Background:The aim of the study was to assess the effectiveness of treatment with pegylated interferon-α2a (PegIFN-α2a) PEGASYS® ROCHE at 180 µg dose administered 1 × week in combination with ribavirin (RBV) COPEGUS® at 800 mg/d dose administered every day for 48 weeks to patients with chronic hepatitis C within the framework of an open-label, non-randomized clinical
study.Material/Methods: The study was carried out in a group of 190 adult patients of both sexes, among them 167 had undergone liver biopsies. The treatment was completed by 181 subjects. In addition to standard biochemical tests, HCV-RNA, genotype and viremia level were determined. Control tests were carried out after 6 months of the end of treatment to assess sustained virological response (SVR).Results: SVR was obtained in 58.2% of patients, without statistically significant difference between men and women; there was a difference between the group of patients over 50 years of age as compared with those below that age (43.2% vs. 62.4%, respectively;p= 0.040). Higher SVR rates (p=0.001) were observed in patients infected with non-1 HCV genotype in comparison with genotype 1 (85.7% vs. 52.8%). In patients with genotype 1 and viremia equal to, or lower than 800 000 lU/ml SVR was 61.3% while in patients with viremia greater than 800.000 IU/ml SVR was 41.9% (p=0.028). Such difference was not found for non-1genotype patients. No significant differences in SVR values related to the stage of fibrosis were observed (patients with stage 1 and 2according to 0–4 staging scale predominated: 73.6%). Higher SVR rates (p=0.034) were obtained in patients receiving ribavirin doses above 10.6 mg/kg b.w. (67.6% and 50%, respectively) without statistically significant difference between the patients treated with interferon and ribavirin doses, considered both jointly and separately, above and below 80% of the scheduled dose. Hemoglobin level, leukocyte and neutrophil counts decreased significantly during the therapy and returned to the reference values after its completion. There was a statistically significant decrease of AIAT activity during the treatment, both in patients with and without SVR, which was observed also 6 months after its completion. The treatment was not completed by 9 patients (5 because of adverse effects, and 4 for subjective reasons).Conclusions: 1. The overall effectiveness of treatment, assessed 6 months after its completion, reached 58.2%, without taking into consideration HCV genotype and viremia level. 2. Patients infected with non-1 genotype responded significantly better than those with genotype 1 (85.7% vs. 52.8%). 3. Patients infected with genotype 1 with low viremia levels responded significantly better than thosewith genotype 1 and high viremia (61.3% vs. 41.9%). 4. The response to treatment was significantly better in patients below 50 years of age. 5. No significant differences in response were found with respect to: sex, previous antiviral treatment and the stage of fibrosis. 6. Patients treated with ribavirin doses ?10.6 mg/kg responded significantly better than those receiving doses

Keywords: combined pegylated interferon-alpha (IFN-alpha) and ribavirin (RBV) therapy, sustained virological response related to HCV genotype, chronic hepatitis C