Hepatitis C, Chronic
Conditions
Brief summary
This open-label, multicenter, treatment response guided study will evaluate the sustained virological response and safety of the triple combination therapy boceprevir, Pegasys (peginterferon alfa-2a) and Copegus (Ribavirin) in previously untreated patients with genotype 1 chronic hepatitis C. In the lead-in phase, patients will receive a dual combination therapy of Pegasys and Copegus for 4 weeks. In the following triple combination therapy phase, 800 mg boceprevir, 180 mcg Pegasys and 1000-1200 mg Copegus will be administered for 24, 32 or 44 weeks; the duration depending on the patient's treatment response. The anticipated time on study treatment is up to 48 weeks.
Interventions
DRUGboceprevir
800 mg three times daily for 24, 32 or 44 weeks
DRUGpeginterferon alfa-2a [Pegasys]
180 mcg subcutaneously once a week for 24, 32 or 44 weeks
DRUGribavirin (Copegus]
1000 mg or 1200 mg orally once a day for 24, 32 or 44 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients \>/=18 years of age * Chronic liver disease consistent with chronic hepatitis C, genotype 1 infection * Serum HCV RNA quantifiable at screening * Patients who have not been previously treated with pegylated interferon (IFN), standard IFN, RBV or any direct acting anti-viral agent * Compensated liver disease (Child-Pugh Grade A clinical classification for patients with cirrhosis: total score \</=6) * Negative urine or blood pregnancy test (for women of childbearing potential)
Exclusion criteria
* Women with ongoing pregnancy or breast feeding * Male partners of women who are pregnant * Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment \</=6 months prior to the first dose of study drug * Any investigational drug \</=6 weeks prior to the first dose of study drug * History or other evidence of decompensated liver disease * History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C * Signs or symptoms of hepatocellular carcinoma * Co-infection with HCV genotypes other than genotype 1 * Co-infection with hepatitis A, hepatitis B, and/or human immunodeficiency virus (HIV) * Any patient with an increased risk for anemia * History of severe psychiatric disease * History of immunologically mediated, chronic pulmonary, or severe cardiac disease * Current diseases that are not adequately controlled
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT) | At 12 weeks after EOT (up to 60 weeks) | SVR at 12 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 12 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower limit of detection (LOD) of 10 to 15 international units per milliliter (IU/mL). The percentage of participants with SVR was calculated as \[number of participants with undetectable HCV RNA at 12 weeks after EOT divided by the number of participants analyzed\] multiplied by 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HCV RNA Levels | At Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; EOT; and 12 and 24 weeks after EOT (up to 72 weeks) | HCV RNA levels were obtained routinely during and after treatment. Mean HCV RNA levels were calculated by averaging the HCV RNA levels among all participants analyzed at each collection timepoint and expressed in log10 IU/mL. |
| Percentage of Participants With Virological Response | At Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT (up to 48 weeks) | HCV RNA levels were obtained routinely during and after treatment. The percentage of participants with undetectable HCV RNA viral load (ie, virological response) was calculated as \[number of participants with undetectable HCV RNA at each timepoint divided by the number of participants analyzed\] multiplied by 100. |
| Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | At Weeks 2, 4, 6, 8, 12, 16, 24, and 28 | HCV RNA levels were obtained routinely during and after treatment. Reductions in HCV RNA viral load by 1-log, 2-log, or 3-log increments were determined relative to Baseline HCV RNA. Each increment represents a reduction greater than or equal to (≥) the specified log value, including results for which HCV RNA was below the limit of quantification (25 IU/mL). The percentage of participants with each log reduction in HCV RNA was calculated as \[number of participants with log reduction divided by the number of participants analyzed\] multiplied by 100. |
| Percentage of Participants With Virological Relapse Following EOT Response | Up to 72 weeks (at 12 and 24 weeks after EOT) | Virological relapse was defined as a detectable post-treatment HCV RNA viral load following a previously undetectable EOT level (ie, virological response). The percentage of participants with virological relapse was calculated as \[number of participants meeting the above criteria divided by the number of participants analyzed\] multiplied by 100. |
| Percentage of Participants With Virological Breakthrough Following On-Treatment Response | Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT) | Virological breakthrough was defined as an HCV RNA viral load greater than (\>) 1000 IU/mL following a previously undetectable level at any time during treatment (ie, virological response). Participants who ultimately achieved an EOT response were not considered for virological breakthrough. The percentage of participants with virological breakthrough was calculated as \[number of participants meeting the above criteria divided by the number of participants analyzed\] multiplied by 100. |
| Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA | Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT) | Virological rebound was defined as an HCV RNA viral load \>1000 IU/mL and a ≥1-log increase from nadir following a decline in HCV RNA from Baseline at any time during treatment (ie, on-treatment decline). Participants who ultimately achieved an EOT response were not considered for virological rebound. The percentage of participants with virological rebound was calculated as \[number of participants meeting the above criteria divided by the number of participants analyzed\] multiplied by 100. |
| Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA | At 12 and 24 weeks | Treatment was to be discontinued for participants who met prespecified criteria, termed the futility rule, after 12 or 24 weeks of treatment. Participants were discontinued from treatment for one of the following reasons: HCV RNA viral load ≥100 IU/mL (Week 12) or a detectable HCV RNA viral load (Week 24). HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with treatment discontinued for each reason was calculated as \[number of participants meeting one of the above criteria divided by the number of participants analyzed\] multiplied by 100. |
| Percentage of Participants With SVR at 24 Weeks After EOT | At 24 weeks after EOT (up to 72 weeks) | SVR at 24 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 24 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with SVR was calculated as \[number of participants with undetectable HCV RNA at 24 weeks after EOT divided by the number of participants analyzed\] multiplied by 100. |
| Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Up to 48 weeks (from Baseline until EOT) | Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Adverse event (AE)-related reasons were documented, as well as reasons related to insufficient efficacy ('Poor efficacy') or other safety-related reasons ('Safety/other'). The percentage of participants with a dose modification documented for each reason was calculated as \[number of participants with dose modification divided by the number of participants analyzed\] multiplied by 100. |
| Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Up to 48 weeks (from Baseline until EOT) | The frequency of missed treatments was examined using the number of administrations received as a percentage of target administrations for each study drug. The maximum number of possible administrations was considered in terms of once-weekly injections with PEG-IFN and in terms of treatment days with RBV and boceprevir. The percentage of target administrations each participant received was separated into ranges of \<60%, 60 to \<80%, 80 to \<95%, and ≥95% for each study drug. The percentage of participants who received each range of target administrations was calculated as \[number of participants in each range divided by the number of participants analyzed\] multiplied by 100. |
| Number of Participants With a Safety-Related Dose Modification | Up to 48 weeks (from Baseline until EOT) | Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. The percentage of participants with a safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was calculated as \[number of participants with dose modification divided by the number of participants analyzed\] multiplied by 100. |
| Time to Safety-Related Dose Modification | Up to 48 weeks (from Baseline until EOT) | Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Median time to safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was estimated using Kaplan-Meier and expressed in weeks. |
| Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up | Up to 72 weeks (from Baseline until 24 weeks after EOT) | Use of concomitant hematopoietic stimulants (such as epoetin) during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant hematopoietic stimulants was calculated as \[number of participants reporting concomitant use divided by the number of participants analyzed\] multiplied by 100. |
| Percentage of Participants With a Concomitant Disease Prior to or During the Study | Up to 76 weeks (from Screening until 24 weeks after EOT) | The prevalence of concomitant disease at any time from Screening through the end of follow-up was documented. The percentage of participants with a concomitant disease was calculated as \[number of participants reporting or diagnosed with concomitant disease divided by the number of participants analyzed\] multiplied by 100. Diseases documented for ≥5% of participants included hypertension, diabetes mellitus, hypothyroidism, and vitamin D deficiency as reported here. |
| Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up | Up to 72 weeks (from Baseline until 24 weeks after EOT) | Use of concomitant prescription or nonprescription medications during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant medications was calculated as \[number of participants reporting concomitant use divided by the number of participants analyzed\] multiplied by 100. Medication classes reported by \>10% of participants included analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, corticosteroids, proton pump inhibitors, vitamins and minerals, and beta-adrenoceptor blocking agents as reported here. |
| Duration of Treatment With PEG-IFN, RBV, and Boceprevir | Up to 48 weeks (from Baseline until EOT) | The duration of treatment with each study drug was determined as the time from treatment start until the last dose of PEG-IFN, RBV, or boceprevir. Median duration of treatment was determined using the actual duration of treatment among individual participants and expressed in weeks. |
Countries
Austria, Germany, Hungary, Poland, Romania, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Population Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. | 165 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event or Intercurrent Illness | 5 |
| Overall Study | Futility Rule (Week 12) | 7 |
| Overall Study | Futility Rule (Week 24) | 3 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Noncompliance | 1 |
| Overall Study | Participant Refusal | 3 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Rebound or Breakthrough | 3 |
| Overall Study | Treatment Discontinued by Error | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Total Population |
|---|---|
| Age, Continuous | 45.8 years STANDARD_DEVIATION 12.53 |
| Gender Female | 83 Participants |
| Gender Male | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 21 | 135 / 144 |
| serious Total, serious adverse events | 7 / 21 | 8 / 144 |
Outcome results
Primary
Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT)
SVR at 12 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 12 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower limit of detection (LOD) of 10 to 15 international units per milliliter (IU/mL). The percentage of participants with SVR was calculated as \[number of participants with undetectable HCV RNA at 12 weeks after EOT divided by the number of participants analyzed\] multiplied by 100.
Time frame: At 12 weeks after EOT (up to 60 weeks)
Population: All-Treated Population. Arms were not mutually exclusive.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Population | Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT) | 81 percentage of participants |
| Cirrhotics | Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT) | 70 percentage of participants |
| Poor Responders | Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT) | 75 percentage of participants |
| Late Responders | Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT) | 88 percentage of participants |
| Early Responders | Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT) | 95 percentage of participants |
| Others | Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT) | 32 percentage of participants |
Secondary
Duration of Treatment With PEG-IFN, RBV, and Boceprevir
The duration of treatment with each study drug was determined as the time from treatment start until the last dose of PEG-IFN, RBV, or boceprevir. Median duration of treatment was determined using the actual duration of treatment among individual participants and expressed in weeks.
Time frame: Up to 48 weeks (from Baseline until EOT)
Population: Safety Population: All participants who received at least one dose of study medication and had at least one post-baseline safety assessment; n = number of participants who received the respective study medication. Arms were not mutually exclusive.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Total Population | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | RBV (n=165,20,24,24,78,19) | 28.0 weeks |
| Total Population | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | PEG-IFN (n=165,20,24,24,78,19) | 28.0 weeks |
| Total Population | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | Boceprevir (n=164,20,24,24,78,18) | 24.0 weeks |
| Cirrhotics | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | RBV (n=165,20,24,24,78,19) | 48.0 weeks |
| Cirrhotics | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | PEG-IFN (n=165,20,24,24,78,19) | 48.0 weeks |
| Cirrhotics | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | Boceprevir (n=164,20,24,24,78,18) | 44.0 weeks |
| Poor Responders | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | RBV (n=165,20,24,24,78,19) | 48.0 weeks |
| Poor Responders | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | PEG-IFN (n=165,20,24,24,78,19) | 48.0 weeks |
| Poor Responders | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | Boceprevir (n=164,20,24,24,78,18) | 44.0 weeks |
| Late Responders | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | RBV (n=165,20,24,24,78,19) | 48.0 weeks |
| Late Responders | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | PEG-IFN (n=165,20,24,24,78,19) | 48.0 weeks |
| Late Responders | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | Boceprevir (n=164,20,24,24,78,18) | 32.0 weeks |
| Early Responders | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | RBV (n=165,20,24,24,78,19) | 28.0 weeks |
| Early Responders | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | PEG-IFN (n=165,20,24,24,78,19) | 28.0 weeks |
| Early Responders | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | Boceprevir (n=164,20,24,24,78,18) | 24.0 weeks |
| Others | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | PEG-IFN (n=165,20,24,24,78,19) | 26.0 weeks |
| Others | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | Boceprevir (n=164,20,24,24,78,18) | 10.0 weeks |
| Others | Duration of Treatment With PEG-IFN, RBV, and Boceprevir | RBV (n=165,20,24,24,78,19) | 27.0 weeks |
Secondary
HCV RNA Levels
HCV RNA levels were obtained routinely during and after treatment. Mean HCV RNA levels were calculated by averaging the HCV RNA levels among all participants analyzed at each collection timepoint and expressed in log10 IU/mL.
Time frame: At Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; EOT; and 12 and 24 weeks after EOT (up to 72 weeks)
Population: All-Treated Population; number (n) = number of participants who provided evaluable data at the respective visit. Arms were not mutually exclusive.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Population | HCV RNA Levels | Baseline (n=165,20,24,24,78,19) | 6.29 log10 IU/mL | Standard Deviation 0.722 |
| Total Population | HCV RNA Levels | Week 2 (n=159,18,24,23,76,18) | 4.86 log10 IU/mL | Standard Deviation 1.418 |
| Total Population | HCV RNA Levels | Week 4 (n=158,20,24,22,75,17) | 4.06 log10 IU/mL | Standard Deviation 1.525 |
| Total Population | HCV RNA Levels | Week 6 (n=151,18,24,21,73,15) | 1.75 log10 IU/mL | Standard Deviation 0.882 |
| Total Population | HCV RNA Levels | Week 8 (n=160,20,24,24,77,15) | 1.47 log10 IU/mL | Standard Deviation 0.638 |
| Total Population | HCV RNA Levels | Week 12 (n=160,20,24,24,77,15) | 1.35 log10 IU/mL | Standard Deviation 0.682 |
| Total Population | HCV RNA Levels | Week 16 (n=156,19,22,24,78,13) | 1.25 log10 IU/mL | Standard Deviation 0.405 |
| Total Population | HCV RNA Levels | Week 24 (n=152,17,23,24,78,10) | 1.41 log10 IU/mL | Standard Deviation 1.042 |
| Total Population | HCV RNA Levels | Week 28 (n=143,15,19,23,76,10) | 1.23 log10 IU/mL | Standard Deviation 0.48 |
| Total Population | HCV RNA Levels | Week 36 (n=71,16,21,24,3,7) | 1.69 log10 IU/mL | Standard Deviation 1.563 |
| Total Population | HCV RNA Levels | EOT (n=162,20,24,23,78,17) | 1.52 log10 IU/mL | Standard Deviation 1.12 |
| Total Population | HCV RNA Levels | 12 weeks after EOT (n=152,19,24,23,74,12) | 1.92 log10 IU/mL | Standard Deviation 1.792 |
| Total Population | HCV RNA Levels | 24 weeks after EOT (n=159,20,23,24,78,14) | 2.00 log10 IU/mL | Standard Deviation 1.874 |
| Cirrhotics | HCV RNA Levels | Week 4 (n=158,20,24,22,75,17) | 4.30 log10 IU/mL | Standard Deviation 1.533 |
| Cirrhotics | HCV RNA Levels | 24 weeks after EOT (n=159,20,23,24,78,14) | 2.66 log10 IU/mL | Standard Deviation 2.351 |
| Cirrhotics | HCV RNA Levels | Baseline (n=165,20,24,24,78,19) | 6.34 log10 IU/mL | Standard Deviation 0.71 |
| Cirrhotics | HCV RNA Levels | Week 24 (n=152,17,23,24,78,10) | 1.80 log10 IU/mL | Standard Deviation 1.753 |
| Cirrhotics | HCV RNA Levels | EOT (n=162,20,24,23,78,17) | 1.58 log10 IU/mL | Standard Deviation 1.167 |
| Cirrhotics | HCV RNA Levels | Week 12 (n=160,20,24,24,77,15) | 1.41 log10 IU/mL | Standard Deviation 0.393 |
| Cirrhotics | HCV RNA Levels | Week 2 (n=159,18,24,23,76,18) | 5.06 log10 IU/mL | Standard Deviation 1.288 |
| Cirrhotics | HCV RNA Levels | Week 28 (n=143,15,19,23,76,10) | 1.18 log10 IU/mL | Standard Deviation 0 |
| Cirrhotics | HCV RNA Levels | 12 weeks after EOT (n=152,19,24,23,74,12) | 2.53 log10 IU/mL | Standard Deviation 2.34 |
| Cirrhotics | HCV RNA Levels | Week 36 (n=71,16,21,24,3,7) | 1.54 log10 IU/mL | Standard Deviation 1.412 |
| Cirrhotics | HCV RNA Levels | Week 8 (n=160,20,24,24,77,15) | 1.69 log10 IU/mL | Standard Deviation 0.65 |
| Cirrhotics | HCV RNA Levels | Week 16 (n=156,19,22,24,78,13) | 1.34 log10 IU/mL | Standard Deviation 0.459 |
| Cirrhotics | HCV RNA Levels | Week 6 (n=151,18,24,21,73,15) | 2.01 log10 IU/mL | Standard Deviation 1.002 |
| Poor Responders | HCV RNA Levels | Week 16 (n=156,19,22,24,78,13) | 1.46 log10 IU/mL | Standard Deviation 0.906 |
| Poor Responders | HCV RNA Levels | Week 28 (n=143,15,19,23,76,10) | 1.45 log10 IU/mL | Standard Deviation 1.173 |
| Poor Responders | HCV RNA Levels | Week 24 (n=152,17,23,24,78,10) | 1.83 log10 IU/mL | Standard Deviation 1.696 |
| Poor Responders | HCV RNA Levels | Week 6 (n=151,18,24,21,73,15) | 2.70 log10 IU/mL | Standard Deviation 0.972 |
| Poor Responders | HCV RNA Levels | Week 4 (n=158,20,24,22,75,17) | 5.78 log10 IU/mL | Standard Deviation 0.55 |
| Poor Responders | HCV RNA Levels | Baseline (n=165,20,24,24,78,19) | 6.40 log10 IU/mL | Standard Deviation 0.592 |
| Poor Responders | HCV RNA Levels | Week 8 (n=160,20,24,24,77,15) | 1.95 log10 IU/mL | Standard Deviation 0.874 |
| Poor Responders | HCV RNA Levels | Week 2 (n=159,18,24,23,76,18) | 6.07 log10 IU/mL | Standard Deviation 0.61 |
| Poor Responders | HCV RNA Levels | EOT (n=162,20,24,23,78,17) | 1.87 log10 IU/mL | Standard Deviation 1.563 |
| Poor Responders | HCV RNA Levels | Week 12 (n=160,20,24,24,77,15) | 1.69 log10 IU/mL | Standard Deviation 1.316 |
| Poor Responders | HCV RNA Levels | 12 weeks after EOT (n=152,19,24,23,74,12) | 2.48 log10 IU/mL | Standard Deviation 2.345 |
| Poor Responders | HCV RNA Levels | Week 36 (n=71,16,21,24,3,7) | 2.00 log10 IU/mL | Standard Deviation 2.069 |
| Poor Responders | HCV RNA Levels | 24 weeks after EOT (n=159,20,23,24,78,14) | 2.39 log10 IU/mL | Standard Deviation 2.327 |
| Late Responders | HCV RNA Levels | Week 24 (n=152,17,23,24,78,10) | 1.18 log10 IU/mL | Standard Deviation 0 |
| Late Responders | HCV RNA Levels | Week 4 (n=158,20,24,22,75,17) | 4.60 log10 IU/mL | Standard Deviation 0.874 |
| Late Responders | HCV RNA Levels | Week 6 (n=151,18,24,21,73,15) | 1.91 log10 IU/mL | Standard Deviation 0.57 |
| Late Responders | HCV RNA Levels | 12 weeks after EOT (n=152,19,24,23,74,12) | 1.48 log10 IU/mL | Standard Deviation 1.087 |
| Late Responders | HCV RNA Levels | Week 8 (n=160,20,24,24,77,15) | 1.52 log10 IU/mL | Standard Deviation 0.329 |
| Late Responders | HCV RNA Levels | Week 12 (n=160,20,24,24,77,15) | 1.25 log10 IU/mL | Standard Deviation 0.107 |
| Late Responders | HCV RNA Levels | Week 16 (n=156,19,22,24,78,13) | 1.19 log10 IU/mL | Standard Deviation 0.045 |
| Late Responders | HCV RNA Levels | Week 28 (n=143,15,19,23,76,10) | 1.18 log10 IU/mL | Standard Deviation 0 |
| Late Responders | HCV RNA Levels | Week 36 (n=71,16,21,24,3,7) | 1.33 log10 IU/mL | Standard Deviation 0.745 |
| Late Responders | HCV RNA Levels | 24 weeks after EOT (n=159,20,23,24,78,14) | 1.77 log10 IU/mL | Standard Deviation 1.605 |
| Late Responders | HCV RNA Levels | EOT (n=162,20,24,23,78,17) | 1.38 log10 IU/mL | Standard Deviation 0.996 |
| Late Responders | HCV RNA Levels | Baseline (n=165,20,24,24,78,19) | 6.46 log10 IU/mL | Standard Deviation 0.53 |
| Late Responders | HCV RNA Levels | Week 2 (n=159,18,24,23,76,18) | 5.38 log10 IU/mL | Standard Deviation 0.767 |
| Early Responders | HCV RNA Levels | Week 28 (n=143,15,19,23,76,10) | 1.18 log10 IU/mL | Standard Deviation 0.025 |
| Early Responders | HCV RNA Levels | Week 12 (n=160,20,24,24,77,15) | 1.18 log10 IU/mL | Standard Deviation 0 |
| Early Responders | HCV RNA Levels | Week 36 (n=71,16,21,24,3,7) | 2.60 log10 IU/mL | Standard Deviation 2.466 |
| Early Responders | HCV RNA Levels | Week 4 (n=158,20,24,22,75,17) | 3.25 log10 IU/mL | Standard Deviation 1.289 |
| Early Responders | HCV RNA Levels | 12 weeks after EOT (n=152,19,24,23,74,12) | 1.40 log10 IU/mL | Standard Deviation 0.946 |
| Early Responders | HCV RNA Levels | Week 2 (n=159,18,24,23,76,18) | 4.27 log10 IU/mL | Standard Deviation 1.441 |
| Early Responders | HCV RNA Levels | EOT (n=162,20,24,23,78,17) | 1.18 log10 IU/mL | Standard Deviation 0.025 |
| Early Responders | HCV RNA Levels | Week 8 (n=160,20,24,24,77,15) | 1.18 log10 IU/mL | Standard Deviation 0 |
| Early Responders | HCV RNA Levels | Baseline (n=165,20,24,24,78,19) | 6.18 log10 IU/mL | Standard Deviation 0.796 |
| Early Responders | HCV RNA Levels | 24 weeks after EOT (n=159,20,23,24,78,14) | 1.42 log10 IU/mL | Standard Deviation 1.053 |
| Early Responders | HCV RNA Levels | Week 24 (n=152,17,23,24,78,10) | 1.18 log10 IU/mL | Standard Deviation 0 |
| Early Responders | HCV RNA Levels | Week 16 (n=156,19,22,24,78,13) | 1.18 log10 IU/mL | Standard Deviation 0 |
| Early Responders | HCV RNA Levels | Week 6 (n=151,18,24,21,73,15) | 1.25 log10 IU/mL | Standard Deviation 0.154 |
| Others | HCV RNA Levels | EOT (n=162,20,24,23,78,17) | 2.73 log10 IU/mL | Standard Deviation 1.943 |
| Others | HCV RNA Levels | Week 28 (n=143,15,19,23,76,10) | 1.48 log10 IU/mL | Standard Deviation 0.822 |
| Others | HCV RNA Levels | 12 weeks after EOT (n=152,19,24,23,74,12) | 3.83 log10 IU/mL | Standard Deviation 2.789 |
| Others | HCV RNA Levels | Week 12 (n=160,20,24,24,77,15) | 1.74 log10 IU/mL | Standard Deviation 1.292 |
| Others | HCV RNA Levels | Week 16 (n=156,19,22,24,78,13) | 1.32 log10 IU/mL | Standard Deviation 0.458 |
| Others | HCV RNA Levels | Week 4 (n=158,20,24,22,75,17) | 4.24 log10 IU/mL | Standard Deviation 1.689 |
| Others | HCV RNA Levels | Week 6 (n=151,18,24,21,73,15) | 2.18 log10 IU/mL | Standard Deviation 1.337 |
| Others | HCV RNA Levels | Week 36 (n=71,16,21,24,3,7) | 1.91 log10 IU/mL | Standard Deviation 1.93 |
| Others | HCV RNA Levels | Week 2 (n=159,18,24,23,76,18) | 4.90 log10 IU/mL | Standard Deviation 1.597 |
| Others | HCV RNA Levels | Week 24 (n=152,17,23,24,78,10) | 2.21 log10 IU/mL | Standard Deviation 1.916 |
| Others | HCV RNA Levels | Week 8 (n=160,20,24,24,77,15) | 1.84 log10 IU/mL | Standard Deviation 1.236 |
| Others | HCV RNA Levels | Baseline (n=165,20,24,24,78,19) | 6.34 log10 IU/mL | Standard Deviation 0.762 |
| Others | HCV RNA Levels | 24 weeks after EOT (n=159,20,23,24,78,14) | 4.05 log10 IU/mL | Standard Deviation 2.592 |
Secondary
Number of Participants With a Safety-Related Dose Modification
Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. The percentage of participants with a safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was calculated as \[number of participants with dose modification divided by the number of participants analyzed\] multiplied by 100.
Time frame: Up to 48 weeks (from Baseline until EOT)
Population: Safety Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Population | Number of Participants With a Safety-Related Dose Modification | 113 participants |
Secondary
Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir
The frequency of missed treatments was examined using the number of administrations received as a percentage of target administrations for each study drug. The maximum number of possible administrations was considered in terms of once-weekly injections with PEG-IFN and in terms of treatment days with RBV and boceprevir. The percentage of target administrations each participant received was separated into ranges of \<60%, 60 to \<80%, 80 to \<95%, and ≥95% for each study drug. The percentage of participants who received each range of target administrations was calculated as \[number of participants in each range divided by the number of participants analyzed\] multiplied by 100.
Time frame: Up to 48 weeks (from Baseline until EOT)
Population: Safety Population; only participants providing evaluable data were included in the analysis. Arms were not mutually exclusive.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Population | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, 95% or more | 86 percentage of participants |
| Total Population | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, 80 to <95% | 3 percentage of participants |
| Total Population | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, 60 to <80% | 0.7 percentage of participants |
| Total Population | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, <60% | 10 percentage of participants |
| Total Population | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, 60 to <80% | 0.7 percentage of participants |
| Total Population | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, <60% | 8 percentage of participants |
| Total Population | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, <60% | 9 percentage of participants |
| Total Population | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, 80 to <95% | 5 percentage of participants |
| Total Population | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, 95% or more | 86 percentage of participants |
| Total Population | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, 80 to <95% | 5 percentage of participants |
| Total Population | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, 60 to <80% | 0.7 percentage of participants |
| Total Population | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, 95% or more | 86 percentage of participants |
| Cirrhotics | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, <60% | 25 percentage of participants |
| Cirrhotics | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, <60% | 25 percentage of participants |
| Cirrhotics | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, 80 to <95% | 10 percentage of participants |
| Cirrhotics | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, 60 to <80% | 0 percentage of participants |
| Cirrhotics | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, 60 to <80% | 5 percentage of participants |
| Cirrhotics | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, <60% | 30 percentage of participants |
| Cirrhotics | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, 95% or more | 60 percentage of participants |
| Cirrhotics | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, 60 to <80% | 0 percentage of participants |
| Cirrhotics | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, 95% or more | 65 percentage of participants |
| Cirrhotics | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, 80 to <95% | 5 percentage of participants |
| Cirrhotics | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, 95% or more | 70 percentage of participants |
| Cirrhotics | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, 80 to <95% | 5 percentage of participants |
| Poor Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, 60 to <80% | 0 percentage of participants |
| Poor Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, 95% or more | 75 percentage of participants |
| Poor Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, 80 to <95% | 0 percentage of participants |
| Poor Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, 60 to <80% | 0 percentage of participants |
| Poor Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, 95% or more | 75 percentage of participants |
| Poor Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, 80 to <95% | 0 percentage of participants |
| Poor Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, 80 to <95% | 0 percentage of participants |
| Poor Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, <60% | 25 percentage of participants |
| Poor Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, <60% | 25 percentage of participants |
| Poor Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, 95% or more | 75 percentage of participants |
| Poor Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, 60 to <80% | 0 percentage of participants |
| Poor Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, <60% | 25 percentage of participants |
| Late Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, <60% | 8 percentage of participants |
| Late Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, 60 to <80% | 0 percentage of participants |
| Late Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, 80 to <95% | 4 percentage of participants |
| Late Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, 95% or more | 88 percentage of participants |
| Late Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, 80 to <95% | 17 percentage of participants |
| Late Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, <60% | 0 percentage of participants |
| Late Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, 60 to <80% | 4 percentage of participants |
| Late Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, 95% or more | 79 percentage of participants |
| Late Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, <60% | 4 percentage of participants |
| Late Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, 60 to <80% | 4 percentage of participants |
| Late Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, 80 to <95% | 8 percentage of participants |
| Late Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, 95% or more | 83 percentage of participants |
| Early Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, 95% or more | 96 percentage of participants |
| Early Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, 60 to <80% | 0 percentage of participants |
| Early Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, 80 to <95% | 4 percentage of participants |
| Early Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, 80 to <95% | 4 percentage of participants |
| Early Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, 60 to <80% | 0 percentage of participants |
| Early Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | PEG-IFN, <60% | 0 percentage of participants |
| Early Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, <60% | 1 percentage of participants |
| Early Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, 95% or more | 95 percentage of participants |
| Early Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, 95% or more | 96 percentage of participants |
| Early Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | Boceprevir, 80 to <95% | 3 percentage of participants |
| Early Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, 60 to <80% | 0 percentage of participants |
| Early Responders | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir | RBV, <60% | 1 percentage of participants |
Secondary
Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up
Use of concomitant hematopoietic stimulants (such as epoetin) during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant hematopoietic stimulants was calculated as \[number of participants reporting concomitant use divided by the number of participants analyzed\] multiplied by 100.
Time frame: Up to 72 weeks (from Baseline until 24 weeks after EOT)
Population: Safety Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Population | Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up | 6 percentage of participants |
Secondary
Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up
Use of concomitant prescription or nonprescription medications during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant medications was calculated as \[number of participants reporting concomitant use divided by the number of participants analyzed\] multiplied by 100. Medication classes reported by \>10% of participants included analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, corticosteroids, proton pump inhibitors, vitamins and minerals, and beta-adrenoceptor blocking agents as reported here.
Time frame: Up to 72 weeks (from Baseline until 24 weeks after EOT)
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Population | Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up | Any medication | 79 percentage of participants |
| Total Population | Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up | Analgesics | 29 percentage of participants |
| Total Population | Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up | NSAIDs | 22 percentage of participants |
| Total Population | Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up | Antihistamines | 19 percentage of participants |
| Total Population | Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up | Corticosteroids | 19 percentage of participants |
| Total Population | Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up | Proton pump inhibitors | 17 percentage of participants |
| Total Population | Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up | Vitamins and minerals | 12 percentage of participants |
| Total Population | Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up | Beta-adrenoceptor blocking agents | 11 percentage of participants |
Secondary
Percentage of Participants With a Concomitant Disease Prior to or During the Study
The prevalence of concomitant disease at any time from Screening through the end of follow-up was documented. The percentage of participants with a concomitant disease was calculated as \[number of participants reporting or diagnosed with concomitant disease divided by the number of participants analyzed\] multiplied by 100. Diseases documented for ≥5% of participants included hypertension, diabetes mellitus, hypothyroidism, and vitamin D deficiency as reported here.
Time frame: Up to 76 weeks (from Screening until 24 weeks after EOT)
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Population | Percentage of Participants With a Concomitant Disease Prior to or During the Study | Any disease | 53 percentage of participants |
| Total Population | Percentage of Participants With a Concomitant Disease Prior to or During the Study | Hypertension | 18 percentage of participants |
| Total Population | Percentage of Participants With a Concomitant Disease Prior to or During the Study | Diabetes mellitus | 8 percentage of participants |
| Total Population | Percentage of Participants With a Concomitant Disease Prior to or During the Study | Hypothyroidism | 6 percentage of participants |
| Total Population | Percentage of Participants With a Concomitant Disease Prior to or During the Study | Vitamin D deficiency | 5 percentage of participants |
Secondary
Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason
Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Adverse event (AE)-related reasons were documented, as well as reasons related to insufficient efficacy ('Poor efficacy') or other safety-related reasons ('Safety/other'). The percentage of participants with a dose modification documented for each reason was calculated as \[number of participants with dose modification divided by the number of participants analyzed\] multiplied by 100.
Time frame: Up to 48 weeks (from Baseline until EOT)
Population: Safety Population; n = number of participants who received the respective study medication. Arms were not mutually exclusive.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Any reason (n=165,20,24,24,78,19) | 64 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Safety/other (n=164,20,24,24,78,18) | 4 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Not specified (n=165,20,24,24,78,19) | 12 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Rash (n=165,20,24,24,78,19) | 0.6 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Safety/other (n=165,20,24,24,78,19) | 8 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Nausea/vomiting (n=164,20,24,24,78,18) | 1 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Nausea/vomiting (n=165,20,24,24,78,19) | 0.6 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Not specified (n=165,20,24,24,78,19) | 11 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Rash (n=164,20,24,24,78,18) | 1 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Thrombocytopenia (n=165,20,24,24,78,19) | 5 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Not specified (n=164,20,24,24,78,18) | 12 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Poor efficacy (n=165,20,24,24,78,19) | 8 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Any reason (n=165,20,24,24,78,19) | 52 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Neutropenia (n=164,20,24,24,78,18) | 4 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Anemia (n=165,20,24,24,78,19) | 46 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Safety/other (n=165,20,24,24,78,19) | 4 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Rash (n=165,20,24,24,78,19) | 1 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Poor efficacy (n=165,20,24,24,78,19) | 8 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Nausea/vomiting (n=165,20,24,24,78,19) | 1 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Asthenia (n=165,20,24,24,78,19) | 1 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Anemia (n=165,20,24,24,78,19) | 1 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Asthenia (n=164,20,24,24,78,18) | 0.6 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Asthenia (n=165,20,24,24,78,19) | 0.6 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Poor efficacy (n=164,20,24,24,78,18) | 7 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Neutropenia (n=165,20,24,24,78,19) | 3 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Any reason (n=164,20,24,24,78,18) | 28 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Neutropenia (n=165,20,24,24,78,19) | 36 percentage of participants |
| Total Population | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Anemia (n=164,20,24,24,78,18) | 2 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Not specified (n=164,20,24,24,78,18) | 10 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Neutropenia (n=165,20,24,24,78,19) | 0 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Not specified (n=165,20,24,24,78,19) | 0 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Rash (n=165,20,24,24,78,19) | 5 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Any reason (n=165,20,24,24,78,19) | 60 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Safety/other (n=165,20,24,24,78,19) | 15 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Poor efficacy (n=165,20,24,24,78,19) | 15 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Poor efficacy (n=164,20,24,24,78,18) | 15 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Asthenia (n=165,20,24,24,78,19) | 0 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Nausea/vomiting (n=165,20,24,24,78,19) | 0 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Safety/other (n=164,20,24,24,78,18) | 10 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Neutropenia (n=165,20,24,24,78,19) | 30 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Rash (n=165,20,24,24,78,19) | 5 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Rash (n=164,20,24,24,78,18) | 5 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Thrombocytopenia (n=165,20,24,24,78,19) | 35 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Neutropenia (n=164,20,24,24,78,18) | 0 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Safety/other (n=165,20,24,24,78,19) | 10 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Poor efficacy (n=165,20,24,24,78,19) | 15 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Nausea/vomiting (n=164,20,24,24,78,18) | 0 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Not specified (n=165,20,24,24,78,19) | 0 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Asthenia (n=164,20,24,24,78,18) | 0 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Any reason (n=165,20,24,24,78,19) | 65 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Anemia (n=165,20,24,24,78,19) | 50 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Anemia (n=164,20,24,24,78,18) | 10 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Asthenia (n=165,20,24,24,78,19) | 0 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Any reason (n=164,20,24,24,78,18) | 45 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Nausea/vomiting (n=165,20,24,24,78,19) | 0 percentage of participants |
| Cirrhotics | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Anemia (n=165,20,24,24,78,19) | 0 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Rash (n=165,20,24,24,78,19) | 0 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Not specified (n=165,20,24,24,78,19) | 8 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Asthenia (n=164,20,24,24,78,18) | 0 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Any reason (n=164,20,24,24,78,18) | 29 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Neutropenia (n=165,20,24,24,78,19) | 38 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Not specified (n=165,20,24,24,78,19) | 8 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Any reason (n=165,20,24,24,78,19) | 67 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Safety/other (n=164,20,24,24,78,18) | 0 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Asthenia (n=165,20,24,24,78,19) | 4 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Anemia (n=164,20,24,24,78,18) | 0 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Poor efficacy (n=164,20,24,24,78,18) | 21 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Anemia (n=165,20,24,24,78,19) | 0 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Anemia (n=165,20,24,24,78,19) | 46 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Safety/other (n=165,20,24,24,78,19) | 8 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Neutropenia (n=165,20,24,24,78,19) | 0 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Poor efficacy (n=165,20,24,24,78,19) | 21 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Not specified (n=164,20,24,24,78,18) | 8 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Safety/other (n=165,20,24,24,78,19) | 4 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Any reason (n=165,20,24,24,78,19) | 54 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Neutropenia (n=164,20,24,24,78,18) | 0 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Nausea/vomiting (n=164,20,24,24,78,18) | 0 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Thrombocytopenia (n=165,20,24,24,78,19) | 4 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Nausea/vomiting (n=165,20,24,24,78,19) | 0 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Poor efficacy (n=165,20,24,24,78,19) | 21 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Nausea/vomiting (n=165,20,24,24,78,19) | 0 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Asthenia (n=165,20,24,24,78,19) | 0 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Rash (n=165,20,24,24,78,19) | 0 percentage of participants |
| Poor Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Rash (n=164,20,24,24,78,18) | 0 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Poor efficacy (n=165,20,24,24,78,19) | 4 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Nausea/vomiting (n=165,20,24,24,78,19) | 0 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Neutropenia (n=165,20,24,24,78,19) | 33 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Not specified (n=165,20,24,24,78,19) | 13 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Any reason (n=165,20,24,24,78,19) | 46 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Anemia (n=165,20,24,24,78,19) | 0 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Asthenia (n=165,20,24,24,78,19) | 4 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Rash (n=165,20,24,24,78,19) | 0 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Thrombocytopenia (n=165,20,24,24,78,19) | 0 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Safety/other (n=165,20,24,24,78,19) | 13 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Poor efficacy (n=165,20,24,24,78,19) | 4 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Any reason (n=165,20,24,24,78,19) | 46 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Anemia (n=165,20,24,24,78,19) | 38 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Asthenia (n=165,20,24,24,78,19) | 0 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Nausea/vomiting (n=165,20,24,24,78,19) | 0 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Neutropenia (n=165,20,24,24,78,19) | 4 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Rash (n=165,20,24,24,78,19) | 0 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Safety/other (n=165,20,24,24,78,19) | 13 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Not specified (n=165,20,24,24,78,19) | 8 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Any reason (n=164,20,24,24,78,18) | 21 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Anemia (n=164,20,24,24,78,18) | 4 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Asthenia (n=164,20,24,24,78,18) | 0 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Nausea/vomiting (n=164,20,24,24,78,18) | 0 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Neutropenia (n=164,20,24,24,78,18) | 4 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Rash (n=164,20,24,24,78,18) | 0 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Safety/other (n=164,20,24,24,78,18) | 4 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Poor efficacy (n=164,20,24,24,78,18) | 0 percentage of participants |
| Late Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Not specified (n=164,20,24,24,78,18) | 8 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Not specified (n=165,20,24,24,78,19) | 8 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Nausea/vomiting (n=165,20,24,24,78,19) | 0 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Asthenia (n=165,20,24,24,78,19) | 1 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Not specified (n=164,20,24,24,78,18) | 10 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Any reason (n=164,20,24,24,78,18) | 12 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Anemia (n=165,20,24,24,78,19) | 53 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Poor efficacy (n=164,20,24,24,78,18) | 0 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Anemia (n=164,20,24,24,78,18) | 0 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Any reason (n=165,20,24,24,78,19) | 62 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Not specified (n=165,20,24,24,78,19) | 8 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Asthenia (n=164,20,24,24,78,18) | 1 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Poor efficacy (n=165,20,24,24,78,19) | 0 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Nausea/vomiting (n=164,20,24,24,78,18) | 0 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Safety/other (n=165,20,24,24,78,19) | 0 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Thrombocytopenia (n=165,20,24,24,78,19) | 1 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Any reason (n=165,20,24,24,78,19) | 42 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Neutropenia (n=164,20,24,24,78,18) | 0 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Rash (n=165,20,24,24,78,19) | 0 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Nausea/vomiting (n=165,20,24,24,78,19) | 1 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Rash (n=164,20,24,24,78,18) | 0 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Neutropenia (n=165,20,24,24,78,19) | 36 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Safety/other (n=164,20,24,24,78,18) | 0 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Asthenia (n=165,20,24,24,78,19) | 0 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Safety/other (n=165,20,24,24,78,19) | 3 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Rash (n=165,20,24,24,78,19) | 0 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Poor efficacy (n=165,20,24,24,78,19) | 0 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Neutropenia (n=165,20,24,24,78,19) | 0 percentage of participants |
| Early Responders | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Anemia (n=165,20,24,24,78,19) | 1 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Neutropenia (n=165,20,24,24,78,19) | 21 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Not specified (n=165,20,24,24,78,19) | 42 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Safety/other (n=164,20,24,24,78,18) | 17 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Asthenia (n=165,20,24,24,78,19) | 0 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Nausea/vomiting (n=165,20,24,24,78,19) | 11 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Neutropenia (n=164,20,24,24,78,18) | 28 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Rash (n=165,20,24,24,78,19) | 0 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Any reason (n=164,20,24,24,78,18) | 89 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Anemia (n=165,20,24,24,78,19) | 26 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Anemia (n=165,20,24,24,78,19) | 5 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Any reason (n=165,20,24,24,78,19) | 89 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Neutropenia (n=165,20,24,24,78,19) | 47 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Safety/other (n=165,20,24,24,78,19) | 16 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Anemia (n=164,20,24,24,78,18) | 0 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Poor efficacy (n=165,20,24,24,78,19) | 21 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Not specified (n=165,20,24,24,78,19) | 42 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Rash (n=164,20,24,24,78,18) | 6 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Poor efficacy (n=164,20,24,24,78,18) | 17 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | RBV, Rash (n=165,20,24,24,78,19) | 5 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Asthenia (n=164,20,24,24,78,18) | 0 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Poor efficacy (n=165,20,24,24,78,19) | 21 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Nausea/vomiting (n=165,20,24,24,78,19) | 0 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Safety/other (n=165,20,24,24,78,19) | 0 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Any reason (n=165,20,24,24,78,19) | 84 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Asthenia (n=165,20,24,24,78,19) | 0 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Nausea/vomiting (n=164,20,24,24,78,18) | 11 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | Boceprevir, Not specified (n=164,20,24,24,78,18) | 28 percentage of participants |
| Others | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason | PEG-IFN, Thrombocytopenia (n=165,20,24,24,78,19) | 0 percentage of participants |
Secondary
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA
HCV RNA levels were obtained routinely during and after treatment. Reductions in HCV RNA viral load by 1-log, 2-log, or 3-log increments were determined relative to Baseline HCV RNA. Each increment represents a reduction greater than or equal to (≥) the specified log value, including results for which HCV RNA was below the limit of quantification (25 IU/mL). The percentage of participants with each log reduction in HCV RNA was calculated as \[number of participants with log reduction divided by the number of participants analyzed\] multiplied by 100.
Time frame: At Weeks 2, 4, 6, 8, 12, 16, 24, and 28
Population: All-Treated Population. Arms were not mutually exclusive.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 6 | 98 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 24 | 91 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 2 | 27 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 4 | 29 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 4 | 51 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 12 | 96 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 6 | 95 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 6 | 88 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 8 | 98 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 24 | 90 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 8 | 93 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 4 | 81 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 28 | 88 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 12 | 95 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 16 | 94 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 2 | 12 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 16 | 94 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 16 | 94 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 2 | 55 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 28 | 88 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 24 | 90 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 12 | 95 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 8 | 97 percentage of participants |
| Total Population | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 28 | 88 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 16 | 95 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 16 | 95 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 4 | 20 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 16 | 95 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 2 | 60 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 2 | 20 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 6 | 95 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 8 | 100 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 6 | 85 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 6 | 95 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 12 | 100 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 4 | 50 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 12 | 100 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 4 | 75 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 2 | 5 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 12 | 100 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 28 | 80 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 8 | 100 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 24 | 80 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 24 | 80 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 28 | 80 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 28 | 80 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 24 | 80 percentage of participants |
| Cirrhotics | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 8 | 95 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 4 | 0 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 2 | 0 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 4 | 0 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 8 | 100 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 6 | 100 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 6 | 75 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 8 | 83 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 12 | 88 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 16 | 88 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 24 | 88 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 24 | 83 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 2 | 0 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 28 | 79 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 2 | 0 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 28 | 79 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 16 | 88 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 6 | 96 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 8 | 100 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 12 | 88 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 4 | 0 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 16 | 88 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 24 | 83 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 12 | 96 percentage of participants |
| Poor Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 28 | 79 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 2 | 0 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 28 | 96 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 24 | 100 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 16 | 100 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 2 | 54 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 12 | 100 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 6 | 100 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 24 | 100 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 12 | 100 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 8 | 100 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 4 | 100 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 16 | 100 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 4 | 8 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 12 | 100 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 28 | 96 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 6 | 92 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 4 | 33 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 16 | 100 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 8 | 100 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 6 | 96 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 28 | 96 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 2 | 8 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 24 | 100 percentage of participants |
| Late Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 8 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 24 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 2 | 19 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 4 | 47 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 6 | 97 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 8 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 12 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 16 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 24 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 28 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 2 | 42 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 4 | 76 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 6 | 99 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 8 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 12 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 16 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 28 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 2 | 73 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 4 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 6 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 8 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 12 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 16 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 24 | 100 percentage of participants |
| Early Responders | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 28 | 100 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 28 | 53 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 24 | 53 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 4 | 26 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 16 | 68 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 2 | 16 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 12 | 74 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 12 | 74 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 8 | 74 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 4 | 37 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 2 | 26 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 2-log, Week 6 | 74 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 16 | 68 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 28 | 53 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 24 | 53 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 16 | 68 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 12 | 74 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 28 | 53 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 24 | 58 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 8 | 68 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 6 | 84 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 4 | 84 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 2 | 42 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 3-log, Week 6 | 63 percentage of participants |
| Others | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA | 1-log, Week 8 | 84 percentage of participants |
Secondary
Percentage of Participants With SVR at 24 Weeks After EOT
SVR at 24 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 24 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with SVR was calculated as \[number of participants with undetectable HCV RNA at 24 weeks after EOT divided by the number of participants analyzed\] multiplied by 100.
Time frame: At 24 weeks after EOT (up to 72 weeks)
Population: All-Treated Population. Arms were not mutually exclusive.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Population | Percentage of Participants With SVR at 24 Weeks After EOT | 80 percentage of participants |
| Cirrhotics | Percentage of Participants With SVR at 24 Weeks After EOT | 70 percentage of participants |
| Poor Responders | Percentage of Participants With SVR at 24 Weeks After EOT | 71 percentage of participants |
| Late Responders | Percentage of Participants With SVR at 24 Weeks After EOT | 88 percentage of participants |
| Early Responders | Percentage of Participants With SVR at 24 Weeks After EOT | 95 percentage of participants |
| Others | Percentage of Participants With SVR at 24 Weeks After EOT | 32 percentage of participants |
Secondary
Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA
Treatment was to be discontinued for participants who met prespecified criteria, termed the futility rule, after 12 or 24 weeks of treatment. Participants were discontinued from treatment for one of the following reasons: HCV RNA viral load ≥100 IU/mL (Week 12) or a detectable HCV RNA viral load (Week 24). HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with treatment discontinued for each reason was calculated as \[number of participants meeting one of the above criteria divided by the number of participants analyzed\] multiplied by 100.
Time frame: At 12 and 24 weeks
Population: All-Treated Population. Arms were not mutually exclusive.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Population | Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA | Week 12 | 4 percentage of participants |
| Total Population | Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA | Week 24 | 3 percentage of participants |
| Cirrhotics | Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA | Week 12 | 10 percentage of participants |
| Cirrhotics | Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA | Week 24 | 5 percentage of participants |
| Poor Responders | Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA | Week 12 | 13 percentage of participants |
| Poor Responders | Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA | Week 24 | 8 percentage of participants |
| Late Responders | Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA | Week 12 | 0 percentage of participants |
| Late Responders | Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA | Week 24 | 0 percentage of participants |
| Early Responders | Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA | Week 12 | 0 percentage of participants |
| Early Responders | Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA | Week 24 | 0 percentage of participants |
| Others | Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA | Week 12 | 11 percentage of participants |
| Others | Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA | Week 24 | 11 percentage of participants |
Secondary
Percentage of Participants With Virological Breakthrough Following On-Treatment Response
Virological breakthrough was defined as an HCV RNA viral load greater than (\>) 1000 IU/mL following a previously undetectable level at any time during treatment (ie, virological response). Participants who ultimately achieved an EOT response were not considered for virological breakthrough. The percentage of participants with virological breakthrough was calculated as \[number of participants meeting the above criteria divided by the number of participants analyzed\] multiplied by 100.
Time frame: Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)
Population: All-Treated Population; only participants with a previous on-treatment virological response were included in the analysis. Arms were not mutually exclusive.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Population | Percentage of Participants With Virological Breakthrough Following On-Treatment Response | 3 percentage of participants |
| Cirrhotics | Percentage of Participants With Virological Breakthrough Following On-Treatment Response | 0 percentage of participants |
| Poor Responders | Percentage of Participants With Virological Breakthrough Following On-Treatment Response | 0 percentage of participants |
| Late Responders | Percentage of Participants With Virological Breakthrough Following On-Treatment Response | 4 percentage of participants |
| Early Responders | Percentage of Participants With Virological Breakthrough Following On-Treatment Response | 0 percentage of participants |
| Others | Percentage of Participants With Virological Breakthrough Following On-Treatment Response | 23 percentage of participants |
Secondary
Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA
Virological rebound was defined as an HCV RNA viral load \>1000 IU/mL and a ≥1-log increase from nadir following a decline in HCV RNA from Baseline at any time during treatment (ie, on-treatment decline). Participants who ultimately achieved an EOT response were not considered for virological rebound. The percentage of participants with virological rebound was calculated as \[number of participants meeting the above criteria divided by the number of participants analyzed\] multiplied by 100.
Time frame: Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)
Population: All-Treated Population; only participants with a previous on-treatment decline in HCV RNA were included in the analysis. Arms were not mutually exclusive.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Population | Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA | 6 percentage of participants |
| Cirrhotics | Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA | 5 percentage of participants |
| Poor Responders | Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA | 17 percentage of participants |
| Late Responders | Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA | 4 percentage of participants |
| Early Responders | Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA | 0 percentage of participants |
| Others | Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA | 22 percentage of participants |
Secondary
Percentage of Participants With Virological Relapse Following EOT Response
Virological relapse was defined as a detectable post-treatment HCV RNA viral load following a previously undetectable EOT level (ie, virological response). The percentage of participants with virological relapse was calculated as \[number of participants meeting the above criteria divided by the number of participants analyzed\] multiplied by 100.
Time frame: Up to 72 weeks (at 12 and 24 weeks after EOT)
Population: All-Treated Population; only participants with a previous EOT virological response were included in the analysis. Arms were not mutually exclusive.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Population | Percentage of Participants With Virological Relapse Following EOT Response | 7 percentage of participants |
| Cirrhotics | Percentage of Participants With Virological Relapse Following EOT Response | 13 percentage of participants |
| Poor Responders | Percentage of Participants With Virological Relapse Following EOT Response | 5 percentage of participants |
| Late Responders | Percentage of Participants With Virological Relapse Following EOT Response | 9 percentage of participants |
| Early Responders | Percentage of Participants With Virological Relapse Following EOT Response | 4 percentage of participants |
| Others | Percentage of Participants With Virological Relapse Following EOT Response | 25 percentage of participants |
Secondary
Percentage of Participants With Virological Response
HCV RNA levels were obtained routinely during and after treatment. The percentage of participants with undetectable HCV RNA viral load (ie, virological response) was calculated as \[number of participants with undetectable HCV RNA at each timepoint divided by the number of participants analyzed\] multiplied by 100.
Time frame: At Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT (up to 48 weeks)
Population: All-Treated Population. Arms were not mutually exclusive.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Population | Percentage of Participants With Virological Response | Week 8 | 61 percentage of participants |
| Total Population | Percentage of Participants With Virological Response | Week 6 | 41 percentage of participants |
| Total Population | Percentage of Participants With Virological Response | EOT | 87 percentage of participants |
| Total Population | Percentage of Participants With Virological Response | Week 36 | 83 percentage of participants |
| Total Population | Percentage of Participants With Virological Response | Week 28 | 87 percentage of participants |
| Total Population | Percentage of Participants With Virological Response | Week 24 | 88 percentage of participants |
| Total Population | Percentage of Participants With Virological Response | Week 4 | 7 percentage of participants |
| Total Population | Percentage of Participants With Virological Response | Week 2 | 4 percentage of participants |
| Total Population | Percentage of Participants With Virological Response | Week 16 | 87 percentage of participants |
| Total Population | Percentage of Participants With Virological Response | Week 12 | 82 percentage of participants |
| Cirrhotics | Percentage of Participants With Virological Response | Week 4 | 0 percentage of participants |
| Cirrhotics | Percentage of Participants With Virological Response | Week 2 | 0 percentage of participants |
| Cirrhotics | Percentage of Participants With Virological Response | Week 6 | 35 percentage of participants |
| Cirrhotics | Percentage of Participants With Virological Response | Week 8 | 45 percentage of participants |
| Cirrhotics | Percentage of Participants With Virological Response | Week 12 | 65 percentage of participants |
| Cirrhotics | Percentage of Participants With Virological Response | Week 16 | 70 percentage of participants |
| Cirrhotics | Percentage of Participants With Virological Response | Week 24 | 80 percentage of participants |
| Cirrhotics | Percentage of Participants With Virological Response | Week 28 | 80 percentage of participants |
| Cirrhotics | Percentage of Participants With Virological Response | Week 36 | 75 percentage of participants |
| Cirrhotics | Percentage of Participants With Virological Response | EOT | 80 percentage of participants |
| Poor Responders | Percentage of Participants With Virological Response | Week 8 | 13 percentage of participants |
| Poor Responders | Percentage of Participants With Virological Response | Week 28 | 79 percentage of participants |
| Poor Responders | Percentage of Participants With Virological Response | Week 2 | 0 percentage of participants |
| Poor Responders | Percentage of Participants With Virological Response | Week 12 | 75 percentage of participants |
| Poor Responders | Percentage of Participants With Virological Response | Week 6 | 0 percentage of participants |
| Poor Responders | Percentage of Participants With Virological Response | Week 4 | 0 percentage of participants |
| Poor Responders | Percentage of Participants With Virological Response | Week 16 | 71 percentage of participants |
| Poor Responders | Percentage of Participants With Virological Response | Week 36 | 75 percentage of participants |
| Poor Responders | Percentage of Participants With Virological Response | EOT | 79 percentage of participants |
| Poor Responders | Percentage of Participants With Virological Response | Week 24 | 79 percentage of participants |
| Late Responders | Percentage of Participants With Virological Response | Week 24 | 100 percentage of participants |
| Late Responders | Percentage of Participants With Virological Response | Week 28 | 96 percentage of participants |
| Late Responders | Percentage of Participants With Virological Response | Week 4 | 0 percentage of participants |
| Late Responders | Percentage of Participants With Virological Response | EOT | 96 percentage of participants |
| Late Responders | Percentage of Participants With Virological Response | Week 36 | 96 percentage of participants |
| Late Responders | Percentage of Participants With Virological Response | Week 2 | 0 percentage of participants |
| Late Responders | Percentage of Participants With Virological Response | Week 16 | 96 percentage of participants |
| Late Responders | Percentage of Participants With Virological Response | Week 12 | 67 percentage of participants |
| Late Responders | Percentage of Participants With Virological Response | Week 8 | 0 percentage of participants |
| Late Responders | Percentage of Participants With Virological Response | Week 6 | 4 percentage of participants |
| Early Responders | Percentage of Participants With Virological Response | Week 24 | 100 percentage of participants |
| Early Responders | Percentage of Participants With Virological Response | Week 8 | 100 percentage of participants |
| Early Responders | Percentage of Participants With Virological Response | Week 12 | 100 percentage of participants |
| Early Responders | Percentage of Participants With Virological Response | Week 16 | 100 percentage of participants |
| Early Responders | Percentage of Participants With Virological Response | Week 2 | 6 percentage of participants |
| Early Responders | Percentage of Participants With Virological Response | Week 28 | 99 percentage of participants |
| Early Responders | Percentage of Participants With Virological Response | EOT | 99 percentage of participants |
| Early Responders | Percentage of Participants With Virological Response | Week 36 | 95 percentage of participants |
| Early Responders | Percentage of Participants With Virological Response | Week 6 | 71 percentage of participants |
| Early Responders | Percentage of Participants With Virological Response | Week 4 | 14 percentage of participants |
| Others | Percentage of Participants With Virological Response | Week 16 | 58 percentage of participants |
| Others | Percentage of Participants With Virological Response | EOT | 47 percentage of participants |
| Others | Percentage of Participants With Virological Response | Week 4 | 5 percentage of participants |
| Others | Percentage of Participants With Virological Response | Week 6 | 26 percentage of participants |
| Others | Percentage of Participants With Virological Response | Week 12 | 53 percentage of participants |
| Others | Percentage of Participants With Virological Response | Week 24 | 42 percentage of participants |
| Others | Percentage of Participants With Virological Response | Week 8 | 53 percentage of participants |
| Others | Percentage of Participants With Virological Response | Week 28 | 42 percentage of participants |
| Others | Percentage of Participants With Virological Response | Week 2 | 5 percentage of participants |
| Others | Percentage of Participants With Virological Response | Week 36 | 37 percentage of participants |
Secondary
Time to Safety-Related Dose Modification
Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Median time to safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was estimated using Kaplan-Meier and expressed in weeks.
Time frame: Up to 48 weeks (from Baseline until EOT)
Population: Safety Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total Population | Time to Safety-Related Dose Modification | 12.1 weeks |