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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Virologic Monitoring of Hepatitis B Virus Therapy in Clinical Trials and Practice: Recommendations for a Standardized Approach</title><author><name sortKey="Pawlotsky, Jean Ichel" sort="Pawlotsky, Jean Ichel" uniqKey="Pawlotsky J" first="Jean Ichel" last="Pawlotsky">Jean Ichel Pawlotsky</name><affiliation><nlm:aff id="A1"> French National Reference Center for Viral Hepatitis B, C and delta, Department of Virology, Henri Mondor Hospital, University of Paris XII, Créteil, France</nlm:aff></affiliation><affiliation><nlm:aff id="A2"> INSERM U841, Créteil, France</nlm:aff></affiliation></author><author><name sortKey="Dusheiko, Geoffrey" sort="Dusheiko, Geoffrey" uniqKey="Dusheiko G" first="Geoffrey" last="Dusheiko">Geoffrey Dusheiko</name><affiliation><nlm:aff id="A3"> Centre for Hepatology, Royal Free and University College School of Medicine, London, United Kingdom</nlm:aff></affiliation></author><author><name sortKey="Hatzakis, Angelos" sort="Hatzakis, Angelos" uniqKey="Hatzakis A" first="Angelos" last="Hatzakis">Angelos Hatzakis</name><affiliation><nlm:aff id="A4"> Department of Hygiene, Epidemiology and Medical Statistics, Athens University Medical School, Athens, Greece</nlm:aff></affiliation></author><author><name sortKey="Lau, Daryl" sort="Lau, Daryl" uniqKey="Lau D" first="Daryl" last="Lau">Daryl Lau</name><affiliation><nlm:aff id="A5">Liver Center, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts</nlm:aff></affiliation></author><author><name sortKey="Lau, George" sort="Lau, George" uniqKey="Lau G" first="George" last="Lau">George Lau</name><affiliation><nlm:aff id="A6"> Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong SAR, China</nlm:aff></affiliation></author><author><name sortKey="Liang, T Jake" sort="Liang, T Jake" uniqKey="Liang T" first="T. Jake" last="Liang">T. Jake Liang</name><affiliation><nlm:aff id="A7">Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland</nlm:aff></affiliation></author><author><name sortKey="Locarnini, Stephen" sort="Locarnini, Stephen" uniqKey="Locarnini S" first="Stephen" last="Locarnini">Stephen Locarnini</name><affiliation><nlm:aff id="A8"> Victorian Infectious Diseases Reference Laboratory, North Melbourne, Victoria, Australia</nlm:aff></affiliation></author><author><name sortKey="Martin, Paul" sort="Martin, Paul" uniqKey="Martin P" first="Paul" last="Martin">Paul Martin</name><affiliation><nlm:aff id="A9"> Division of Liver Diseases and Recanati-Miller Transplant Institute, Mount Sinai School of Medicine, New York, New York</nlm:aff></affiliation></author><author><name sortKey="Richman, Douglas D" sort="Richman, Douglas D" uniqKey="Richman D" first="Douglas D." last="Richman">Douglas D. Richman</name><affiliation><nlm:aff id="A10"> VA San Diego Healthcare System and University of California San Diego, La Jolla, California</nlm:aff></affiliation></author><author><name sortKey="Zoulim, Fabien" sort="Zoulim, Fabien" uniqKey="Zoulim F" first="Fabien" last="Zoulim">Fabien Zoulim</name><affiliation><nlm:aff id="A11"> INSERM U871, Hospices Civils de Lyon, Department of Liver Diseases, Université Lyon 1, Lyon, France</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">18242209</idno><idno type="pmc">2676233</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2676233</idno><idno type="RBID">PMC:2676233</idno><idno type="doi">10.1053/j.gastro.2007.11.036</idno><date when="2007">2007</date><idno type="wicri:Area/Pmc/Corpus">001407</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001407</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Virologic Monitoring of Hepatitis B Virus Therapy in Clinical Trials and Practice: Recommendations for a Standardized Approach</title><author><name sortKey="Pawlotsky, Jean Ichel" sort="Pawlotsky, Jean Ichel" uniqKey="Pawlotsky J" first="Jean Ichel" last="Pawlotsky">Jean Ichel Pawlotsky</name><affiliation><nlm:aff id="A1"> French National Reference Center for Viral Hepatitis B, C and delta, Department of Virology, Henri Mondor Hospital, University of Paris XII, Créteil, France</nlm:aff></affiliation><affiliation><nlm:aff id="A2"> INSERM U841, Créteil, France</nlm:aff></affiliation></author><author><name sortKey="Dusheiko, Geoffrey" sort="Dusheiko, Geoffrey" uniqKey="Dusheiko G" first="Geoffrey" last="Dusheiko">Geoffrey Dusheiko</name><affiliation><nlm:aff id="A3"> Centre for Hepatology, Royal Free and University College School of Medicine, London, United Kingdom</nlm:aff></affiliation></author><author><name sortKey="Hatzakis, Angelos" sort="Hatzakis, Angelos" uniqKey="Hatzakis A" first="Angelos" last="Hatzakis">Angelos Hatzakis</name><affiliation><nlm:aff id="A4"> Department of Hygiene, Epidemiology and Medical Statistics, Athens University Medical School, Athens, Greece</nlm:aff></affiliation></author><author><name sortKey="Lau, Daryl" sort="Lau, Daryl" uniqKey="Lau D" first="Daryl" last="Lau">Daryl Lau</name><affiliation><nlm:aff id="A5">Liver Center, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts</nlm:aff></affiliation></author><author><name sortKey="Lau, George" sort="Lau, George" uniqKey="Lau G" first="George" last="Lau">George Lau</name><affiliation><nlm:aff id="A6"> Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong SAR, China</nlm:aff></affiliation></author><author><name sortKey="Liang, T Jake" sort="Liang, T Jake" uniqKey="Liang T" first="T. Jake" last="Liang">T. Jake Liang</name><affiliation><nlm:aff id="A7">Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland</nlm:aff></affiliation></author><author><name sortKey="Locarnini, Stephen" sort="Locarnini, Stephen" uniqKey="Locarnini S" first="Stephen" last="Locarnini">Stephen Locarnini</name><affiliation><nlm:aff id="A8"> Victorian Infectious Diseases Reference Laboratory, North Melbourne, Victoria, Australia</nlm:aff></affiliation></author><author><name sortKey="Martin, Paul" sort="Martin, Paul" uniqKey="Martin P" first="Paul" last="Martin">Paul Martin</name><affiliation><nlm:aff id="A9"> Division of Liver Diseases and Recanati-Miller Transplant Institute, Mount Sinai School of Medicine, New York, New York</nlm:aff></affiliation></author><author><name sortKey="Richman, Douglas D" sort="Richman, Douglas D" uniqKey="Richman D" first="Douglas D." last="Richman">Douglas D. Richman</name><affiliation><nlm:aff id="A10"> VA San Diego Healthcare System and University of California San Diego, La Jolla, California</nlm:aff></affiliation></author><author><name sortKey="Zoulim, Fabien" sort="Zoulim, Fabien" uniqKey="Zoulim F" first="Fabien" last="Zoulim">Fabien Zoulim</name><affiliation><nlm:aff id="A11"> INSERM U871, Hospices Civils de Lyon, Department of Liver Diseases, Université Lyon 1, Lyon, France</nlm:aff></affiliation></author></analytic><series><title level="j">Gastroenterology</title><idno type="ISSN">0016-5085</idno><idno type="eISSN">1528-0012</idno><imprint><date when="2007">2007</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p id="P1">Treatment of chronic hepatitis B virus (HBV) infection is aimed at suppressing viral replication to the lowest possible level, and thereby to halt the progression of liver disease and prevent the onset of complications. Two categories of drugs are used in HBV therapy: the interferons, including standard interferon alfa or pegylated interferon alfa, and specific nucleoside or nucleotide HBV inhibitors that target the reverse-transcriptase function of HBV-DNA polymerase. The reported results of clinical trials have used varying definitions of efficacy, failure, and resistance based on different measures of virologic responses. This article discusses HBV virologic markers and tests, and their optimal use both for planning and reporting clinical trials and in clinical practice.</p></div></front></TEI><pmc article-type="research-article" xml:lang="EN"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">0374630</journal-id><journal-id journal-id-type="pubmed-jr-id">3841</journal-id><journal-id journal-id-type="nlm-ta">Gastroenterology</journal-id><journal-title>Gastroenterology</journal-title><issn pub-type="ppub">0016-5085</issn><issn pub-type="epub">1528-0012</issn></journal-meta><article-meta><article-id pub-id-type="pmid">18242209</article-id><article-id pub-id-type="pmc">2676233</article-id><article-id pub-id-type="doi">10.1053/j.gastro.2007.11.036</article-id><article-id pub-id-type="manuscript">NIHMS105573</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Virologic Monitoring of Hepatitis B Virus Therapy in Clinical Trials and Practice: Recommendations for a Standardized Approach</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>PAWLOTSKY</surname><given-names>JEAN–MICHEL</given-names></name><xref rid="A1" ref-type="aff">*</xref><xref rid="A2" ref-type="aff">‡</xref></contrib><contrib contrib-type="author"><name><surname>DUSHEIKO</surname><given-names>GEOFFREY</given-names></name><xref rid="A3" ref-type="aff">§</xref></contrib><contrib contrib-type="author"><name><surname>HATZAKIS</surname><given-names>ANGELOS</given-names></name><xref rid="A4" ref-type="aff">||</xref></contrib><contrib contrib-type="author"><name><surname>LAU</surname><given-names>DARYL</given-names></name><xref rid="A5" ref-type="aff">¶</xref></contrib><contrib contrib-type="author"><name><surname>LAU</surname><given-names>GEORGE</given-names></name><xref rid="A6" ref-type="aff">#</xref></contrib><contrib contrib-type="author"><name><surname>LIANG</surname><given-names>T. JAKE</given-names></name><xref rid="A7" ref-type="aff">**</xref></contrib><contrib contrib-type="author"><name><surname>LOCARNINI</surname><given-names>STEPHEN</given-names></name><xref rid="A8" ref-type="aff">‡‡</xref></contrib><contrib contrib-type="author"><name><surname>MARTIN</surname><given-names>PAUL</given-names></name><xref rid="A9" ref-type="aff">§§</xref></contrib><contrib contrib-type="author"><name><surname>RICHMAN</surname><given-names>DOUGLAS D.</given-names></name><xref rid="A10" ref-type="aff">|| ||</xref></contrib><contrib contrib-type="author"><name><surname>ZOULIM</surname><given-names>FABIEN</given-names></name><xref rid="A11" ref-type="aff">¶¶</xref></contrib></contrib-group><aff id="A1"><label>*</label> French National Reference Center for Viral Hepatitis B, C and delta, Department of Virology, Henri Mondor Hospital, University of Paris XII, Créteil, France</aff><aff id="A2"><label>‡</label> INSERM U841, Créteil, France</aff><aff id="A3"><label>§</label> Centre for Hepatology, Royal Free and University College School of Medicine, London, United Kingdom</aff><aff id="A4"><label>||</label> Department of Hygiene, Epidemiology and Medical Statistics, Athens University Medical School, Athens, Greece</aff><aff id="A5"><label>¶</label>Liver Center, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts</aff><aff id="A6"><label>#</label> Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong SAR, China</aff><aff id="A7"><label>**</label>Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland</aff><aff id="A8"><label>‡‡</label> Victorian Infectious Diseases Reference Laboratory, North Melbourne, Victoria, Australia</aff><aff id="A9"><label>§§</label> Division of Liver Diseases and Recanati-Miller Transplant Institute, Mount Sinai School of Medicine, New York, New York</aff><aff id="A10"><label>|| ||</label> VA San Diego Healthcare System and University of California San Diego, La Jolla, California</aff><aff id="A11"><label>¶¶</label> INSERM U871, Hospices Civils de Lyon, Department of Liver Diseases, Université Lyon 1, Lyon, France</aff><author-notes><corresp id="FN1">Address requests for reprints to: Jean-Michel Pawlotsky, MD, PhD, Department of Virology, Hopital Henri Mondor, 51 Avenue du Maréchal de Lattre de Tassigny, 94010 Crtéil, France. e-mail: <email>jean-michel.pawlotsky@hmn.aphp.fr</email>; fax: (33) 1-4981-4831</corresp></author-notes><pub-date pub-type="nihms-submitted"><day>27</day><month>3</month><year>2009</year></pub-date><pub-date pub-type="epub"><day>28</day><month>11</month><year>2007</year></pub-date><pub-date pub-type="ppub"><month>2</month><year>2008</year></pub-date><pub-date pub-type="pmc-release"><day>2</day><month>5</month><year>2009</year></pub-date><volume>134</volume><issue>2</issue><fpage>405</fpage><lpage>415</lpage><abstract><p id="P1">Treatment of chronic hepatitis B virus (HBV) infection is aimed at suppressing viral replication to the lowest possible level, and thereby to halt the progression of liver disease and prevent the onset of complications. Two categories of drugs are used in HBV therapy: the interferons, including standard interferon alfa or pegylated interferon alfa, and specific nucleoside or nucleotide HBV inhibitors that target the reverse-transcriptase function of HBV-DNA polymerase. The reported results of clinical trials have used varying definitions of efficacy, failure, and resistance based on different measures of virologic responses. This article discusses HBV virologic markers and tests, and their optimal use both for planning and reporting clinical trials and in clinical practice.</p></abstract><contract-num rid="DK1">Z01 DK054500-11</contract-num><contract-sponsor id="DK1">National Institute of Diabetes and Digestive and Kidney Diseases : NIDDK</contract-sponsor></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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