A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

Study Overview
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Brief Summary
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This multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated time of study treatment is 48 weeks, follow-up is 24 weeks.

Official Title
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A Clinical Trial Comparing the Sustained Virological Response in Terms of Expression Profile of IL- 28B in Genotype 1 HCV-Infected Treatment-Naïve Subjects With Chronic Hepatitis C on Pegasys® (Peginterferon Alfa-2A) Plus Copegus® (Ribavirin)

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: peginterferon alfa-2a
* Drug: ribavirin [Copegus]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, >/=18 and <70 years of age at initiation of treatment Body weight between 50 kg and 125 kg at baseline Chronic hepatitis C, genotype 1 Chronic liver disease consistent with HCV infection Compensated liver disease (Child-Pugh Grade A) Exclusion Criteria: Pregnant or lactating women, and male partners of pregnant women Chronic hepatitis C, genotype 2, 3, 4, 5 or 6 Previous treatment with interferon or ribavirin Positive for hepatitis A, hepatitis B or HIV infection History or evidence of a medical condition associated with liver disease other than chronic hepatitis C Decompensated liver disease and/or liver disease Child-Pugh classification >6 Hepatocellular carcinoma History or evidence of esophageal bleeding Hemoglobinopathy, or any other cause for possible hemolysis Hb <11 g/dL in women, <12 g/L in males

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peginterferon Alfa-2a Plus Ribavirin<br> | Drug: peginterferon alfa-2a<br>* 180 mcg sc weekly, 48 weeks<br>Drug: ribavirin [Copegus]<br>* 1'000 or 1'200 mg orally daily, 48 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression | Participants with sustained virological response (SVR) rate in relation to interleukin 28B expression were reported. SVR rate is defined as the percentage of participants with undetectable HCV Ribonucleic acid (RNA), measured at least 24 weeks after the end of treatment (48 weeks) in terms of the expression profile of Interleukin 28B (IL-28B) (CC, CT or TT) in participants with genotype 1 hepatitis C virus (HCV) chronic infection. Participants with detectable HCV RNA or without measurement at the end of the follow-up period were considered as non-responders. | At Week 72 | 
| Percentage of Participants With Incidence of Anemia | Anemia is a condition marked by a deficiency of red blood cells (RBCs) or of hemoglobin (Hb) in the blood, resulting in pallor and weariness anemia (Hb < 11 gram per decilitre (g/dL) for women and Hb < 12 g/dL for men). Incidence of anemia was calculated by dividing the number of participants who experienced the event by the number of participants in the safety population. | Up to Week 72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression | Viral Response rate (rapid/early/end of treatment) in relation to IL28-B expression (measured by the rate of non-detection of HCV RNA at treatment Weeks 4, 12, 24 and after the End of Treatment (EOT, i.e. Week 48) based on the expression profile of IL-28B (CC, CT or TT) were reported. Rapid virologic response (RVR) was defined as undetectable HCV RNA at treatment Week 4. Partial early virological response (pEVR) was defined as positive HCV viral load, but with a >= 2 log10 international units (IU) per millilitre (mL) reduction at treatment Week 12 from Baseline (Week 0); Complete early virologic response (cEVR) was defined as undetectable HCV RNA at treatment Week 12; Virologic response at treatment Week 24 (VR 24) was defined as undetectable HCV RNA at treatment Week 24; Virologic response at end of treatment (EOT) was defined as undetectable HCV RNA at treatment Week 48; SVR at 24 weeks after end of treatment was defined as undetectable HCV RNA at 24 weeks after EOT. | Weeks 4, 12, 24, 48, 60 and 72 | 
| Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment | Participants with sustained virological response (SVR) and development of anemia during the first month and after the first month of treatment according to the different expression profiles of IL-28B were reported. | Up to Week 72 | 
| Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12 | Viral load reduction at Week 4 and Week 12 relative to the Baseline (Week 0) in terms of the expression profile of IL-28b was reported. The reduction was measured according to the following ranges: < 1.0 log IU/ml; >= 1.0 and < 2.0 log IU/ml; >= 2.0 and < 3.0 log IU/ml; >= 3.0 and <4.0 log IU/ml; >= 4.0 log IU/ml. Changes in viral load are usually reported as a log change (in powers of 10). For example, a two log decrease in viral load (2 Log10) is a decrease of 10^2 or 100 times to the previously reported levels. N = number of participants, for Week 0 to Week 4 (n = 34, 68, 17) and Week 0 to Week 12 (n = 35, 69, 18) for CC, CT and TT genotypes respectively. | From Baseline (Week 0) to Week 12 |