Virologic, serologic, and biochemical outcomes through 2 years of treatment with entecavir and lamivudine in nucleoside-naïve Chinese patients with chronic hepatitis B: a randomized, multicenter study
Identifieur interne : 000246 ( Pmc/Curation ); précédent : 000245; suivant : 000247Virologic, serologic, and biochemical outcomes through 2 years of treatment with entecavir and lamivudine in nucleoside-naïve Chinese patients with chronic hepatitis B: a randomized, multicenter study
Auteurs : Guangbi Yao [République populaire de Chine] ; Chengwei Chen [République populaire de Chine] ; Weilun Lu [République populaire de Chine] ; Hong Ren [République populaire de Chine] ; Deming Tan [République populaire de Chine] ; Yuming Wang [République populaire de Chine] ; Daozheng Xu [République populaire de Chine] ; Jessica Liu [Belgique] ; Dong Xu [États-Unis] ; Cyril Llamoso [États-Unis]Source :
- Hepatology International [ 1936-0533 ] ; 2008.
Abstract
Entecavir demonstrated superior virologic and biochemical benefits over lamivudine at 48 weeks in nucleoside-naïve Chinese patients with chronic hepatitis B (CHB). We evaluated the effect of continued entecavir and lamivudine treatment in patients who continued treatment in year 2 and the off-treatment durability of patients who achieved a protocol-defined
Chinese adults (
Among patients treated during year 2 (entecavir:
Through 96 weeks of treatment, entecavir resulted in continued clinical benefit in nucleoside-naïve Chinese patients with CHB, with a safety profile comparable with lamivudine.
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DOI: 10.1007/s12072-008-9088-8
PubMed: 19669324
PubMed Central: 2716907
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Virologic, serologic, and biochemical outcomes through 2 years of treatment with entecavir and lamivudine in nucleoside-naïve Chinese patients with chronic hepatitis B: a randomized, multicenter study</title><author><name sortKey="Yao, Guangbi" sort="Yao, Guangbi" uniqKey="Yao G" first="Guangbi" last="Yao">Guangbi Yao</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Shanghai Jing An Qu Central Hospital, No. 259 Xikang Road, Shanghai, 200040 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Shanghai Jing An Qu Central Hospital, No. 259 Xikang Road, Shanghai</wicri:regionArea></affiliation></author><author><name sortKey="Chen, Chengwei" sort="Chen, Chengwei" uniqKey="Chen C" first="Chengwei" last="Chen">Chengwei Chen</name><affiliation wicri:level="1"><nlm:aff id="Aff2">Shanghai Liver Disease Research Center of the Nanjing Military Area, The 85th Hospital of PLA, Shanghai, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Shanghai Liver Disease Research Center of the Nanjing Military Area, The 85th Hospital of PLA, Shanghai</wicri:regionArea></affiliation></author><author><name sortKey="Lu, Weilun" sort="Lu, Weilun" uniqKey="Lu W" first="Weilun" last="Lu">Weilun Lu</name><affiliation wicri:level="1"><nlm:aff id="Aff3">No. 3 Hospital, Zhongshan University, Guangzhou, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>No. 3 Hospital, Zhongshan University, Guangzhou</wicri:regionArea></affiliation></author><author><name sortKey="Ren, Hong" sort="Ren, Hong" uniqKey="Ren H" first="Hong" last="Ren">Hong Ren</name><affiliation wicri:level="1"><nlm:aff id="Aff4">2nd Hospital, Chongqing Medical University, Chongqing, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>2nd Hospital, Chongqing Medical University, Chongqing</wicri:regionArea></affiliation></author><author><name sortKey="Tan, Deming" sort="Tan, Deming" uniqKey="Tan D" first="Deming" last="Tan">Deming Tan</name><affiliation wicri:level="1"><nlm:aff id="Aff5">Department of Infectious Diseases, Xiang Ya Hospital, Central South University, Changsha, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Infectious Diseases, Xiang Ya Hospital, Central South University, Changsha</wicri:regionArea></affiliation></author><author><name sortKey="Wang, Yuming" sort="Wang, Yuming" uniqKey="Wang Y" first="Yuming" last="Wang">Yuming Wang</name><affiliation wicri:level="1"><nlm:aff id="Aff6">Southwest Hospital, 3rd Military Medical University, Chongqing, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Southwest Hospital, 3rd Military Medical University, Chongqing</wicri:regionArea></affiliation></author><author><name sortKey="Xu, Daozheng" sort="Xu, Daozheng" uniqKey="Xu D" first="Daozheng" last="Xu">Daozheng Xu</name><affiliation wicri:level="1"><nlm:aff id="Aff7">Beijing Di Tan Hospital, Beijing, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Beijing Di Tan Hospital, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Liu, Jessica" sort="Liu, Jessica" uniqKey="Liu J" first="Jessica" last="Liu">Jessica Liu</name><affiliation wicri:level="1"><nlm:aff id="Aff8">Bristol-Myers Squibb Company, Braine L’Alleud, Belgium</nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea>Bristol-Myers Squibb Company, Braine L’Alleud</wicri:regionArea></affiliation></author><author><name sortKey="Xu, Dong" sort="Xu, Dong" uniqKey="Xu D" first="Dong" last="Xu">Dong Xu</name><affiliation wicri:level="2"><nlm:aff id="Aff9">Bristol-Myers Squibb Company, Wallingford, CT USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Connecticut</region></placeName><wicri:cityArea>Bristol-Myers Squibb Company, Wallingford</wicri:cityArea></affiliation></author><author><name sortKey="Llamoso, Cyril" sort="Llamoso, Cyril" uniqKey="Llamoso C" first="Cyril" last="Llamoso">Cyril Llamoso</name><affiliation wicri:level="2"><nlm:aff id="Aff9">Bristol-Myers Squibb Company, Wallingford, CT USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Connecticut</region></placeName><wicri:cityArea>Bristol-Myers Squibb Company, Wallingford</wicri:cityArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">19669324</idno><idno type="pmc">2716907</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2716907</idno><idno type="RBID">PMC:2716907</idno><idno type="doi">10.1007/s12072-008-9088-8</idno><date when="2008">2008</date><idno type="wicri:Area/Pmc/Corpus">000246</idno><idno type="wicri:Area/Pmc/Curation">000246</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Virologic, serologic, and biochemical outcomes through 2 years of treatment with entecavir and lamivudine in nucleoside-naïve Chinese patients with chronic hepatitis B: a randomized, multicenter study</title><author><name sortKey="Yao, Guangbi" sort="Yao, Guangbi" uniqKey="Yao G" first="Guangbi" last="Yao">Guangbi Yao</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Shanghai Jing An Qu Central Hospital, No. 259 Xikang Road, Shanghai, 200040 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Shanghai Jing An Qu Central Hospital, No. 259 Xikang Road, Shanghai</wicri:regionArea></affiliation></author><author><name sortKey="Chen, Chengwei" sort="Chen, Chengwei" uniqKey="Chen C" first="Chengwei" last="Chen">Chengwei Chen</name><affiliation wicri:level="1"><nlm:aff id="Aff2">Shanghai Liver Disease Research Center of the Nanjing Military Area, The 85th Hospital of PLA, Shanghai, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Shanghai Liver Disease Research Center of the Nanjing Military Area, The 85th Hospital of PLA, Shanghai</wicri:regionArea></affiliation></author><author><name sortKey="Lu, Weilun" sort="Lu, Weilun" uniqKey="Lu W" first="Weilun" last="Lu">Weilun Lu</name><affiliation wicri:level="1"><nlm:aff id="Aff3">No. 3 Hospital, Zhongshan University, Guangzhou, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>No. 3 Hospital, Zhongshan University, Guangzhou</wicri:regionArea></affiliation></author><author><name sortKey="Ren, Hong" sort="Ren, Hong" uniqKey="Ren H" first="Hong" last="Ren">Hong Ren</name><affiliation wicri:level="1"><nlm:aff id="Aff4">2nd Hospital, Chongqing Medical University, Chongqing, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>2nd Hospital, Chongqing Medical University, Chongqing</wicri:regionArea></affiliation></author><author><name sortKey="Tan, Deming" sort="Tan, Deming" uniqKey="Tan D" first="Deming" last="Tan">Deming Tan</name><affiliation wicri:level="1"><nlm:aff id="Aff5">Department of Infectious Diseases, Xiang Ya Hospital, Central South University, Changsha, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Infectious Diseases, Xiang Ya Hospital, Central South University, Changsha</wicri:regionArea></affiliation></author><author><name sortKey="Wang, Yuming" sort="Wang, Yuming" uniqKey="Wang Y" first="Yuming" last="Wang">Yuming Wang</name><affiliation wicri:level="1"><nlm:aff id="Aff6">Southwest Hospital, 3rd Military Medical University, Chongqing, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Southwest Hospital, 3rd Military Medical University, Chongqing</wicri:regionArea></affiliation></author><author><name sortKey="Xu, Daozheng" sort="Xu, Daozheng" uniqKey="Xu D" first="Daozheng" last="Xu">Daozheng Xu</name><affiliation wicri:level="1"><nlm:aff id="Aff7">Beijing Di Tan Hospital, Beijing, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Beijing Di Tan Hospital, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Liu, Jessica" sort="Liu, Jessica" uniqKey="Liu J" first="Jessica" last="Liu">Jessica Liu</name><affiliation wicri:level="1"><nlm:aff id="Aff8">Bristol-Myers Squibb Company, Braine L’Alleud, Belgium</nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea>Bristol-Myers Squibb Company, Braine L’Alleud</wicri:regionArea></affiliation></author><author><name sortKey="Xu, Dong" sort="Xu, Dong" uniqKey="Xu D" first="Dong" last="Xu">Dong Xu</name><affiliation wicri:level="2"><nlm:aff id="Aff9">Bristol-Myers Squibb Company, Wallingford, CT USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Connecticut</region></placeName><wicri:cityArea>Bristol-Myers Squibb Company, Wallingford</wicri:cityArea></affiliation></author><author><name sortKey="Llamoso, Cyril" sort="Llamoso, Cyril" uniqKey="Llamoso C" first="Cyril" last="Llamoso">Cyril Llamoso</name><affiliation wicri:level="2"><nlm:aff id="Aff9">Bristol-Myers Squibb Company, Wallingford, CT USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Connecticut</region></placeName><wicri:cityArea>Bristol-Myers Squibb Company, Wallingford</wicri:cityArea></affiliation></author></analytic><series><title level="j">Hepatology International</title><idno type="ISSN">1936-0533</idno><idno type="eISSN">1936-0541</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Purpose</title><p>Entecavir demonstrated superior virologic and biochemical benefits over lamivudine at 48 weeks in nucleoside-naïve Chinese patients with chronic hepatitis B (CHB). We evaluated the effect of continued entecavir and lamivudine treatment in patients who continued treatment in year 2 and the off-treatment durability of patients who achieved a protocol-defined <italic>consolidated response</italic> at week 48.</p></sec><sec><title>Methods</title><p>Chinese adults (<italic>n</italic> = 519) with CHB were randomized to a minimum of 52 weeks of treatment with entecavir 0.5 mg/day or lamivudine 100 mg/day. Patients with a <italic>consolidated response</italic> at week 48 (HBV DNA <0.7 MEq/ml for ≥24 weeks, ALT <1.25 times ULN, and, if HBeAg(+) at baseline, loss of HBeAg for at least 24 weeks) stopped treatment at week 52 and were followed off-treatment. Patients with a <italic>partial response</italic> at week 48 (HBV DNA <0.7 MEq/ml in the absence of other criteria for a consolidated response) could continue blinded treatment for up to 96 weeks. Patients were assessed for HBV DNA, ALT normalization, safety, and, if HBeAg(+) at baseline, for HBe seroconversion. Cumulative proportions of all treated patients who ever achieved these responses were also analyzed.</p></sec><sec><title>Results</title><p>Among patients treated during year 2 (entecavir: <italic>n</italic> = 193; lamivudine: <italic>n</italic> = 145), 74% of entecavir-treated and 41% of lamivudine-treated patients had HBV DNA <300 copies/ml by PCR at end of dosing and 96% of entecavir-treated and 82% of lamivudine-treated patients normalized ALT. Eleven percent of entecavir-treated versus 19% of lamivudine-treated patients underwent HBe seroconversion during year 2. Cumulative confirmed analysis for all treated patients through 96 weeks showed that 79% of entecavir-treated versus 46% of lamivudine-treated patients (<italic>p</italic> < 0.0001) achieved HBV DNA <300 copies/ml by PCR. Similar proportions of entecavir- and lamivudine-treated patients achieved confirmed ALT normalization and HBe seroconversion. Safety profile was comparable for both treatment groups.</p></sec><sec><title>Conclusions</title><p>Through 96 weeks of treatment, entecavir resulted in continued clinical benefit in nucleoside-naïve Chinese patients with CHB, with a safety profile comparable with lamivudine.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><pmc xml:lang="EN" article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Hepatol Int</journal-id><journal-title>Hepatology International</journal-title><issn pub-type="ppub">1936-0533</issn><issn pub-type="epub">1936-0541</issn><publisher><publisher-name>Springer-Verlag</publisher-name><publisher-loc>New York</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">19669324</article-id><article-id pub-id-type="pmc">2716907</article-id><article-id pub-id-type="publisher-id">9088</article-id><article-id pub-id-type="doi">10.1007/s12072-008-9088-8</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Article</subject></subj-group></article-categories><title-group><article-title>Virologic, serologic, and biochemical outcomes through 2 years of treatment with entecavir and lamivudine in nucleoside-naïve Chinese patients with chronic hepatitis B: a randomized, multicenter study</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name name-style="western"><surname>Yao</surname><given-names>Guangbi</given-names></name><address><email>yaogb@yahoo.com.cn</email></address><xref ref-type="aff" rid="Aff1">1</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Chen</surname><given-names>ChengWei</given-names></name><address><email>ganzang@online.sh.cn</email></address><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Lu</surname><given-names>WeiLun</given-names></name><address><email>gzdoctor@163.com</email></address><xref ref-type="aff" rid="Aff3">3</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Ren</surname><given-names>Hong</given-names></name><address><email>renhong0531@vip.sina.com.cn</email></address><xref ref-type="aff" rid="Aff4">4</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Tan</surname><given-names>DeMing</given-names></name><address><email>dmt2008@yahoo.com.cn</email></address><xref ref-type="aff" rid="Aff5">5</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Wang</surname><given-names>YuMing</given-names></name><address><email>wym417@mail.tm.mu.com.cn</email></address><xref ref-type="aff" rid="Aff6">6</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Xu</surname><given-names>DaoZheng</given-names></name><address><email>xudaozhen@126.com</email></address><xref ref-type="aff" rid="Aff7">7</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Liu</surname><given-names>Jessica</given-names></name><address><email>jessica.liu@bms.com</email></address><xref ref-type="aff" rid="Aff8">8</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Xu</surname><given-names>Dong</given-names></name><address><email>dong.xu@bms.com</email></address><xref ref-type="aff" rid="Aff9">9</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Llamoso</surname><given-names>Cyril</given-names></name><address><email>cyril.llamoso@bms.com</email></address><xref ref-type="aff" rid="Aff9">9</xref></contrib><aff id="Aff1"><label>1</label>Shanghai Jing An Qu Central Hospital, No. 259 Xikang Road, Shanghai, 200040 China</aff><aff id="Aff2"><label>2</label>Shanghai Liver Disease Research Center of the Nanjing Military Area, The 85th Hospital of PLA, Shanghai, China</aff><aff id="Aff3"><label>3</label>No. 3 Hospital, Zhongshan University, Guangzhou, China</aff><aff id="Aff4"><label>4</label>2nd Hospital, Chongqing Medical University, Chongqing, China</aff><aff id="Aff5"><label>5</label>Department of Infectious Diseases, Xiang Ya Hospital, Central South University, Changsha, China</aff><aff id="Aff6"><label>6</label>Southwest Hospital, 3rd Military Medical University, Chongqing, China</aff><aff id="Aff7"><label>7</label>Beijing Di Tan Hospital, Beijing, China</aff><aff id="Aff8"><label>8</label>Bristol-Myers Squibb Company, Braine L’Alleud, Belgium</aff><aff id="Aff9"><label>9</label>Bristol-Myers Squibb Company, Wallingford, CT USA</aff></contrib-group><pub-date pub-type="epub"><day>30</day><month>8</month><year>2008</year></pub-date><pub-date pub-type="ppub"><month>12</month><year>2008</year></pub-date><volume>2</volume><issue>4</issue><fpage>486</fpage><lpage>493</lpage><history><date date-type="received"><day>9</day><month>8</month><year>2007</year></date><date date-type="accepted"><day>23</day><month>6</month><year>2008</year></date></history><permissions><copyright-statement>© Asian Pacific Association for the Study of the Liver 2008</copyright-statement></permissions><abstract xml:lang="EN"><sec><title>Purpose</title><p>Entecavir demonstrated superior virologic and biochemical benefits over lamivudine at 48 weeks in nucleoside-naïve Chinese patients with chronic hepatitis B (CHB). We evaluated the effect of continued entecavir and lamivudine treatment in patients who continued treatment in year 2 and the off-treatment durability of patients who achieved a protocol-defined <italic>consolidated response</italic> at week 48.</p></sec><sec><title>Methods</title><p>Chinese adults (<italic>n</italic> = 519) with CHB were randomized to a minimum of 52 weeks of treatment with entecavir 0.5 mg/day or lamivudine 100 mg/day. Patients with a <italic>consolidated response</italic> at week 48 (HBV DNA <0.7 MEq/ml for ≥24 weeks, ALT <1.25 times ULN, and, if HBeAg(+) at baseline, loss of HBeAg for at least 24 weeks) stopped treatment at week 52 and were followed off-treatment. Patients with a <italic>partial response</italic> at week 48 (HBV DNA <0.7 MEq/ml in the absence of other criteria for a consolidated response) could continue blinded treatment for up to 96 weeks. Patients were assessed for HBV DNA, ALT normalization, safety, and, if HBeAg(+) at baseline, for HBe seroconversion. Cumulative proportions of all treated patients who ever achieved these responses were also analyzed.</p></sec><sec><title>Results</title><p>Among patients treated during year 2 (entecavir: <italic>n</italic> = 193; lamivudine: <italic>n</italic> = 145), 74% of entecavir-treated and 41% of lamivudine-treated patients had HBV DNA <300 copies/ml by PCR at end of dosing and 96% of entecavir-treated and 82% of lamivudine-treated patients normalized ALT. Eleven percent of entecavir-treated versus 19% of lamivudine-treated patients underwent HBe seroconversion during year 2. Cumulative confirmed analysis for all treated patients through 96 weeks showed that 79% of entecavir-treated versus 46% of lamivudine-treated patients (<italic>p</italic> < 0.0001) achieved HBV DNA <300 copies/ml by PCR. Similar proportions of entecavir- and lamivudine-treated patients achieved confirmed ALT normalization and HBe seroconversion. Safety profile was comparable for both treatment groups.</p></sec><sec><title>Conclusions</title><p>Through 96 weeks of treatment, entecavir resulted in continued clinical benefit in nucleoside-naïve Chinese patients with CHB, with a safety profile comparable with lamivudine.</p></sec></abstract><kwd-group><title>Keywords</title><kwd>Entecavir</kwd><kwd>Lamivudine</kwd><kwd>Hepatitis B Virus</kwd></kwd-group><custom-meta-wrap><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© Asian Pacific Association for the Study of the Liver 2008</meta-value></custom-meta></custom-meta-wrap></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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