On-treatment serum HBsAg level is predictive of sustained off-treatment virologic response to telbivudine in HBeAg-positive chronic hepatitis B patients

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JOURNAL OF CLINICAL VIROLOGY

On-treatment serum HBsAg level is predictive of sustained off-treatment

virologic response to telbivudine in HBeAg-positive chronic hepatitis B patients

Wei Caia, Qing Xiea, Baoyan Ana, Hui Wanga, Xiaqiu Zhoua, Guomin Zhaoa, Qing

Guoa, Ruiying Gua, Shisan Baoab

Received 21 December 2009; received in revised form 10 February 2010; accepted

17 February 2010. published online 16 March 2010.

Corrected Proof

Abstract

Background

Effective management of chronic hepatitis B infection is still very challenging,

despite decades of clinical research. Telbivudine is one of the most frequently

used antiviral drug at the current stage, but its long-term effectiveness,

particularly at off-treatment, is still unclear.

Objectives

To assess on-treatment HBsAg kinetics in patients treated with telbivudine for 2

years, and predicting sustained virologic response (SR) at 2 years

off-treatment.

Study design

Serum HBV DNA/HBsAg levels were assessed from 17 HBeAg+ patients treated with

telbivudine 600mg/day for 104 weeks, at baseline, weeks 24, 52 and 104, as well

as during off-treatment follow-up.

Results

HBsAg levels <2log10IU/ml at treatment week 104 were highly predictive of SR

(i.e., HBV DNA <300copies/ml, HBeAg seroconversion, ALT normalization) at 2

years off-treatment (positive predictive value [PPV], 93%; negative predictive

value [NPV], 100%). HBsAg levels consistently declined from baseline only in

patients achieving SR during 2 years off-treatment. At weeks 24 and 52, HBsAg

decline rate was a better predictor of off-treatment response than HBV DNA

decline rate. HBsAg decline rates of>0.8 and>1log10IU/ml at treatment weeks 24

and 52 were predictive of SR (PPV, 75%; NPV, 86% at week 24; PPV, 75%; NPV, 86%

at week 52).

Conclusions

Serum HBsAg levels <2log10IU/ml at treatment week 104 are highly predictive of

SR to telbivudine at 2 years off-treatment. HBsAg decline rate at on-treatment

weeks 24 and 52 from baseline were also more predictive of SR than HBV DNA

decline rate.

Abbreviations: SR, sustained virologic response, NAs, nucleos(t)ide analogs,

cccDNA, covalently closed circular DNA, VR, virologic response, CP,

consolidation period, pts, patients

a Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiaotong

University School of Medicine, Shanghai 200025, People's Republic of China

b Discipline of Pathology, University of Sydney, NSW 2006, Australia

Corresponding author. Tel.: +86 21 64370045; fax: +86 21 64454930.

Corresponding author at: Discipline of Pathology, University of Sydney, NSW

2006, Australia. Tel.: +61 2 9351 6156; fax: +61 2 9351 3429.

PII: S1386-6532(10)00086-7

doi:10.1016/j.jcv.2010.02.014

Crown . Published by Elsevier Inc. All rights reserved.