Optimal duration of additional therapy after biochemical and virological responses to lamivudine in

June 1, 2008

http://www.blackwell-synergy.com/doi/abs/10.1111/j.1872-034X.2008.00378.x

Hepatology Research

OnlineEarly Articles

To cite this article: Masaru Enomoto, Akihiro Tamori, Madoka Toyama Kohmoto,

Takehiro Hayashi, Hiroyasu Morikawa, Hisato Jomura, Hiroki Sakaguchi, Daiki

Habu, Norifumi Kawada, Susumu Shiomi, Shuhei Nishiguchi (2008)

Optimal duration of additional therapy after biochemical and virological

responses to lamivudine in patients with HBeAg-negative chronic hepatitis B: a

randomized trial

doi:10.1111/j.1872-034X.2008.00378.x

Abstract

Short Communication

Optimal duration of additional therapy after biochemical and virological

responses to lamivudine in patients with HBeAg-negative chronic hepatitis B: a

randomized trial

Masaru Enomoto,11Department of Hepatology and Akihiro Tamori,11Department of

Hepatology and Madoka Toyama Kohmoto,11Department of Hepatology and Takehiro

Hayashi,11Department of Hepatology and Hiroyasu Morikawa,11Department of

Hepatology and Hisato Jomura,11Department of Hepatology and Hiroki

Sakaguchi,11Department of Hepatology and Daiki Habu,11Department of Hepatology

and Norifumi Kawada,11Department of Hepatology and Dr Norifumi Kawada,

Department of Hepatology, Graduate School of Medicine, Osaka City University

Medical School, 1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan. Email:

kawadanori@... Susumu Shiomi22Department of Nuclear Medicine,

Graduate School of Medicine, Osaka City University Medical School, Osaka, Japan,

and and Shuhei Nishiguchi33Department of Internal Medicine, Hyogo College of

Medicine, Nishinomiya, Japan1Department of Hepatology and 2Department of Nuclear

Medicine, Graduate School of Medicine, Osaka City University Medical School,

Osaka, Japan, and 3Department of Internal Medicine, Hyogo College of Medicine,

Nishinomiya, Japan

Dr Norifumi Kawada, Department of Hepatology, Graduate School of Medicine, Osaka

City University Medical School, 1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585,

Japan. Email: kawadanori@...

Abstract

Aim: The endpoint of treatment with nucleoside analogs remains unclear for

patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B. We

report the results of a randomized trial to determine the optimal duration of

additional therapy after response to lamivudine in HBeAg-negative patients.

Methods: Twenty-two patients with HBeAg-negative chronic hepatitis B who

exhibited biochemical and virological responses to lamivudine were enrolled.

When patients responded to treatment, they were randomly assigned to receive 12

more months of therapy (Group A, 11 patients) or 24 more months of therapy

(Group B, 11 patients).

Results: The baseline characteristics of the patients were similar in the two

groups. Biochemical and virological responses were obtained in all patients

within 6 months. Drug resistance developed in one patient in Group A during

month 7 of additional therapy, and in five patients in Group B from months 13–23

of additional therapy. Ten patients in Group A and six in Group B completed the

protocol and were included in analysis. Eight of the 10 patients in Group A

experienced relapse between months 2 and 14 after the discontinuation of

therapy, while three of the six patients in Group B experienced relapse between

months 2 and 24. There was no difference in cumulative relapse rate between the

groups (P = 0.275).

Conclusion: Additional therapy with lamivudine for longer than 12 months after

biochemical and virological responses in patients with HBeAg-negative chronic

hepatitis B could increase the risk of drug resistance, but did not reduce the

rate of relapse.

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June 1, 2008