A short induction regimen of interferon‐α is not effective for treatment of relapse in chronic hepatitis C: a randomized trial

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Abstract
The aim of this work was to assess the effect of a high‐dose (10 million units, MU) short‐duration (14 weeks) interferon‐α2b (IFN‐α2b) regimen in relapsers compared with the standard IFN regimen of 3 MU three times weekly (t.i.w.) for 6 months. Fifty‐eight non‐cirrhotic patients (who had relapsed after previous treatment with IFN) with chronic hepatitis were randomized: 29 to the high‐dose, short‐duration regimen and 29 to the standard regimen. By the end of IFN therapy, in the high‐dose, short‐duration group alanine aminotransferase (ALT) normalization was observed in 23 (79%) of 29 patients, and undetectable hepatitis C virus (HCV) RNA in eight (28%) vs 25 (86%) and 11 (38%) of the 29 patients in the standard group, respectively (P = NS). At the end of the 72‐week follow‐up, in the high‐dose, short‐duration group a sustained ALT normalization was observed in two (7%) patients, and undetectable HCV RNA in 0 (0%) vs five (17%) and four (14%) patients in the standard group (P = NS). There was less fibrosis improvement in the high‐dose, short‐duration group (two of 26 patients, 8%) than in the standard group (eight of 25 patients, 32%) (P = 0.04). Tolerance to IFN was good and similar in the two groups. In conclusion, in IFN relapsers, high‐dose, short‐duration treatment with IFN‐α has no advantage when compared to a 6‐month treatment with 3 MU IFN t.i.w.