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dc.contributor.authorYun Fan Liawen_US
dc.contributor.authorMaria Raptopoulou-Gigien_US
dc.contributor.authorHugo Cheinqueren_US
dc.contributor.authorShiv Kumar Sarinen_US
dc.contributor.authorTawesak Tanwandeeen_US
dc.contributor.authorNancy Leungen_US
dc.contributor.authorCheng Yuan Pengen_US
dc.contributor.authorRobert P. Myersen_US
dc.contributor.authorRobert S. Brownen_US
dc.contributor.authorLennox Jeffersen_US
dc.contributor.authorNaoky Tsaien_US
dc.contributor.authorJolanta Bialkowskaen_US
dc.contributor.authorShijie Tangen_US
dc.contributor.authorSuzanne Beebeen_US
dc.contributor.authorElizabeth Cooneyen_US
dc.contributor.otherChang Gung University College of Medicineen_US
dc.contributor.otherAristotle University of Thessalonikien_US
dc.contributor.otherUniversidade Federal do Rio Grande do Sulen_US
dc.contributor.otherG.B. Pant Hospital Indiaen_US
dc.contributor.otherMahidol Universityen_US
dc.contributor.otherAlice Ho Miu Ling Nethersole Hospitalen_US
dc.contributor.otherChina Medical University Hospital Taichungen_US
dc.contributor.otherUniversity of Calgaryen_US
dc.contributor.otherColumbia University Medical Centeren_US
dc.contributor.otherVA Medical Centeren_US
dc.contributor.otherUniversity of Hawaii at Manoa John A. Burns School of Medicineen_US
dc.contributor.otherMedical University of Lodzen_US
dc.contributor.otherBristol-Myers Squibben_US
dc.identifier.citationHepatology. Vol.54, No.1 (2011), 91-100en_US
dc.description.abstractA 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.en_US
dc.rightsMahidol Universityen_US
dc.titleEfficacy and safety of entecavir versus adefovir in chronic hepatitis B patients with hepatic decompensation: A randomized, open-label studyen_US
Appears in Collections:Scopus 2011-2015

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