Large Intestine Histopathology of Pegylated-Interferon-Alpha Plus Ribavirin Treated Chronic Hepatitis C Patients

Gastrointestinal disorders (especially diarrhea) are observed in a proportion of patients treated with the currently approved combination treatment for chronic hepatitis C (CHC), pegylated-interferon alpha (PEG-IFNa) plus rib-avirin (RIB) [1]. Several reports suggest that the presence of inflammatory bowel disease (IBD) is not a contraindica-tion for interferon-alpha-(IFNa-) based treatments [2, 3]. Furthermore, a randomised placebo-controlled trial of PEG-IFNa in patients with active ulcerative colitis concluded that PEG-IFNa is safe but not effective treatment for these patients [4]. On the contrary, several reports [5–8] revealed that treatment of chronic viral hepatitis with IFNa or PEG-IFNa with or without RIB was related with the onset of clinically and histologically confirmed acute colitis of the IBD type. To our knowledge the effect of chronic hepatitis C virus (HCV) infection or PEG-IFNa plus RIB combination treatment on large intestine histopathology has not been investigated , within a clinical trial. The principal aim of our study was to investigate the effect of PEG-IFNa plus RIB treatment on the large intestine histology of treated CHC patients. Twenty-four treatment-na¨ıve CHC patients with sero-and histologically (liver biopsy-Ishak scoring system) confirmed CHC and no contraindication of receiving combination treatment with PEG-IFNα2b and RIB were enrolled in this pilot study. All patients were treated with weight-based dosing of pegylated interferon-a2b (Peg-Intron, 1.5 μg/kg/week) and genotype-related rib-avirin dose (Rebetol, 800 mg/day for genotype 2/3 and 1000– 1200 mg/day for genotype 1/4-infected patients, depending on baseline body weight < or ≥85 kg, resp.) for 24 weeks. Patients were evaluated for the presence of gastrointesti-nal symptoms, by receiving a detailed history, before the beginning of treatment, during the treatment period and at week 24 of treatment. The study population underwent recto-sigmoidoscopic examination prior to the beginning of the treatment schedule. Three to five biopsy specimens were taken from the rectosigmoid area. Histological findings characteristic of inflammation as well as the presence of architectural disorders and the quantity of mucus production, the presence of ulcerations and Paneth cells as well as the numbers of lymphoid follicles in every biopsy specimen were evaluated. Fifteen patients underwent the same procedure after the completion of 24-week treatment course and three of them were also evaluated during treatment because of diarrhea. Ten age-, sex-, and BMI-matched healthy subjects (control group) underwent recto-sigmoidoscopic examination and biopsy. All controls had no history of inflammatory bowel disease or other gastrointesti-nal diseases, did not receive any medication and did not report symptoms …