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Simeprevir versus telaprevir with peginterferon and ribavirin in previous null or partial responders with chronic hepatitis C virus genotype 1 infection (ATTAIN): a randomised, double-blind, non-inferiority phase 3 trial.

Identifieur interne : 002834 ( Main/Exploration ); précédent : 002833; suivant : 002835

Simeprevir versus telaprevir with peginterferon and ribavirin in previous null or partial responders with chronic hepatitis C virus genotype 1 infection (ATTAIN): a randomised, double-blind, non-inferiority phase 3 trial.

Auteurs : K Rajender Reddy [États-Unis] ; Stefan Zeuzem [Allemagne] ; Fabien Zoulim [France] ; Ola Weiland [Suède] ; Andrzej Horban [Pologne] ; Carol Stanciu [Roumanie] ; Federico Guillermo Villamil [Argentine] ; Pietro Andreone [Italie] ; Jacob George [Australie] ; Elisabeth Dammers [Belgique] ; Min Fu [États-Unis] ; Darryl Kurland [États-Unis] ; Oliver Lenz [Belgique] ; Sivi Ouwerkerk-Mahadevan [Belgique] ; Thierry Verbinnen [Belgique] ; Jane Scott [Royaume-Uni] ; Wolfgang Jessner [Belgique]

Source :

RBID : pubmed:25482330

Descripteurs français

English descriptors

Abstract

We did a phase 3 study in previous non-responders with chronic hepatitis C virus (HCV) genotype 1 infection and compensated liver disease that related to the standard of care for these patients at the time this study was initiated. We investigated whether simeprevir is non-inferior in terms of efficacy to telaprevir, each in combination with peginterferon alfa-2a and ribavirin.

DOI: 10.1016/S1473-3099(14)71002-3
PubMed: 25482330


Affiliations:


Links toward previous steps (curation, corpus...)


Le document en format XML

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<name sortKey="Villamil, Federico Guillermo" sort="Villamil, Federico Guillermo" uniqKey="Villamil F" first="Federico Guillermo" last="Villamil">Federico Guillermo Villamil</name>
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<name sortKey="Andreone, Pietro" sort="Andreone, Pietro" uniqKey="Andreone P" first="Pietro" last="Andreone">Pietro Andreone</name>
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<name sortKey="Dammers, Elisabeth" sort="Dammers, Elisabeth" uniqKey="Dammers E" first="Elisabeth" last="Dammers">Elisabeth Dammers</name>
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<name sortKey="Fu, Min" sort="Fu, Min" uniqKey="Fu M" first="Min" last="Fu">Min Fu</name>
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<name sortKey="Kurland, Darryl" sort="Kurland, Darryl" uniqKey="Kurland D" first="Darryl" last="Kurland">Darryl Kurland</name>
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<name sortKey="Jessner, Wolfgang" sort="Jessner, Wolfgang" uniqKey="Jessner W" first="Wolfgang" last="Jessner">Wolfgang Jessner</name>
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<title xml:lang="en">Simeprevir versus telaprevir with peginterferon and ribavirin in previous null or partial responders with chronic hepatitis C virus genotype 1 infection (ATTAIN): a randomised, double-blind, non-inferiority phase 3 trial.</title>
<author>
<name sortKey="Reddy, K Rajender" sort="Reddy, K Rajender" uniqKey="Reddy K" first="K Rajender" last="Reddy">K Rajender Reddy</name>
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<country xml:lang="fr">États-Unis</country>
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<name sortKey="Stanciu, Carol" sort="Stanciu, Carol" uniqKey="Stanciu C" first="Carol" last="Stanciu">Carol Stanciu</name>
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<nlm:affiliation>Gastromedica Clinic, University Hospital St Spiridon, Iasi, Romania.</nlm:affiliation>
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<wicri:noRegion>Iasi</wicri:noRegion>
</affiliation>
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<name sortKey="Villamil, Federico Guillermo" sort="Villamil, Federico Guillermo" uniqKey="Villamil F" first="Federico Guillermo" last="Villamil">Federico Guillermo Villamil</name>
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<nlm:affiliation>CIPREC, Buenos Aires, Argentina.</nlm:affiliation>
<country xml:lang="fr">Argentine</country>
<wicri:regionArea>CIPREC, Buenos Aires</wicri:regionArea>
<wicri:noRegion>Buenos Aires</wicri:noRegion>
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<name sortKey="Andreone, Pietro" sort="Andreone, Pietro" uniqKey="Andreone P" first="Pietro" last="Andreone">Pietro Andreone</name>
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<nlm:affiliation>Dipartimento di Scienze Mediche e Chirurgiche, University of Bologna and AOU Policlinico Sant'Orsola-Malpighi, Bologna, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
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<name sortKey="George, Jacob" sort="George, Jacob" uniqKey="George J" first="Jacob" last="George">Jacob George</name>
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<country xml:lang="fr">Australie</country>
<wicri:regionArea>Storr Liver Unit, Westmead Hospital and Westmead Millennium Institute, Westmead, NSW</wicri:regionArea>
<wicri:noRegion>NSW</wicri:noRegion>
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<name sortKey="Dammers, Elisabeth" sort="Dammers, Elisabeth" uniqKey="Dammers E" first="Elisabeth" last="Dammers">Elisabeth Dammers</name>
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<wicri:noRegion>Beerse</wicri:noRegion>
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</author>
<author>
<name sortKey="Fu, Min" sort="Fu, Min" uniqKey="Fu M" first="Min" last="Fu">Min Fu</name>
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<nlm:affiliation>Janssen Research and Development, Spring House, PA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Janssen Research and Development, Spring House, PA</wicri:regionArea>
<placeName>
<region type="state">Pennsylvanie</region>
</placeName>
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<name sortKey="Kurland, Darryl" sort="Kurland, Darryl" uniqKey="Kurland D" first="Darryl" last="Kurland">Darryl Kurland</name>
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<nlm:affiliation>Janssen Research and Development, Titusville, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Janssen Research and Development, Titusville, NJ</wicri:regionArea>
<placeName>
<region type="state">New Jersey</region>
</placeName>
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<name sortKey="Lenz, Oliver" sort="Lenz, Oliver" uniqKey="Lenz O" first="Oliver" last="Lenz">Oliver Lenz</name>
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<nlm:affiliation>Janssen Infectious Diseases BVBA, Beerse, Belgium.</nlm:affiliation>
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<wicri:noRegion>Beerse</wicri:noRegion>
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<name sortKey="Ouwerkerk Mahadevan, Sivi" sort="Ouwerkerk Mahadevan, Sivi" uniqKey="Ouwerkerk Mahadevan S" first="Sivi" last="Ouwerkerk-Mahadevan">Sivi Ouwerkerk-Mahadevan</name>
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<nlm:affiliation>Janssen Research and Development, Beerse, Belgium.</nlm:affiliation>
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<name sortKey="Verbinnen, Thierry" sort="Verbinnen, Thierry" uniqKey="Verbinnen T" first="Thierry" last="Verbinnen">Thierry Verbinnen</name>
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<nlm:affiliation>Janssen Infectious Diseases BVBA, Beerse, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Janssen Infectious Diseases BVBA, Beerse</wicri:regionArea>
<wicri:noRegion>Beerse</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Scott, Jane" sort="Scott, Jane" uniqKey="Scott J" first="Jane" last="Scott">Jane Scott</name>
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<nlm:affiliation>Janssen Global Services, High Wycombe, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Janssen Global Services, High Wycombe</wicri:regionArea>
<wicri:noRegion>High Wycombe</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Jessner, Wolfgang" sort="Jessner, Wolfgang" uniqKey="Jessner W" first="Wolfgang" last="Jessner">Wolfgang Jessner</name>
<affiliation wicri:level="1">
<nlm:affiliation>Janssen Infectious Diseases BVBA, Beerse, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Janssen Infectious Diseases BVBA, Beerse</wicri:regionArea>
<wicri:noRegion>Beerse</wicri:noRegion>
</affiliation>
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<series>
<title level="j">The Lancet. Infectious diseases</title>
<idno type="eISSN">1474-4457</idno>
<imprint>
<date when="2015" type="published">2015</date>
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<term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Antiviral Agents (therapeutic use)</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Genotype</term>
<term>Hepacivirus (classification)</term>
<term>Hepacivirus (genetics)</term>
<term>Hepacivirus (isolation & purification)</term>
<term>Hepatitis C, Chronic (drug therapy)</term>
<term>Hepatitis C, Chronic (virology)</term>
<term>Heterocyclic Compounds, 3-Ring (therapeutic use)</term>
<term>Humans</term>
<term>Interferon-alpha (therapeutic use)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Oligopeptides (therapeutic use)</term>
<term>Placebos (administration & dosage)</term>
<term>Polyethylene Glycols (therapeutic use)</term>
<term>Recombinant Proteins (therapeutic use)</term>
<term>Ribavirin (therapeutic use)</term>
<term>Simeprevir</term>
<term>Sulfonamides (therapeutic use)</term>
<term>Treatment Outcome</term>
<term>Young Adult</term>
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<term>Hepacivirus ()</term>
<term>Hepacivirus (génétique)</term>
<term>Hepacivirus (isolement et purification)</term>
<term>Humains</term>
<term>Hépatite C chronique (traitement médicamenteux)</term>
<term>Hépatite C chronique (virologie)</term>
<term>Interféron alpha (usage thérapeutique)</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Oligopeptides (usage thérapeutique)</term>
<term>Placebo (administration et posologie)</term>
<term>Polyéthylène glycols (usage thérapeutique)</term>
<term>Protéines recombinantes (usage thérapeutique)</term>
<term>Ribavirine (usage thérapeutique)</term>
<term>Résultat thérapeutique</term>
<term>Siméprévir</term>
<term>Sujet âgé</term>
<term>Sulfonamides (usage thérapeutique)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en">
<term>Placebos</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en">
<term>Antiviral Agents</term>
<term>Heterocyclic Compounds, 3-Ring</term>
<term>Interferon-alpha</term>
<term>Oligopeptides</term>
<term>Polyethylene Glycols</term>
<term>Recombinant Proteins</term>
<term>Ribavirin</term>
<term>Sulfonamides</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr">
<term>Placebo</term>
</keywords>
<keywords scheme="MESH" qualifier="classification" xml:lang="en">
<term>Hepacivirus</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>Hepatitis C, Chronic</term>
</keywords>
<keywords scheme="MESH" qualifier="genetics" xml:lang="en">
<term>Hepacivirus</term>
</keywords>
<keywords scheme="MESH" qualifier="génétique" xml:lang="fr">
<term>Hepacivirus</term>
</keywords>
<keywords scheme="MESH" qualifier="isolation & purification" xml:lang="en">
<term>Hepacivirus</term>
</keywords>
<keywords scheme="MESH" qualifier="isolement et purification" xml:lang="fr">
<term>Hepacivirus</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr">
<term>Hépatite C chronique</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr">
<term>Antiviraux</term>
<term>Composés hétérocycliques 3 noyaux</term>
<term>Interféron alpha</term>
<term>Oligopeptides</term>
<term>Polyéthylène glycols</term>
<term>Protéines recombinantes</term>
<term>Ribavirine</term>
<term>Sulfonamides</term>
</keywords>
<keywords scheme="MESH" qualifier="virologie" xml:lang="fr">
<term>Hépatite C chronique</term>
</keywords>
<keywords scheme="MESH" qualifier="virology" xml:lang="en">
<term>Hepatitis C, Chronic</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Genotype</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Simeprevir</term>
<term>Treatment Outcome</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Femelle</term>
<term>Génotype</term>
<term>Hepacivirus</term>
<term>Humains</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Résultat thérapeutique</term>
<term>Siméprévir</term>
<term>Sujet âgé</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">We did a phase 3 study in previous non-responders with chronic hepatitis C virus (HCV) genotype 1 infection and compensated liver disease that related to the standard of care for these patients at the time this study was initiated. We investigated whether simeprevir is non-inferior in terms of efficacy to telaprevir, each in combination with peginterferon alfa-2a and ribavirin.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Argentine</li>
<li>Australie</li>
<li>Belgique</li>
<li>France</li>
<li>Italie</li>
<li>Pologne</li>
<li>Roumanie</li>
<li>Royaume-Uni</li>
<li>Suède</li>
<li>États-Unis</li>
</country>
<region>
<li>Auvergne-Rhône-Alpes</li>
<li>District de Darmstadt</li>
<li>Hesse (Land)</li>
<li>New Jersey</li>
<li>Pennsylvanie</li>
<li>Rhône-Alpes</li>
<li>Svealand</li>
</region>
<settlement>
<li>Francfort-sur-le-Main</li>
<li>Lyon</li>
<li>Stockholm</li>
</settlement>
</list>
<tree>
<country name="États-Unis">
<region name="Pennsylvanie">
<name sortKey="Reddy, K Rajender" sort="Reddy, K Rajender" uniqKey="Reddy K" first="K Rajender" last="Reddy">K Rajender Reddy</name>
</region>
<name sortKey="Fu, Min" sort="Fu, Min" uniqKey="Fu M" first="Min" last="Fu">Min Fu</name>
<name sortKey="Kurland, Darryl" sort="Kurland, Darryl" uniqKey="Kurland D" first="Darryl" last="Kurland">Darryl Kurland</name>
</country>
<country name="Allemagne">
<region name="Hesse (Land)">
<name sortKey="Zeuzem, Stefan" sort="Zeuzem, Stefan" uniqKey="Zeuzem S" first="Stefan" last="Zeuzem">Stefan Zeuzem</name>
</region>
</country>
<country name="France">
<region name="Auvergne-Rhône-Alpes">
<name sortKey="Zoulim, Fabien" sort="Zoulim, Fabien" uniqKey="Zoulim F" first="Fabien" last="Zoulim">Fabien Zoulim</name>
</region>
</country>
<country name="Suède">
<region name="Svealand">
<name sortKey="Weiland, Ola" sort="Weiland, Ola" uniqKey="Weiland O" first="Ola" last="Weiland">Ola Weiland</name>
</region>
</country>
<country name="Pologne">
<noRegion>
<name sortKey="Horban, Andrzej" sort="Horban, Andrzej" uniqKey="Horban A" first="Andrzej" last="Horban">Andrzej Horban</name>
</noRegion>
</country>
<country name="Roumanie">
<noRegion>
<name sortKey="Stanciu, Carol" sort="Stanciu, Carol" uniqKey="Stanciu C" first="Carol" last="Stanciu">Carol Stanciu</name>
</noRegion>
</country>
<country name="Argentine">
<noRegion>
<name sortKey="Villamil, Federico Guillermo" sort="Villamil, Federico Guillermo" uniqKey="Villamil F" first="Federico Guillermo" last="Villamil">Federico Guillermo Villamil</name>
</noRegion>
</country>
<country name="Italie">
<noRegion>
<name sortKey="Andreone, Pietro" sort="Andreone, Pietro" uniqKey="Andreone P" first="Pietro" last="Andreone">Pietro Andreone</name>
</noRegion>
</country>
<country name="Australie">
<noRegion>
<name sortKey="George, Jacob" sort="George, Jacob" uniqKey="George J" first="Jacob" last="George">Jacob George</name>
</noRegion>
</country>
<country name="Belgique">
<noRegion>
<name sortKey="Dammers, Elisabeth" sort="Dammers, Elisabeth" uniqKey="Dammers E" first="Elisabeth" last="Dammers">Elisabeth Dammers</name>
</noRegion>
<name sortKey="Jessner, Wolfgang" sort="Jessner, Wolfgang" uniqKey="Jessner W" first="Wolfgang" last="Jessner">Wolfgang Jessner</name>
<name sortKey="Lenz, Oliver" sort="Lenz, Oliver" uniqKey="Lenz O" first="Oliver" last="Lenz">Oliver Lenz</name>
<name sortKey="Ouwerkerk Mahadevan, Sivi" sort="Ouwerkerk Mahadevan, Sivi" uniqKey="Ouwerkerk Mahadevan S" first="Sivi" last="Ouwerkerk-Mahadevan">Sivi Ouwerkerk-Mahadevan</name>
<name sortKey="Verbinnen, Thierry" sort="Verbinnen, Thierry" uniqKey="Verbinnen T" first="Thierry" last="Verbinnen">Thierry Verbinnen</name>
</country>
<country name="Royaume-Uni">
<noRegion>
<name sortKey="Scott, Jane" sort="Scott, Jane" uniqKey="Scott J" first="Jane" last="Scott">Jane Scott</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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