| Primary | Percentage of Participants With Sustained Virologic Response (SVR) | SVR was defined as having un-detectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 International Units per milliliter [IU/mL]). Participants with detectable HCV RNA or without measurement at the end of the 24 week after completion of study treatment were considered as non-responders. | Intent-to-treat (ITT) analysis population | Posted | | Number | 95% Confidence Interval | percentage of participants | | 24 weeks after completion of study treatment (up to Week 72 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and up to Week 96 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm) | | | | ID | Title | Description |
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| OG000 | Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks | Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. | | OG001 | Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks | Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00023.8(15.0 to 34.6)
- OG00136.5(26.3 to 47.6)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Fisher Exact | | 0.0536 | | Difference in Response Rates | 12.7 | | | 2-Sided | 95 | -0.01 | 26.6 | | | Exact 95% confidence interval was from the binomial distribution for response rate. | No | Superiority or Other | | |
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| Secondary | Percentage of Participants With Undetectable HCV RNA | HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Data for this outcome measure was to be reported up to end of treatment visit (Week 48 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm). | ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and "n" = participants who were evaluable for this outcome at specified time-point; for each arm, respectively. | Posted | | Number | 95% Confidence Interval | percentage of participants | | For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Weeks 4, 12, 24, and 48; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Weeks 4, 12, 24, 48, and 72 | | | | ID | Title | Description |
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| OG000 | Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks | Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. | | OG001 | Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks | Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. |
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| Secondary | Percentage of Participants With Undetectable HCV RNA 12 Weeks After the Last Dose of Peg-IFN-Alpha-2A | HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Participants with detectable HCV RNA or without measurement at the end of 12 weeks after the last dose of Peg-IFN-Alpha-2A were considered as non-responders. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | 12 weeks after the last dose of Peg-IFN-Alpha-2A (up to Week 60 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and up to Week 84 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm) | | | | ID | Title | Description |
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| OG000 | Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks | Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. | | OG001 | Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks | Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. |
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| Secondary | Percentage of Participants Without SVR Among Participants With Undetectable HCV RNA at the End of Treatment | SVR was defined as having undetectable HCV RNA levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Percentage of participants without SVR among participants with undetectable HCV RNA at the end of treatment was reported (end of treatment = Week 48 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and Week 72 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm). | ITT analysis population. Here, number of participants analyzed signifies participants with undetectable HCV RNA at the end of treatment. | Posted | | Number | | percentage of participants | | 24 weeks after completion of study treatment (up to Week 72 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and up to Week 96 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm) | | | | ID | Title | Description |
|---|
| OG000 | Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks | Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. | | OG001 | Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks | |
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| Secondary | Serum Human Immunodeficiency Virus (HIV) RNA Levels | HIV RNA levels were measured using Roche AMPLICOR MONITOR HIV-1 Test (limit of detection: 400 HIV-1 RNA copies/mL). Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm). | ITT analysis population. Here, number of participants analyzed = participants with detectable HIV RNA levels and "n" = participants with detectable HIV RNA levels at specified time-point; for each arm, respectively. | Posted | | Mean | Standard Deviation | Log10 copies per milliliter | | For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Weeks 4, 12, 24, 48, 72, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks | Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. | | OG001 | Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks | Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. |
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| Secondary | Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96 | Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm). | ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and "n" = participants who were evaluable at specified time-point; for each arm, respectively. | Posted | | Mean | Standard Deviation | Cells per cubic millimeter (cells/mm^3) | | For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks | Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. | | OG001 | Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks | Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. |
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| Secondary | Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96 | Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm). | ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and "n" = participants who were evaluable at specified time-point; for each arm, respectively. | Posted | | Mean | Standard Deviation | Ratio | | For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96 | | | | ID | Title | Description |
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| OG000 | Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks | Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. | | OG001 | Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks | Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. |
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| Secondary | Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories | ALT levels were classified as: Normal Limit (NL) (as per laboratory standard), >1-2 Upper Normal Limit (ULN), >2-5 ULN, >5-10 ULN, and >10 ULN. Percentage of participants in each of these ALT level categories was reported. Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm). | Safety analysis population: all randomized participants who receive >/=1 dose of any study medication and had >/=1 post-baseline safety assessment. Number of participants analyzed= overall participants who were evaluable for this outcome at any time-point and "n" = participants who were evaluable at specified time-point; for each arm, respectively. | Posted | | Number | | percentage of participants | | For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Weeks 4, 12, 24, 48, 72, and 96 | | | | ID | Title | Description |
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| OG000 | Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks | Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. | | OG001 |
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