A randomized study of patients with HBeAg-positive chronic hepatitis B.
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PEG-IFN alfa-2b (1.5 μg/kg/wk or 1.0 μg/kg/wk) was administered for 24 or 48 weeks.
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HBeAg loss was greater in patients receiving PEG-IFN (1.5 μg/kg/wk) for 48 weeks.
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Secondary measures of efficacy also favor the 48-week regimen.
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Safety was generally similar with 24- and 48-week regimens.
Abstract
Background
In mainland China, peginterferon (PEG-IFN) alfa-2b 1.0 μg/kg/wk for 24 weeks is the approved treatment for HBeAg-positive chronic hepatitis B.
Objective
This multicenter, randomized trial evaluated the safety and efficacy of regimens utilizing increased dose or treatment duration in treatment-naive Chinese patients with chronic hepatitis B.
Study design
670 HBeAg-positive patients from China, Malaysia, Taiwan area, Singapore, and Thailand were enrolled. Patients received PEG-IFN alfa-2b 1.0 μg/kg/wk (arm A) or 1.5 μg/kg/wk (arm B) for 24 weeks, or 1.5 μg/kg/wk for 48 weeks (arm C). The primary end point was loss of HBeAg 24 weeks after end of treatment.
Results
At the end of follow-up, HBeAg loss was significantly greater in arm C compared with arm A (31.3% vs. 17.3%; P = 0.001) and arm B (31.3% vs. 18.1%; P = 0.001). No significant difference in the rate of HBeAg loss was observed between arms A and B. The proportions of patients with HBe seroconversion, HBV DNA levels <20,000 IU/mL, and ALT normalization at the end of follow-up were significantly higher in arm C compared with arm A and arm B. In arms A, B, and C, rates of early treatment discontinuation were 6.3%, 4.9%, and 8.9%; of discontinuation due to an AE, 2%, 3%, and 3%; and of AEs requiring dose modification, 3%, 6%, and 10%, respectively.
Conclusions
In Chinese patients with HBeAg-positive chronic hepatitis B, PEG-IFN alfa-2b 1.5 μg/kg/wk for 48 weeks is more efficacious compared with 1.0 and 1.5 μg/kg/wk for 24 weeks.