Fixed versus titrated interferon-α2B in chronic hepatitis C. A randomized controlled multicenter trial

Background/Aim: Interferon has become the mainstay of treatment of chronic hepatitis C; however, duration of treatment and dose remain unresolved questions. The present study aimed to compare standard dose interferon with a titrated dose regimen carried out for 1 year. Methods: This was a randomized, controlled multicenter trial. Patients with chronic hepatitis C were randomly allocated to a control group (n=30), to a fixed dose group (n=31) where interferon-α2b 3 MU thrice weekly was given for 1 year or a titrated group (n=34) where interferon was titrated starting at 5 MU thrice weekly to the lowest dose keeping the patient in remission as assessed by a normal ALT value. Liver biopsies were obtained before and at the end of treatment; in addition, galactose elimination capacity was measured as a measure of cytosolic function. Results: In the control, fixed an titrated groups a complete response was achieved in , and , respectively (p<0.001 in favor of treatment, p=n.s. for the two treatments). The corresponding figure for sustained response was , and (p=n.s.). In the titrated group, a complete (sustained) response was achieved with 5 MU in 2 (2), with 4 MU in 1 (0), with 3 MU in 4 (0), with 2 MU in 3 (0) and with 1 MU in 5 (4). Liver biopsy score and galactose elimination capacity improved significantly in responders but not in treatment failures. Conclusions: Both fixed and titrated dosing of interferon given for 1 year induced virus clearance in only a minority of treated patients. However, in a small number of patients, a complete and sustained response can be achieved with low doses of interferon. Dose titration could be an interesting approach to decreasing the cost and side effects in the treatment of chronic hepatitis C.