A Phase 4 interventional study of peginterferon alfa-2a [Pegasys] and ribavirin [Copegus] in Hepatitis C, Chronic, sponsored by Hoffmann-La Roche. Completed at 66 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-07.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
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.
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Exclusion Criteria:
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 piogliatzone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a) subcutaneous (sc) once a week plus ribavirin (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.
Drug: peginterferon alfa-2a [Pegasys] · Drug: ribavirin [Copegus] · Drug: Pioglitazone
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a) subcutaneous (sc) once a week plus ribavirin (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.
Drug: peginterferon alfa-2a [Pegasys] · Drug: ribavirin [Copegus]
180 micrograms subcutaneous weekly for 48 weeks
Also known as: Pegasys
1000-1600 mg day orally for 48 weeks.
Also known as: Copegus
30 mg daily for 8 weeks increasing to 45 mg daily for 64 weeks.
Also known as: Actos
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Started | 79 | 76 |
| Safety set | 77 | 75 |
| Intent-to-treat (itt) | 77 | 73 |
| Completed | 33 | 41 |
| Not completed | 46 | 35 |
| Withdrew: Adverse event | 10 | 5 |
| Withdrew: Violation of selection criteria at entry | 5 | 1 |
| Withdrew: Protocol violation | 2 | 0 |
| Withdrew: Refused treatment | 9 | 7 |
| Withdrew: Failure to return | 4 | 6 |
| Withdrew: Insufficient response | 14 | 15 |
| Withdrew: Physician decision | 2 | 1 |
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.
| IU/mL | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | 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 | -3.5 ± 0.22 | -3.7 ± 0.19 |
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.
| IU/mL | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Week 24 (N=60, 72) | -4.0 ± 0.23 | -3.9 ± 0.21 |
| Week 48 (N=62, 73) | -3.5 ± 0.27 | -3.6 ± 0.24 |
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 | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Weeks 4 | 6.5 | 16.4 |
| Week 12 | 33.8 | 49.3 |
| Week 24 | 46.8 | 63.0 |
| Week 48 | 39.0 | 56.2 |
| Week 60 | 26.0 | 39.7 |
| Week 72 | 26.0 | 38.4 |
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 | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Weeks 4 | 41.6 | 52.1 |
| Week 12 | 58.4 | 76.7 |
| Week 24 | 51.9 | 72.6 |
| Week 48 | 39.0 | 54.8 |
| Week 60 | 26.0 | 41.1 |
| Week 72 | 26.0 | 37.0 |
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 | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment) | 15.6 | 19.2 |
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 Participants | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks | 15.6 | 13.7 |
Nonresponders are defined as patients who did not achieve undetectable HCV RNA during anti-HCV treatment
| Percentage of Participants | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Percentage of Nonresponders During the 48 Week Anti-HCV Treatment Period | 45.5 | 30.1 |
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.
| IU/mL | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone |
|---|---|
| Week -12 (n=74) | -0.01 ± 0.037 |
| Week -8 (n=68) | 0.00 ± 0.049 |
| Week -4 (n=66) | 0.07 ± 0.048 |
| Week 0 (n=64) | -0.03 ± 0.046 |
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.
| mmol/L | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Week 4 (n=58, 70) | -0.4 ± 0.24 | -0.2 ± 0.17 |
| Week 8 (n=57, 68) | -0.7 ± 0.25 | -0.1 ± 0.33 |
| Week 12 (n=55, 66) | -0.8 ± 0.25 | -0.6 ± 0.28 |
| Week 16 (n=53, 61) | -0.8 ± 0.26 | -0.5 ± 0.36 |
| Week 20 (n=46, 57) | -0.6 ± 0.19 | -0.3 ± 0.19 |
| Week 24 (n=47, 61) | -0.5 ± 0.30 | -0.3 ± 0.15 |
| Week 28 (n=51, 62) | -0.4 ± 0.16 | -0.3 ± 0.16 |
| Week 32 (n=39, 47) | -0.5 ± 0.19 | -0.5 ± 0.23 |
| Week 36 (n=38, 46) | -0.6 ± 0.20 | -0.4 ± 0.23 |
| Week 40 (n=44, 50) | -0.4 ± 0.20 | -0.7 ± 0.20 |
| Week 44 (n=37, 43) | -0.4 ± 0.33 | -0.2 ± 0.25 |
| Week 48 (n=34, 46) | -0.5 ± 0.22 | -0.1 ± 0.24 |
| Week 60 (n=33, 41) | -0.6 ± 0.23 | -0.1 ± 0.34 |
| Week 72 (n=30, 38) | -0.6 ± 0.22 | -0.1 ± 0.31 |
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.
| pmol/L | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Week 4 (N=56, 43) | 6.4 ± 20.9 | -28.4 ± 30.1 |
| Week 8 (N=4, 27) | -40.6 ± 33.1 | 7.3 ± 37.1 |
| Week 12 (N=52, 65) | -34.4 ± 17.2 | -36.0 ± 23.8 |
| Week 16 (N=5, 5) | -59.0 ± 49.9 | -162.2 ± 198.8 |
| Week 20 (N=2, 3) | 132.6 ± 127.8 | 180.1 ± 644.4 |
| Week 24 (N=42, 60) | -38.4 ± 16.7 | -29.1 ± 10.1 |
| Week 28 (N=12, 13) | 11.8 ± 44.6 | -21.2 ± 30.1 |
| Week 32 (N=2, 3) | -47.2 ± 36.8 | 41.7 ± 119.5 |
| Week 36 (N=0, 2) | NA ± NA | 41.0 ± 33.3 |
| Week 40 (N=8, 2) | 2.0 ± 71.0 | 62.2 ± 76.0 |
| Week 44 (N=4, 0) | 370.5 ± 405.6 | NA ± NA |
| Week 48 (N=32, 46) | -38.0 ± 20.7 | -14.3 ± 17.2 |
| Week 60 (N=1, 3) | -13.2 ± NA | 91.0 ± 66.8 |
| Week 72 (N=30, 40) | -61.4 ± 17.2 | -4.8 ± 26.3 |
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.
| Percent | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Week 4 (n=3, 5) | -0.4 ± 0.35 | -0.1 ± 0.22 |
| Week 8 (n=4, 28) | -0.9 ± 0.13 | -1.0 ± 0.18 |
| Week 12 (n=50, 65) | -1.1 ± 0.10 | -1.5 ± 0.12 |
| Week 16 (n=5, 4) | -0.8 ± 0.12 | -1.7 ± 0.64 |
| Week 20 (n=1, 4) | -0.6 ± NA | -1.3 ± 0.30 |
| Week 24 (n=41, 51) | -1.0 ± 0.10 | -1.5 ± 0.12 |
| Week 28 (n=11, 12) | -0.7 ± 0.20 | -1.1 ± 0.17 |
| Week 32 (n=2, 2) | -1.0 ± 0.40 | -1.7 ± 0.80 |
| Week 36 (n=0, 2) | NA ± NA | -0.5 ± 0.05 |
| Week 40 (n=8, 1) | -0.3 ± 0.28 | -1.8 ± NA |
| Week 44 (n=7, 0) | -0.7 ± 0.22 | NA ± NA |
| Week 48 (N=31, 46) | -0.8 ± 0.13 | -1.1 ± 0.15 |
| Week 60 (N=1, 2) | -0.2 ± NA | -0.1 ± 0.30 |
| Week 72 (N=29, 38) | -0.1 ± 0.10 | -0.1 ± 0.11 |
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.
| HOMA Score | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Week 4 (n=54, 42) | 0.6 ± 1.31 | -0.8 ± 1.52 |
| Week 8 (n=3, 25) | -2.3 ± 1.74 | 0.6 ± 1.80 |
| Week 12 (n=51, 63) | -2.0 ± 0.74 | -2.1 ± 1.07 |
| Week 16 (n=5, 5) | -3.2 ± 2.28 | -9.1 ± 7.96 |
| Week 20 (n=2, 3) | 4.0 ± 4.60 | 10.5 ± 32.38 |
| Week 24 (n=42, 60) | -1.8 ± 0.74 | -1.3 ± 0.45 |
| Week 28 (n=10, 13) | 0.8 ± 1.95 | -1.0 ± 1.36 |
| Week 32 (n=2, 2) | -1.8 ± 1.27 | 4.2 ± 6.81 |
| Week 36 (n=0, 2) | NA ± NA | 2.0 ± 0.41 |
| Week 40 (n=6, 2) | 0.2 ± 4.00 | 1.0 ± 3.91 |
| Week 44 (n=4, 0) | 30.4 ± 31.74 | NA ± NA |
| Week 48 (n=30, 44) | -1.6 ± 0.98 | -0.3 ± 0.91 |
| Week 60 (n=1, 2) | 0.6 ± NA | 5.0 ± 3.83 |
| Week 72 (n=27, 35) | -2.7 ± 1.01 | -0.1 ± 1.39 |
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.
| mmol/L | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Week 4 (n=61, 72) | 0.5 ± 0.21 | 0.4 ± 0.11 |
| Week 8 (n=58, 69) | 0.2 ± 0.09 | 0.5 ± 0.12 |
| Week 12 (n=56, 68) | 0.2 ± 0.11 | 0.7 ± 0.23 |
| Week 16 (n=53, 62) | 0.2 ± 0.08 | 0.6 ± 0.20 |
| Week 20 (n=46, 59) | 0.2 ± 0.11 | 0.6 ± 0.16 |
| Week 24 (n=47, 61) | 0.5 ± 0.26 | 0.3 ± 0.10 |
| Week 28 (n=52, 62) | 0.2 ± 0.10 | 0.4 ± 0.14 |
| Week 32 (n=38, 47) | 0.3 ± 0.13 | 0.5 ± 0.19 |
| Week 36 (n=38, 46) | 0.1 ± 0.11 | 0.5 ± 0.15 |
| Week 40 (n=45, 49) | 0.2 ± 0.12 | 0.4 ± 0.13 |
| Week 44 (n=37, 43) | 0.3 ± 0.23 | 0.3 ± 0.12 |
| Week 48 (n=34, 46) | 0.2 ± 0.13 | 0.5 ± 0.18 |
| Week 60 (n=33, 41) | -0.2 ± 0.11 | 0.3 ± 0.16 |
| Week 72 (n=30, 39) | -0.1 ± 0.16 | 0.2 ± 0.12 |
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.
| mmol/L | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Week 4 (n=61, 72) | -0.2 ± 0.08 | -0.5 ± 0.07 |
| Week 8 (n=58, 69) | -0.2 ± 0.07 | -0.6 ± 0.08 |
| Week 12 (n=56, 68) | -0.2 ± 0.07 | -0.6 ± 0.09 |
| Week 16 (n=53, 62) | -0.3 ± 0.07 | -0.7 ± 0.11 |
| Week 20 (n=46, 59) | -0.3 ± 0.08 | -0.6 ± 0.11 |
| Week 24 (n=47, 61) | -0.2 ± 0.09 | -0.7 ± 0.10 |
| Week 28 (n=52, 62) | -0.3 ± 0.08 | -0.7 ± 0.10 |
| Week 32 (n=38, 47) | -0.4 ± 0.10 | -0.8 ± 0.11 |
| Week 36 (n=38, 46) | -0.3 ± 0.10 | -0.7 ± 0.12 |
| Week 40 (n=45, 49) | -0.3 ± 0.08 | -0.8 ± 0.12 |
| Week 44 (n=37, 43) | -0.2 ± 0.11 | -0.8 ± 0.13 |
| Week 48 (n=34, 46) | -0.3 ± 0.11 | -0.7 ± 0.11 |
| Week 60 (n=33, 41) | 0.0 ± 0.15 | 0.1 ± 0.14 |
| Week 72 (n=30, 39) | 0.3 ± 0.15 | 0.2 ± 0.14 |
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.
| mmol/L | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Week 4 (n=58, 70) | -0.3 ± 0.07 | -0.5 ± 0.07 |
| Week 8 (n=57, 66) | -0.2 ± 0.06 | -0.6 ± 0.08 |
| Week 12 (n=55, 62) | -0.2 ± 0.07 | -0.5 ± 0.10 |
| Week 16 (n=53, 58) | -0.2 ± 0.07 | -0.6 ± 0.10 |
| Week 20 (n=46, 56) | -0.2 ± 0.07 | -0.6 ± 0.11 |
| Week 24 (n=45, 60) | -0.2 ± 0.08 | -0.6 ± 0.10 |
| Week 28 (n=52, 60) | -0.2 ± 0.08 | -0.6 ± 0.09 |
| Week 32 (N=38, 44) | -0.40 ± 0.09 | -0.7 ± 0.12 |
| Week 36 (n=37, 44) | -0.2 ± 0.08 | -0.7 ± 0.11 |
| Week 40 (n=44, 49) | -0.3 ± 0.08 | -0.7 ± 0.11 |
| Week 44 (n=36, 43) | -0.2 ± 0.08 | -0.7 ± 0.11 |
| Week 48 (n=34, 44) | -0.3 ± 0.09 | -0.7 ± 0.10 |
| Week 60 (n=33, 39) | 0.1 ± 0.12 | 0.1 ± 0.13 |
| Week 72 (n=30, 38) | 0.2 ± 0.10 | 0.0 ± 0.13 |
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.
| mmol/L | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Week 4 (n=61, 72) | -0.1 ± 0.04 | -0.1 ± 0.03 |
| Week 8 (n=58, 69) | -0.1 ± 0.03 | -0.2 ± 0.03 |
| Week 12 (n=56, 68) | -0.1 ± 0.03 | -0.2 ± 0.03 |
| Week 16 (n=53, 62) | -0.2 ± 0.03 | -0.2 ± 0.03 |
| Week 20 (n=46, 59) | -0.1 ± 0.04 | -0.2 ± 0.04 |
| Week 24 (n=47, 61) | -0.2 ± 0.03 | -0.2 ± 0.04 |
| Week 28 (n=52, 62) | -0.1 ± 0.03 | -0.2 ± 0.04 |
| Week 32 (n=38, 47) | -0.2 ± 0.04 | -0.3 ± 0.04 |
| Week 36 (n=38, 46) | -0.1 ± 0.04 | -0.3 ± 0.05 |
| Week 40 (n=45, 49) | -0.1 ± 0.03 | -0.3 ± 0.05 |
| Week 44 (n=37, 43) | -0.1 ± 0.04 | -0.2 ± 0.05 |
| Week 48 (n=34, 46) | -0.1 ± 0.05 | -0.2 ± 0.05 |
| Week 60 (n=33, 41) | 0.1 ± 0.06 | -0.1 ± 0.04 |
| Week 72 (n=30, 39) | 0.2 ± 0.07 | 0.1 ± 0.04 |
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.
| pg/mL | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Week 4 (n=56, 41) | -1.9 ± 0.88 | -0.9 ± 1.26 |
| Week 8 (n=5, 25) | -3.7 ± 3.93 | 1.1 ± 0.36 |
| Week 12 (n=51, 45) | -2.0 ± 0.89 | 2.8 ± 3.84 |
| Week 16 (n=5, 4) | -1.2 ± 1.74 | 0.6 ± 1.85 |
| Week 20 (n=2, 3) | 0.7 ± 0.38 | -3.5 ± 3.64 |
| Week 24 (n=42, 57) | -1.1 ± 1.50 | -1.8 ± 1.31 |
| Week 28 (n=12, 12) | -0.7 ± 1.73 | -0.1 ± 0.68 |
| Week 32 (n=2, 2) | -0.8 ± 0.90 | -1.0 ± 0.07 |
| Week 36 (n=0, 2) | NA ± NA | 2.7 ± 2.66 |
| Week 40 (n=7, 1) | -3.3 ± 1.58 | 3.6 ± NA |
| Week 44 (n=4, 0) | -2.1 ± 0.35 | NA ± NA |
| Week 48 (n=32, 44) | -2.5 ± 0.91 | -1.4 ± 1.33 |
| Week 60 (n=1, 2) | -2.4 ± NA | -1.4 ± 0.20 |
| Week 72 (n=29, 37) | -3.7 ± 1.54 | -2.0 ± 0.31 |
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.
| pg/mL | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Week 4 (n=56, 41) | -14891 ± 1406 | -7256 ± 1711 |
| Week 8 (n=5, 25) | -16224 ± 8318 | -13955 ± 2190 |
| Week 12 (n=51, 45) | -17666 ± 1655 | -11447 ± 2141 |
| Week 16 (n=5, 4) | -6164 ± 8199 | -14570 ± 4272 |
| Week 20 (n=2, 3) | -10653 ± 1886 | -11290 ± 10160 |
| Week 24 (n=42, 57) | -15976 ± 1727 | -13875 ± 1619 |
| Week 28 (n=12, 12) | -4071 ± 2864 | -9242 ± 3185 |
| Week 32 (n=2, 2) | -19750 ± 12614 | -18973 ± 5737 |
| Week 36 (n=0, 2) | NA ± NA | 8724 ± 12181 |
| Week 40 (n=7, 1) | -3119 ± 4460 | 1785 ± NA |
| Week 44 (n=4, 0) | -6415 ± 5890 | NA ± NA |
| Week 48 (n=32, 44) | -16510 ± 2573 | -10149 ± 2285 |
| Week 60 (n=1, 2) | -14539 ± NA | -3612 ± 5410 |
| Week 72 (n=29, 37) | -6403 ± 2504 | -1347 ± 2327 |
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.
| μg/mL | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Week 4 (n=56, 39) | 13.0 ± 1.15 | 1.6 ± 0.80 |
| Week 8 (n=5, 23) | 12.2 ± 5.11 | -1.1 ± 0.60 |
| Week 12 (n=49, 45) | 10.7 ± 1.17 | 0.3 ± 0.59 |
| Week 16 (n=5, 4) | 9.0 ± 2.30 | -1.0 ± 0.41 |
| Week 20 (n=2, 3) | 3.0 ± 2.00 | 4.0 ± 0.58 |
| Week 24 (n=41, 55) | 12.5 ± 1.27 | 0.2 ± 0.57 |
| Week 28 (n=11, 11) | 4.4 ± 2.18 | -1.0 ± 1.39 |
| Week 32 (n=2, 2) | 13.0 ± 4.00 | 1.5 ± 0.50 |
| Week 36 (n=0, 2) | NA ± NA | 0.0 ± 1.00 |
| Week 40 (n=7, 1) | 2.9 ± 1.61 | -4.0 ± NA |
| Week 44 (n=3, 0) | 3.7 ± 1.67 | NA ± NA |
| Week 48 (n=31, 44) | 10.8 ± 1.70 | 0.3 ± 0.62 |
| Week 60 (n=1, 2) | -1.0 ± NA | 3.0 ± 1.00 |
| Week 72 (n=29, 36) | 8.2 ± 2.07 | -0.1 ± 0.38 |
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.
| ng/mL | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Week 4 (n=56, 39) | -1.8 ± 1.38 | -2.4 ± 0.73 |
| Week 8 (n=5, 22) | -1.9 ± 1.43 | -3.0 ± 0.89 |
| Week 12 (n=48, 44) | -3.1 ± 1.38 | -3.8 ± 1.01 |
| Week 16 (n=5, 4) | -6.4 ± 6.67 | -7.9 ± 7.37 |
| Week 20 (n=2, 3) | -2.9 ± 0.70 | -4.0 ± 1.85 |
| Week 24 (n=42, 54) | -5.8 ± 1.55 | -5.0 ± 0.84 |
| Week 28 (n=11, 11) | -3.7 ± 2.05 | -4.1 ± 1.93 |
| Week 32 (n=2, 2) | -4.5 ± 1.10 | -4.9 ± 0.90 |
| Week 36 (n=0, 2) | NA ± NA | -1.5 ± 1.20 |
| Week 40 (n=7, 1) | -4.8 ± 2.32 | 11.5 ± NA |
| Week 44 (n=3, 0) | 6.0 ± 8.70 | NA ± NA |
| Week 48 (n=31, 43) | -4.6 ± 1.31 | -5.5 ± 1.25 |
| Week 60 (n=1, 2) | 3.4 ± NA | -0.6 ± 1.50 |
| Week 72 (n=29, 36) | 1.3 ± 2.12 | 1.4 ± 1.17 |
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.
| mmol/L | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Week 4 (n=55, 35) | 0.0 ± 0.09 | 0.1 ± 0.05 |
| Week 8 (n=2, 2) | -0.1 ± 0.08 | 0.0 ± 0.31 |
| Week 12 (n=52, 32) | -0.0 ± 0.07 | 0.2 ± 0.12 |
| Week 16 (n=5, 3) | -0.0 ± 0.16 | -0.1 ± 0.26 |
| Week 20 (n=2, 3) | -0.5 ± 0.34 | 0.1 ± 0.38 |
| Week 24 (n=40, 31) | -0.1 ± 0.09 | 0.2 ± 0.05 |
| Week 28 (n=11, 5) | 0.0 ± 0.09 | 0.1 ± 0.13 |
| Week 32 (n=2, 1) | 0.3 ± 0.12 | -0.4 ± NA |
| Week 36 (n=0, 1) | NA ± NA | 0.2 ± NA |
| Week 40 (n=8, 1) | 0.2 ± 0.31 | -0.3 ± NA |
| Week 44 (n=4, 0) | -0.0 ± 0.05 | NA ± NA |
| Week 48 (n=32, 24) | -0.2 ± 0.09 | 0.0 ± 0.05 |
| Week 60 (n=1, 0) | 0.1 ± NA | NA ± NA |
| Week 72 (n=30, 19) | -0.2 ± 0.11 | 0.1 ± 0.07 |
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.
| Percentage of Participants | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| Week 4 (n=61, 71) | 6.6 | 12.7 |
| Week 8 (n=57, 69) | 5.3 | 7.2 |
| Week 12 (n=55, 67) | 10.9 | 11.9 |
| Week 16 (n=50, 62) | 6.0 | 4.8 |
| Week 20 (n=46, 59) | 8.7 | 3.4 |
| Week 24 (n=45, 60) | 2.2 | 10.0 |
| Week 28 (n=46, 59) | 8.7 | 3.4 |
| Week 32 (n=37, 46) | 5.4 | 4.3 |
| Week 36 (n=37, 46) | 5.4 | 6.5 |
| Week 40 (n=42, 44) | 4.8 | 2.3 |
| Week 44 (n=36, 40) | 0 | 2.5 |
| Week 48 (n=32, 45) | 0 | 0 |
| Week 60 (n=1, 3) | 0 | 33.3 |
| Week 72 (n=30, 39) | 3.3 | 7.7 |
Collected over 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | — | 10/77 (13%) | 68/77 (88.3%) |
| PEG-INF Alpha-2a + Ribavirin | — | 9/75 (12%) | 75/75 (100%) |
| Event | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| PneumoniaInfections and infestations | 1/77 | 2/75 |
| Suicidal ideationPsychiatric disorders | 2/77 | 1/75 |
| AppendicitisInfections and infestations | 1/77 | 1/75 |
| GastroenteritisInfections and infestations | 0/77 | 1/75 |
| Hepatic cirrhosisHepatobiliary disorders | 0/77 | 1/75 |
| MegacolonGastrointestinal disorders | 0/77 | 1/75 |
| Obstruction gastricGastrointestinal disorders | 0/77 | 1/75 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/77 | 1/75 |
| Atrial fibrillationCardiac disorders | 0/77 | 1/75 |
| RetinopathyEye disorders | 0/77 | 1/75 |
| Event | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin |
|---|---|---|
| FatigueGeneral disorders | 30/77 | 35/75 |
| AnaemiaBlood and lymphatic system disorders | 27/77 | 24/75 |
| NauseaGastrointestinal disorders | 26/77 | 21/75 |
| InsomniaPsychiatric disorders | 21/77 | 23/75 |
| DepressionPsychiatric disorders | 9/77 | 23/75 |
| HeadacheNervous system disorders | 14/77 | 20/75 |
| RashSkin and subcutaneous tissue disorders | 11/77 | 19/75 |
| Injection site erythemaGeneral disorders | 1/77 | 17/75 |
| PruritusSkin and subcutaneous tissue disorders | 15/77 | 13/75 |
| NeutropeniaBlood and lymphatic system disorders | 15/77 | 12/75 |
| Age, Customized(participants) | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin | Total |
|---|---|---|---|
| <=40 years | 6 | 8 | 14 |
| >40 years | 71 | 65 | 136 |
| Sex: Female, Male(Participants) | PEG-INF Alpha-2a + Ribavirin+ Pioglitazone | PEG-INF Alpha-2a + Ribavirin | Total |
|---|---|---|---|
| Female | 27 | 28 | 55 |
| Male | 50 | 45 | 95 |
The record gives a start of Jan 2008, a primary completion of Dec 2010 and a completion of Dec 2010. It does not say whether these dates are actual or estimated.
Results were first posted in May 2012, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Pioglitazone