AustralieFrV1, Main, Exploration, bibRecord, 002E67

Efficacy and Safety of Faldaprevir, Deleobuvir, and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C Virus Infection and Advanced Liver Fibrosis or Cirrhosis

Identifieur interne : 002E67 ( Main/Exploration ); précédent : 002E66; suivant : 002E68

Efficacy and Safety of Faldaprevir, Deleobuvir, and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C Virus Infection and Advanced Liver Fibrosis or Cirrhosis

Auteurs : Stefan Zeuzem [Allemagne] ; Vicente Soriano [Espagne] ; Tarik Asselah [France] ; Edward J. Gane [Nouvelle-Zélande] ; Jean-Pierre Bronowicki [France] ; Peter Angus [Australie] ; Ansgar W. Lohse [Allemagne] ; Felix Stickel [Suisse] ; Beat Müllhaupt [Suisse] ; Stuart Roberts [Australie] ; Marcus Schuchmann [Allemagne] ; Michael Manns [Allemagne] ; Marc Bourlière [France] ; Maria Buti [Espagne] ; Jerry O. Stern [États-Unis] ; John-Paul Gallivan [Allemagne] ; Florian Voss [Allemagne] ; John P. Sabo [États-Unis] ; Wulf Böcher [Allemagne] ; Federico J. Mensa [États-Unis]

Source :

Antimicrobial Agents and Chemotherapy [ 0066-4804 ] ; 2015.

RBID : PMC:4335863

Descripteurs français

KwdFr :
- Acrylates (effets indésirables), Acrylates (usage thérapeutique), Adulte, Adulte d'âge moyen, Antiviraux (effets indésirables), Antiviraux (usage thérapeutique), Benzimidazoles (effets indésirables), Benzimidazoles (usage thérapeutique), Cirrhose du foie (), Cirrhose du foie (traitement médicamenteux), Femelle, Humains, Hépatite C chronique (), Hépatite C chronique (traitement médicamenteux), Jeune adulte, Mâle, Oligopeptides (effets indésirables), Oligopeptides (usage thérapeutique), Ribavirine (effets indésirables), Ribavirine (usage thérapeutique), Sujet âgé, Sujet âgé de 80 ans ou plus, Thiazoles (effets indésirables), Thiazoles (usage thérapeutique).
MESH :
- effets indésirables : Acrylates, Antiviraux, Benzimidazoles, Oligopeptides, Ribavirine, Thiazoles.
- traitement médicamenteux : Cirrhose du foie, Hépatite C chronique.
- usage thérapeutique : Acrylates, Antiviraux, Benzimidazoles, Oligopeptides, Ribavirine, Thiazoles.
- Adulte, Adulte d'âge moyen, Cirrhose du foie, Femelle, Humains, Hépatite C chronique, Jeune adulte, Mâle, Sujet âgé, Sujet âgé de 80 ans ou plus.

English descriptors

KwdEn :
- Acrylates (adverse effects), Acrylates (therapeutic use), Adult, Aged, Aged, 80 and over, Antiviral Agents (adverse effects), Antiviral Agents (therapeutic use), Benzimidazoles (adverse effects), Benzimidazoles (therapeutic use), Female, Hepatitis C, Chronic (complications), Hepatitis C, Chronic (drug therapy), Humans, Liver Cirrhosis (complications), Liver Cirrhosis (drug therapy), Male, Middle Aged, Oligopeptides (adverse effects), Oligopeptides (therapeutic use), Ribavirin (adverse effects), Ribavirin (therapeutic use), Thiazoles (adverse effects), Thiazoles (therapeutic use), Young Adult.
MESH :
- chemical , adverse effects : Acrylates, Antiviral Agents, Benzimidazoles, Oligopeptides, Ribavirin, Thiazoles.
- chemical , therapeutic use : Acrylates, Antiviral Agents, Benzimidazoles, Oligopeptides, Ribavirin, Thiazoles.
- complications : Hepatitis C, Chronic, Liver Cirrhosis.
- drug therapy : Hepatitis C, Chronic, Liver Cirrhosis.
- Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Young Adult.

Abstract

Patients with advanced hepatic fibrosis or cirrhosis with chronic hepatitis C virus (HCV) infection represent an unmet need. The HCV NS3/4A inhibitor, faldaprevir, was evaluated in combination with the nonnucleoside NS5B inhibitor, deleobuvir, with or without ribavirin in treatment-naive patients with HCV genotype 1 infection in the SOUND-C2 study. Here, the efficacy and safety of this interferon-free regimen in a subset of patients with advanced liver fibrosis, including those with compensated cirrhosis, were assessed. Patients (n = 362) were randomized to once-daily faldaprevir with either twice-daily (BID) or three-times-daily (TID) deleobuvir for 16 (TID16W), 28 (TID28W and BID28W), or 40 (TID40W) weeks with or without ribavirin (TID28W-NR). Patients were classified according to fibrosis stage (F0 to F2 versus F3 to F4) and the presence of cirrhosis (yes/no). In total, 85 (24%) patients had advanced fibrosis/cirrhosis (F3 to F4) and 33 (9%) had cirrhosis. Within each treatment arm, differences in rates of sustained virologic response 12 weeks after completion of treatment (SVR12) between patients with mild to moderate fibrosis (F0 to F2) versus F3 to F4 did not show a consistent pattern and were not statistically significant (63% versus 47% for TID16W, 53% versus 76% for TID28W, 48% versus 67% for TID40W, 70% versus 67% for BID28W, and 40% versus 36% for TID28W-NR, respectively; P > 0.05 for each arm). The most frequent adverse events in patients with/without cirrhosis were gastrointestinal and skin events, which were mostly mild or moderate in intensity. The degree of liver fibrosis did not appear to affect the probability of achieving SVR12 following treatment with the interferon-free regimen of faldaprevir, deleobuvir, and ribavirin. (This study has been registered at ClinicalTrials.gov under registration no. NCT01132313.)

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4335863

DOI: 10.1128/AAC.04383-14
PubMed: 25512403
PubMed Central: 4335863

Affiliations:

Le document en format XML

<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Efficacy and Safety of Faldaprevir, Deleobuvir, and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C Virus Infection and Advanced Liver Fibrosis or Cirrhosis</title>
<author><name sortKey="Zeuzem, Stefan" sort="Zeuzem, Stefan" uniqKey="Zeuzem S" first="Stefan" last="Zeuzem">Stefan Zeuzem</name>
<affiliation wicri:level="3"><nlm:aff id="aff1">J. W. Goethe University Hospital, Frankfurt, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>J. W. Goethe University Hospital, Frankfurt</wicri:regionArea>
<placeName><region type="land" nuts="1">Hesse (Land)</region>
<region type="district" nuts="2">District de Darmstadt</region>
<settlement type="city">Francfort-sur-le-Main</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Soriano, Vicente" sort="Soriano, Vicente" uniqKey="Soriano V" first="Vicente" last="Soriano">Vicente Soriano</name>
<affiliation wicri:level="3"><nlm:aff id="aff2">Hospital Carlos III, Madrid, Spain</nlm:aff>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Hospital Carlos III, Madrid</wicri:regionArea>
<placeName><settlement type="city">Madrid</settlement>
<region nuts="2" type="region">Communauté de Madrid</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Asselah, Tarik" sort="Asselah, Tarik" uniqKey="Asselah T" first="Tarik" last="Asselah">Tarik Asselah</name>
<affiliation wicri:level="1"><nlm:aff id="aff3">Service d'Hépatologie, Hôpital Beaujon, INSERM UMR S 1149, CRI, Université Paris Diderot, DHU UNITY, Clichy, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Service d'Hépatologie, Hôpital Beaujon, INSERM UMR S 1149, CRI, Université Paris Diderot, DHU UNITY, Clichy</wicri:regionArea>
<wicri:noRegion>Clichy</wicri:noRegion>
<wicri:noRegion>Clichy</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gane, Edward J" sort="Gane, Edward J" uniqKey="Gane E" first="Edward J." last="Gane">Edward J. Gane</name>
<affiliation wicri:level="1"><nlm:aff id="aff4">Auckland Clinical Studies, Auckland, New Zealand</nlm:aff>
<country xml:lang="fr">Nouvelle-Zélande</country>
<wicri:regionArea>Auckland Clinical Studies, Auckland</wicri:regionArea>
<wicri:noRegion>Auckland</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bronowicki, Jean Pierre" sort="Bronowicki, Jean Pierre" uniqKey="Bronowicki J" first="Jean-Pierre" last="Bronowicki">Jean-Pierre Bronowicki</name>
<affiliation wicri:level="3"><nlm:aff id="aff5">INSERM 954, Centre Hospitalier Universitaire de Nancy, Vandoeuvre les Nancy, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>INSERM 954, Centre Hospitalier Universitaire de Nancy, Vandoeuvre les Nancy</wicri:regionArea>
<placeName><region type="region" nuts="2">Grand Est</region>
<region type="old region" nuts="2">Lorraine (région)</region>
<settlement type="city">Vandœuvre-lès-Nancy</settlement>
<settlement type="city" wicri:auto="agglo">Nancy</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Angus, Peter" sort="Angus, Peter" uniqKey="Angus P" first="Peter" last="Angus">Peter Angus</name>
<affiliation wicri:level="1"><nlm:aff id="aff6">Austin Health, Heidelberg, Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Austin Health, Heidelberg</wicri:regionArea>
<wicri:noRegion>Heidelberg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Lohse, Ansgar W" sort="Lohse, Ansgar W" uniqKey="Lohse A" first="Ansgar W." last="Lohse">Ansgar W. Lohse</name>
<affiliation wicri:level="3"><nlm:aff id="aff7">University Hospital Hamburg-Eppendorf, Hamburg, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>University Hospital Hamburg-Eppendorf, Hamburg</wicri:regionArea>
<placeName><settlement type="city">Hambourg</settlement>
<region type="land" nuts="2">Hambourg</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Stickel, Felix" sort="Stickel, Felix" uniqKey="Stickel F" first="Felix" last="Stickel">Felix Stickel</name>
<affiliation wicri:level="4"><nlm:aff id="aff8">University of Bern, Bern, Switzerland</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>University of Bern, Bern</wicri:regionArea>
<placeName><settlement type="city">Berne</settlement>
<region type="région" nuts="3">Canton de Berne</region>
<settlement type="city">Berne</settlement>
</placeName>
<orgName type="university">Université de Berne</orgName>
</affiliation>
</author>
<author><name sortKey="Mullhaupt, Beat" sort="Mullhaupt, Beat" uniqKey="Mullhaupt B" first="Beat" last="Müllhaupt">Beat Müllhaupt</name>
<affiliation wicri:level="1"><nlm:aff id="aff9">University Hospital of Zurich, Zurich, Switzerland</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>University Hospital of Zurich, Zurich</wicri:regionArea>
<wicri:noRegion>Zurich</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Roberts, Stuart" sort="Roberts, Stuart" uniqKey="Roberts S" first="Stuart" last="Roberts">Stuart Roberts</name>
<affiliation wicri:level="3"><nlm:aff id="aff10">Alfred Hospital, Melbourne, Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Alfred Hospital, Melbourne</wicri:regionArea>
<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schuchmann, Marcus" sort="Schuchmann, Marcus" uniqKey="Schuchmann M" first="Marcus" last="Schuchmann">Marcus Schuchmann</name>
<affiliation wicri:level="3"><nlm:aff id="aff11">University Hospital Mainz, Mainz, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>University Hospital Mainz, Mainz</wicri:regionArea>
<placeName><region type="land" nuts="2">Rhénanie-Palatinat</region>
<settlement type="city">Mayence</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Manns, Michael" sort="Manns, Michael" uniqKey="Manns M" first="Michael" last="Manns">Michael Manns</name>
<affiliation wicri:level="3"><nlm:aff id="aff12">Medical School of Hannover, Hannover, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Medical School of Hannover, Hannover</wicri:regionArea>
<placeName><region type="land" nuts="2">Basse-Saxe</region>
<settlement type="city">Hanovre</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bourliere, Marc" sort="Bourliere, Marc" uniqKey="Bourliere M" first="Marc" last="Bourlière">Marc Bourlière</name>
<affiliation wicri:level="3"><nlm:aff id="aff13">Hôpital Saint Joseph, Marseille, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Hôpital Saint Joseph, Marseille</wicri:regionArea>
<placeName><region type="region">Provence-Alpes-Côte d'Azur</region>
<region type="old region">Provence-Alpes-Côte d'Azur</region>
<settlement type="city">Marseille</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Buti, Maria" sort="Buti, Maria" uniqKey="Buti M" first="Maria" last="Buti">Maria Buti</name>
<affiliation wicri:level="3"><nlm:aff id="aff14">Hospital Universitario Valle Hebron and Ciberehd del Instituto Carlos III, Barcelona, Spain</nlm:aff>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Hospital Universitario Valle Hebron and Ciberehd del Instituto Carlos III, Barcelona</wicri:regionArea>
<placeName><settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Stern, Jerry O" sort="Stern, Jerry O" uniqKey="Stern J" first="Jerry O." last="Stern">Jerry O. Stern</name>
<affiliation wicri:level="2"><nlm:aff id="aff15">Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut</wicri:regionArea>
<placeName><region type="state">Connecticut</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Gallivan, John Paul" sort="Gallivan, John Paul" uniqKey="Gallivan J" first="John-Paul" last="Gallivan">John-Paul Gallivan</name>
<affiliation wicri:level="1"><nlm:aff id="aff16">Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim</wicri:regionArea>
<wicri:noRegion>Ingelheim</wicri:noRegion>
<wicri:noRegion>Ingelheim</wicri:noRegion>
<wicri:noRegion>Ingelheim</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Voss, Florian" sort="Voss, Florian" uniqKey="Voss F" first="Florian" last="Voss">Florian Voss</name>
<affiliation wicri:level="1"><nlm:aff id="aff16">Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim</wicri:regionArea>
<wicri:noRegion>Ingelheim</wicri:noRegion>
<wicri:noRegion>Ingelheim</wicri:noRegion>
<wicri:noRegion>Ingelheim</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Sabo, John P" sort="Sabo, John P" uniqKey="Sabo J" first="John P." last="Sabo">John P. Sabo</name>
<affiliation wicri:level="2"><nlm:aff id="aff15">Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut</wicri:regionArea>
<placeName><region type="state">Connecticut</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bocher, Wulf" sort="Bocher, Wulf" uniqKey="Bocher W" first="Wulf" last="Böcher">Wulf Böcher</name>
<affiliation wicri:level="1"><nlm:aff id="aff16">Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim</wicri:regionArea>
<wicri:noRegion>Ingelheim</wicri:noRegion>
<wicri:noRegion>Ingelheim</wicri:noRegion>
<wicri:noRegion>Ingelheim</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mensa, Federico J" sort="Mensa, Federico J" uniqKey="Mensa F" first="Federico J." last="Mensa">Federico J. Mensa</name>
<affiliation wicri:level="2"><nlm:aff id="aff15">Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut</wicri:regionArea>
<placeName><region type="state">Connecticut</region>
</placeName>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PMC</idno>
<idno type="pmid">25512403</idno>
<idno type="pmc">4335863</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4335863</idno>
<idno type="RBID">PMC:4335863</idno>
<idno type="doi">10.1128/AAC.04383-14</idno>
<date when="2015">2015</date>
<idno type="wicri:Area/Pmc/Corpus">001741</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001741</idno>
<idno type="wicri:Area/Pmc/Curation">001601</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">001601</idno>
<idno type="wicri:Area/Pmc/Checkpoint">001039</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">001039</idno>
<idno type="wicri:source">PubMed</idno>
<idno type="wicri:Area/PubMed/Corpus">003023</idno>
<idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">003023</idno>
<idno type="wicri:Area/PubMed/Curation">002F42</idno>
<idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">002F42</idno>
<idno type="wicri:Area/PubMed/Checkpoint">002F42</idno>
<idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">002F42</idno>
<idno type="wicri:Area/Ncbi/Merge">002103</idno>
<idno type="wicri:Area/Ncbi/Curation">002103</idno>
<idno type="wicri:Area/Ncbi/Checkpoint">002103</idno>
<idno type="wicri:doubleKey">0066-4804:2015:Zeuzem S:efficacy:and:safety</idno>
<idno type="wicri:Area/Main/Merge">002E68</idno>
<idno type="wicri:Area/Main/Curation">002E67</idno>
<idno type="wicri:Area/Main/Exploration">002E67</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Efficacy and Safety of Faldaprevir, Deleobuvir, and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C Virus Infection and Advanced Liver Fibrosis or Cirrhosis</title>
<author><name sortKey="Zeuzem, Stefan" sort="Zeuzem, Stefan" uniqKey="Zeuzem S" first="Stefan" last="Zeuzem">Stefan Zeuzem</name>
<affiliation wicri:level="3"><nlm:aff id="aff1">J. W. Goethe University Hospital, Frankfurt, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>J. W. Goethe University Hospital, Frankfurt</wicri:regionArea>
<placeName><region type="land" nuts="1">Hesse (Land)</region>
<region type="district" nuts="2">District de Darmstadt</region>
<settlement type="city">Francfort-sur-le-Main</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Soriano, Vicente" sort="Soriano, Vicente" uniqKey="Soriano V" first="Vicente" last="Soriano">Vicente Soriano</name>
<affiliation wicri:level="3"><nlm:aff id="aff2">Hospital Carlos III, Madrid, Spain</nlm:aff>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Hospital Carlos III, Madrid</wicri:regionArea>
<placeName><settlement type="city">Madrid</settlement>
<region nuts="2" type="region">Communauté de Madrid</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Asselah, Tarik" sort="Asselah, Tarik" uniqKey="Asselah T" first="Tarik" last="Asselah">Tarik Asselah</name>
<affiliation wicri:level="1"><nlm:aff id="aff3">Service d'Hépatologie, Hôpital Beaujon, INSERM UMR S 1149, CRI, Université Paris Diderot, DHU UNITY, Clichy, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Service d'Hépatologie, Hôpital Beaujon, INSERM UMR S 1149, CRI, Université Paris Diderot, DHU UNITY, Clichy</wicri:regionArea>
<wicri:noRegion>Clichy</wicri:noRegion>
<wicri:noRegion>Clichy</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gane, Edward J" sort="Gane, Edward J" uniqKey="Gane E" first="Edward J." last="Gane">Edward J. Gane</name>
<affiliation wicri:level="1"><nlm:aff id="aff4">Auckland Clinical Studies, Auckland, New Zealand</nlm:aff>
<country xml:lang="fr">Nouvelle-Zélande</country>
<wicri:regionArea>Auckland Clinical Studies, Auckland</wicri:regionArea>
<wicri:noRegion>Auckland</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bronowicki, Jean Pierre" sort="Bronowicki, Jean Pierre" uniqKey="Bronowicki J" first="Jean-Pierre" last="Bronowicki">Jean-Pierre Bronowicki</name>
<affiliation wicri:level="3"><nlm:aff id="aff5">INSERM 954, Centre Hospitalier Universitaire de Nancy, Vandoeuvre les Nancy, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>INSERM 954, Centre Hospitalier Universitaire de Nancy, Vandoeuvre les Nancy</wicri:regionArea>
<placeName><region type="region" nuts="2">Grand Est</region>
<region type="old region" nuts="2">Lorraine (région)</region>
<settlement type="city">Vandœuvre-lès-Nancy</settlement>
<settlement type="city" wicri:auto="agglo">Nancy</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Angus, Peter" sort="Angus, Peter" uniqKey="Angus P" first="Peter" last="Angus">Peter Angus</name>
<affiliation wicri:level="1"><nlm:aff id="aff6">Austin Health, Heidelberg, Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Austin Health, Heidelberg</wicri:regionArea>
<wicri:noRegion>Heidelberg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Lohse, Ansgar W" sort="Lohse, Ansgar W" uniqKey="Lohse A" first="Ansgar W." last="Lohse">Ansgar W. Lohse</name>
<affiliation wicri:level="3"><nlm:aff id="aff7">University Hospital Hamburg-Eppendorf, Hamburg, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>University Hospital Hamburg-Eppendorf, Hamburg</wicri:regionArea>
<placeName><settlement type="city">Hambourg</settlement>
<region type="land" nuts="2">Hambourg</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Stickel, Felix" sort="Stickel, Felix" uniqKey="Stickel F" first="Felix" last="Stickel">Felix Stickel</name>
<affiliation wicri:level="4"><nlm:aff id="aff8">University of Bern, Bern, Switzerland</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>University of Bern, Bern</wicri:regionArea>
<placeName><settlement type="city">Berne</settlement>
<region type="région" nuts="3">Canton de Berne</region>
<settlement type="city">Berne</settlement>
</placeName>
<orgName type="university">Université de Berne</orgName>
</affiliation>
</author>
<author><name sortKey="Mullhaupt, Beat" sort="Mullhaupt, Beat" uniqKey="Mullhaupt B" first="Beat" last="Müllhaupt">Beat Müllhaupt</name>
<affiliation wicri:level="1"><nlm:aff id="aff9">University Hospital of Zurich, Zurich, Switzerland</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>University Hospital of Zurich, Zurich</wicri:regionArea>
<wicri:noRegion>Zurich</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Roberts, Stuart" sort="Roberts, Stuart" uniqKey="Roberts S" first="Stuart" last="Roberts">Stuart Roberts</name>
<affiliation wicri:level="3"><nlm:aff id="aff10">Alfred Hospital, Melbourne, Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Alfred Hospital, Melbourne</wicri:regionArea>
<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schuchmann, Marcus" sort="Schuchmann, Marcus" uniqKey="Schuchmann M" first="Marcus" last="Schuchmann">Marcus Schuchmann</name>
<affiliation wicri:level="3"><nlm:aff id="aff11">University Hospital Mainz, Mainz, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>University Hospital Mainz, Mainz</wicri:regionArea>
<placeName><region type="land" nuts="2">Rhénanie-Palatinat</region>
<settlement type="city">Mayence</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Manns, Michael" sort="Manns, Michael" uniqKey="Manns M" first="Michael" last="Manns">Michael Manns</name>
<affiliation wicri:level="3"><nlm:aff id="aff12">Medical School of Hannover, Hannover, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Medical School of Hannover, Hannover</wicri:regionArea>
<placeName><region type="land" nuts="2">Basse-Saxe</region>
<settlement type="city">Hanovre</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bourliere, Marc" sort="Bourliere, Marc" uniqKey="Bourliere M" first="Marc" last="Bourlière">Marc Bourlière</name>
<affiliation wicri:level="3"><nlm:aff id="aff13">Hôpital Saint Joseph, Marseille, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Hôpital Saint Joseph, Marseille</wicri:regionArea>
<placeName><region type="region">Provence-Alpes-Côte d'Azur</region>
<region type="old region">Provence-Alpes-Côte d'Azur</region>
<settlement type="city">Marseille</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Buti, Maria" sort="Buti, Maria" uniqKey="Buti M" first="Maria" last="Buti">Maria Buti</name>
<affiliation wicri:level="3"><nlm:aff id="aff14">Hospital Universitario Valle Hebron and Ciberehd del Instituto Carlos III, Barcelona, Spain</nlm:aff>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Hospital Universitario Valle Hebron and Ciberehd del Instituto Carlos III, Barcelona</wicri:regionArea>
<placeName><settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Stern, Jerry O" sort="Stern, Jerry O" uniqKey="Stern J" first="Jerry O." last="Stern">Jerry O. Stern</name>
<affiliation wicri:level="2"><nlm:aff id="aff15">Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut</wicri:regionArea>
<placeName><region type="state">Connecticut</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Gallivan, John Paul" sort="Gallivan, John Paul" uniqKey="Gallivan J" first="John-Paul" last="Gallivan">John-Paul Gallivan</name>
<affiliation wicri:level="1"><nlm:aff id="aff16">Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim</wicri:regionArea>
<wicri:noRegion>Ingelheim</wicri:noRegion>
<wicri:noRegion>Ingelheim</wicri:noRegion>
<wicri:noRegion>Ingelheim</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Voss, Florian" sort="Voss, Florian" uniqKey="Voss F" first="Florian" last="Voss">Florian Voss</name>
<affiliation wicri:level="1"><nlm:aff id="aff16">Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim</wicri:regionArea>
<wicri:noRegion>Ingelheim</wicri:noRegion>
<wicri:noRegion>Ingelheim</wicri:noRegion>
<wicri:noRegion>Ingelheim</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Sabo, John P" sort="Sabo, John P" uniqKey="Sabo J" first="John P." last="Sabo">John P. Sabo</name>
<affiliation wicri:level="2"><nlm:aff id="aff15">Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut</wicri:regionArea>
<placeName><region type="state">Connecticut</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bocher, Wulf" sort="Bocher, Wulf" uniqKey="Bocher W" first="Wulf" last="Böcher">Wulf Böcher</name>
<affiliation wicri:level="1"><nlm:aff id="aff16">Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim</wicri:regionArea>
<wicri:noRegion>Ingelheim</wicri:noRegion>
<wicri:noRegion>Ingelheim</wicri:noRegion>
<wicri:noRegion>Ingelheim</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mensa, Federico J" sort="Mensa, Federico J" uniqKey="Mensa F" first="Federico J." last="Mensa">Federico J. Mensa</name>
<affiliation wicri:level="2"><nlm:aff id="aff15">Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut</wicri:regionArea>
<placeName><region type="state">Connecticut</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">Antimicrobial Agents and Chemotherapy</title>
<idno type="ISSN">0066-4804</idno>
<idno type="eISSN">1098-6596</idno>
<imprint><date when="2015">2015</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Acrylates (adverse effects)</term>
<term>Acrylates (therapeutic use)</term>
<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Antiviral Agents (adverse effects)</term>
<term>Antiviral Agents (therapeutic use)</term>
<term>Benzimidazoles (adverse effects)</term>
<term>Benzimidazoles (therapeutic use)</term>
<term>Female</term>
<term>Hepatitis C, Chronic (complications)</term>
<term>Hepatitis C, Chronic (drug therapy)</term>
<term>Humans</term>
<term>Liver Cirrhosis (complications)</term>
<term>Liver Cirrhosis (drug therapy)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Oligopeptides (adverse effects)</term>
<term>Oligopeptides (therapeutic use)</term>
<term>Ribavirin (adverse effects)</term>
<term>Ribavirin (therapeutic use)</term>
<term>Thiazoles (adverse effects)</term>
<term>Thiazoles (therapeutic use)</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Acrylates (effets indésirables)</term>
<term>Acrylates (usage thérapeutique)</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Antiviraux (effets indésirables)</term>
<term>Antiviraux (usage thérapeutique)</term>
<term>Benzimidazoles (effets indésirables)</term>
<term>Benzimidazoles (usage thérapeutique)</term>
<term>Cirrhose du foie ()</term>
<term>Cirrhose du foie (traitement médicamenteux)</term>
<term>Femelle</term>
<term>Humains</term>
<term>Hépatite C chronique ()</term>
<term>Hépatite C chronique (traitement médicamenteux)</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Oligopeptides (effets indésirables)</term>
<term>Oligopeptides (usage thérapeutique)</term>
<term>Ribavirine (effets indésirables)</term>
<term>Ribavirine (usage thérapeutique)</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Thiazoles (effets indésirables)</term>
<term>Thiazoles (usage thérapeutique)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Acrylates</term>
<term>Antiviral Agents</term>
<term>Benzimidazoles</term>
<term>Oligopeptides</term>
<term>Ribavirin</term>
<term>Thiazoles</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Acrylates</term>
<term>Antiviral Agents</term>
<term>Benzimidazoles</term>
<term>Oligopeptides</term>
<term>Ribavirin</term>
<term>Thiazoles</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Hepatitis C, Chronic</term>
<term>Liver Cirrhosis</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Hepatitis C, Chronic</term>
<term>Liver Cirrhosis</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Acrylates</term>
<term>Antiviraux</term>
<term>Benzimidazoles</term>
<term>Oligopeptides</term>
<term>Ribavirine</term>
<term>Thiazoles</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Cirrhose du foie</term>
<term>Hépatite C chronique</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Acrylates</term>
<term>Antiviraux</term>
<term>Benzimidazoles</term>
<term>Oligopeptides</term>
<term>Ribavirine</term>
<term>Thiazoles</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Cirrhose du foie</term>
<term>Femelle</term>
<term>Humains</term>
<term>Hépatite C chronique</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><p>Patients with advanced hepatic fibrosis or cirrhosis with chronic hepatitis C virus (HCV) infection represent an unmet need. The HCV NS3/4A inhibitor, faldaprevir, was evaluated in combination with the nonnucleoside NS5B inhibitor, deleobuvir, with or without ribavirin in treatment-naive patients with HCV genotype 1 infection in the SOUND-C2 study. Here, the efficacy and safety of this interferon-free regimen in a subset of patients with advanced liver fibrosis, including those with compensated cirrhosis, were assessed. Patients (<italic>n</italic>
 = 362) were randomized to once-daily faldaprevir with either twice-daily (BID) or three-times-daily (TID) deleobuvir for 16 (TID16W), 28 (TID28W and BID28W), or 40 (TID40W) weeks with or without ribavirin (TID28W-NR). Patients were classified according to fibrosis stage (F0 to F2 versus F3 to F4) and the presence of cirrhosis (yes/no). In total, 85 (24%) patients had advanced fibrosis/cirrhosis (F3 to F4) and 33 (9%) had cirrhosis. Within each treatment arm, differences in rates of sustained virologic response 12 weeks after completion of treatment (SVR12) between patients with mild to moderate fibrosis (F0 to F2) versus F3 to F4 did not show a consistent pattern and were not statistically significant (63% versus 47% for TID16W, 53% versus 76% for TID28W, 48% versus 67% for TID40W, 70% versus 67% for BID28W, and 40% versus 36% for TID28W-NR, respectively; <italic>P</italic>
 > 0.05 for each arm). The most frequent adverse events in patients with/without cirrhosis were gastrointestinal and skin events, which were mostly mild or moderate in intensity. The degree of liver fibrosis did not appear to affect the probability of achieving SVR12 following treatment with the interferon-free regimen of faldaprevir, deleobuvir, and ribavirin. (This study has been registered at ClinicalTrials.gov under registration no. NCT01132313.)</p>
</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Espagne</li>
<li>France</li>
<li>Nouvelle-Zélande</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region><li>Basse-Saxe</li>
<li>Canton de Berne</li>
<li>Catalogne</li>
<li>Communauté de Madrid</li>
<li>Connecticut</li>
<li>District de Darmstadt</li>
<li>Grand Est</li>
<li>Hambourg</li>
<li>Hesse (Land)</li>
<li>Lorraine (région)</li>
<li>Provence-Alpes-Côte d'Azur</li>
<li>Rhénanie-Palatinat</li>
<li>Victoria (État)</li>
</region>
<settlement><li>Barcelone</li>
<li>Berne</li>
<li>Francfort-sur-le-Main</li>
<li>Hambourg</li>
<li>Hanovre</li>
<li>Madrid</li>
<li>Marseille</li>
<li>Mayence</li>
<li>Melbourne</li>
<li>Nancy</li>
<li>Vandœuvre-lès-Nancy</li>
</settlement>
<orgName><li>Université de Berne</li>
</orgName>
</list>
<tree><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>
<name sortKey="Bocher, Wulf" sort="Bocher, Wulf" uniqKey="Bocher W" first="Wulf" last="Böcher">Wulf Böcher</name>
<name sortKey="Gallivan, John Paul" sort="Gallivan, John Paul" uniqKey="Gallivan J" first="John-Paul" last="Gallivan">John-Paul Gallivan</name>
<name sortKey="Lohse, Ansgar W" sort="Lohse, Ansgar W" uniqKey="Lohse A" first="Ansgar W." last="Lohse">Ansgar W. Lohse</name>
<name sortKey="Manns, Michael" sort="Manns, Michael" uniqKey="Manns M" first="Michael" last="Manns">Michael Manns</name>
<name sortKey="Schuchmann, Marcus" sort="Schuchmann, Marcus" uniqKey="Schuchmann M" first="Marcus" last="Schuchmann">Marcus Schuchmann</name>
<name sortKey="Voss, Florian" sort="Voss, Florian" uniqKey="Voss F" first="Florian" last="Voss">Florian Voss</name>
</country>
<country name="Espagne"><region name="Communauté de Madrid"><name sortKey="Soriano, Vicente" sort="Soriano, Vicente" uniqKey="Soriano V" first="Vicente" last="Soriano">Vicente Soriano</name>
</region>
<name sortKey="Buti, Maria" sort="Buti, Maria" uniqKey="Buti M" first="Maria" last="Buti">Maria Buti</name>
</country>
<country name="France"><noRegion><name sortKey="Asselah, Tarik" sort="Asselah, Tarik" uniqKey="Asselah T" first="Tarik" last="Asselah">Tarik Asselah</name>
</noRegion>
<name sortKey="Bourliere, Marc" sort="Bourliere, Marc" uniqKey="Bourliere M" first="Marc" last="Bourlière">Marc Bourlière</name>
<name sortKey="Bronowicki, Jean Pierre" sort="Bronowicki, Jean Pierre" uniqKey="Bronowicki J" first="Jean-Pierre" last="Bronowicki">Jean-Pierre Bronowicki</name>
</country>
<country name="Nouvelle-Zélande"><noRegion><name sortKey="Gane, Edward J" sort="Gane, Edward J" uniqKey="Gane E" first="Edward J." last="Gane">Edward J. Gane</name>
</noRegion>
</country>
<country name="Australie"><noRegion><name sortKey="Angus, Peter" sort="Angus, Peter" uniqKey="Angus P" first="Peter" last="Angus">Peter Angus</name>
</noRegion>
<name sortKey="Roberts, Stuart" sort="Roberts, Stuart" uniqKey="Roberts S" first="Stuart" last="Roberts">Stuart Roberts</name>
</country>
<country name="Suisse"><region name="Canton de Berne"><name sortKey="Stickel, Felix" sort="Stickel, Felix" uniqKey="Stickel F" first="Felix" last="Stickel">Felix Stickel</name>
</region>
<name sortKey="Mullhaupt, Beat" sort="Mullhaupt, Beat" uniqKey="Mullhaupt B" first="Beat" last="Müllhaupt">Beat Müllhaupt</name>
</country>
<country name="États-Unis"><region name="Connecticut"><name sortKey="Stern, Jerry O" sort="Stern, Jerry O" uniqKey="Stern J" first="Jerry O." last="Stern">Jerry O. Stern</name>
</region>
<name sortKey="Mensa, Federico J" sort="Mensa, Federico J" uniqKey="Mensa F" first="Federico J." last="Mensa">Federico J. Mensa</name>
<name sortKey="Sabo, John P" sort="Sabo, John P" uniqKey="Sabo J" first="John P." last="Sabo">John P. Sabo</name>
</country>
</tree>
</affiliations>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Wicri/Asie/explor/AustralieFrV1/Data/Main/Exploration

HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 002E67 | SxmlIndent | more

HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 002E67 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Wicri/Asie
   |area=    AustralieFrV1
   |flux=    Main
   |étape=   Exploration
   |type=    RBID
   |clé=     PMC:4335863
   |texte=   Efficacy and Safety of Faldaprevir, Deleobuvir, and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C Virus Infection and Advanced Liver Fibrosis or Cirrhosis
}}

Pour générer des pages wiki

HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i   -Sk "pubmed:25512403" \
       | HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd   \
       | NlmPubMed2Wicri -a AustralieFrV1

This area was generated with Dilib version V0.6.33.
Data generation: Tue Dec 5 10:43:12 2017. Site generation: Tue Mar 5 14:07:20 2024

Serveur d'exploration sur les relations entre la France et l'Australie

Efficacy and Safety of Faldaprevir, Deleobuvir, and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C Virus Infection and Advanced Liver Fibrosis or Cirrhosis

Efficacy and Safety of Faldaprevir, Deleobuvir, and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C Virus Infection and Advanced Liver Fibrosis or Cirrhosis

Source :

Descripteurs français

English descriptors

Abstract

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

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri

Pour générer des pages wiki

	Serveur d'exploration sur les relations entre la France et l'Australie
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.