Randomised clinical trial: efficacy of peginterferon alfa-2a in HBeAg positive chronic hepatitis B patients with lamivudine resistance

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http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2036.2011.04750.x/abstract

Randomised clinical trial: efficacy of peginterferon alfa-2a in HBeAg positive

chronic hepatitis B patients with lamivudine resistance

J. Sun1, J.-L. Hou1, Q. Xie2, X.-H. Li3, J.-M. Zhang4, Y.-M. Wang5, H. Wang6,

J.-Y. Lai7, S.-J. Chen8, J.-D. Jia9, J.-F. Sheng10, H. L. Y. Chan11, J.-F.

Wang12, M. K. K. Li13, M. Jiang14, M. Popescu15, J. J. Y. Sung11

Article first published online: 22 JUN 2011

DOI: 10.1111/j.1365-2036.2011.04750.x

© 2011 Blackwell Publishing Ltd

Issue

Alimentary Pharmacology & Therapeutics

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

Summary

Background  Previous studies suggested that a finite course of peginterferon

alfa-2a may offer an alternative rescue therapy for patients with lamivudine

resistance. However, because of the limitation of study design and small sample

size, it is difficult to make definitive conclusion.

Aim  To explore the role of peginterferon alfa-2a, in the rescue treatment of

HBeAg-positive chronic hepatitis B patients with lamivudine resistance.

Methods  In this randomised study, chronic hepatitis B patients with

lamivudine resistance were treated with peginterferon alfa-2a for 48 weeks (n =

155) or adefovir for 72 weeks (n = 80). All enrolled patients were treated with

lamivudine for the first 12 weeks.

Results  At 6 months posttreatment, 14.6% (18/123) of peginterferon

alfa-2a-treated patients achieved HBeAg seroconversion, in contrast to 3.8%

(3/80) of adefovir-treated patients after 72 weeks continuous therapy (P =

0.01). For peginterferon alfa-2a-treated patients, the rate of HBeAg

seroconversion at week 72 was significantly higher in patients who had HBsAg

decline >0.5 Log10 IU/mL from baseline at week 24, compared with patients with

HBsAg decline ≤0.5 Log10 IU/mL from baseline at week 24 (25.5% vs. 7.7%, P =

0.01). After 72 weeks continuous adefovir treatment, 22.5% of patients achieved

HBV DNA <80 IU/mL, compared with 10.6% in peginterferon alfa-2a-treated patients

at 6 months off-treatment (P = 0.02).

Conclusions  Overall, the response to peginterferon alfa-2a among patients

with lamivudine resistance was suboptimal. HBeAg seroconversion rate at week 72

by 48 weeks peginterferon alfa-2a treatment was higher than continuous adefovir

therapy. Monitoring HBsAg levels can help to predict response to peginterferon

alfa-2a.