0 17

Cited 0 times in

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

Authors
 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 
Citation
 JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Vol.31(4) : 865-871, 2016-04 
Journal Title
 JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY 
ISSN
 0815-9319 
Issue Date
2016-04
Keywords
entecavir ; hepatitis B ; lamivudine
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 < 60 International Unit (IU)/mL) were enrolled. Entecavir or lamivudine were administered orally for up to 96 weeks. 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 < 60 IU/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.
Full Text
https://onlinelibrary.wiley.com/doi/full/10.1111/jgh.13231
DOI
10.1111/jgh.13231
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Jun Yong(박준용) ORCID logo https://orcid.org/0000-0001-6324-2224
Ahn, Sang Hoon(안상훈) ORCID logo https://orcid.org/0000-0002-3629-4624
Han, Kwang-Hyub(한광협) ORCID logo https://orcid.org/0000-0003-3960-6539
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/178485
사서에게 알리기
  feedback

qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

Browse

Links