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A short induction regimen of interferon‐α is not effective for treatment of relapse in chronic hepatitis C: a randomized trial
Author(s) -
Poynard T.,
Daurat V.,
Chevret S.,
Moussalli J.,
Degos F.,
Bailly F.,
Borotto E.,
Buffet C.,
BartolomeiPortal I.,
Richardet J. P.,
Riachi G.,
Calmus Y.,
Bréchot C.,
Vidaud M.,
Olivi M.,
Bedossa P.,
Riffaud P. Chaumet,
Chastang C.
Publication year - 1999
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1046/j.1365-2893.1999.00170.x
Subject(s) - regimen , medicine , gastroenterology , randomized controlled trial , interferon , chronic hepatitis , alpha interferon , immunology , virus
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.