Randomized Trial of 24 or 48 Weeks of Peginterferon Alfa-2a Plus Ribavirin for HCV Genotype 1-infected Patients
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Pegylated interferon alfa-2a plus ribavirin; Pegylated interferon alfa-2a plus ribavirin
Intervention description: Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks; Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 308.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic hepatitis C; Genotype 1; Interferon; Ribavirin

Summary:

      Chronic hepatitis C virus (HCV) infection is prevalent in the world, affecting 3% of the
      world's population. The current standard of therapy is pegylated interferon and ribavirin,
      reaching 54-63% of successful rates. In patients with HCV genotype 1 infection, a 48 week
      course of combination therapy has achieved a higher successful rate that a 24 weeks course of
      therapy. However, several studies in Taiwan have shown that a 24 week course of therapy has
      comparable or even better response to a 48 week course of therapy in Western countries.
      Therefore, whether a 48 week course of therapy can achieve a higher response to a 24 week
      course of therapy in Taiwanese patients with genotype 1 HCV infection remains unclear.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment naïve

          -  Age 18 and older than 18 years old

          -  Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive > 6 months

          -  Detectable serum quantitative HCV-RNA (Cobas Amplicor HCV Monitor v2.0, Roche
             Molecular Systems, Pleasanton, CA) with dynamic range 600~<500,000 IU/ml

          -  HCV genotype 1 (Inno-LiPA HCV II, Innogenetics, Ghent, Belgium)

          -  Serum alanine aminotransferase levels above the upper limit of normal with 6 months of
             enrollment

          -  A liver biopsy consistent with the diagnosis of chronic hepatitis C

        Exclusion Criteria:

          -  Anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for
             women)

          -  Neutropenia (neutrophil count <1,500 per cubic milliliter)

          -  Thrombocytopenia (platelet <90,000 per cubic milliliter)

          -  Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

          -  Chronic alcohol abuse (daily consumption > 20 gram per day)

          -  Decompensated liver disease (Child-Pugh class B or C)

          -  Serum creatinine level more than 1.5 times the upper limit of normal

          -  Autoimmune liver disease

          -  Neoplastic disease

          -  An organ transplant

          -  Immunosuppressive therapy

          -  Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases,
             psychiatric diseases, neurological diseases, diabetes mellitus

          -  Evidence of drug abuse

          -  Unwilling to have contraception