Faldaprevir (BI 201335), deleobuvir (BI 207127) and ribavirin oral therapy for treatment-naive HCV genotype 1: SOUND-C1 final results
Identifieur interne : 004F51 ( Main/Exploration ); précédent : 004F50; suivant : 004F52Faldaprevir (BI 201335), deleobuvir (BI 207127) and ribavirin oral therapy for treatment-naive HCV genotype 1: SOUND-C1 final results
Auteurs : Stefan Zeuzem [Allemagne] ; Tarik Asselah [France] ; Peter Angus [Australie] ; Jean-Pierre Zarski [France] ; Dominique Larrey [France] ; Beat Müllhaupt [Suisse] ; Ed Gane [Nouvelle-Zélande] ; Marcus Schuchmann [Allemagne] ; Ansgar W. Lohse [Allemagne] ; Stanislas Pol [France] ; Jean-Pierre Bronowicki [France] ; Stuart Roberts [Australie] ; Keikawus Arasteh [Allemagne] ; Fabien Zoulim [France] ; Markus Heim [Suisse] ; Jerry O. Stern [États-Unis] ; Gerhard Nehmiz [Allemagne] ; George Kukolj [Canada] ; Wulf O. Böcher [Allemagne] ; Federico J. Mensa [États-Unis]Source :
- Antiviral therapy : (London) [ 1359-6535 ] ; 2013.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
Background: Faldaprevir (BI 201335) and deleobuvir (BI 207127) are direct-acting antiviral agents under development for the treatment of chronic HCV infection. This article describes the final results of the Phase Ib S0UND-C1 study that evaluated the interferon-free oral combination of faldaprevir, deleobuvir and ribavirin in 32 treatment-naive patients infected with HCV genotype 1. Methods: Patients were randomized to receive deleobuvir 400 mg (n=15) or 600 mg (n=17) three times daily plus faldaprevir 120 mg once daily and weight-based ribavirin for 4 weeks. Interferon-free therapy was followed by response-guided faldaprevir plus pegylated interferon-α2a/ribavirin to week 24 or 48. Results: At week 4, 73% (11/15) and 100% (17/17) of patients in the deleobuvir 400 mg and 600 mg groups achieved HCV RNA<25 IU/ml. respectively. During interferon-free treatment, virological breakthrough was reported in one patient and re-increase of HCV RNA in one patient. Both patients were successfully treated with interferon-containing therapy. The rate of sustained virological response 24 weeks after completion of treatment was 73% (11/15) in the deleobuvir 400 mg group and 94% (16/17) in the 600 mg group. During faldaprevir plus pegylated interferon-α2a/ ribavirin treatment, the most common adverse events were pruritus (38% of patients), rash (31%) and asthenia (31%); these were severe in approximately 3% of patients. Conclusions: Potent antiviral activity and favourable safety of the treatment regimen were demonstrated. Furthermore, the results suggest that patients with breakthrough at week 4 may be rescued with an interferon-containing regimen.
Affiliations:
- Allemagne, Australie, Canada, France, Nouvelle-Zélande, Suisse, États-Unis
- Auvergne-Rhône-Alpes, Berlin, Canton de Zurich, District de Darmstadt, Grand Est, Hambourg, Hesse (Land), Languedoc-Roussillon, Lorraine (région), Occitanie (région administrative), Rhénanie-Palatinat, Rhône-Alpes, Île-de-France
- Berlin, Francfort-sur-le-Main, Grenoble, Hambourg, Lyon, Mayence, Montpellier, Nancy, Paris, Vandœuvre-lès-Nancy, Zurich
- Université Paris-Descartes
Links toward previous steps (curation, corpus...)
- to stream PascalFrancis, to step Corpus: 000542
- to stream PascalFrancis, to step Curation: 005916
- to stream PascalFrancis, to step Checkpoint: 000954
- to stream Main, to step Merge: 005128
- to stream Main, to step Curation: 004F51
Le document en format XML
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<author><name sortKey="Heim, Markus" sort="Heim, Markus" uniqKey="Heim M" first="Markus" last="Heim">Markus Heim</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Faldaprevir (BI 201335), deleobuvir (BI 207127) and ribavirin oral therapy for treatment-naive HCV genotype 1: SOUND-C1 final results</title>
<author><name sortKey="Zeuzem, Stefan" sort="Zeuzem, Stefan" uniqKey="Zeuzem S" first="Stefan" last="Zeuzem">Stefan Zeuzem</name>
<affiliation wicri:level="3"><inist:fA14 i1="01"><s1>JW Goethe University Hospital</s1>
<s2>Frankfurt am Main</s2>
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<author><name sortKey="Zarski, Jean Pierre" sort="Zarski, Jean Pierre" uniqKey="Zarski J" first="Jean-Pierre" last="Zarski">Jean-Pierre Zarski</name>
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<author><name sortKey="Larrey, Dominique" sort="Larrey, Dominique" uniqKey="Larrey D" first="Dominique" last="Larrey">Dominique Larrey</name>
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<author><name sortKey="Mullhaupt, Beat" sort="Mullhaupt, Beat" uniqKey="Mullhaupt B" first="Beat" last="Müllhaupt">Beat Müllhaupt</name>
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<sZ>6 aut.</sZ>
</inist:fA14>
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<author><name sortKey="Gane, Ed" sort="Gane, Ed" uniqKey="Gane E" first="Ed" last="Gane">Ed Gane</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Auckland City Hospital</s1>
<s2>Auckland</s2>
<s3>NZL</s3>
<sZ>7 aut.</sZ>
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<author><name sortKey="Schuchmann, Marcus" sort="Schuchmann, Marcus" uniqKey="Schuchmann M" first="Marcus" last="Schuchmann">Marcus Schuchmann</name>
<affiliation wicri:level="3"><inist:fA14 i1="08"><s1>University Medical Center Mainz</s1>
<s2>Mainz</s2>
<s3>DEU</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><region type="land" nuts="2">Rhénanie-Palatinat</region>
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<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"><inist:fA14 i1="09"><s1>University Hospital Hamburg-Eppendorf</s1>
<s2>Hamburg</s2>
<s3>DEU</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><settlement type="city">Hambourg</settlement>
<region type="land" nuts="2">Hambourg</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Pol, Stanislas" sort="Pol, Stanislas" uniqKey="Pol S" first="Stanislas" last="Pol">Stanislas Pol</name>
<affiliation wicri:level="4"><inist:fA14 i1="10"><s1>Université Paris Descartes, INSERM U1016 et APHP, Hôpital Cochin</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
<settlement type="city">Paris</settlement>
</placeName>
<orgName type="university">Université Paris-Descartes</orgName>
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</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"><inist:fA14 i1="11"><s1>INSERM U954, Centre Hospitalier Universitaire de Nancy, Université de Lorraine</s1>
<s2>Vandoeuvre-lès-Nancy</s2>
<s3>FRA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>France</country>
<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="Roberts, Stuart" sort="Roberts, Stuart" uniqKey="Roberts S" first="Stuart" last="Roberts">Stuart Roberts</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Alfred Hospital</s1>
<s2>Melbourne, Victoria</s2>
<s3>AUS</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Alfred Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Arasteh, Keikawus" sort="Arasteh, Keikawus" uniqKey="Arasteh K" first="Keikawus" last="Arasteh">Keikawus Arasteh</name>
<affiliation wicri:level="3"><inist:fA14 i1="13"><s1>Epimed GmbH</s1>
<s2>Berlin</s2>
<s3>DEU</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Zoulim, Fabien" sort="Zoulim, Fabien" uniqKey="Zoulim F" first="Fabien" last="Zoulim">Fabien Zoulim</name>
<affiliation wicri:level="3"><inist:fA14 i1="14"><s1>Hepatology Department, Hospices Civils de Lyon, Lyon University</s1>
<s2>Lyon</s2>
<s3>FRA</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Rhône-Alpes</region>
<settlement type="city">Lyon</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Heim, Markus" sort="Heim, Markus" uniqKey="Heim M" first="Markus" last="Heim">Markus Heim</name>
<affiliation wicri:level="1"><inist:fA14 i1="15"><s1>University Hospital Basel</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
<wicri:noRegion>University Hospital Basel</wicri:noRegion>
</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="1"><inist:fA14 i1="16"><s1>Boehringer Ingelheim Pharmaceuticals Inc.</s1>
<s2>Ridgefield, CT</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Boehringer Ingelheim Pharmaceuticals Inc.</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Nehmiz, Gerhard" sort="Nehmiz, Gerhard" uniqKey="Nehmiz G" first="Gerhard" last="Nehmiz">Gerhard Nehmiz</name>
<affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Boehringer Ingelheim Pharma GmbH Et Co KG</s1>
<s2>Ingelheim</s2>
<s3>DEU</s3>
<sZ>17 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<wicri:noRegion>Ingelheim</wicri:noRegion>
<wicri:noRegion>Boehringer Ingelheim Pharma GmbH Et Co KG</wicri:noRegion>
<wicri:noRegion>Boehringer Ingelheim Pharma GmbH Et Co KG</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kukolj, George" sort="Kukolj, George" uniqKey="Kukolj G" first="George" last="Kukolj">George Kukolj</name>
<affiliation wicri:level="1"><inist:fA14 i1="18"><s1>Boehringer Ingelheim (Canada) Ltd</s1>
<s2>Laval, QC</s2>
<s3>CAN</s3>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Boehringer Ingelheim (Canada) Ltd</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bocher, Wulf O" sort="Bocher, Wulf O" uniqKey="Bocher W" first="Wulf O." last="Böcher">Wulf O. Böcher</name>
<affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Boehringer Ingelheim Pharma GmbH Et Co KG</s1>
<s2>Ingelheim</s2>
<s3>DEU</s3>
<sZ>17 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<wicri:noRegion>Ingelheim</wicri:noRegion>
<wicri:noRegion>Boehringer Ingelheim Pharma GmbH Et Co KG</wicri:noRegion>
<wicri:noRegion>Boehringer Ingelheim Pharma GmbH Et Co KG</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="1"><inist:fA14 i1="16"><s1>Boehringer Ingelheim Pharmaceuticals Inc.</s1>
<s2>Ridgefield, CT</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Boehringer Ingelheim Pharmaceuticals Inc.</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Antiviral therapy : (London)</title>
<title level="j" type="abbreviated">Antivir. ther. : (Lond.)</title>
<idno type="ISSN">1359-6535</idno>
<imprint><date when="2013">2013</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Antiviral therapy : (London)</title>
<title level="j" type="abbreviated">Antivir. ther. : (Lond.)</title>
<idno type="ISSN">1359-6535</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiviral</term>
<term>Deleobuvir</term>
<term>Faldaprevir</term>
<term>Genotype</term>
<term>Hepatitis C virus</term>
<term>Oral administration</term>
<term>Result</term>
<term>Ribavirin</term>
<term>Typing</term>
<term>Viral hepatitis C</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Ribavirine</term>
<term>Voie orale</term>
<term>Virus hépatite C</term>
<term>Génotype</term>
<term>Typage</term>
<term>Résultat</term>
<term>Antiviral</term>
<term>Hépatite virale C</term>
<term>Traitement initial</term>
<term>Faldaprévir</term>
<term>Déléobuvir</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Background: Faldaprevir (BI 201335) and deleobuvir (BI 207127) are direct-acting antiviral agents under development for the treatment of chronic HCV infection. This article describes the final results of the Phase Ib S0UND-C1 study that evaluated the interferon-free oral combination of faldaprevir, deleobuvir and ribavirin in 32 treatment-naive patients infected with HCV genotype 1. Methods: Patients were randomized to receive deleobuvir 400 mg (n=15) or 600 mg (n=17) three times daily plus faldaprevir 120 mg once daily and weight-based ribavirin for 4 weeks. Interferon-free therapy was followed by response-guided faldaprevir plus pegylated interferon-α2a/ribavirin to week 24 or 48. Results: At week 4, 73% (11/15) and 100% (17/17) of patients in the deleobuvir 400 mg and 600 mg groups achieved HCV RNA<25 IU/ml. respectively. During interferon-free treatment, virological breakthrough was reported in one patient and re-increase of HCV RNA in one patient. Both patients were successfully treated with interferon-containing therapy. The rate of sustained virological response 24 weeks after completion of treatment was 73% (11/15) in the deleobuvir 400 mg group and 94% (16/17) in the 600 mg group. During faldaprevir plus pegylated interferon-α2a/ ribavirin treatment, the most common adverse events were pruritus (38% of patients), rash (31%) and asthenia (31%); these were severe in approximately 3% of patients. Conclusions: Potent antiviral activity and favourable safety of the treatment regimen were demonstrated. Furthermore, the results suggest that patients with breakthrough at week 4 may be rescued with an interferon-containing regimen.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Canada</li>
<li>France</li>
<li>Nouvelle-Zélande</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region><li>Auvergne-Rhône-Alpes</li>
<li>Berlin</li>
<li>Canton de Zurich</li>
<li>District de Darmstadt</li>
<li>Grand Est</li>
<li>Hambourg</li>
<li>Hesse (Land)</li>
<li>Languedoc-Roussillon</li>
<li>Lorraine (région)</li>
<li>Occitanie (région administrative)</li>
<li>Rhénanie-Palatinat</li>
<li>Rhône-Alpes</li>
<li>Île-de-France</li>
</region>
<settlement><li>Berlin</li>
<li>Francfort-sur-le-Main</li>
<li>Grenoble</li>
<li>Hambourg</li>
<li>Lyon</li>
<li>Mayence</li>
<li>Montpellier</li>
<li>Nancy</li>
<li>Paris</li>
<li>Vandœuvre-lès-Nancy</li>
<li>Zurich</li>
</settlement>
<orgName><li>Université Paris-Descartes</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="Arasteh, Keikawus" sort="Arasteh, Keikawus" uniqKey="Arasteh K" first="Keikawus" last="Arasteh">Keikawus Arasteh</name>
<name sortKey="Bocher, Wulf O" sort="Bocher, Wulf O" uniqKey="Bocher W" first="Wulf O." last="Böcher">Wulf O. Böcher</name>
<name sortKey="Lohse, Ansgar W" sort="Lohse, Ansgar W" uniqKey="Lohse A" first="Ansgar W." last="Lohse">Ansgar W. Lohse</name>
<name sortKey="Nehmiz, Gerhard" sort="Nehmiz, Gerhard" uniqKey="Nehmiz G" first="Gerhard" last="Nehmiz">Gerhard Nehmiz</name>
<name sortKey="Schuchmann, Marcus" sort="Schuchmann, Marcus" uniqKey="Schuchmann M" first="Marcus" last="Schuchmann">Marcus Schuchmann</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="Bronowicki, Jean Pierre" sort="Bronowicki, Jean Pierre" uniqKey="Bronowicki J" first="Jean-Pierre" last="Bronowicki">Jean-Pierre Bronowicki</name>
<name sortKey="Larrey, Dominique" sort="Larrey, Dominique" uniqKey="Larrey D" first="Dominique" last="Larrey">Dominique Larrey</name>
<name sortKey="Pol, Stanislas" sort="Pol, Stanislas" uniqKey="Pol S" first="Stanislas" last="Pol">Stanislas Pol</name>
<name sortKey="Zarski, Jean Pierre" sort="Zarski, Jean Pierre" uniqKey="Zarski J" first="Jean-Pierre" last="Zarski">Jean-Pierre Zarski</name>
<name sortKey="Zoulim, Fabien" sort="Zoulim, Fabien" uniqKey="Zoulim F" first="Fabien" last="Zoulim">Fabien Zoulim</name>
</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 Zurich"><name sortKey="Mullhaupt, Beat" sort="Mullhaupt, Beat" uniqKey="Mullhaupt B" first="Beat" last="Müllhaupt">Beat Müllhaupt</name>
</region>
<name sortKey="Heim, Markus" sort="Heim, Markus" uniqKey="Heim M" first="Markus" last="Heim">Markus Heim</name>
</country>
<country name="Nouvelle-Zélande"><noRegion><name sortKey="Gane, Ed" sort="Gane, Ed" uniqKey="Gane E" first="Ed" last="Gane">Ed Gane</name>
</noRegion>
</country>
<country name="États-Unis"><noRegion><name sortKey="Stern, Jerry O" sort="Stern, Jerry O" uniqKey="Stern J" first="Jerry O." last="Stern">Jerry O. Stern</name>
</noRegion>
<name sortKey="Mensa, Federico J" sort="Mensa, Federico J" uniqKey="Mensa F" first="Federico J." last="Mensa">Federico J. Mensa</name>
</country>
<country name="Canada"><noRegion><name sortKey="Kukolj, George" sort="Kukolj, George" uniqKey="Kukolj G" first="George" last="Kukolj">George Kukolj</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>
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