Phase 4
Completed N=155
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance.
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00545233 ↗
Enrolled (actual)
155
Serious AEs
12.5%
Results posted
May 2012
Primary outcomePrimary: 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; -3.7 IU/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
-3.5; -3.7 | — |
| SECONDARY Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy |
-4.0; -3.9; -3.5; -3.6 | — |
| SECONDARY Percentage of Participants Achieving Virologic Response |
6.5; 16.4; 33.8; 49.3; 46.8; 63.0 | — |
| 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 |
41.6; 52.1; 58.4; 76.7; 51.9; 72.6 | — |
| SECONDARY Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment) |
15.6; 19.2 | — |
| SECONDARY Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks |
15.6; 13.7 | — |
| SECONDARY Percentage of Nonresponders During the 48 Week Anti-HCV Treatment Period |
45.5; 30.1 | — |
| 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 |
-0.01; 0.00; 0.07; -0.03 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed |
-0.4; -0.2; -0.7; -0.1; -0.8; -0.6 | — |
| SECONDARY Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed. |
6.4; -28.4; -40.6; 7.3; -34.4; -36.0 | — |
| SECONDARY Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed |
-0.4; -0.1; -0.9; -1.0; -1.1; -1.5 | — |
| SECONDARY Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed |
0.6; -0.8; -2.3; 0.6; -2.0; -2.1 | — |
| SECONDARY Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed |
0.5; 0.4; 0.2; 0.5; 0.2; 0.7 | — |
| SECONDARY Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed |
-0.2; -0.5; -0.2; -0.6; -0.2; -0.6 | — |
| SECONDARY Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed |
-0.3; -0.5; -0.2; -0.6; -0.2; -0.5 | — |
| SECONDARY Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed |
-0.1; -0.1; -0.1; -0.2; -0.1; -0.2 | — |
| SECONDARY Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed |
-1.9; -0.9; -3.7; 1.1; -2.0; 2.8 | — |
| SECONDARY Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed |
-14891; -7256; -16224; -13955; -17666; -11447 | — |
| SECONDARY Change From Baseline in Adiponectin Levels at Each Time Point Assessed |
13.0; 1.6; 12.2; -1.1; 10.7; 0.3 | — |
| SECONDARY Change From Baseline in Leptin Levels at Each Time Point Assessed |
-1.8; -2.4; -1.9; -3.0; -3.1; -3.8 | — |
| SECONDARY Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed |
0.0; 0.1; -0.1; 0.0; -0.0; 0.2 | — |
| SECONDARY Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed |
6.6; 12.7; 5.3; 7.2; 10.9; 11.9 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00545233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.