Efficacy and Safety of Two-Dose Regimens of Peginterferon Alpha-2a Compared with Interferon Alpha-2a in Chronic Hepatitis C: A Multicenter, Randomized Controlled Trial

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Abstract

OBJECTIVES

This study compared the efficacy and safety of peginterferon alpha-2a 135 μg/wk, peginterferon alpha-2a 180 μg/wk and interferon alpha-2a in patients with chronic hepatitis C.

METHODS

A total of 639 patients received peginterferon alpha-2a 135 μg or 180 μg once weekly, or interferon alpha-2a 3 MIU thrice weekly for 48 wk.

RESULTS

Sustained virological responses were significantly higher with peginterferon alpha-2a than with interferon alpha-2a 3 MIU (28% in the 135 μg and 180 μg peginterferon alpha-2a groups vs 11% with interferon alpha-2a, p = 0.001). The proportion of patients with clinically significant histological improvement was lower in the peginterferon alpha-2a 135 μg (48%) than the 180 μg group (58%, p = 0.035 vs peginterferon alpha-2a 135 μg), but similar to that in the interferon alpha-2a group (45%, p = 0.820 vs peginterferon alpha-2a 135 μg and p = 0.017 vs peginterferon alpha-2a 180 μg, respectively). The overall safety profiles were similar for the three treatments.

RESULTS

In patients with chronic hepatitis C, peginterferon alpha-2a 135 μg/wk and 180 μg/wk produced similar sustained virological response rates, both of which were significantly higher than that achieved with interferon alpha-2a thrice weekly. A significantly higher proportion of patients treated with the 180 μg dose of peginterferon alpha-2a had clinically significant histological improvement.

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