Influence of Ribavirin on the Initial Virological Response in Treatment Naïve Patients With Hepatitis C Genotype 1 Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Pegylated Interferon (PEG-IFN) alfa-2a; Placebo; Ribavirin
Intervention description: Pegylated interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.; Ribavirin matching placebo orally (PO) twice daily for 6 weeks.; Ribavirin, 1000 mg orally (PO) (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Intervention MeSH terms: Interferons; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study examined the influence of ribavirin on the initial virological response in
      treatment-naïve participants with chronic hepatitis C, genotype 1. Participants were
      randomized to 1 of 3 treatment groups to receive placebo, ribavirin monotherapy 1000
      milligrams (mg) to 1200 mg orally daily depending on body weight or pegylated interferon
      (PEG-IFN) alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously (SC) weekly, for 6 weeks.
      Following the initial 6 weeks, all participants received combination therapy with PEG-IFN
      alfa-2a plus ribavirin (Copegus®) for 12 weeks. If there was an initial virological response
      after 12 weeks of combination therapy, treatment could be continued for a further 36 weeks
      outside of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Caucasians, male or female aged between 18 and 70 years

          -  Indication: serological proof of a chronic hepatitis C infection with positive result
             of anti-Hepatitis C virus (HCV) test and detectable HCV- Ribo Nucleic Acid (RNA) in
             serum

          -  Proven HCV genotype 1 by means of the reverse hybridization assays

          -  Proven histological infection activity within the liver with or without proven
             compensated cirrhosis within the last 24 months prior to start of the study
             (Child-Pugh degree A)

          -  Participants without previous anti-HCV therapy

        Exclusion Criteria:

          -  Known hypersensitivity to interferon or ribavirin or any of the other component parts

          -  Pregnant or nursing women, women with child bearing potential and without using a high
             effective method of contraception. The urine and serum pregnancy test at visit 0 in
             fertile participants or cohabitants of participants must show a negative result

          -  Male partners of pregnant women

          -  Infection with HCV genotype 2, 3, 4, 5, or 6

          -  Pretreatment with interferon and/or ribavirin

          -  Immunocompromised participants

          -  Treatment of systemic anti-neoplastic or immunomodulatoric medication (including
             supraphysiological doses of steroids or radiation therapy) within the last 6 months
             prior to the start of treatment and during the complete time interval of study
             treatment

          -  Chronic hepatitis due to hepatitis C virus (e.g. haemochromatosis,
             autoimmunohepatitis, metabolic or alcohol-related liver disease)

          -  Decompensated liver cirrhosis or liver disease Child-Pugh degree B or C or condition
             after decompensation

          -  Signs of a hepatocellular carcinoma within 2 months prior to randomization in case of
             a cirrhosis or a transition to cirrhosis

          -  Ascites or esophagus varices with bleedings as documented in anamnesis

          -  Any medical condition that questions in the opinion of the investigator the
             participant's enrollment and participation in the trial

          -  Hemoglobin <13 grams/deciliter (g/dl) in females and <14 g/dl in males in screening
             phase

          -  Patients with an increased anemia risk (e.g. thalassemia, spherocytosis, etc.) or
             patients which would be at a particular medical risk in case of an anemia

          -  Diagnosed neutropenia <1.500/microliter (mcl) or thrombocytopenia <90.000/mcl in
             screening phase