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.
Url:
DOI: 10.1007/s12072-008-9088-8
PubMed: 19669324
PubMed Central: 2716907
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<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>
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<author><name sortKey="Chen, Chengwei" sort="Chen, Chengwei" uniqKey="Chen C" first="Chengwei" last="Chen">Chengwei Chen</name>
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<wicri:regionArea>Shanghai Liver Disease Research Center of the Nanjing Military Area, The 85th Hospital of PLA, Shanghai</wicri:regionArea>
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<author><name sortKey="Lu, Weilun" sort="Lu, Weilun" uniqKey="Lu W" first="Weilun" last="Lu">Weilun Lu</name>
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<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>
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<author><name sortKey="Tan, Deming" sort="Tan, Deming" uniqKey="Tan D" first="Deming" last="Tan">Deming Tan</name>
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<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>Department of Infectious Diseases, Xiang Ya Hospital, Central South University, Changsha</wicri:regionArea>
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<author><name sortKey="Wang, Yuming" sort="Wang, Yuming" uniqKey="Wang Y" first="Yuming" last="Wang">Yuming Wang</name>
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<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>
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<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>
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<author><name sortKey="Xu, Dong" sort="Xu, Dong" uniqKey="Xu D" first="Dong" last="Xu">Dong Xu</name>
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<placeName><region type="state">Connecticut</region>
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<wicri:cityArea>Bristol-Myers Squibb Company, Wallingford</wicri:cityArea>
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<author><name sortKey="Llamoso, Cyril" sort="Llamoso, Cyril" uniqKey="Llamoso C" first="Cyril" last="Llamoso">Cyril Llamoso</name>
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<placeName><region type="state">Connecticut</region>
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<wicri:cityArea>Bristol-Myers Squibb Company, Wallingford</wicri:cityArea>
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<author><name sortKey="Yao, Guangbi" sort="Yao, Guangbi" uniqKey="Yao G" first="Guangbi" last="Yao">Guangbi Yao</name>
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<country xml:lang="fr">République populaire de Chine</country>
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<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>
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<author><name sortKey="Lu, Weilun" sort="Lu, Weilun" uniqKey="Lu W" first="Weilun" last="Lu">Weilun Lu</name>
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<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>
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<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>
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<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>
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<series><title level="j">Hepatology International</title>
<idno type="ISSN">1936-0533</idno>
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<imprint><date when="2008">2008</date>
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<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>
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<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>
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