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 : 001270 ( Main/Merge ); précédent : 001269; suivant : 001271Virologic, 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="Liu, Jessica" sort="Liu, Jessica" uniqKey="Liu J" first="Jessica" last="Liu">Jessica Liu</name>
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<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>
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<country xml:lang="fr">République populaire de Chine</country>
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<country xml:lang="fr">République populaire de Chine</country>
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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>
<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>
<wicri:noRegion>Changsha</wicri:noRegion>
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<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>
<wicri:noRegion>Chongqing</wicri:noRegion>
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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="3"><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>
<placeName><settlement type="city">Pékin</settlement>
</placeName>
</affiliation>
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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>
<wicri:noRegion>Braine L’Alleud</wicri:noRegion>
</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>
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<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>
<idno type="eISSN">1936-0541</idno>
<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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