Low-Dose Peginterferon and Ribavirin to Treat Chronic Hepatitis C in Patients Infected With HCV Genotype 2 or 3
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Peginterferon alfa-2a; Peginterferon alfa-2a; Ribavirin
Intervention description: Peginterferon alfa-2a 90 mcg/week; 180 mcg/week; 800 mg/day
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C Virus; Antiviral Agents; Hemolysis; Neutropenia; Cirrhosis; Hemolytic Anemia; Viral Hepatitis; Ribavirin; Alfa Interferon; Pegylated Interferon; Hepatitis C; HCV

Summary:

      This study will examine the effectiveness of low-dose peginterferon and ribavirin therapy for
      certain patients with chronic hepatitis C-a liver disease that, in some patients, can
      progress to cirrhosis of the liver, liver cancer, and liver failure.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Age above 18 years, male or female.

        Presence of anti-HCV in serum.

        Positive HCV RNA determination in serum.

        HCV genotype 2 or 3 as determined by Inno LiPa assay or by direct sequencing. Patients with
        mixed genotypes will not be eligible if they have genotypes other than 2 or 3.

        Written informed consent.

        EXCLUSION CRITERIA:

        Previous treatment with interferon alpha or peginterferon.

        Decompensated liver disease, as marked by bilirubin greater than 4 mg/dL, albumin less than
        3.0 g/dL, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal
        varices, ascites or hepatic encephalopathy.

        Patients with ALT levels greater than 1000 U/L (greater than 25 times ULN) will not be
        enrolled but may be followed until three determinations are below this level.

        Pregnancy or, in women of child-bearing potential or in spouses of such women, inability to
        practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or
        use of condoms and spermicidal, or birth control pills, or an intrauterine device.

        Significant systemic or major illnesses other than liver disease, including congestive
        heart failure, renal failure (creatinine clearance less than 50 ml/min), organ
        transplantation, serious psychiatric disease not controlled by psychotropic agents, and
        angina pectoris.

        Evidence of coronary artery disease or cerebral vascular disease, including abnormalities
        on exercise stress testing in patients with defined risk factors who will be screened for
        evidence of underlying coronary artery disease.

        Pre-existing, severe bone marrow compromise; anemia (hematocrit less than 30%), neutropenia
        (less than 1000 neutrophils/microliter) or thrombocytopenia (less than 70,000
        cells/microliter).

        History of hemolytic anemia.

        Evidence of another form of liver disease in addition to hepatitis C (for example hepatitis
        B, autoimmune liver disease, Wilson's disease, alcoholic liver disease).

        Active substance abuse, such as alcohol, inhaled or injection drugs within the previous six
        months.

        Evidence of hepatocellular carcinoma: either alfa-fetoprotein (AFP) levels greater than 50
        ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a
        mass suggestive of liver cancer.

        Clinical gout.

        HIV infection.

        Quiescent or active, serious autoimmune disease such as lupus erythematosus, ulcerative
        colitis, Crohn's disease or rheumatoid arthritis that in the opinion of the investigators
        might be exacerbated by therapy with alfa interferon.

        The use of immunosuppressive medications, including corticosteroids in doses of 10 mg of
        prednisone or its equivalent and higher.