Influence of Ribavirin on the Initial Virological Response in Treatment Naïve Patients With Hepatitis C Genotype 1 Infection
Influence of Ribavirin on the Initial Virological Response in Treatment Naïve Patients With Hepatitis C Genotype 1 Infection
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.
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