{"@context":{"@vocab":"https://cir.nii.ac.jp/schema/1.0/","rdfs":"http://www.w3.org/2000/01/rdf-schema#","dc":"http://purl.org/dc/elements/1.1/","dcterms":"http://purl.org/dc/terms/","foaf":"http://xmlns.com/foaf/0.1/","prism":"http://prismstandard.org/namespaces/basic/2.0/","cinii":"http://ci.nii.ac.jp/ns/1.0/","datacite":"https://schema.datacite.org/meta/kernel-4/","ndl":"http://ndl.go.jp/dcndl/terms/","jpcoar":"https://github.com/JPCOAR/schema/blob/master/2.0/"},"@id":"https://cir.nii.ac.jp/crid/1363388846226485760.json","@type":"Article","productIdentifier":[{"identifier":{"@type":"DOI","@value":"10.1002/hep.24361"}},{"identifier":{"@type":"URI","@value":"https://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1002%2Fhep.24361"}},{"identifier":{"@type":"URI","@value":"https://journals.lww.com/01515467-201107000-00014"}}],"dc:title":[{"@value":"Efficacy and safety of entecavir versus adefovir in chronic hepatitis B patients with hepatic decompensation: A randomized, open-label study"}],"description":[{"type":"abstract","notation":[{"@value":"<jats:title>\n                           <jats:bold>Abstract:</jats:bold>\n                        </jats:title>\n          <jats:sec>\n            <jats:title/>\n            <jats:p>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<jats:sub>10</jats:sub> copies/mL [95% confidence interval −2.30, −1.18]; <jats:italic toggle=\"yes\">P</jats:italic> < 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%; <jats:italic toggle=\"yes\">P</jats:italic> < 0.0001) and 48 (entecavir 57%; adefovir 20%; <jats:italic toggle=\"yes\">P</jats:italic> < 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. <jats:italic toggle=\"yes\">Conclusion:</jats:italic> 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. (HEPATOLOGY 2011;)</jats:p>\n          </jats:sec>"}]}],"creator":[{"@id":"https://cir.nii.ac.jp/crid/1383388846226485761","@type":"Researcher","foaf:name":[{"@value":"Yun-Fan Liaw"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388846226485890","@type":"Researcher","foaf:name":[{"@value":"Maria Raptopoulou-Gigi"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388846226485760","@type":"Researcher","foaf:name":[{"@value":"Hugo Cheinquer"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388846226485891","@type":"Researcher","foaf:name":[{"@value":"Shiv Kumar Sarin"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388846226485762","@type":"Researcher","foaf:name":[{"@value":"Tawesak Tanwandee"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388846226485892","@type":"Researcher","foaf:name":[{"@value":"Nancy Leung"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388846226485763","@type":"Researcher","foaf:name":[{"@value":"Cheng-Yuan Peng"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388846226485894","@type":"Researcher","foaf:name":[{"@value":"Robert P. Myers"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388846226485765","@type":"Researcher","foaf:name":[{"@value":"Robert S. Brown"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388846226485893","@type":"Researcher","foaf:name":[{"@value":"Lennox Jeffers"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388846226485888","@type":"Researcher","foaf:name":[{"@value":"Naoky Tsai"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388846226485764","@type":"Researcher","foaf:name":[{"@value":"Jolanta Bialkowska"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388846226485896","@type":"Researcher","foaf:name":[{"@value":"Shijie Tang"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388846226485895","@type":"Researcher","foaf:name":[{"@value":"Suzanne Beebe"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388846226485889","@type":"Researcher","foaf:name":[{"@value":"Elizabeth Cooney"}]}],"publication":{"publicationIdentifier":[{"@type":"PISSN","@value":"02709139"}],"prism:publicationName":[{"@value":"Hepatology"}],"dc:publisher":[{"@value":"Ovid Technologies (Wolters Kluwer Health)"}],"prism:publicationDate":"2011-07","prism:volume":"54","prism:number":"1","prism:startingPage":"91","prism:endingPage":"100"},"reviewed":"false","dc:rights":["http://doi.wiley.com/10.1002/tdm_license_1"],"url":[{"@id":"https://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1002%2Fhep.24361"},{"@id":"https://journals.lww.com/01515467-201107000-00014"}],"createdAt":"2011-04-18","modifiedAt":"2024-12-01","relatedProduct":[{"@id":"https://cir.nii.ac.jp/crid/1360565168116348928","@type":"Article","resourceType":"学術雑誌論文(journal article)","relationType":["isReferencedBy"],"jpcoar:relatedTitle":[{"@value":"JSH Guidelines for the Management of Hepatitis B Virus Infection"}]},{"@id":"https://cir.nii.ac.jp/crid/1390282679771619840","@type":"Article","relationType":["isReferencedBy"],"jpcoar:relatedTitle":[{"@language":"en","@value":"Two cases of acute hepatitis due to hepatitis E virus that are indigenous to Kitakyushu: a case report"},{"@language":"ja","@value":"北九州に土着したE型肝炎ウイルス株による急性肝炎の2例"},{"@value":"B型肝炎治療ガイドライン(第1.1版)"},{"@language":"ja-Kana","@value":"Bガタ カンエン チリョウ ガイドライン(ダイ1.1ハン)"},{"@language":"ja-Kana","@value":"キタキュウシュウ ニ ドチャク シタ Eガタ カンエンウイルスカブ ニ ヨル キュウセイ カンエン ノ 2レイ"},{"@value":"Guidelines for the management of hepatitis B virus infection"}]},{"@id":"https://cir.nii.ac.jp/crid/1390282679888296960","@type":"Article","relationType":["isReferencedBy"],"jpcoar:relatedTitle":[{"@language":"ja","@value":"<b>非代償性肝硬変の難治性腹水に茵蔯蒿湯合五苓散料が奏効した一例</b>"},{"@language":"en","@value":"<b>A Case of Refractory Ascites with Liver Cirrhosis Successfully Treated by the Combination of Inchinkoto and Goreisan (Inchinkoto-Go-Goreisan)</b>"},{"@value":"臨床報告 非代償性肝硬変の難治性腹水に茵蔯蒿湯合五苓散料が奏効した一例"},{"@language":"ja-Kana","@value":"リンショウ ホウコク ヒダイショウセイ カンコウヘン ノ ナンチセイ フクスイ ニ インチンコウトウゴウゴレイサンリョウ ガ ソウコウ シタ イチレイ"}]}],"dataSourceIdentifier":[{"@type":"CROSSREF","@value":"10.1002/hep.24361"},{"@type":"CROSSREF","@value":"10.3937/kampomed.66.337_references_DOI_8UvokUAA7WZhtK5Na1YkU7yaDCf"},{"@type":"CROSSREF","@value":"10.1111/hepr.12269_references_DOI_8UvokUAA7WZhtK5Na1YkU7yaDCf"},{"@type":"CROSSREF","@value":"10.2957/kanzo.54.402_references_DOI_8UvokUAA7WZhtK5Na1YkU7yaDCf"}]}