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Title: Efficacy and safety of entecavir versus adefovir in chronic hepatitis B patients with hepatic decompensation: A randomized, open-label study
Authors: Yun Fan Liaw
Maria Raptopoulou-Gigi
Hugo Cheinquer
Shiv Kumar Sarin
Tawesak Tanwandee
Nancy Leung
Cheng Yuan Peng
Robert P. Myers
Robert S. Brown
Lennox Jeffers
Naoky Tsai
Jolanta Bialkowska
Shijie Tang
Suzanne Beebe
Elizabeth Cooney
Chang Gung University College of Medicine
Aristotle University of Thessaloniki
Universidade Federal do Rio Grande do Sul
G.B. Pant Hospital India
Mahidol University
Alice Ho Miu Ling Nethersole Hospital
China Medical University Hospital Taichung
University of Calgary
Columbia University Medical Center
VA Medical Center
University of Hawaii at Manoa John A. Burns School of Medicine
Medical University of Lodz
Bristol-Myers Squibb
Keywords: Medicine
Issue Date: 1-Jul-2011
Citation: Hepatology. Vol.54, No.1 (2011), 91-100
Abstract: A randomized, open-label comparative study of entecavir versus adefovir therapy was performed in subjects with chronic hepatitis B who had hepatic decompensation (Child-Turcotte-Pugh score ≥7). Adult subjects were randomized and treated (n = 191) with entecavir 1.0 mg or adefovir 10 mg daily for up to 96 weeks from the date of last subject randomization. Subjects were positive or negative for hepatitis B e antigen and experienced or naive for treatment with nucleos(t)ide analogues. The primary efficacy endpoint was the mean reduction in serum hepatitis B virus (HBV) DNA, as determined by polymerase chain reaction, at week 24, adjusted for baseline HBV DNA and lamivudine resistance status by linear regression analysis. Entecavir demonstrated superiority to adefovir for this endpoint (treatment difference 1.74 log 10 copies/mL [95% confidence interval -2.30, -1.18]; P < 0.0001). The entecavir group showed a greater change from baseline in HBV DNA at all time points through week 48 and a higher proportion of subjects who achieved HBV DNA < 300 copies/mL at weeks 24 (entecavir 49%; adefovir 16%; P < 0.0001) and 48 (entecavir 57%; adefovir 20%; P < 0.0001). Approximately two-thirds of subjects in both groups showed improvement/stabilization in Child-Turcotte-Pugh status. Model for End-Stage Liver Disease score change at week 48 was -2.6 for entecavir and -1.7 for adefovir. Adverse event rates were comparable between groups. Cumulative hepatocellular carcinoma rates were 12% for entecavir and 20% for adefovir. Cumulative death rates were 23% for entecavir and 33% for adefovir. Week 24 mortality rates were 12% for both groups. Conclusion: Entecavir demonstrated superior virologic efficacy to adefovir in a population of patients with chronic hepatitis B who had hepatic decompensation. Biochemical and clinical benefits were also demonstrated. Entecavir was well tolerated, and early mortality rates were consistent with rates observed in similar populations treated with lamivudine. © 2011 American Association for the Study of Liver Diseases.
ISSN: 15273350
Appears in Collections:Scopus 2011-2015

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