Safety and efficacy of two-step peginterferon a-2a treatment in patients of chronic hepatitis B with acute exacerbation

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http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2893.2011.01469.x/abstract

Safety and efficacy of two-step peginterferon α-2a treatment in patients of

chronic hepatitis B with acute exacerbation

C.-C. Chen, P.-C. Wang, H.-W. Chang, C.-F. Chen

Article first published online: 4 JUL 2011

DOI: 10.1111/j.1365-2893.2011.01469.x

© 2011 Blackwell Publishing Ltd

Issue

Journal of Viral Hepatitis

Early View (Online Version of Record published before inclusion in an issue)

Summary.  The focus of this study was to evaluate the safety and efficacy of

sequential peginterferon α-2a (Pegasys) therapy for chronic hepatitis B with

acute exacerbation [ALT > 10 × upper limit of normal (ULN), bilirubin <2.0

mg/dL]. Four groups of patients categorized by HBeAg status and treatment

regimens were studied since May 2007. Nineteen HBeAg-positive patients (Group 1)

had received entecavir  pretreatment  (when ALT > 10 × ULN) plus Pegasys

(180 μg/kg/week, when ALT was 5–10 × ULN) for 24 weeks. Thirteen

HBeAg-negative patients (Group 2) had the same protocol for 48 weeks. In both

groups, entecavir was then discontinued 14 days after the initiation of Pegasys.

The results were compared, respectively, to 35 HBeAg-positive patients (Group 3)

and 24 HBeAg-negative patients (Group 4), all with ALT > 5 × ULN, under

continual entecavir monotherapy. The ALT levels of patients in Group 1 and 2 who

had received entecavir pretreatment for a duration of 19.63 ± 3.34 days were

below four times of ULN following 4 weeks of Pegasys treatment. At week 96, the

rates of sustained virological response were 69.2% (9/13) and 80% (8/10), and

the relapse rates were 23.1% (3/13) and 11.2% (1/9) for HBeAg-positive and

HBeAg-negative patients with two-step Pegasys treatment, respectively. The HBeAg

seroconversion rates were 46.2% in Group 1, and 42.1% in Group 3; HBsAg loss

rates were 15.4% (2/13) in Group 1, and 30% (3/10) in Group 2, whereas none

achieved HBsAg loss with entecavir monotherapy (Group 3 and 4). The two-step

Pegasys treatment offers an alternative, other than the nucleos(t)ides, for

treating chronic hepatitis B with acute exacerbation and provides a safe,

efficacious, short-term and finite strategy.