Treatment of mild chronic hepatitis C with interferon alpha-2b: results ofa multi-centre randomized study in 80 patients

Objective The natural history of mild chronic hepatitis C is not well-known and the benefit of treating this form of the disease is not well-defined. We conducted a pilot study to answer this question. Design Mild chronic hepatitis C was defined by positivity for anti-HCV anti bodies, detectable serum HCV RNA by PCR, and a Knodell score less than or e qual to 5 on a liver biopsy performed within the previous 6 months. Eighty patients from six centres were randomized into two groups receiving interfe ron alpha -2b, 3 MU three times a week for 6 months (group 1, n = 39) or no treatment (group 2, n = 41). Sustained response was defined by the loss of detectable serum HCV RNA at 6 months after therapy. Results The two groups were not different at entry with respect to age, sex ratio, source of infection, disease duration, genotype, viral load and Kno dell score. One patient (group 1) was excluded from the study, while two pa tients in group 1 (5%) and seven in group 2 (17.1%) did not complete the tr ial. A sustained response was observed in seven patients (18%) in group 1 v ersus none in group 2 (P < 0.01). The difference in mean Knodell score rema ined non-statistically significant between the two groups at the end of the study. Reduction or interruption of interferon was necessary in eight pati ents (24.2%). Conclusions This first randomized controlled study in mild chronic hepatiti s C shows a proportion of sustained responders to interferon a-2b similar t o that observed in active chronic hepatitis C. Eur J Gastroenterol Hepatol 13:143-147 (C) 2001 Lippincott Williams & Wilkins.