HBV DNA suppression and HBsAg clearance in HBeAg negative chronic hepatitis B patients on lamivudine therapy for over 5 years

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• 作者：Massimo Fasano¹ ; Pietro Lampertico² ; Alfredo Marzano³ ; Vito Di Marco⁴ ; Grazia Anna Niro⁵ ; Giuseppina Brancaccio⁶ ; Andrea Marengo³ ; Gaetano Scotto⁷ ; Maurizia Rossana Brunetto⁸ ; Giovanni Battista Gaeta⁶ ; Mario Rizzetto³ ; Gioacchino Angarano¹ ; Teresa Santantonio⁷ ; ^{t.santantonio@unifg.it} ; ^{t.santantonio@clininf.uniba.it}
• 关键词：LAM ; lamivudine ; HBsAg ; hepatitis B surface antigen ; HBeAg ; hepatitis B e antigen ; HBV ; hepatitis B virus ; RT ; reverse transcriptase ; ALT ; alanine aminotransferase ; LAM-R ; LAM resistance ; NA ; nucleos(t)ide analogue ; VB ; virological breakthrough
• 刊名：Journal of Hepatology
• 出版年：2012
• 期刊代码：162_01688278
• 类别：med
• 出版时间：June, 2012
• 卷：56
• 期：6
• 页码：1254-1258
• 文件大小：540 K

摘要

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Background & Aims

In long-term responder patients, it is unclear whether lamivudine (LAM) monotherapy should be continued or switched to a high-genetic-barrier analogue. This study aims at assessing LAM efficacy over a 5-year period and the residual risk of drug resistance. The rate of HBsAg clearance and LAM long-term safety profile were also evaluated.

Methods

One hundred and ninety-one patients with chronic HBeAg-negative hepatitis B successfully treated with LAM monotherapy for at least 5 years were included. Biochemical and virological tests were assessed every 3 months in all patients and HBsAg quantification was performed in 45/191. Reverse-transcriptase (RT) region was directly sequenced in virological breakthrough patients.

Results

One hundred and ninety-one patients (148 males, median age 53 years, 72 with compensated cirrhosis) responding to 60-month LAM monotherapy continued to receive LAM monotherapy beyond the initial 5 years and were followed for an additional 36-month median period (range 1-108). Virological response was maintained in 128/191 patients (67%) and HBsAg clearance was observed in 15/128 (11.7%) after a 32-month median period (range 1-65). The 63 remaining patients (33%) showed virological breakthrough after a 15-month median treatment (range 1-78). RT region analysis was performed in 38/63 breakthrough patients and LAM resistant mutations were found in 37/38. No significant side effects were observed.

Conclusions

In long-term responder patients, continuation of LAM monotherapy resulted in persistent viral suppression in most cases with undetectable HBV DNA by real-time PCR; moreover, 11.7%of these patients cleared HBsAg. Selection of LAM resistance, however, can still occur even after successful long-term therapy, thus emphasising the importance of a careful virological monitoring.