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

• Change in health related quality as measured by short from 36 (SF-36) from baseline to 24 weeks after the end of treatment [ Time Frame: baseline, 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
• Sick leave in patients treated for 24 or 48 weeks treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

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.

• Drug: Peginterferon alfa2a
  patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
• Drug: Ribavirin
  patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
• Drug: Peginterferon alfa2a
  patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
• Drug: Ribavirin
  patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks

• Experimental: 24-Week treatment group
  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
  Interventions:

  • Drug: Peginterferon alfa2a
  • Drug: Ribavirin
• Active Comparator: 48-Week treatment group
  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
  Interventions:

  • Drug: Peginterferon alfa2a
  • Drug: Ribavirin

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