0 14

Cited 0 times in

Efficacy and safety of entecavir versus lamivudine over 5 years of treatment: A randomized controlled trial in Korean patients with hepatitis B e antigen-negative chronic hepatitis B

Other Titles
 Efficacy and safety of entecavir versus lamivudine over 5 years of treatment: A randomized controlled trial in Korean patients with hepatitis B e antigen-negative chronic hepatitis B 
Authors
 Kwan Sik Lee  ;  Young-Oh Kweon  ;  Soon-Ho Um  ;  Byung-Ho Kim  ;  Young Suk Lim  ;  Seung Woon Paik  ;  Jeong Heo  ;  Heon-Ju Lee  ;  Dong Joon Kim  ;  Tae Hun Kim  ;  Young-Sok Lee  ;  Kwan Soo Byun  ;  Daeghon Kim  ;  Myung Seok Lee  ;  Kyungha Yu  ;  Dong Jin Suh 
Citation
 Clinical and Molecular Hepatology, Vol.23(4) : 331-339, 2017 
Journal Title
 Clinical and Molecular Hepatology 
ISSN
 2287-2728 
Issue Date
2017
Keywords
Entecavir ; Hepatitis B ; Lamivudine ; Long-term effects
Abstract
BACKGROUND/AIMS: Long-term data on antiviral therapy in Korean patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) are limited. This study evaluated the efficacy and safety of entecavir (ETV) and lamivudine (LAM) over 240 weeks. METHODS: Treatment-naive patients with HBeAg-negative CHB were randomized to receive ETV 0.5 mg/day or LAM 100 mg/day during the 96 week double-blind phase, followed by open-label treatment through week 240. The primary endpoint was the proportion of patients with virologic response (VR; hepatitis B virus [HBV] DNA<300 copies/mL) at week 24. Secondary objectives included alanine aminotransferase (ALT) normalization and emergence of ETV resistance (week 96), VR and log reduction in HBV DNA levels (week 240), and safety evaluation. RESULTS: In total, 120 patients (>16 years old) were included (ETV, n=56; LAM, n=64). Baseline characteristics were comparable between the two groups. A significantly higher proportion of ETV-treated patients achieved VR compared to LAM at week 24 (92.9% vs. 67.2%, P=0.0006), week 96 (94.6% vs. 48.4%, P<0.0001), and week 240 (95.0% vs. 47.6%, P<0.0001). At week 96, ALT normalization was observed in 87.5% and 51.6% of ETV and LAM patients, respectively (P<0.0001). Virologic breakthrough occurred in one patient (1.8%) receiving ETV and 26 patients (42.6%) receiving LAM (P<0.0001) up to week 96. Emergence of resistance to ETV was not detected. The incidence of serious adverse events was low and unrelated to the study medications. CONCLUSIONS: Long-term ETV treatment was superior to LAM, with a significantly higher proportion of patients achieving VR. Both treatments were well tolerated.
URI
http://ir.ymlib.yonsei.ac.kr/handle/22282913/161599
DOI
10.3350/cmh.2016.0040
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실)
Yonsei Authors
이관식(Lee, Kwan Sik)
사서에게 알리기
  feedback
Export
RIS (EndNote)
XLS (Excel)
XML

qrcode

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

Browse