A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for Patients With Genotype 1 Hepatitis C and IL28B CC Polymorphism

Study Overview
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Brief Summary
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Patients with HCV genotype 1 and IL28B CC Polymorphism who have a rapid virological response to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Peginterferon alfa2a
* Drug: Ribavirin
* Drug: Peginterferon alfa2a
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Serum Hepatitis C RNA > 10,000IU/mL Hepatitis C virus genotype 1 IL28B CC polymorphism Exclusion Criteria: Previous treatment for chronic Hepatitis C clinical or biological evidence of acute hepatitis, including serum ALT or AST > 300U/ml HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease Contraindications to PR-based treatment: Uncontrolled psychiatric illness Active substance dependency Known autoimmune disorder Untreated thyroid disease Uncontrolled seizure disorder Pregnancy, lactation or inability to maintain contraception Chronic kidney disease w/ estimated GFR< 60 ANC<1.5/nl, Hb<12g/dl, or platelets<75/nl Clinical or biochemical evidence of decompensated liver disease including: History of encephalopathy Ascites Variceal bleeding Bilirubin > 3g/dl or INR > 1.5 Life threatening disorder with expected median survival less than 5 years Inability to comply with drug regimens or testing schedule required for study

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 24-Week treatment group<br>Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 20 weeks | Drug: Peginterferon alfa2a<br>* patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks<br>Drug: Ribavirin<br>* patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks<br>|
| Active Comparator: 48-Week treatment group<br>Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 44 weeks | Drug: Peginterferon alfa2a<br>* patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks<br>Drug: Ribavirin<br>* patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response (SVR) | Undetectable HCVRNA in serum(<15IU/ml) 24 weeks after the end of treatment | 24 weeks after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health related quality as measured by short from 36 (SF-36) from baseline to 24 weeks after the end of treatment |  | baseline, 24 weeks after the end of treatment | 
| Sick leave in patients treated for 24 or 48 weeks treatment |  | 48 weeks |