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Poor durability of lamivudine effectiveness despite stringent cessation criteria: A prospective clinical study in hepatitis B e antigen-negative chronic hepatitis B patients

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Poor durability of lamivudine effectiveness despite stringent cessation

criteria: A prospective clinical study in hepatitis B e antigen-negative chronic

hepatitis B patients

Feng Liu1,2,†, Lei Wang1,*,†, Xiao Ying Li3, You De Liu4, Jing Bo Wang3,

Zhao Hua Zhang3, Yao Zong Wang3

Article first published online: 17 FEB 2011

DOI: 10.1111/j.1440-1746.2010.06492.x

© 2011 Journal of Gastroenterology and Hepatology Foundation and Blackwell

Publishing Asia Pty Ltd

Issue

Journal of Gastroenterology and Hepatology

Volume 26, Issue 3, pages 456–460, March 2011

Abstract

Background and Aims:  Lamivudine, a nucleoside analog, is commonly used for

treatment of chronic hepatitis B (CHB) but its durability of effectiveness after

withdrawal is still uncertain. This study was designed to assess the durability

of lamivudine treatment with stringent cessation criteria in hepatitis B e

antigen (HBeAg)-negative patients and to explore potential predictive factors.

Methods:  Sixty one HBeAg-negative CHB patients who had received lamivudine

for at least 24 months and had maintained undetectable serum hepatitis B virus

(HBV) DNA plus normal alanine aminotransferase for ≥ 18 months before

withdrawal were included. They were followed up monthly during the first 4

months and at 3-month or 6-month intervals thereafter. Relapse was defined as

serum HBV DNA ≥ 104 copies/mL.

Results:  Thirty one of 61 patients relapsed during follow-up, over 90%

occurred within 18 months after lamivudine withdrawal. Cumulative relapse rates

at months 6, 12, 24, 36, 48 and 60 were 26.2%, 43.6%, 49.7%, 52.1%, 56.1% and

56.1%, respectively. regression revealed that age was the only predictive

factor for relapse, with lower relapse rates found in younger patients.

Hepatitis B surface antigen (HBsAg) turned negative in eight patients, and none

of them relapsed during follow-up.

Conclusion:  Effectiveness of lamivudine treatment is not durable in

HBeAg-negative CHB patients even when stringent cessation criteria are adopted,

with the exception of patients aged ≤ 20 years. The ideal end point of

lamivudine treatment is clearance of serum HBsAg.

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Poor durability of lamivudine effectiveness despite stringent cessation

criteria: A prospective clinical study in hepatitis B e antigen-negative chronic

hepatitis B patients

Feng Liu1,2,†, Lei Wang1,*,†, Xiao Ying Li3, You De Liu4, Jing Bo Wang3,

Zhao Hua Zhang3, Yao Zong Wang3

Article first published online: 17 FEB 2011

DOI: 10.1111/j.1440-1746.2010.06492.x

© 2011 Journal of Gastroenterology and Hepatology Foundation and Blackwell

Publishing Asia Pty Ltd

Issue

Journal of Gastroenterology and Hepatology

Volume 26, Issue 3, pages 456–460, March 2011

Abstract

Background and Aims:  Lamivudine, a nucleoside analog, is commonly used for

treatment of chronic hepatitis B (CHB) but its durability of effectiveness after

withdrawal is still uncertain. This study was designed to assess the durability

of lamivudine treatment with stringent cessation criteria in hepatitis B e

antigen (HBeAg)-negative patients and to explore potential predictive factors.

Methods:  Sixty one HBeAg-negative CHB patients who had received lamivudine

for at least 24 months and had maintained undetectable serum hepatitis B virus

(HBV) DNA plus normal alanine aminotransferase for ≥ 18 months before

withdrawal were included. They were followed up monthly during the first 4

months and at 3-month or 6-month intervals thereafter. Relapse was defined as

serum HBV DNA ≥ 104 copies/mL.

Results:  Thirty one of 61 patients relapsed during follow-up, over 90%

occurred within 18 months after lamivudine withdrawal. Cumulative relapse rates

at months 6, 12, 24, 36, 48 and 60 were 26.2%, 43.6%, 49.7%, 52.1%, 56.1% and

56.1%, respectively. regression revealed that age was the only predictive

factor for relapse, with lower relapse rates found in younger patients.

Hepatitis B surface antigen (HBsAg) turned negative in eight patients, and none

of them relapsed during follow-up.

Conclusion:  Effectiveness of lamivudine treatment is not durable in

HBeAg-negative CHB patients even when stringent cessation criteria are adopted,

with the exception of patients aged ≤ 20 years. The ideal end point of

lamivudine treatment is clearance of serum HBsAg.

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