Sustained virological response in chronic hepatitis C patients after a 6-and a 36-month interferon-alpha 2b treatment schedule - A multicenter, randomized, controlled study

Background: In patients with chronic hepatitis C (HCV) Interferon-alpha (IF N) treatment for 12-18 months is more effective than 6 months in inducing a sustained virological response. Methods: In a multicenter, randomized, con trolled trial, 88 patients with chronic HCV were enrolled (47 treated with IFN-alpha 2b and 41 constituted an untreated control group). Treatment cons isted of 5 million units (MU) IFN thrice a week (tiw) for 8 weeks and subse quently 2.5 MU IFN tiw for 16 weeks ('standard treatment'). After week 24 ( 'long-term treatment'), in virological non-responders treatment was continu ed using 5 MU IFN tiw for up to week 156, whereas in virological responders IFN was discontinued. In case of a virological relapse, treatment with 5 M U IFN tiw was restarted and continued up to week 156. Results: Sustained vi rological response rate was 6/47 (13%) after standard treatment and increas ed to 19/47 (40%) after long-term treatment (McNemar paired test; P = 0.002 ). Of the 18 patients with a breakthrough or relapse during or after standa rd treatment, 14 (78%) became sustained virological responders upon long-te rm treatment. Of the 4 patients who did not have a sustained virological re sponse after long-term treatment, 3 did not receive complete treatment due to side effects and/or non-compliance. In patients who failed to respond to standard treatment, no virological response was observed during long-term treatment. In the control group, no spontaneous clearance of HCV was observ ed. Conclusions: Long-term IFN (re)treatment enhanced the virological susta ined response rate significantly and was particularly effective in patients with a breakthrough or relapse following standard treatment.