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Hepatitis B Surface Antigen Loss in Antiviral-Treated Patients with HBeAg(+) Ch

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www.hbvadvocate.org

AASLD 2006

992. Hepatitis B Surface Antigen Loss in Antiviral-Treated Patients with

HBeAg(+) Chronic Hepatits B (CHB) Infection: Observations from

Antiviral-Naïve Patients Treated with Entecavir (ETV) or Lamivudine (LVD)

R. Gish; T. Chang; C. Lai; R. de Man; A. Gadano; F. Poordad; J. Zhu; J.

Yang; H. Brett-

Background:

Hepatitis B surface antigen (HBsAg) loss and HBsAg seroconversion are

considered an important goal of HBV therapy but are seldom achieved with

current treatments. We describe baseline characteristics and Week 24

treatment responses of patients who demonstrated confirmed HBsAg loss by

Week 120 (on-treatment or during the 24-week follow-up period).

Methods:

A total of 709 nucleose-naïve, HBeAg(+) patients received ETV 0.5 mg (n=354)

or LVD 100 mg (n=355) once daily for a minimum of 52 Wks and maximum of 96

Wks in the randomized, double-blind ETV-022 trial. Entry criteria included:

biopsy-confirmed liver disease, serum HBV DNA by bDNA levels & #8805;3

MEq/mL, ALT levels 1.3-10 x ULN and no prior nucleose therapy >12 Wks. Serum

HBV DNA, HBV serology (HBeAg/anti-HBe) and ALT were measured on treatment

and through 24 weeks off-treatment.

Results:

HBsAg loss was confirmed in 28/709 (4%) patients (18 for ETV and 10 for LVD)

by Wk 120. Baseline characteristics and Week (Wk) 24 treatment responses for

patients with confirmed HBsAg loss by Wk 120 are presented below.

Conclusions:

Patients with confirmed HBsAg loss by Wk 120 were characterized by genotype

A or D, male sex and Caucasian race at baseline and by HBeAg loss and HBeAg

seroconversion at Wk 24.

Baseline characteristics

Patients with confirmed HBsAg loss by Wk 120

Overall (N=28)

Male(%)

23(82%)

Asian(%)

4(14%)

Caucasian(%)

22(79%)

Other(%)

2(7%)

Mean viral load (log10 copies/ml)

9.8

Genotype A

15(54%)

Genotype B

3(11%)

Genotype C

1(4%)

Genotype D

7(25%)

Knodell necroinflammatory score (mean)

9.1

Mean and Median ALT (U/L)

226, 163

Week 24 Responses

HBeAg loss

14(50%)

HBeAg seroconversion

12(43%)

ALT normalization ( & #8804;1 x ULN)

15(54%)

HBV DNA <300 copies/mL

13(46%)

http://www.hbvadvocate.org/news/reports/HBV_AASLD_2006/HBV%20Abstracts/hbvabstra\

ctstreatmentOct30.htm#HBV992

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