Virological, serological and biochemical outcomes through 3 years of entecavir treatment in nucleoside-naive Chinese chronic hepatitis B patients

[Guest guest]

http://www3.interscience.wiley.com/journal/123308910/abstract

Journal of Viral Hepatitis

Volume 17 Issue s1, Pages 51 - 58

Special Issue: Conquering Hepatitis B: Experience from China

Published Online: 3 Mar 2010

© 2010 Blackwell Publishing Ltd

Virological, serological and biochemical outcomes through 3 years of entecavir

treatment in nucleoside-naive Chinese chronic hepatitis B patients

G. B. Yao 1 , H. Ren 2 , D. Z. Xu 3 , X. Q. Zhou 4 , J. D. Jia 5 , Y. M. Wang 6

and C. W. Chen 7

1 Clinical Immunology Research Center, Department of Gastroenterology and

Hepatology, Shanghai Jing An Central Hospital, Shanghai ; 2 Department of

Infectious Diseases, No. 2 Hospital Affiliated with Chongqing Medical University

; 3 Department of Infectious Diseases, Beijing Ditan Hospital, Beijing

University ; 4 Department of Infectious Diseases, Ruijin Hospital, Shanghai

JiaoTong University School of Medicine ; 5 Department of Gastroenterology,

Liver Research Center, Beijing Friendship Hospital, Capital University of

Medical Sciences ; 6 Department of Infectious Diseases, Southwest Hospital

Affiliated with the 3rd Military Medical University ; and 7 The 85th Hospital

of the PLA, Shanghai Liver Disease Research Center of the Nanjing Military Area,

China

Correspondence to Dr Guang Bi Yao, Clinical Immunology Research Center,

Department of Gastroenterology and Hepatology, Shanghai Jing An Central

Hospital, No. 259 Xikang Road, Shanghai, 200040 China. E-mail:

yaogb@...

Copyright © 2010 Blackwell Publishing Ltd

ABSTRACT

Summary. Hepatitis B virus (HBV) infection has a high prevalence in China.

Entecavir has shown superior efficacy over lamivudine in Chinese

nucleoside-naive chronic hepatitis B (CHB) patients over 48 weeks, with

continued clinical benefit to 96 weeks. The present study evaluates the

long-term efficacy of entecavir in Chinese CHB patients who continued entecavir

treatment for 144 weeks. Patients receiving either entecavir 0.5 mg/day (n =

258) or lamivudine 100 mg/day (n = 261) entered the initial 96-week randomized,

double-blind, controlled efficacy study. Patients who did not achieve a

consolidated response [HBV DNA <0.7 MEq/mL; alanine aminotransferase (ALT) <1.25

× upper limit of normal; and if hepatitis B e antigen (HBeAg) positive at

baseline, loss of HBeAg for ≥24 weeks] or who experienced viral breakthrough

or relapse entered a 48-week entecavir rollover study. A total of 160 patients

received continuous entecavir for 144 weeks; of these, 89% had undetectable

serum HBV DNA, 86% showed ALT normalization, 20% reported HBeAg loss and 8%

experienced HBeAg seroconversion. The cumulative rates of HBeAg loss and

seroconversion were 36% and 27% at Week 144, respectively. The development of

resistance was low, with three patients up to Week 96 and an additional two

patients in Weeks 96–144 showing evidence of associated genotypic mutations.

Entecavir was well tolerated. Adverse event rates were similar to those in

lamivudine-treated patients, but patients receiving entecavir experienced fewer

ALT flares. This study demonstrates that entecavir provides durable, long-term

suppression of HBV DNA and ALT normalization in Chinese CHB patients, and is

associated with low rates of emerging resistance. The results are consistent

with the findings using entecavir globally and in Japan.

--------------------------------------------------------------------------------

Received June 2009; accepted for publication September 2009

DIGITAL OBJECT IDENTIFIER (DOI)

10.1111/j.1365-2893.2010.01271

[Guest guest]

http://www3.interscience.wiley.com/journal/123308910/abstract

Journal of Viral Hepatitis

Volume 17 Issue s1, Pages 51 - 58

Special Issue: Conquering Hepatitis B: Experience from China

Published Online: 3 Mar 2010

© 2010 Blackwell Publishing Ltd

Virological, serological and biochemical outcomes through 3 years of entecavir

treatment in nucleoside-naive Chinese chronic hepatitis B patients

G. B. Yao 1 , H. Ren 2 , D. Z. Xu 3 , X. Q. Zhou 4 , J. D. Jia 5 , Y. M. Wang 6

and C. W. Chen 7

1 Clinical Immunology Research Center, Department of Gastroenterology and

Hepatology, Shanghai Jing An Central Hospital, Shanghai ; 2 Department of

Infectious Diseases, No. 2 Hospital Affiliated with Chongqing Medical University

; 3 Department of Infectious Diseases, Beijing Ditan Hospital, Beijing

University ; 4 Department of Infectious Diseases, Ruijin Hospital, Shanghai

JiaoTong University School of Medicine ; 5 Department of Gastroenterology,

Liver Research Center, Beijing Friendship Hospital, Capital University of

Medical Sciences ; 6 Department of Infectious Diseases, Southwest Hospital

Affiliated with the 3rd Military Medical University ; and 7 The 85th Hospital

of the PLA, Shanghai Liver Disease Research Center of the Nanjing Military Area,

China

Correspondence to Dr Guang Bi Yao, Clinical Immunology Research Center,

Department of Gastroenterology and Hepatology, Shanghai Jing An Central

Hospital, No. 259 Xikang Road, Shanghai, 200040 China. E-mail:

yaogb@...

Copyright © 2010 Blackwell Publishing Ltd

ABSTRACT

Summary. Hepatitis B virus (HBV) infection has a high prevalence in China.

Entecavir has shown superior efficacy over lamivudine in Chinese

nucleoside-naive chronic hepatitis B (CHB) patients over 48 weeks, with

continued clinical benefit to 96 weeks. The present study evaluates the

long-term efficacy of entecavir in Chinese CHB patients who continued entecavir

treatment for 144 weeks. Patients receiving either entecavir 0.5 mg/day (n =

258) or lamivudine 100 mg/day (n = 261) entered the initial 96-week randomized,

double-blind, controlled efficacy study. Patients who did not achieve a

consolidated response [HBV DNA <0.7 MEq/mL; alanine aminotransferase (ALT) <1.25

× upper limit of normal; and if hepatitis B e antigen (HBeAg) positive at

baseline, loss of HBeAg for ≥24 weeks] or who experienced viral breakthrough

or relapse entered a 48-week entecavir rollover study. A total of 160 patients

received continuous entecavir for 144 weeks; of these, 89% had undetectable

serum HBV DNA, 86% showed ALT normalization, 20% reported HBeAg loss and 8%

experienced HBeAg seroconversion. The cumulative rates of HBeAg loss and

seroconversion were 36% and 27% at Week 144, respectively. The development of

resistance was low, with three patients up to Week 96 and an additional two

patients in Weeks 96–144 showing evidence of associated genotypic mutations.

Entecavir was well tolerated. Adverse event rates were similar to those in

lamivudine-treated patients, but patients receiving entecavir experienced fewer

ALT flares. This study demonstrates that entecavir provides durable, long-term

suppression of HBV DNA and ALT normalization in Chinese CHB patients, and is

associated with low rates of emerging resistance. The results are consistent

with the findings using entecavir globally and in Japan.

--------------------------------------------------------------------------------

Received June 2009; accepted for publication September 2009

DIGITAL OBJECT IDENTIFIER (DOI)

10.1111/j.1365-2893.2010.01271