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Entecavir Therapy for up to 96 Weeks in Patients With HBeAg-Positive Chronic Hepatitis B

Authors
 Robert G. Gish  ;  Anna S. Lok  ;  Helena Brett–Smit  ;  Richard Colonno  ;  Joanna Yang  ;  Melissa Harris  ;  Shou–Dong Lee  ;  You–Chen Chao  ;  Kwang–Hyub Han  ;  José Sollano  ;  Adrian Gadano  ;  Robert A. de Man  ;  Ting–Tsung Chang 
Citation
 GASTROENTEROLOGY, Vol.133(5) : 1437-1444, 2007 
Journal Title
GASTROENTEROLOGY
ISSN
 0016-5085 
Issue Date
2007
MeSH
Alanine Transaminase/blood ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use* ; DNA, Viral/blood ; Dose-Response Relationship, Drug ; Double-Blind Method ; Guanine/adverse effects ; Guanine/analogs & derivatives* ; Guanine/therapeutic use ; Hepatitis B e Antigens/blood* ; Hepatitis B virus/genetics ; Hepatitis B, Chronic/drug therapy* ; Hepatitis B, Chronic/immunology* ; Humans ; Lamivudine/adverse effects ; Lamivudine/therapeutic use
Abstract
BACKGROUND & AIMS:
Entecavir demonstrated superior benefit to lamivudine at 48 weeks in nucleoside-naive patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB). We evaluated continued entecavir and lamivudine treatment through 96 weeks.
METHODS:
709 HBeAg-positive CHB patients were randomized to entecavir 0.5 mg (n = 354) or lamivudine 100 mg (n = 355) once daily. At week 52, protocol-defined virologic responders could continue blinded treatment for up to 96 weeks. Patients continuing in year 2 (entecavir, n = 243; lamivudine, n = 164) were assessed for serum hepatitis B virus (HBV) DNA, alanine aminotransferase (ALT) normalization, HBeAg seroconversion, and safety. Cumulative confirmed proportions of all treated patients who achieved these responses were also analyzed.
RESULTS:
Among patients treated in year 2, 74% of entecavir-treated versus 37% of lamivudine-treated patients achieved HBV DNA <300 copies/mL by polymerase chain reaction (PCR), and 79% of entecavir-treated versus 68% of lamivudine-treated patients normalized ALT levels. Similar proportions of entecavir-treated and lamivudine-treated patients achieved HBeAg seroconversion (11% vs 12%, respectively). Higher proportions of entecavir-treated than lamivudine-treated patients achieved cumulative confirmed HBV DNA <300 copies/mL by PCR (80% vs 39%; P < .0001) and ALT normalization (87% vs 79%; P = .0056) through 96 weeks. Cumulative confirmed HBeAg seroconversion occurred in 31% of entecavir-treated versus 25% of lamivudine-treated patients (P = NS). Through 96 weeks, no patient experienced virologic breakthrough due to entecavir resistance. The safety profile was comparable in both groups.
CONCLUSIONS:
Entecavir treatment through 96 weeks results in continued benefit for patients with HBeAg-positive CHB.
Full Text
http://www.sciencedirect.com/science/article/pii/S0016508507014825
DOI
10.1053/j.gastro.2007.08.025
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Han, Kwang-Hyub(한광협) ORCID logo https://orcid.org/0000-0003-3960-6539
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/96042
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