A 96-week randomized trial of switching to entecavir in patients who achieved virological suppression on lamivudine therapy

Sang Hoon Ahn, Jeong Heo, Jun Yong Park, Hyun Young Woo, Heon Ju Lee, Won Young Tak, Soon-Ho Um, Ki Tae Yoon, Soo Young Park, Chang Wook Kim, Hyung Hoi Kim, Kwang Hyub Han, Mong Cho

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background and Aim:: There are limited data assessing whether patients who achieved virological suppression on lamivudine but remain hepatitis B "e" antigen-positive should be switched to a more potent antiviral with a high genetic barrier to resistance or continue with lamivudine. We compared the safety and efficacy of switching with entecavir versus continuing lamivudine. Methods:: This was a Phase IV, randomized, open-label, prospective study in a tertiary care setting. Seventy-three chronic hepatitis B patients who achieved virological suppression on lamivudine (serum hepatitis B virus DNA<60International Unit (IU)/mL) were enrolled. Entecavir or lamivudine were administered orally for up to 96weeks. Virologic and serologic responses were measured throughout the study. Results:: A significantly higher proportion of patients in the entecavir group achieved hepatitis B virus DNA<60IU/mL at Weeks 48 (100% [38/38] vs 62.8% [22/35]; P<0.001) and 96 (97.4% [37/38] vs 57.1% [20/35]; P<0.001). A greater number of patients had virologic breakthrough (Week 96 cumulative incidence 42.9% vs 2.6%; P<0.001) and genotypic lamivudine resistance (28.6% [10/35] vs 0% [0/38]; P<0.001) in the lamivudine group. No serious adverse events or laboratory abnormalities were reported. Conclusions:: Even after achieving virological suppression on lamivudine therapy, the risk of emergent lamivudine resistance increases over time. Switching to entecavir resulted in a maintained virologic response and superior serologic responses versus continued lamivudine therapy. This study supports a rationale for switching to entecavir in chronic hepatitis B patients with virological suppression on lamivudine.

Original languageEnglish
Pages (from-to)865-871
Number of pages7
JournalJournal of Gastroenterology and Hepatology (Australia)
Volume31
Issue number4
DOIs
Publication statusPublished - 2016 Apr 1

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Lamivudine
Therapeutics
Chronic Hepatitis B
Hepatitis B virus
entecavir
Hepatitis B e Antigens
DNA
Tertiary Healthcare
Antiviral Agents
Prospective Studies
Safety

Keywords

  • Entecavir
  • Hepatitis B
  • Lamivudine

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

A 96-week randomized trial of switching to entecavir in patients who achieved virological suppression on lamivudine therapy. / Ahn, Sang Hoon; Heo, Jeong; Park, Jun Yong; Woo, Hyun Young; Lee, Heon Ju; Tak, Won Young; Um, Soon-Ho; Yoon, Ki Tae; Park, Soo Young; Kim, Chang Wook; Kim, Hyung Hoi; Han, Kwang Hyub; Cho, Mong.

In: Journal of Gastroenterology and Hepatology (Australia), Vol. 31, No. 4, 01.04.2016, p. 865-871.

Research output: Contribution to journalArticle

Ahn, SH, Heo, J, Park, JY, Woo, HY, Lee, HJ, Tak, WY, Um, S-H, Yoon, KT, Park, SY, Kim, CW, Kim, HH, Han, KH & Cho, M 2016, 'A 96-week randomized trial of switching to entecavir in patients who achieved virological suppression on lamivudine therapy', Journal of Gastroenterology and Hepatology (Australia), vol. 31, no. 4, pp. 865-871. https://doi.org/10.1111/jgh.13231
Ahn, Sang Hoon ; Heo, Jeong ; Park, Jun Yong ; Woo, Hyun Young ; Lee, Heon Ju ; Tak, Won Young ; Um, Soon-Ho ; Yoon, Ki Tae ; Park, Soo Young ; Kim, Chang Wook ; Kim, Hyung Hoi ; Han, Kwang Hyub ; Cho, Mong. / A 96-week randomized trial of switching to entecavir in patients who achieved virological suppression on lamivudine therapy. In: Journal of Gastroenterology and Hepatology (Australia). 2016 ; Vol. 31, No. 4. pp. 865-871.
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AU - Woo, Hyun Young

AU - Lee, Heon Ju

AU - Tak, Won Young

AU - Um, Soon-Ho

AU - Yoon, Ki Tae

AU - Park, Soo Young

AU - Kim, Chang Wook

AU - Kim, Hyung Hoi

AU - Han, Kwang Hyub

AU - Cho, Mong

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KW - Hepatitis B

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