D Ouzan, G Banbany, D Valla, P Opolon.
Comparison of High Initial and Fixed-Dose Regimens of Interferon a2a in Chronic Hepatitis C: a Randomized Controlled Trial.
Med Channel Jan ;4(2):51-7.

The efficacy of a high dose de-escalating treatment regimen census the standard fixed treatment regimen of interferon a2a (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 weeks for 3 months followed by 3 MIU three times a week for the next 3 months. The group 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 percent and 66% of the patients in the fixed and de-escalating treatment groups and 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 deescalating 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 r-glutamyl transpeptidase and ferritin levels. Multivariate analysis indicated that only ALT activity assessed at month (P<0.01) was significant predictor of sustained response. These findings suggest that that although the difference ill the response rate between the deescalating (6 MIU three times a week for 3 months; 3 MI U three times a week for 3 months) and fixed (3 MIU three times a week for 6 months) treatment regimens did not reach statistical significance, there was a clear trend towards higher response with the 6 MIU indication dose in patients without cirrhosis.

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