Peginterferon alfa-2b in the treatment of Chinese patients with HBeAg-positive chronic hepatitis B: A randomized trial

https://doi.org/10.1016/j.jcv.2014.08.008Get rights and content
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Highlights

  • A randomized study of patients with HBeAg-positive chronic hepatitis B.

  • PEG-IFN alfa-2b (1.5 μg/kg/wk or 1.0 μg/kg/wk) was administered for 24 or 48 weeks.

  • HBeAg loss was greater in patients receiving PEG-IFN (1.5 μg/kg/wk) for 48 weeks.

  • Secondary measures of efficacy also favor the 48-week regimen.

  • 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.

Abbreviations

AE
adverse event
AFP
alfa-fetoprotein
ALT
alanine aminotransferase
CI
confidence interval
HbEAb
hepatitis B e antibody
HBeAg
hepatitis B e antigen
HbSAb
antibody to hepatitis B surface antigen
HBsAg
surface antigen of the hepatitis B virus
HBV
hepatitis B virus
ITT
intent-to-treat
PEG-IFN
peginterferon
SAE
serious adverse event

Keywords

Peginterferon
Hepatitis B
Randomized

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