Hepatitis C, Chronic
Conditions
Brief summary
This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day (according to body weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day + pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Interventions
DRUGpeginterferon alfa-2a [Pegasys]
180 micrograms subcutaneous weekly for 48 weeks
1000-1600 mg day orally for 48 weeks.
DRUGPioglitazone
30 mg daily for 8 weeks increasing to 45 mg daily for 64 weeks.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 hepatitis C, genotype 1; * insulin resistance.
Exclusion criteria
* other forms of liver disease; * cirrhosis; * previous treatment for chronic hepatitis C; * insulin treatment during prior 2 weeks; * type 1 diabetes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Initiation of Pegasys Plus Copegus in log10 Hepatitis C Virus Ribonucleic Acid (HCV RNA) Viral Load to Week 12 of Anti-HCV Therapy | Initiation of Pegasys plus Copegus, Week 12 of anti-HCV treatment | Serum samples were collected for HCV RNA. The change from initiation of Pegasys plus Copegus to Week 12 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Virologic Response | Weeks 4, 12, 24, 48, 60, 72 | Virologic response was defined as undetectable HCV RNA \< 28 IU/mL. Patients with missing HCV RNA values are considered as non-responders. |
| Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72 | Initiation of Pegasys plus Copegus, Weeks 4, 12, 24, 48, 60, 72 | Serum samples were collected for HCV RNA. The percentage of participants with a ≥ 2 log10 decrease in HCV RNA from initiation of Pegasys plus Copegus to time point was calculated. |
| Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment) | Week 72 | Virologic relapse was defined as the reappearance of HCV-RNA in serum after PEG-INF alpha 2a therapy is discontinued in a patient who was HCV-RNA undetectable at the completion of anti-HCV therapy. |
| Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks | Up to 48 Weeks | Virological breakthrough is a detectable HCV RNA at any time during anti-HCV treatment up to Week 48 after the attainment of undetectable HCV RNA. |
| Percentage of Nonresponders During the 48 Week Anti-HCV Treatment Period | Up to 48 Weeks | Nonresponders are defined as patients who did not achieve undetectable HCV RNA during anti-HCV treatment |
| Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only | Randomization (Week-16),Weeks -12, -8, -4 and 0 | Serum HCV RNA was collected at randomization and during the pioglitazone run-in period at various time points for the with pioglitazone arm only. The change from randomization to each of these time points was calculated. |
| Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72 | Blood was collected for plasma fasting glucose levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated. |
| Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72 | Blood was collected for fasting insulin levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated. |
| Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72 | Blood was collected for a fasting Hemoglobin A1C level at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated. |
| Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72 | Insulin resistance (IR) is calculated using the following formula: HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. Baseline for with pioglitazone arm occurred prior to the start of 16 week run-in period and for without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the start of anti-HCV therapy is calculated. A normal patient can have a HOMA score up to 3. A patient with a score of \>3 is definitely IR. Patients scoring 2-3 can be IR but other factors may be causing this without being IR. |
| Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy | Initiation of Pegasys Plus Copegus, Week 24 and Week 48 of anti-HCV therapy | Serum samples were collected for HCV RNA. The change from Initiation of Pegasys Plus Copegus to Week 24 and Week 48 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment. |
| Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72 | Blood was collected and assayed for fasting serum cholesterol levels at various time points throughout the study and was used as an indicator of lipid control. Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated. |
| Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72 | Blood was collected and assayed for fasting serum low-density lipoprotein (LDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control. Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated. |
| Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72 | Blood was collected and assayed for fasting high-density lipoprotein (HDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control. Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated. |
| Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72 | Blood was collected for tumor necrosis factor alpha at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated. |
| Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72 | Blood was collected for Transforming Growth Factor beta at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated. |
| Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72 | Blood was collected for adiponectin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated. |
| Change From Baseline in Leptin Levels at Each Time Point Assessed | Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72 | Blood was collected for leptin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated. |
| Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72 | Blood was collected for free fatty acids at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated. |
| Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72 | The BDI-FS consisted of seven areas with four statements (labeled 0, 1, 2, and 3) offered to describe the area of interest, with 0 indicating no effect and 3 indicating the worst effect. The individual area scores were summed to provide a total score. The degree of depression was assessed with 0 to 3 indicating minimal depression, 4 to 8 mild depression, 9 to 12 moderate depression and 13 to 21 severe depression. |
| Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60, 72 | Blood was collected and assayed for fasting serum triglyceride levels at various time points throughout the study and was used as an indicator of lipid control. Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated. |
Countries
Puerto Rico, United States
Participant flow
Pre-assignment details
Patients randomized to the pioglitazone arm participated in a 16-week pioglitazone run-in (Week -16 to Week 0) prior to beginning anti-HCV therapy: PEG-INF alpha-2a \[Pegasys\] plus ribavarin \[Copegus\]. Patients randomized to the without pioglitazone arm started anti-HCV therapy immediately.
Participants by arm
| Arm | Count |
|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period. | 77 |
| PEG-INF Alpha-2a + Ribavirin Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period. | 73 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 10 | 5 |
| Overall Study | Failure to Return | 4 | 6 |
| Overall Study | Insufficient response | 14 | 15 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Refused Treatment | 9 | 7 |
| Overall Study | Violation of Selection Criteria at Entry | 5 | 1 |
Baseline characteristics
| Characteristic | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin | Total |
|---|---|---|---|
| Age, Customized <=40 years | 6 participants | 8 participants | 14 participants |
| Age, Customized >40 years | 71 participants | 65 participants | 136 participants |
| Sex: Female, Male Female | 27 Participants | 28 Participants | 55 Participants |
| Sex: Female, Male Male | 50 Participants | 45 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 68 / 77 | 75 / 75 |
| serious Total, serious adverse events | 10 / 77 | 9 / 75 |
Outcome results
Primary
Change From Initiation of Pegasys Plus Copegus in log10 Hepatitis C Virus Ribonucleic Acid (HCV RNA) Viral Load to Week 12 of Anti-HCV Therapy
Serum samples were collected for HCV RNA. The change from initiation of Pegasys plus Copegus to Week 12 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.
Time frame: Initiation of Pegasys plus Copegus, Week 12 of anti-HCV treatment
Population: Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Last Observation Carried Forward (LOCF) was used to replace missing data after dropout with the last observed data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Initiation of Pegasys Plus Copegus in log10 Hepatitis C Virus Ribonucleic Acid (HCV RNA) Viral Load to Week 12 of Anti-HCV Therapy | -3.5 IU/mL | Standard Error 0.22 |
| PEG-INF Alpha-2a + Ribavirin | Change From Initiation of Pegasys Plus Copegus in log10 Hepatitis C Virus Ribonucleic Acid (HCV RNA) Viral Load to Week 12 of Anti-HCV Therapy | -3.7 IU/mL | Standard Error 0.19 |
Secondary
Change From Baseline in Adiponectin Levels at Each Time Point Assessed
Blood was collected for adiponectin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Time frame: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 32 (n=2, 2) | 13.0 μg/mL | Standard Error 4 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 4 (n=56, 39) | 13.0 μg/mL | Standard Error 1.15 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 8 (n=5, 23) | 12.2 μg/mL | Standard Error 5.11 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 12 (n=49, 45) | 10.7 μg/mL | Standard Error 1.17 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 16 (n=5, 4) | 9.0 μg/mL | Standard Error 2.3 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 20 (n=2, 3) | 3.0 μg/mL | Standard Error 2 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 24 (n=41, 55) | 12.5 μg/mL | Standard Error 1.27 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 28 (n=11, 11) | 4.4 μg/mL | Standard Error 2.18 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 36 (n=0, 2) | NA μg/mL | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 40 (n=7, 1) | 2.9 μg/mL | Standard Error 1.61 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 44 (n=3, 0) | 3.7 μg/mL | Standard Error 1.67 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 48 (n=31, 44) | 10.8 μg/mL | Standard Error 1.7 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 60 (n=1, 2) | -1.0 μg/mL | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 72 (n=29, 36) | 8.2 μg/mL | Standard Error 2.07 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 44 (n=3, 0) | NA μg/mL | — |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 32 (n=2, 2) | 1.5 μg/mL | Standard Error 0.5 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 28 (n=11, 11) | -1.0 μg/mL | Standard Error 1.39 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 4 (n=56, 39) | 1.6 μg/mL | Standard Error 0.8 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 60 (n=1, 2) | 3.0 μg/mL | Standard Error 1 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 8 (n=5, 23) | -1.1 μg/mL | Standard Error 0.6 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 36 (n=0, 2) | 0.0 μg/mL | Standard Error 1 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 12 (n=49, 45) | 0.3 μg/mL | Standard Error 0.59 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 48 (n=31, 44) | 0.3 μg/mL | Standard Error 0.62 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 16 (n=5, 4) | -1.0 μg/mL | Standard Error 0.41 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 40 (n=7, 1) | -4.0 μg/mL | — |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 20 (n=2, 3) | 4.0 μg/mL | Standard Error 0.58 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 72 (n=29, 36) | -0.1 μg/mL | Standard Error 0.38 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Adiponectin Levels at Each Time Point Assessed | Week 24 (n=41, 55) | 0.2 μg/mL | Standard Error 0.57 |
Secondary
Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
Blood was collected for a fasting Hemoglobin A1C level at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Time frame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72
Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 16 (n=5, 4) | -0.8 Percent | Standard Error 0.12 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 32 (n=2, 2) | -1.0 Percent | Standard Error 0.4 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 4 (n=3, 5) | -0.4 Percent | Standard Error 0.35 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 36 (n=0, 2) | NA Percent | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 20 (n=1, 4) | -0.6 Percent | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 40 (n=8, 1) | -0.3 Percent | Standard Error 0.28 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 12 (n=50, 65) | -1.1 Percent | Standard Error 0.1 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 44 (n=7, 0) | -0.7 Percent | Standard Error 0.22 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 24 (n=41, 51) | -1.0 Percent | Standard Error 0.1 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 8 (n=4, 28) | -0.9 Percent | Standard Error 0.13 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 60 (N=1, 2) | -0.2 Percent | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 28 (n=11, 12) | -0.7 Percent | Standard Error 0.2 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 72 (N=29, 38) | -0.1 Percent | Standard Error 0.1 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 48 (N=31, 46) | -0.8 Percent | Standard Error 0.13 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 72 (N=29, 38) | -0.1 Percent | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 4 (n=3, 5) | -0.1 Percent | Standard Error 0.22 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 8 (n=4, 28) | -1.0 Percent | Standard Error 0.18 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 12 (n=50, 65) | -1.5 Percent | Standard Error 0.12 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 16 (n=5, 4) | -1.7 Percent | Standard Error 0.64 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 20 (n=1, 4) | -1.3 Percent | Standard Error 0.3 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 24 (n=41, 51) | -1.5 Percent | Standard Error 0.12 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 28 (n=11, 12) | -1.1 Percent | Standard Error 0.17 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 32 (n=2, 2) | -1.7 Percent | Standard Error 0.8 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 36 (n=0, 2) | -0.5 Percent | Standard Error 0.05 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 40 (n=8, 1) | -1.8 Percent | — |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 44 (n=7, 0) | NA Percent | — |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 48 (N=31, 46) | -1.1 Percent | Standard Error 0.15 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed | Week 60 (N=1, 2) | -0.1 Percent | Standard Error 0.3 |
Secondary
Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
Blood was collected for fasting insulin levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Time frame: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 4 (N=56, 43) | 6.4 pmol/L | Standard Error 20.9 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 8 (N=4, 27) | -40.6 pmol/L | Standard Error 33.1 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 12 (N=52, 65) | -34.4 pmol/L | Standard Error 17.2 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 16 (N=5, 5) | -59.0 pmol/L | Standard Error 49.9 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 20 (N=2, 3) | 132.6 pmol/L | Standard Error 127.8 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 24 (N=42, 60) | -38.4 pmol/L | Standard Error 16.7 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 28 (N=12, 13) | 11.8 pmol/L | Standard Error 44.6 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 32 (N=2, 3) | -47.2 pmol/L | Standard Error 36.8 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 36 (N=0, 2) | NA pmol/L | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 40 (N=8, 2) | 2.0 pmol/L | Standard Error 71 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 44 (N=4, 0) | 370.5 pmol/L | Standard Error 405.6 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 48 (N=32, 46) | -38.0 pmol/L | Standard Error 20.7 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 60 (N=1, 3) | -13.2 pmol/L | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 72 (N=30, 40) | -61.4 pmol/L | Standard Error 17.2 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 44 (N=4, 0) | NA pmol/L | — |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 4 (N=56, 43) | -28.4 pmol/L | Standard Error 30.1 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 32 (N=2, 3) | 41.7 pmol/L | Standard Error 119.5 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 8 (N=4, 27) | 7.3 pmol/L | Standard Error 37.1 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 60 (N=1, 3) | 91.0 pmol/L | Standard Error 66.8 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 12 (N=52, 65) | -36.0 pmol/L | Standard Error 23.8 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 36 (N=0, 2) | 41.0 pmol/L | Standard Error 33.3 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 16 (N=5, 5) | -162.2 pmol/L | Standard Error 198.8 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 48 (N=32, 46) | -14.3 pmol/L | Standard Error 17.2 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 20 (N=2, 3) | 180.1 pmol/L | Standard Error 644.4 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 40 (N=8, 2) | 62.2 pmol/L | Standard Error 76 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 24 (N=42, 60) | -29.1 pmol/L | Standard Error 10.1 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 72 (N=30, 40) | -4.8 pmol/L | Standard Error 26.3 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. | Week 28 (N=12, 13) | -21.2 pmol/L | Standard Error 30.1 |
Secondary
Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
Blood was collected for plasma fasting glucose levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Time frame: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 48 (n=34, 46) | -0.5 mmol/L | Standard Error 0.22 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 32 (n=39, 47) | -0.5 mmol/L | Standard Error 0.19 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 16 (n=53, 61) | -0.8 mmol/L | Standard Error 0.26 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 36 (n=38, 46) | -0.6 mmol/L | Standard Error 0.2 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 8 (n=57, 68) | -0.7 mmol/L | Standard Error 0.25 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 40 (n=44, 50) | -0.4 mmol/L | Standard Error 0.2 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 4 (n=58, 70) | -0.4 mmol/L | Standard Error 0.24 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 44 (n=37, 43) | -0.4 mmol/L | Standard Error 0.33 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 24 (n=47, 61) | -0.5 mmol/L | Standard Error 0.3 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 12 (n=55, 66) | -0.8 mmol/L | Standard Error 0.25 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 60 (n=33, 41) | -0.6 mmol/L | Standard Error 0.23 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 28 (n=51, 62) | -0.4 mmol/L | Standard Error 0.16 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 72 (n=30, 38) | -0.6 mmol/L | Standard Error 0.22 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 20 (n=46, 57) | -0.6 mmol/L | Standard Error 0.19 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 72 (n=30, 38) | -0.1 mmol/L | Standard Error 0.31 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 4 (n=58, 70) | -0.2 mmol/L | Standard Error 0.17 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 8 (n=57, 68) | -0.1 mmol/L | Standard Error 0.33 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 12 (n=55, 66) | -0.6 mmol/L | Standard Error 0.28 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 16 (n=53, 61) | -0.5 mmol/L | Standard Error 0.36 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 20 (n=46, 57) | -0.3 mmol/L | Standard Error 0.19 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 24 (n=47, 61) | -0.3 mmol/L | Standard Error 0.15 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 28 (n=51, 62) | -0.3 mmol/L | Standard Error 0.16 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 32 (n=39, 47) | -0.5 mmol/L | Standard Error 0.23 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 36 (n=38, 46) | -0.4 mmol/L | Standard Error 0.23 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 40 (n=44, 50) | -0.7 mmol/L | Standard Error 0.2 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 44 (n=37, 43) | -0.2 mmol/L | Standard Error 0.25 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 48 (n=34, 46) | -0.1 mmol/L | Standard Error 0.24 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed | Week 60 (n=33, 41) | -0.1 mmol/L | Standard Error 0.34 |
Secondary
Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
Blood was collected for free fatty acids at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Time frame: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 16 (n=5, 3) | -0.0 mmol/L | Standard Error 0.16 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 48 (n=32, 24) | -0.2 mmol/L | Standard Error 0.09 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 24 (n=40, 31) | -0.1 mmol/L | Standard Error 0.09 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 60 (n=1, 0) | 0.1 mmol/L | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 12 (n=52, 32) | -0.0 mmol/L | Standard Error 0.07 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 72 (n=30, 19) | -0.2 mmol/L | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 28 (n=11, 5) | 0.0 mmol/L | Standard Error 0.09 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 4 (n=55, 35) | 0.0 mmol/L | Standard Error 0.09 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 40 (n=8, 1) | 0.2 mmol/L | Standard Error 0.31 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 20 (n=2, 3) | -0.5 mmol/L | Standard Error 0.34 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 32 (n=2, 1) | 0.3 mmol/L | Standard Error 0.12 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 44 (n=4, 0) | -0.0 mmol/L | Standard Error 0.05 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 36 (n=0, 1) | NA mmol/L | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 8 (n=2, 2) | -0.1 mmol/L | Standard Error 0.08 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 36 (n=0, 1) | 0.2 mmol/L | — |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 8 (n=2, 2) | 0.0 mmol/L | Standard Error 0.31 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 12 (n=52, 32) | 0.2 mmol/L | Standard Error 0.12 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 16 (n=5, 3) | -0.1 mmol/L | Standard Error 0.26 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 20 (n=2, 3) | 0.1 mmol/L | Standard Error 0.38 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 24 (n=40, 31) | 0.2 mmol/L | Standard Error 0.05 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 40 (n=8, 1) | -0.3 mmol/L | — |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 44 (n=4, 0) | NA mmol/L | — |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 48 (n=32, 24) | 0.0 mmol/L | Standard Error 0.05 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 60 (n=1, 0) | NA mmol/L | — |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 72 (n=30, 19) | 0.1 mmol/L | Standard Error 0.07 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 4 (n=55, 35) | 0.1 mmol/L | Standard Error 0.05 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 28 (n=11, 5) | 0.1 mmol/L | Standard Error 0.13 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed | Week 32 (n=2, 1) | -0.4 mmol/L | — |
Secondary
Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
Blood was collected and assayed for fasting high-density lipoprotein (HDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control. Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Time frame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72
Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 8 (n=58, 69) | -0.1 mmol/L | Standard Error 0.03 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 36 (n=38, 46) | -0.1 mmol/L | Standard Error 0.04 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 12 (n=56, 68) | -0.1 mmol/L | Standard Error 0.03 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 60 (n=33, 41) | 0.1 mmol/L | Standard Error 0.06 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 16 (n=53, 62) | -0.2 mmol/L | Standard Error 0.03 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 44 (n=37, 43) | -0.1 mmol/L | Standard Error 0.04 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 20 (n=46, 59) | -0.1 mmol/L | Standard Error 0.04 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 72 (n=30, 39) | 0.2 mmol/L | Standard Error 0.07 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 24 (n=47, 61) | -0.2 mmol/L | Standard Error 0.03 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 32 (n=38, 47) | -0.2 mmol/L | Standard Error 0.04 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 4 (n=61, 72) | -0.1 mmol/L | Standard Error 0.04 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 40 (n=45, 49) | -0.1 mmol/L | Standard Error 0.03 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 48 (n=34, 46) | -0.1 mmol/L | Standard Error 0.05 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 28 (n=52, 62) | -0.1 mmol/L | Standard Error 0.03 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 72 (n=30, 39) | 0.1 mmol/L | Standard Error 0.04 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 28 (n=52, 62) | -0.2 mmol/L | Standard Error 0.04 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 36 (n=38, 46) | -0.3 mmol/L | Standard Error 0.05 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 40 (n=45, 49) | -0.3 mmol/L | Standard Error 0.05 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 44 (n=37, 43) | -0.2 mmol/L | Standard Error 0.05 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 48 (n=34, 46) | -0.2 mmol/L | Standard Error 0.05 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 60 (n=33, 41) | -0.1 mmol/L | Standard Error 0.04 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 4 (n=61, 72) | -0.1 mmol/L | Standard Error 0.03 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 8 (n=58, 69) | -0.2 mmol/L | Standard Error 0.03 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 12 (n=56, 68) | -0.2 mmol/L | Standard Error 0.03 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 16 (n=53, 62) | -0.2 mmol/L | Standard Error 0.03 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 20 (n=46, 59) | -0.2 mmol/L | Standard Error 0.04 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 32 (n=38, 47) | -0.3 mmol/L | Standard Error 0.04 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed | Week 24 (n=47, 61) | -0.2 mmol/L | Standard Error 0.04 |
Secondary
Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
Insulin resistance (IR) is calculated using the following formula: HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. Baseline for with pioglitazone arm occurred prior to the start of 16 week run-in period and for without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the start of anti-HCV therapy is calculated. A normal patient can have a HOMA score up to 3. A patient with a score of \>3 is definitely IR. Patients scoring 2-3 can be IR but other factors may be causing this without being IR.
Time frame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72
Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 28 (n=10, 13) | 0.8 HOMA Score | Standard Error 1.95 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 12 (n=51, 63) | -2.0 HOMA Score | Standard Error 0.74 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 32 (n=2, 2) | -1.8 HOMA Score | Standard Error 1.27 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 16 (n=5, 5) | -3.2 HOMA Score | Standard Error 2.28 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 36 (n=0, 2) | NA HOMA Score | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 72 (n=27, 35) | -2.7 HOMA Score | Standard Error 1.01 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 40 (n=6, 2) | 0.2 HOMA Score | Standard Error 4 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 20 (n=2, 3) | 4.0 HOMA Score | Standard Error 4.6 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 44 (n=4, 0) | 30.4 HOMA Score | Standard Error 31.74 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 48 (n=30, 44) | -1.6 HOMA Score | Standard Error 0.98 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 8 (n=3, 25) | -2.3 HOMA Score | Standard Error 1.74 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 60 (n=1, 2) | 0.6 HOMA Score | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 24 (n=42, 60) | -1.8 HOMA Score | Standard Error 0.74 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 4 (n=54, 42) | 0.6 HOMA Score | Standard Error 1.31 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 72 (n=27, 35) | -0.1 HOMA Score | Standard Error 1.39 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 44 (n=4, 0) | NA HOMA Score | — |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 4 (n=54, 42) | -0.8 HOMA Score | Standard Error 1.52 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 8 (n=3, 25) | 0.6 HOMA Score | Standard Error 1.8 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 16 (n=5, 5) | -9.1 HOMA Score | Standard Error 7.96 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 20 (n=2, 3) | 10.5 HOMA Score | Standard Error 32.38 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 24 (n=42, 60) | -1.3 HOMA Score | Standard Error 0.45 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 28 (n=10, 13) | -1.0 HOMA Score | Standard Error 1.36 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 32 (n=2, 2) | 4.2 HOMA Score | Standard Error 6.81 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 36 (n=0, 2) | 2.0 HOMA Score | Standard Error 0.41 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 40 (n=6, 2) | 1.0 HOMA Score | Standard Error 3.91 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 48 (n=30, 44) | -0.3 HOMA Score | Standard Error 0.91 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 60 (n=1, 2) | 5.0 HOMA Score | Standard Error 3.83 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed | Week 12 (n=51, 63) | -2.1 HOMA Score | Standard Error 1.07 |
Secondary
Change From Baseline in Leptin Levels at Each Time Point Assessed
Blood was collected for leptin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Time frame: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 40 (n=7, 1) | -4.8 ng/mL | Standard Error 2.32 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 8 (n=5, 22) | -1.9 ng/mL | Standard Error 1.43 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 44 (n=3, 0) | 6.0 ng/mL | Standard Error 8.7 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 24 (n=42, 54) | -5.8 ng/mL | Standard Error 1.55 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 48 (n=31, 43) | -4.6 ng/mL | Standard Error 1.31 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 16 (n=5, 4) | -6.4 ng/mL | Standard Error 6.67 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 60 (n=1, 2) | 3.4 ng/mL | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 12 (n=48, 44) | -3.1 ng/mL | Standard Error 1.38 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 4 (n=56, 39) | -1.8 ng/mL | Standard Error 1.38 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 28 (n=11, 11) | -3.7 ng/mL | Standard Error 2.05 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 36 (n=0, 2) | NA ng/mL | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 32 (n=2, 2) | -4.5 ng/mL | Standard Error 1.1 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 72 (n=29, 36) | 1.3 ng/mL | Standard Error 2.12 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 20 (n=2, 3) | -2.9 ng/mL | Standard Error 0.7 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 72 (n=29, 36) | 1.4 ng/mL | Standard Error 1.17 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 8 (n=5, 22) | -3.0 ng/mL | Standard Error 0.89 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 12 (n=48, 44) | -3.8 ng/mL | Standard Error 1.01 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 16 (n=5, 4) | -7.9 ng/mL | Standard Error 7.37 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 20 (n=2, 3) | -4.0 ng/mL | Standard Error 1.85 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 24 (n=42, 54) | -5.0 ng/mL | Standard Error 0.84 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 32 (n=2, 2) | -4.9 ng/mL | Standard Error 0.9 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 36 (n=0, 2) | -1.5 ng/mL | Standard Error 1.2 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 40 (n=7, 1) | 11.5 ng/mL | — |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 44 (n=3, 0) | NA ng/mL | — |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 48 (n=31, 43) | -5.5 ng/mL | Standard Error 1.25 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 60 (n=1, 2) | -0.6 ng/mL | Standard Error 1.5 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 28 (n=11, 11) | -4.1 ng/mL | Standard Error 1.93 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Leptin Levels at Each Time Point Assessed | Week 4 (n=56, 39) | -2.4 ng/mL | Standard Error 0.73 |
Secondary
Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
Blood was collected and assayed for fasting serum low-density lipoprotein (LDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control. Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Time frame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72
Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 72 (n=30, 38) | 0.2 mmol/L | Standard Error 0.1 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 4 (n=58, 70) | -0.3 mmol/L | Standard Error 0.07 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 40 (n=44, 49) | -0.3 mmol/L | Standard Error 0.08 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 16 (n=53, 58) | -0.2 mmol/L | Standard Error 0.07 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 24 (n=45, 60) | -0.2 mmol/L | Standard Error 0.08 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 8 (n=57, 66) | -0.2 mmol/L | Standard Error 0.06 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 28 (n=52, 60) | -0.2 mmol/L | Standard Error 0.08 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 44 (n=36, 43) | -0.2 mmol/L | Standard Error 0.08 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 32 (N=38, 44) | -0.40 mmol/L | Standard Error 0.09 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 48 (n=34, 44) | -0.3 mmol/L | Standard Error 0.09 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 36 (n=37, 44) | -0.2 mmol/L | Standard Error 0.08 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 20 (n=46, 56) | -0.2 mmol/L | Standard Error 0.07 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 60 (n=33, 39) | 0.1 mmol/L | Standard Error 0.12 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 12 (n=55, 62) | -0.2 mmol/L | Standard Error 0.07 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 72 (n=30, 38) | 0.0 mmol/L | Standard Error 0.13 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 8 (n=57, 66) | -0.6 mmol/L | Standard Error 0.08 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 16 (n=53, 58) | -0.6 mmol/L | Standard Error 0.1 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 20 (n=46, 56) | -0.6 mmol/L | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 40 (n=44, 49) | -0.7 mmol/L | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 48 (n=34, 44) | -0.7 mmol/L | Standard Error 0.1 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 60 (n=33, 39) | 0.1 mmol/L | Standard Error 0.13 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 12 (n=55, 62) | -0.5 mmol/L | Standard Error 0.1 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 24 (n=45, 60) | -0.6 mmol/L | Standard Error 0.1 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 28 (n=52, 60) | -0.6 mmol/L | Standard Error 0.09 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 32 (N=38, 44) | -0.7 mmol/L | Standard Error 0.12 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 36 (n=37, 44) | -0.7 mmol/L | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 44 (n=36, 43) | -0.7 mmol/L | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed | Week 4 (n=58, 70) | -0.5 mmol/L | Standard Error 0.07 |
Secondary
Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
Blood was collected and assayed for fasting serum triglyceride levels at various time points throughout the study and was used as an indicator of lipid control. Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Time frame: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60, 72
Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 12 (n=56, 68) | 0.2 mmol/L | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 72 (n=30, 39) | -0.1 mmol/L | Standard Error 0.16 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 32 (n=38, 47) | 0.3 mmol/L | Standard Error 0.13 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 16 (n=53, 62) | 0.2 mmol/L | Standard Error 0.08 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 36 (n=38, 46) | 0.1 mmol/L | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 8 (n=58, 69) | 0.2 mmol/L | Standard Error 0.09 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 40 (n=45, 49) | 0.2 mmol/L | Standard Error 0.12 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 20 (n=46, 59) | 0.2 mmol/L | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 44 (n=37, 43) | 0.3 mmol/L | Standard Error 0.23 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 4 (n=61, 72) | 0.5 mmol/L | Standard Error 0.21 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 48 (n=34, 46) | 0.2 mmol/L | Standard Error 0.13 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 24 (n=47, 61) | 0.5 mmol/L | Standard Error 0.26 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 60 (n=33, 41) | -0.2 mmol/L | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 28 (n=52, 62) | 0.2 mmol/L | Standard Error 0.1 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 60 (n=33, 41) | 0.3 mmol/L | Standard Error 0.16 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 72 (n=30, 39) | 0.2 mmol/L | Standard Error 0.12 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 4 (n=61, 72) | 0.4 mmol/L | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 8 (n=58, 69) | 0.5 mmol/L | Standard Error 0.12 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 12 (n=56, 68) | 0.7 mmol/L | Standard Error 0.23 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 16 (n=53, 62) | 0.6 mmol/L | Standard Error 0.2 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 20 (n=46, 59) | 0.6 mmol/L | Standard Error 0.16 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 24 (n=47, 61) | 0.3 mmol/L | Standard Error 0.1 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 28 (n=52, 62) | 0.4 mmol/L | Standard Error 0.14 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 32 (n=38, 47) | 0.5 mmol/L | Standard Error 0.19 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 36 (n=38, 46) | 0.5 mmol/L | Standard Error 0.15 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 40 (n=45, 49) | 0.4 mmol/L | Standard Error 0.13 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 44 (n=37, 43) | 0.3 mmol/L | Standard Error 0.12 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed | Week 48 (n=34, 46) | 0.5 mmol/L | Standard Error 0.18 |
Secondary
Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
Blood was collected and assayed for fasting serum cholesterol levels at various time points throughout the study and was used as an indicator of lipid control. Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Time frame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72
Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 24 (n=47, 61) | -0.2 mmol/L | Standard Error 0.09 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 8 (n=58, 69) | -0.2 mmol/L | Standard Error 0.07 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 28 (n=52, 62) | -0.3 mmol/L | Standard Error 0.08 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 32 (n=38, 47) | -0.4 mmol/L | Standard Error 0.1 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 40 (n=45, 49) | -0.3 mmol/L | Standard Error 0.08 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 12 (n=56, 68) | -0.2 mmol/L | Standard Error 0.07 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 44 (n=37, 43) | -0.2 mmol/L | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 16 (n=53, 62) | -0.3 mmol/L | Standard Error 0.07 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 48 (n=34, 46) | -0.3 mmol/L | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 4 (n=61, 72) | -0.2 mmol/L | Standard Error 0.08 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 60 (n=33, 41) | 0.0 mmol/L | Standard Error 0.15 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 20 (n=46, 59) | -0.3 mmol/L | Standard Error 0.08 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 72 (n=30, 39) | 0.3 mmol/L | Standard Error 0.15 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 36 (n=38, 46) | -0.3 mmol/L | Standard Error 0.1 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 72 (n=30, 39) | 0.2 mmol/L | Standard Error 0.14 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 32 (n=38, 47) | -0.8 mmol/L | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 36 (n=38, 46) | -0.7 mmol/L | Standard Error 0.12 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 4 (n=61, 72) | -0.5 mmol/L | Standard Error 0.07 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 8 (n=58, 69) | -0.6 mmol/L | Standard Error 0.08 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 16 (n=53, 62) | -0.7 mmol/L | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 20 (n=46, 59) | -0.6 mmol/L | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 24 (n=47, 61) | -0.7 mmol/L | Standard Error 0.1 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 28 (n=52, 62) | -0.7 mmol/L | Standard Error 0.1 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 40 (n=45, 49) | -0.8 mmol/L | Standard Error 0.12 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 44 (n=37, 43) | -0.8 mmol/L | Standard Error 0.13 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 48 (n=34, 46) | -0.7 mmol/L | Standard Error 0.11 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 60 (n=33, 41) | 0.1 mmol/L | Standard Error 0.14 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed | Week 12 (n=56, 68) | -0.6 mmol/L | Standard Error 0.09 |
Secondary
Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
Blood was collected for Transforming Growth Factor beta at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Time frame: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 24 (n=42, 57) | -15976 pg/mL | Standard Error 1727 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 20 (n=2, 3) | -10653 pg/mL | Standard Error 1886 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 8 (n=5, 25) | -16224 pg/mL | Standard Error 8318 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 32 (n=2, 2) | -19750 pg/mL | Standard Error 12614 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 28 (n=12, 12) | -4071 pg/mL | Standard Error 2864 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 36 (n=0, 2) | NA pg/mL | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 12 (n=51, 45) | -17666 pg/mL | Standard Error 1655 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 40 (n=7, 1) | -3119 pg/mL | Standard Error 4460 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 60 (n=1, 2) | -14539 pg/mL | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 44 (n=4, 0) | -6415 pg/mL | Standard Error 5890 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 48 (n=32, 44) | -16510 pg/mL | Standard Error 2573 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 16 (n=5, 4) | -6164 pg/mL | Standard Error 8199 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 72 (n=29, 37) | -6403 pg/mL | Standard Error 2504 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 4 (n=56, 41) | -14891 pg/mL | Standard Error 1406 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 72 (n=29, 37) | -1347 pg/mL | Standard Error 2327 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 44 (n=4, 0) | NA pg/mL | — |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 48 (n=32, 44) | -10149 pg/mL | Standard Error 2285 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 4 (n=56, 41) | -7256 pg/mL | Standard Error 1711 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 8 (n=5, 25) | -13955 pg/mL | Standard Error 2190 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 12 (n=51, 45) | -11447 pg/mL | Standard Error 2141 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 20 (n=2, 3) | -11290 pg/mL | Standard Error 10160 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 24 (n=42, 57) | -13875 pg/mL | Standard Error 1619 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 28 (n=12, 12) | -9242 pg/mL | Standard Error 3185 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 32 (n=2, 2) | -18973 pg/mL | Standard Error 5737 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 36 (n=0, 2) | 8724 pg/mL | Standard Error 12181 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 40 (n=7, 1) | 1785 pg/mL | — |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 60 (n=1, 2) | -3612 pg/mL | Standard Error 5410 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed | Week 16 (n=5, 4) | -14570 pg/mL | Standard Error 4272 |
Secondary
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
Blood was collected for tumor necrosis factor alpha at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Time frame: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 16 (n=5, 4) | -1.2 pg/mL | Standard Error 1.74 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 32 (n=2, 2) | -0.8 pg/mL | Standard Error 0.9 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 4 (n=56, 41) | -1.9 pg/mL | Standard Error 0.88 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 36 (n=0, 2) | NA pg/mL | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 20 (n=2, 3) | 0.7 pg/mL | Standard Error 0.38 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 40 (n=7, 1) | -3.3 pg/mL | Standard Error 1.58 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 12 (n=51, 45) | -2.0 pg/mL | Standard Error 0.89 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 44 (n=4, 0) | -2.1 pg/mL | Standard Error 0.35 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 48 (n=32, 44) | -2.5 pg/mL | Standard Error 0.91 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 24 (n=42, 57) | -1.1 pg/mL | Standard Error 1.5 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 60 (n=1, 2) | -2.4 pg/mL | — |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 8 (n=5, 25) | -3.7 pg/mL | Standard Error 3.93 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 72 (n=29, 37) | -3.7 pg/mL | Standard Error 1.54 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 28 (n=12, 12) | -0.7 pg/mL | Standard Error 1.73 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 72 (n=29, 37) | -2.0 pg/mL | Standard Error 0.31 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 4 (n=56, 41) | -0.9 pg/mL | Standard Error 1.26 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 8 (n=5, 25) | 1.1 pg/mL | Standard Error 0.36 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 12 (n=51, 45) | 2.8 pg/mL | Standard Error 3.84 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 16 (n=5, 4) | 0.6 pg/mL | Standard Error 1.85 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 20 (n=2, 3) | -3.5 pg/mL | Standard Error 3.64 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 24 (n=42, 57) | -1.8 pg/mL | Standard Error 1.31 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 28 (n=12, 12) | -0.1 pg/mL | Standard Error 0.68 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 32 (n=2, 2) | -1.0 pg/mL | Standard Error 0.07 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 36 (n=0, 2) | 2.7 pg/mL | Standard Error 2.66 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 40 (n=7, 1) | 3.6 pg/mL | — |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 48 (n=32, 44) | -1.4 pg/mL | Standard Error 1.33 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 60 (n=1, 2) | -1.4 pg/mL | Standard Error 0.2 |
| PEG-INF Alpha-2a + Ribavirin | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed | Week 44 (n=4, 0) | NA pg/mL | — |
Secondary
Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy
Serum samples were collected for HCV RNA. The change from Initiation of Pegasys Plus Copegus to Week 24 and Week 48 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.
Time frame: Initiation of Pegasys Plus Copegus, Week 24 and Week 48 of anti-HCV therapy
Population: Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Last Observation Carried Forward (LOCF) was used to replace missing data after dropout with the last observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy | Week 24 (N=60, 72) | -4.0 IU/mL | Standard Error 0.23 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy | Week 48 (N=62, 73) | -3.5 IU/mL | Standard Error 0.27 |
| PEG-INF Alpha-2a + Ribavirin | Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy | Week 24 (N=60, 72) | -3.9 IU/mL | Standard Error 0.21 |
| PEG-INF Alpha-2a + Ribavirin | Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy | Week 48 (N=62, 73) | -3.6 IU/mL | Standard Error 0.24 |
Secondary
Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only
Serum HCV RNA was collected at randomization and during the pioglitazone run-in period at various time points for the with pioglitazone arm only. The change from randomization to each of these time points was calculated.
Time frame: Randomization (Week-16),Weeks -12, -8, -4 and 0
Population: Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only | Week -12 (n=74) | -0.01 IU/mL | Standard Error 0.037 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only | Week -8 (n=68) | 0.00 IU/mL | Standard Error 0.049 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only | Week -4 (n=66) | 0.07 IU/mL | Standard Error 0.048 |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only | Week 0 (n=64) | -0.03 IU/mL | Standard Error 0.046 |
Secondary
Percentage of Nonresponders During the 48 Week Anti-HCV Treatment Period
Nonresponders are defined as patients who did not achieve undetectable HCV RNA during anti-HCV treatment
Time frame: Up to 48 Weeks
Population: Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Nonresponders During the 48 Week Anti-HCV Treatment Period | 45.5 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Nonresponders During the 48 Week Anti-HCV Treatment Period | 30.1 Percentage of Participants |
Secondary
Percentage of Participants Achieving Virologic Response
Virologic response was defined as undetectable HCV RNA \< 28 IU/mL. Patients with missing HCV RNA values are considered as non-responders.
Time frame: Weeks 4, 12, 24, 48, 60, 72
Population: Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants Achieving Virologic Response | Week 48 | 39.0 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants Achieving Virologic Response | Weeks 4 | 6.5 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants Achieving Virologic Response | Week 60 | 26.0 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants Achieving Virologic Response | Week 24 | 46.8 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants Achieving Virologic Response | Week 72 | 26.0 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants Achieving Virologic Response | Week 12 | 33.8 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants Achieving Virologic Response | Week 72 | 38.4 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants Achieving Virologic Response | Week 24 | 63.0 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants Achieving Virologic Response | Weeks 4 | 16.4 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants Achieving Virologic Response | Week 48 | 56.2 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants Achieving Virologic Response | Week 60 | 39.7 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants Achieving Virologic Response | Week 12 | 49.3 Percentage of Participants |
Secondary
Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72
Serum samples were collected for HCV RNA. The percentage of participants with a ≥ 2 log10 decrease in HCV RNA from initiation of Pegasys plus Copegus to time point was calculated.
Time frame: Initiation of Pegasys plus Copegus, Weeks 4, 12, 24, 48, 60, 72
Population: Intent-to Treat population included all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72 | Weeks 4 | 41.6 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72 | Week 12 | 58.4 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72 | Week 24 | 51.9 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72 | Week 48 | 39.0 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72 | Week 60 | 26.0 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72 | Week 72 | 26.0 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72 | Week 60 | 41.1 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72 | Weeks 4 | 52.1 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72 | Week 48 | 54.8 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72 | Week 12 | 76.7 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72 | Week 72 | 37.0 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72 | Week 24 | 72.6 Percentage of Participants |
Secondary
Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks
Virological breakthrough is a detectable HCV RNA at any time during anti-HCV treatment up to Week 48 after the attainment of undetectable HCV RNA.
Time frame: Up to 48 Weeks
Population: Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks | 15.6 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks | 13.7 Percentage of Participants |
Secondary
Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment)
Virologic relapse was defined as the reappearance of HCV-RNA in serum after PEG-INF alpha 2a therapy is discontinued in a patient who was HCV-RNA undetectable at the completion of anti-HCV therapy.
Time frame: Week 72
Population: Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment) | 15.6 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment) | 19.2 Percentage of Participants |
Secondary
Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
The BDI-FS consisted of seven areas with four statements (labeled 0, 1, 2, and 3) offered to describe the area of interest, with 0 indicating no effect and 3 indicating the worst effect. The individual area scores were summed to provide a total score. The degree of depression was assessed with 0 to 3 indicating minimal depression, 4 to 8 mild depression, 9 to 12 moderate depression and 13 to 21 severe depression.
Time frame: Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Population: Participants from the Safety population who received at least one dose of study drug and who had data available at the given time point for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 4 (n=61, 71) | 6.6 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 8 (n=57, 69) | 5.3 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 12 (n=55, 67) | 10.9 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 20 (n=46, 59) | 8.7 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 24 (n=45, 60) | 2.2 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 28 (n=46, 59) | 8.7 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 32 (n=37, 46) | 5.4 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 36 (n=37, 46) | 5.4 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 40 (n=42, 44) | 4.8 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 16 (n=50, 62) | 6.0 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 44 (n=36, 40) | 0 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 60 (n=1, 3) | 0 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 48 (n=32, 45) | 0 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 72 (n=30, 39) | 3.3 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 48 (n=32, 45) | 0 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 4 (n=61, 71) | 12.7 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 36 (n=37, 46) | 6.5 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 8 (n=57, 69) | 7.2 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 60 (n=1, 3) | 33.3 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 16 (n=50, 62) | 4.8 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 12 (n=55, 67) | 11.9 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 20 (n=46, 59) | 3.4 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 44 (n=36, 40) | 2.5 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 24 (n=45, 60) | 10.0 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 40 (n=42, 44) | 2.3 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 28 (n=46, 59) | 3.4 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 72 (n=30, 39) | 7.7 Percentage of Participants |
| PEG-INF Alpha-2a + Ribavirin | Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed | Week 32 (n=37, 46) | 4.3 Percentage of Participants |