FIXED VERSUS TITRATED INTERFERON-ALPHA(2B) IN CHRONIC HEPATITIS-C - ARANDOMIZED CONTROLLED MULTICENTER TRIAL

Background/Aim: Interferon has become the mainstay of treatment of chr onic hepatitis C; however, duration of treatment and dose remain unres olved questions, The present study aimed to compare standard dose inte rferon with a titrated dose regimen carried out for 1 year. Methods: T his was a randomized, controlled multicenter trial, Patients with chro nic hepatitis C were randomly allocated to a control group (n=30), to a fixed dose group (n=31) where interferon-alpha(2b) 3 MU thrice weekl y 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 th e patient in remission as assessed by a normal ALT value, Liver biopsi es were obtained before and at the end of treatment; in addition, gala ctose elimination capacity was measured as a measure of cytosolic func tion. Results: In the control, fixed and titrated groups a complete re sponse was achieved in 2/29, 10/28 and 15/31, respectively (p<0.001 in favor of treatment, p=n.s. for the two treatments), The corresponding figure for sustained response was 1/29, 5/28 and 6/31 (p=n.s.), In th e 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 fa ilures. Conclusions: Both fixed and titrated dosing of interferon give n for 1 year induced virus clearance in only a minority of treated pat ients, However, in a small number of patients, a complete and sustaine d response can be achieved with low doses of interferon, Dose titratio n could be an interesting approach to decreasing the cost and side eff ects in the treatment of chronic hepatitis C.