Longterm efficacy of entecavir in adefovir-refractory chronic hepatitis B patients with prior lamivudine resistance

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J Viral Hepat. 2011 Oct;18(10):e475-81. doi: 10.1111/j.1365-2893.2011.01479.x.

Epub 2011 Jun 1.

Long-term efficacy of entecavir in adefovir-refractory chronic hepatitis B

patients with prior lamivudine resistance.

Park JW, Kim HS, Seo DD, Jang JS, Shin WG, Kim KH, Jang MK, Lee JH, Kim HY, Kim

DJ, Lee MS, Park CK.

Source

Department of Internal Medicine, Hallym University Medical Center, Seoul, Korea

Department of Internal Medicine, University of Inje College of Medicine, Seoul,

Korea Department of Internal Medicine, Seoul Veterans Hospital, Seoul, Korea.

Abstract

Summary.  This study aimed to evaluate the long-term efficacy of entecavir

(ETV) in adefovir (ADV)-refractory chronic hepatitis B (CHB) patients with prior

lamivudine (LMV) resistance. A total of 55 ADV-refractory CHB patients with

prior LMV resistance, who received rescue therapy with ETV 1 mg daily for at

least 12 months, were consecutively enrolled and analysed. Forty-four patients

were men, and their median age was 47 (25-69). Ten patients had liver cirrhosis

and 46 patients were positive for hepatitis B e antigen (HBeAg). Median

hepatitis B virus DNA levels were 6.6 (4.3-8.0) log(10)  copies/mL, and the

median duration of ETV therapy was 24 (12-47) months. Cumulative virologic

response rates at 6, 12, 24 and 36 months were 18%, 29%, 58% and 75%,

respectively. HBeAg loss occurred in 10 (21.7%) of 46 HBeAg-positive patients.

In multivariate analysis, only initial virologic response at 3 months remained

as an independent predictor for virologic response (RR 3.143; 95% CI

1.387-7.120; P = 0.006). The patients with a virological response at

3 months had not only a significantly higher probability of achieving a

virologic response (P < 0.001) but also lower probability of experiencing a

virologic breakthrough (P = 0.043) than the patients without an early

response. Viral breakthrough was observed in 29 patients during the follow-up

period. Cumulative breakthrough rates at 6, 12, 24 and 36 months were 0%, 15%,

45% and 73%, respectively. ETV monotherapy may be considerably efficacious in

cases with an initial virological response but its efficacy is attenuated by

frequent emergence of ETV resistance in ADV-refractory CHB patients with prior

LMV resistance.

© 2011 Blackwell Publishing Ltd.

PMID: 21914066 [PubMed - in process]