Defining Virologic Relapse in Chronic Hepatitis B

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http://www.springerlink.com/content/n5729360x07736mm/

Digestive Diseases and Sciences

DOI: 10.1007/s10620-011-1597-yOnline First¢â

Original Article

Defining Virologic Relapse in Chronic Hepatitis B

Kyung Hee Kim, Dong Hyun Sinn, Won Kyoung Yun, Hyun Chin Cho, Yun Young Lee,

Geum-Youn Gwak, Moon Seok Choi, Joon Hyeok Lee, Kwang Cheol Koh and Byung Chul

Yoo, et al.

Abstract

Background and Aims

Different definitions of virologic relapse (VR) are being used. One way of

defining VR is ¡°reappearance of HBV DNA in the serum,¡± while another

definition is an ¡°increase in HBV DNA level greater than 1 log in two

determinations at least 4 weeks apart.¡± The aim of this study was to see the

effectiveness of these two definitions

Methods

Forty-five HBeAg-positive chronic hepatitis B patients with a virologic response

[negative PCR (<12 IU/ml)] who had discontinued therapy were analyzed

retrospectively for VR, HBeAg reversion and biochemical flare.

Results

HBV DNA reappeared in the serum (¡Ã12 IU/ml) of all 45 patients (100%). An

increase in HBV DNA level greater than 1 log in two determinations at least 4

weeks apart was identified in 20 of 25 patients (80%). Biochemical flare and

HBeAg reversion were observed in 18 (40%) and 14 (31%) patients, respectively.

Peak off-therapy HBV DNA level was significantly associated with biochemical

flare (r = 0.758, P < 0.001) and HBeAg reversion (r = 0.645, P < 0.001). Two

patients with high initial off-therapy HBV DNA levels (¡Ã4.0 log10 IU/ml) were

reassessed at 4 weeks, and both experienced a biochemical flare and HBeAg

reversion. Two patients had an increase in HBV DNA level greater than 1 log at a

very low level (1 log to 2 or 3 log), but did not experience biochemical flare

or HBeAg reversion during follow-up.

Conclusions

Reappearance of HBV DNA was universal when sensitive HBV DNA assay was used.

Waiting 4 weeks to confirm VR may be harmful for patients with a high HBV DNA

level, and was ineffective to indicate re-therapy for patients with increase in

HBV DNA at a very low level. There is a need for improved and standardized

definitions of VR.