67 percentage of participants |
Comparison: The relationship between the body weight-normalized dose of ribavirin and relapse rate was analyzed using Chi-square test.p-value: 0.0062Chi-squared
Secondary
Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with viral relapse or breakthrough in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each cumulative dose group (\<60%, 60-69%, 70-79%, 80-89%, and \>90%) is reported.
Time frame: Up to 24 weeks after EOT (maximum up to 96 weeks)
Population: ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Cumulative dose <60%: None (n=33) | 57.58 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Cumulative dose <60%: Relapse (n=33) | 39.39 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Cumulative dose = 60-69%: None (n=21) | 66.67 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Cumulative dose = 60-69%: Relapse (n=21) | 33.33 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Cumulative dose = 60-69%: Breakthrough (n=21) | 0.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Cumulative dose = 70-79%: None (n=32) | 53.13 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Cumulative dose = 70-79%: Relapse (n=32) | 40.63 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Cumulative dose = 70-79%: Breakthrough (n=32) | 6.25 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Cumulative dose = 80-89%: None (n=50) | 52.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Cumulative dose = 80-89%: Relapse (n=50) | 38.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Cumulative dose = 80-89%: Breakthrough (n=50) | 10.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Cumulative dose >90%: None (n=257) | 70.98 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Cumulative dose >90%: Relapse (n=257) | 23.92 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Cumulative dose >90%: Breakthrough (n=257) | 5.10 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Cumulative dose <60%: Breakthrough (n=33) | 3.03 percentage of participants |
Comparison: The relationship between the cumulative dose of ribavirin and relapse rate was analyzed using Chi-square test.p-value: 0.1499Chi-squared
Secondary
Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.
Time frame: Up to 24 weeks after EOT (maximum up to 96 weeks)
Population: ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin | No Dose Reduction: None (n=278) | 70.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin | No Dose Reduction: Relapse (n=278) | 23.57 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin | No Dose Reduction: Breakthrough (n=278) | 6.43 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin | Within 12 weeks: None (n=87) | 57.47 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin | Within 12 weeks: Relapse (n=87) | 35.63 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin | Within 12 weeks: Breakthrough (n=87) | 6.90 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin | After 12 weeks: None (n=57) | 63.16 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin | After 12 weeks: Relapse (n=57) | 33.33 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin | Not specified: None (n=19) | 68.42 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin | Not specified: Relapse (n=19) | 26.32 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin | Not specified: Breakthrough (n=19) | 5.26 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin | After 12 weeks: Breakthrough (n=57) | 3.51 percentage of participants |
Secondary
Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose group (600 mg, 800 mg, 1000 mg, 1200 mg, and 1400 mg) is presented.
Time frame: Week 4, 12, 24, at EOT Visit, 24 weeks after EOT (maximum up to 96 weeks)
Population: ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Starting dose = 600mg: None (n=2) | 100.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Starting dose = 600mg: Relapse (n=2) | 0.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Starting dose = 600mg: Breakthrough (n=2) | 0.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Starting dose = 800mg: None (n=25) | 80.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Starting dose = 800mg: Relapse (n=25) | 8.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Starting dose = 800mg: Breakthrough (n=25) | 12.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Starting dose = 1000mg: Relapse (n=171) | 29.82 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Starting dose = 1000mg: Breakthrough (n=171) | 4.09 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Starting dose = 1200mg: Relapse (n=217) | 27.19 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Starting dose = 1200mg: Breakthrough (n=217) | 6.45 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Starting dose = 1400mg: None (n=26) | 57.69 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Starting dose = 1400mg: Relapse (n=26) | 30.77 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Starting dose = 1400mg: Breakthrough (n=26) | 11.54 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Starting dose = 1000mg: None (n=171) | 66.08 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Starting dose = 1200mg: None (n=217) | 66.36 percentage of participants |
Comparison: The relationship between the starting dose of ribavirin and relapse rate was analyzed using Chi-square test.p-value: 0.5885Chi-squared
Secondary
Percentage of Participants With Virologic Response
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response.
Time frame: Week 4, 12, 24 and at EOT (maximum up to 72 weeks)
Population: ITT Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response | Week 4 | 18.7 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response | Week 12 | 32.7 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response | Week 24 | 14.8 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response | EOT | 1.8 percentage of participants |
Secondary
Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each body weight-normalized (measured in milligram per kilogram per day \[mg/kg/day\]) dose group is presented.
Time frame: Up to EOT (maximum up to 72 weeks)
Population: ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose <5mg/kg/day (n=5) | 40.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose = 5-10 mg/kg/day (n=33) | 90.91 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose = 10-15 mg/kg/day (n=383) | 68.93 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose = 15-20 mg/kg/day (n=251) | 64.94 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin | Ribavirin dose >20mg/kg/day (n=19) | 68.42 percentage of participants |
Comparison: The relationship between the body weight-normalized dose of ribavirin and virological response was analyzed using Chi-square test.p-value: 0.0263Chi-squared, Corrected
Secondary
Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.
Time frame: Up to EOT (maximum up to 72 weeks)
Population: ITT Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin | None (n=443) | 67.49 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin | Within 12 weeks (n = 140) | 65.71 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin | After 12 weeks (n = 78) | 79.49 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin | Not Specified (n =32) | 62.50 percentage of participants |
Secondary
Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response for each IL-28B allele (CC allele, CT allele, TT allele) is presented.
Time frame: Up to EOT (maximum up to 72 weeks)
Population: ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism | CC Allele (n = 26) | 84.62 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism | CT Allele (n = 52) | 65.38 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism | TT Allele (n = 19) | 73.68 percentage of participants |
Secondary
Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose group is presented.
Time frame: Up to EOT (maximum up to 72 weeks)
Population: ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin | Starting dose of ribavirin = 400mg (n=2) | 50.00 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin | Starting dose of ribavirin = 600mg (n=3) | 66.67 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin | Starting dose of ribavirin = 800mg (n=35) | 77.14 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin | Starting dose of ribavirin = 1000mg (n=277) | 67.15 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin | Starting dose of ribavirin = 1200mg (n=332) | 68.67 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin | Starting dose of ribavirin = 1400mg (n=40) | 67.50 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin | Starting dose of ribavirin = 200mg (n=1) | 0.00 percentage of participants |
Comparison: The relationship between the starting dose ribavirin and virological response was analyzed using Chi-square test.p-value: 0.6859Chi-squared