Final Results of the Telaprevir Access Program: FibroScan Values Predict Safety and Efficacy in Hepatitis C Patients with Advanced Fibrosis or Cirrhosis.
Identifieur interne : 002932 ( PubMed/Corpus ); précédent : 002931; suivant : 002933Final Results of the Telaprevir Access Program: FibroScan Values Predict Safety and Efficacy in Hepatitis C Patients with Advanced Fibrosis or Cirrhosis.
Auteurs : Antonia Lepida ; Massimo Colombo ; Inmaculada Fernandez ; Djamal Abdurakhmanov ; Paulo Abrao Ferreira ; Simone I. Strasser ; Petr Urbanek ; Alessandra Mangia ; José L. Calleja ; Wafae Iraqi ; Ralph Demasi ; Isabelle Lonjon-Domanec ; Christophe Moreno ; Heiner WedemeyerSource :
- PloS one [ 1932-6203 ] ; 2015.
English descriptors
- KwdEn :
- Adult, Aged, Anemia (etiology), Biomechanical Phenomena (drug effects), Female, Health Services Accessibility, Hepacivirus (drug effects), Hepacivirus (physiology), Hepatitis C (complications), Hepatitis C (drug therapy), Hepatitis C (physiopathology), Hepatitis C (virology), Humans, Intention to Treat Analysis, Liver (drug effects), Liver (pathology), Liver (physiopathology), Liver Cirrhosis (complications), Liver Cirrhosis (drug therapy), Liver Cirrhosis (physiopathology), Male, Middle Aged, Multivariate Analysis, Oligopeptides (adverse effects), Oligopeptides (pharmacology), Oligopeptides (therapeutic use), Risk Factors, Treatment Outcome, Young Adult.
- MESH :
- chemical , adverse effects : Oligopeptides.
- complications : Hepatitis C, Liver Cirrhosis.
- drug effects : Biomechanical Phenomena, Hepacivirus, Liver.
- drug therapy : Hepatitis C, Liver Cirrhosis.
- etiology : Anemia.
- pathology : Liver.
- chemical , pharmacology : Oligopeptides.
- physiology : Hepacivirus.
- physiopathology : Hepatitis C, Liver, Liver Cirrhosis.
- chemical , therapeutic use : Oligopeptides.
- virology : Hepatitis C.
- Adult, Aged, Female, Health Services Accessibility, Humans, Intention to Treat Analysis, Male, Middle Aged, Multivariate Analysis, Risk Factors, Treatment Outcome, Young Adult.
Abstract
Liver stiffness determined by transient elastography is correlated with hepatic fibrosis stage and has high accuracy for detecting severe fibrosis and cirrhosis in chronic hepatitis C patients. We evaluated the clinical value of baseline FibroScan values for the prediction of safety and efficacy of telaprevir-based therapy in patients with advanced fibrosis and cirrhosis in the telaprevir Early Access Program HEP3002.
DOI: 10.1371/journal.pone.0138503
PubMed: 26398503
Links to Exploration step
pubmed:26398503Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Final Results of the Telaprevir Access Program: FibroScan Values Predict Safety and Efficacy in Hepatitis C Patients with Advanced Fibrosis or Cirrhosis.</title><author><name sortKey="Lepida, Antonia" sort="Lepida, Antonia" uniqKey="Lepida A" first="Antonia" last="Lepida">Antonia Lepida</name><affiliation><nlm:affiliation>Liver Unit, Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Colombo, Massimo" sort="Colombo, Massimo" uniqKey="Colombo M" first="Massimo" last="Colombo">Massimo Colombo</name><affiliation><nlm:affiliation>Department of Medicine, Division of Gastroenterology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Universita' degli Studi di Milano, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Fernandez, Inmaculada" sort="Fernandez, Inmaculada" uniqKey="Fernandez I" first="Inmaculada" last="Fernandez">Inmaculada Fernandez</name><affiliation><nlm:affiliation>Hospital Universitario 12 de Octubre, Sección de Aparato Digestivo, Madrid, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Abdurakhmanov, Djamal" sort="Abdurakhmanov, Djamal" uniqKey="Abdurakhmanov D" first="Djamal" last="Abdurakhmanov">Djamal Abdurakhmanov</name><affiliation><nlm:affiliation>I.M. Sechenov First Moscow State Medical University, E.M. Tareev Clinic for Nephrology, Internal and Occupational Medicine, Moscow, Russia.</nlm:affiliation></affiliation></author><author><name sortKey="Ferreira, Paulo Abrao" sort="Ferreira, Paulo Abrao" uniqKey="Ferreira P" first="Paulo Abrao" last="Ferreira">Paulo Abrao Ferreira</name><affiliation><nlm:affiliation>Outpatient Clinic to HIV and Viral Hepatitis Division of Infectious Disease, Federal University of São Paulo, São Paulo, Brazil.</nlm:affiliation></affiliation></author><author><name sortKey="Strasser, Simone I" sort="Strasser, Simone I" uniqKey="Strasser S" first="Simone I" last="Strasser">Simone I. Strasser</name><affiliation><nlm:affiliation>AW Morrow Gastroenterology and Liver Center, Royal Prince Alfred hospital and University of Sydney, Sydney, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Urbanek, Petr" sort="Urbanek, Petr" uniqKey="Urbanek P" first="Petr" last="Urbanek">Petr Urbanek</name><affiliation><nlm:affiliation>Department of Internal Medicine, First Medical Faculty, Charles University, and Central Military Hospital Prague, Prague, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Mangia, Alessandra" sort="Mangia, Alessandra" uniqKey="Mangia A" first="Alessandra" last="Mangia">Alessandra Mangia</name><affiliation><nlm:affiliation>Liver Unit, IRCCS Hospital 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Calleja, Jose L" sort="Calleja, Jose L" uniqKey="Calleja J" first="José L" last="Calleja">José L. Calleja</name><affiliation><nlm:affiliation>Gastroenterology, Hospital Universitario Puerta de Hierro, Universidad Autonoma de Madrid, CIBERehd, Madrid, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Iraqi, Wafae" sort="Iraqi, Wafae" uniqKey="Iraqi W" first="Wafae" last="Iraqi">Wafae Iraqi</name><affiliation><nlm:affiliation>Janssen Pharmaceuticals, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Demasi, Ralph" sort="Demasi, Ralph" uniqKey="Demasi R" first="Ralph" last="Demasi">Ralph Demasi</name><affiliation><nlm:affiliation>Janssen Research and development, Titusville, New Jersey, United States of America.</nlm:affiliation></affiliation></author><author><name sortKey="Lonjon Domanec, Isabelle" sort="Lonjon Domanec, Isabelle" uniqKey="Lonjon Domanec I" first="Isabelle" last="Lonjon-Domanec">Isabelle Lonjon-Domanec</name><affiliation><nlm:affiliation>Janssen Pharmaceuticals, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Moreno, Christophe" sort="Moreno, Christophe" uniqKey="Moreno C" first="Christophe" last="Moreno">Christophe Moreno</name><affiliation><nlm:affiliation>Liver Unit, Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Wedemeyer, Heiner" sort="Wedemeyer, Heiner" uniqKey="Wedemeyer H" first="Heiner" last="Wedemeyer">Heiner Wedemeyer</name><affiliation><nlm:affiliation>Medizinische Hochschule Hannover, Hannover, Germany.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:26398503</idno><idno type="pmid">26398503</idno><idno type="doi">10.1371/journal.pone.0138503</idno><idno type="wicri:Area/PubMed/Corpus">002932</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002932</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Final Results of the Telaprevir Access Program: FibroScan Values Predict Safety and Efficacy in Hepatitis C Patients with Advanced Fibrosis or Cirrhosis.</title><author><name sortKey="Lepida, Antonia" sort="Lepida, Antonia" uniqKey="Lepida A" first="Antonia" last="Lepida">Antonia Lepida</name><affiliation><nlm:affiliation>Liver Unit, Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Colombo, Massimo" sort="Colombo, Massimo" uniqKey="Colombo M" first="Massimo" last="Colombo">Massimo Colombo</name><affiliation><nlm:affiliation>Department of Medicine, Division of Gastroenterology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Universita' degli Studi di Milano, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Fernandez, Inmaculada" sort="Fernandez, Inmaculada" uniqKey="Fernandez I" first="Inmaculada" last="Fernandez">Inmaculada Fernandez</name><affiliation><nlm:affiliation>Hospital Universitario 12 de Octubre, Sección de Aparato Digestivo, Madrid, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Abdurakhmanov, Djamal" sort="Abdurakhmanov, Djamal" uniqKey="Abdurakhmanov D" first="Djamal" last="Abdurakhmanov">Djamal Abdurakhmanov</name><affiliation><nlm:affiliation>I.M. Sechenov First Moscow State Medical University, E.M. Tareev Clinic for Nephrology, Internal and Occupational Medicine, Moscow, Russia.</nlm:affiliation></affiliation></author><author><name sortKey="Ferreira, Paulo Abrao" sort="Ferreira, Paulo Abrao" uniqKey="Ferreira P" first="Paulo Abrao" last="Ferreira">Paulo Abrao Ferreira</name><affiliation><nlm:affiliation>Outpatient Clinic to HIV and Viral Hepatitis Division of Infectious Disease, Federal University of São Paulo, São Paulo, Brazil.</nlm:affiliation></affiliation></author><author><name sortKey="Strasser, Simone I" sort="Strasser, Simone I" uniqKey="Strasser S" first="Simone I" last="Strasser">Simone I. Strasser</name><affiliation><nlm:affiliation>AW Morrow Gastroenterology and Liver Center, Royal Prince Alfred hospital and University of Sydney, Sydney, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Urbanek, Petr" sort="Urbanek, Petr" uniqKey="Urbanek P" first="Petr" last="Urbanek">Petr Urbanek</name><affiliation><nlm:affiliation>Department of Internal Medicine, First Medical Faculty, Charles University, and Central Military Hospital Prague, Prague, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Mangia, Alessandra" sort="Mangia, Alessandra" uniqKey="Mangia A" first="Alessandra" last="Mangia">Alessandra Mangia</name><affiliation><nlm:affiliation>Liver Unit, IRCCS Hospital 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Calleja, Jose L" sort="Calleja, Jose L" uniqKey="Calleja J" first="José L" last="Calleja">José L. Calleja</name><affiliation><nlm:affiliation>Gastroenterology, Hospital Universitario Puerta de Hierro, Universidad Autonoma de Madrid, CIBERehd, Madrid, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Iraqi, Wafae" sort="Iraqi, Wafae" uniqKey="Iraqi W" first="Wafae" last="Iraqi">Wafae Iraqi</name><affiliation><nlm:affiliation>Janssen Pharmaceuticals, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Demasi, Ralph" sort="Demasi, Ralph" uniqKey="Demasi R" first="Ralph" last="Demasi">Ralph Demasi</name><affiliation><nlm:affiliation>Janssen Research and development, Titusville, New Jersey, United States of America.</nlm:affiliation></affiliation></author><author><name sortKey="Lonjon Domanec, Isabelle" sort="Lonjon Domanec, Isabelle" uniqKey="Lonjon Domanec I" first="Isabelle" last="Lonjon-Domanec">Isabelle Lonjon-Domanec</name><affiliation><nlm:affiliation>Janssen Pharmaceuticals, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Moreno, Christophe" sort="Moreno, Christophe" uniqKey="Moreno C" first="Christophe" last="Moreno">Christophe Moreno</name><affiliation><nlm:affiliation>Liver Unit, Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Wedemeyer, Heiner" sort="Wedemeyer, Heiner" uniqKey="Wedemeyer H" first="Heiner" last="Wedemeyer">Heiner Wedemeyer</name><affiliation><nlm:affiliation>Medizinische Hochschule Hannover, Hannover, Germany.</nlm:affiliation></affiliation></author></analytic><series><title level="j">PloS one</title><idno type="eISSN">1932-6203</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Anemia (etiology)</term><term>Biomechanical Phenomena (drug effects)</term><term>Female</term><term>Health Services Accessibility</term><term>Hepacivirus (drug effects)</term><term>Hepacivirus (physiology)</term><term>Hepatitis C (complications)</term><term>Hepatitis C (drug therapy)</term><term>Hepatitis C (physiopathology)</term><term>Hepatitis C (virology)</term><term>Humans</term><term>Intention to Treat Analysis</term><term>Liver (drug effects)</term><term>Liver (pathology)</term><term>Liver (physiopathology)</term><term>Liver Cirrhosis (complications)</term><term>Liver Cirrhosis (drug therapy)</term><term>Liver Cirrhosis (physiopathology)</term><term>Male</term><term>Middle Aged</term><term>Multivariate Analysis</term><term>Oligopeptides (adverse effects)</term><term>Oligopeptides (pharmacology)</term><term>Oligopeptides (therapeutic use)</term><term>Risk Factors</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Oligopeptides</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Hepatitis C</term><term>Liver Cirrhosis</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Biomechanical Phenomena</term><term>Hepacivirus</term><term>Liver</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Hepatitis C</term><term>Liver Cirrhosis</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Anemia</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Liver</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Oligopeptides</term></keywords><keywords scheme="MESH" qualifier="physiology" xml:lang="en"><term>Hepacivirus</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Hepatitis C</term><term>Liver</term><term>Liver Cirrhosis</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Oligopeptides</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Hepatitis C</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Female</term><term>Health Services Accessibility</term><term>Humans</term><term>Intention to Treat Analysis</term><term>Male</term><term>Middle Aged</term><term>Multivariate Analysis</term><term>Risk Factors</term><term>Treatment Outcome</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Liver stiffness determined by transient elastography is correlated with hepatic fibrosis stage and has high accuracy for detecting severe fibrosis and cirrhosis in chronic hepatitis C patients. We evaluated the clinical value of baseline FibroScan values for the prediction of safety and efficacy of telaprevir-based therapy in patients with advanced fibrosis and cirrhosis in the telaprevir Early Access Program HEP3002.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26398503</PMID><DateCreated><Year>2015</Year><Month>09</Month><Day>24</Day></DateCreated><DateCompleted><Year>2016</Year><Month>05</Month><Day>30</Day></DateCompleted><DateRevised><Year>2017</Year><Month>02</Month><Day>20</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Electronic">1932-6203</ISSN><JournalIssue CitedMedium="Internet"><Volume>10</Volume><Issue>9</Issue><PubDate><Year>2015</Year></PubDate></JournalIssue><Title>PloS one</Title><ISOAbbreviation>PLoS ONE</ISOAbbreviation></Journal><ArticleTitle>Final Results of the Telaprevir Access Program: FibroScan Values Predict Safety and Efficacy in Hepatitis C Patients with Advanced Fibrosis or Cirrhosis.</ArticleTitle><Pagination><MedlinePgn>e0138503</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1371/journal.pone.0138503</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Liver stiffness determined by transient elastography is correlated with hepatic fibrosis stage and has high accuracy for detecting severe fibrosis and cirrhosis in chronic hepatitis C patients. We evaluated the clinical value of baseline FibroScan values for the prediction of safety and efficacy of telaprevir-based therapy in patients with advanced fibrosis and cirrhosis in the telaprevir Early Access Program HEP3002.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">1,772 patients with HCV-1 and bridging fibrosis or cirrhosis were treated with telaprevir plus pegylated interferon-α and ribavirin (PR) for 12 weeks followed by PR alone, the total treatment duration depending on virological response and previous response type. Liver fibrosis stage was determined either by liver biopsy or by non-invasive markers. 1,282 patients (72%) had disease stage assessed by FibroScan; among those 46% were classified as Metavir F3 at baseline and 54% as F4.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Overall, 1,139 patients (64%) achieved a sustained virological response (SVR) by intention-to-treat analysis. Baseline FibroScan values were tested for association with SVR and the occurrence of adverse events. By univariate analysis, higher baseline FibroScan values were predictive of lower sustained virological response rates and treatment-related anemia. By multivariate analysis, FibroScan was no longer statistically significant as an independent predictor, but higher FibroScan values were correlated with the occurrence of infections and serious adverse events.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">FibroScan has a limited utility as a predictor of safety and efficacy in patients treated with telaprevir-based triple therapy. Nevertheless it can be used in association with other clinical and biological parameters to help determine patients who will benefit from the triple regiments.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">ClinicalTrials.gov NCT01508286.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Lepida</LastName><ForeName>Antonia</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Liver Unit, Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Colombo</LastName><ForeName>Massimo</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Medicine, Division of Gastroenterology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Universita' degli Studi di Milano, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fernandez</LastName><ForeName>Inmaculada</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Hospital Universitario 12 de Octubre, Sección de Aparato Digestivo, Madrid, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Abdurakhmanov</LastName><ForeName>Djamal</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>I.M. Sechenov First Moscow State Medical University, E.M. Tareev Clinic for Nephrology, Internal and Occupational Medicine, Moscow, Russia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ferreira</LastName><ForeName>Paulo Abrao</ForeName><Initials>PA</Initials><AffiliationInfo><Affiliation>Outpatient Clinic to HIV and Viral Hepatitis Division of Infectious Disease, Federal University of São Paulo, São Paulo, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Strasser</LastName><ForeName>Simone I</ForeName><Initials>SI</Initials><AffiliationInfo><Affiliation>AW Morrow Gastroenterology and Liver Center, Royal Prince Alfred hospital and University of Sydney, Sydney, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Urbanek</LastName><ForeName>Petr</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, First Medical Faculty, Charles University, and Central Military Hospital Prague, Prague, Czech Republic.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mangia</LastName><ForeName>Alessandra</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Liver Unit, IRCCS Hospital 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Calleja</LastName><ForeName>José L</ForeName><Initials>JL</Initials><AffiliationInfo><Affiliation>Gastroenterology, Hospital Universitario Puerta de Hierro, Universidad Autonoma de Madrid, CIBERehd, Madrid, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Iraqi</LastName><ForeName>Wafae</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Janssen Pharmaceuticals, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>DeMasi</LastName><ForeName>Ralph</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Janssen Research and development, Titusville, New Jersey, United States of America.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lonjon-Domanec</LastName><ForeName>Isabelle</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Janssen Pharmaceuticals, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Moreno</LastName><ForeName>Christophe</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Liver Unit, Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wedemeyer</LastName><ForeName>Heiner</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Medizinische Hochschule Hannover, Hannover, Germany.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01508286</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>09</Month><Day>23</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>PLoS One</MedlineTA><NlmUniqueID>101285081</NlmUniqueID><ISSNLinking>1932-6203</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D009842">Oligopeptides</NameOfSubstance></Chemical><Chemical><RegistryNumber>655M5O3W0U</RegistryNumber><NameOfSubstance 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use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012307" MajorTopicYN="N">Risk Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="NLM">PMC4580464</OtherID></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>05</Month><Day>28</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>08</Month><Day>29</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>9</Month><Day>24</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>9</Month><Day>24</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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