Premium
Comparison of high initial and fixed‐dose regimens of interferon‐α2a in chronic hepatitis C: a randomized controlled trial
Author(s) -
Ouzan D.,
Babany >.,
Valla D.,
Opolon P.
Publication year - 1998
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.1365-2893.1998.00080.x
Subject(s) - medicine , gastroenterology , regimen , randomized controlled trial , cirrhosis , univariate analysis , hepatitis , multivariate analysis
The efficacy of a high‐dose de‐escalating treatment regimen versus the standard, fixed‐treatment regimen of interferon‐α2a (IFN; Roferon®‐A) in chronic hepatitis C was evaluated in 291 patients who had elevated alanine aminotransferase (ALT) levels, for at least 6 months prior to the study, and histologically proven chronic hepatitis. Patients were randomized into two groups: 142 patients received IFN at a fixed dose (3 million international units (MIU) three times a week for 6 months) and 149 patients received 6MIU three times a week for 3 months followed by 3MIU three times a week for the next 3 months. The groups did not differ significantly with respect to age, gender or percentage of patients with cirrhosis. Response was evaluated by monitoring ALT levels monthly during treatment and during the 6 months post‐treatment follow‐up. Sixty‐one per cent and 66% of the patients in the fixed and de‐escalating treatment groups had a primary response (serum ALT normalization) during the treatment period; sustained‐response rates at the end of follow‐up were 20% and 29%, respectively (not significant). In non‐cirrhotic patients, a primary response was recorded in 65% and 70% of the patients in the fixed and de‐escalating groups; sustained‐response rates were 22% and 33%, respectively. Overall, 62% of patients with a sustained response showed histological improvement. In univariate analysis, patients with sustained response tended to be non‐cirrhotic and had lower initial serum γ‐glutamyl transpeptidase and ferritin levels. Multivariate analysis indicated that only ALT activity assessed at month 1 ( P <0.01) was a significant predictor of sustained response. These findings suggest that although the difference in the response rates between the de‐escalating (6MIU three times a week for 3 months; 3MIU three times a week for 3 months) and fixed (3MIU three times a week for 6 months) treatment regimens did not reach statistical significance, there was a clear trend towards higher response with the 6MIU induction dose in patients without cirrhosis.