All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study
Identifieur interne : 004309 ( Main/Exploration ); précédent : 004308; suivant : 004310All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study
Auteurs : Michael Manns [Allemagne] ; Stanislas Pol [France] ; Ira M. Jacobson [États-Unis] ; Patrick Marcellin [France] ; Stuart C. Gordon [États-Unis] ; Cheng-Yuan Peng [Taïwan] ; Ting-Tsung Chang [Taïwan] ; Gregory T. Everson [États-Unis] ; JEONG HEO [Corée du Sud] ; Guido Gerken [Allemagne] ; Boris Yoffe [États-Unis] ; William J. Towner [États-Unis] ; Marc Bourliere [France] ; Sophie Metivier [France] ; Chi-Jen Chu [Taïwan] ; William Sievert [Australie] ; Jean-Pierre Bronowicki [France] ; Dominique Thabut [France] ; Youn-Jae Lee [Corée du Sud] ; Jia-Horng Kao [Taïwan] ; Fiona Mcphee [États-Unis] ; Justin Kopit [États-Unis] ; Patricia Mendez [États-Unis] ; Misti Linaberry [États-Unis] ; Eric Hughes [États-Unis] ; Stephanie Noviello [États-Unis]Source :
- Lancet : (British edition) [ 0140-6736 ] ; 2014.
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English descriptors
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Abstract
Background An unmet need exists for interferon-free and ribavirin-free treatments for chronic hepatitis C virus (HCV) infection. In this study, we assessed all-oral therapy with daclatasvir (NS5A replication complex inhibitor) plus asunaprevir (NS3 protease inhibitor) in patients with genotype 1b infection, including those with high unmet needs or cirrhosis, or both. Methods We did this phase 3, multicohort study (HALLMARK-DUAL) at 116 sites in 18 countries between May 11, 2012, and Oct 9, 2013. Patients were adults with chronic HCV genotype 1b infection who were treatment-naive; previous non-responders to peginterferon alfa plus ribavirin; or medically ineligible for, previously intolerant of, or ineligible for and intolerant of peginterferon alfa plus ribavirin. Treatment-naive patients were randomly assigned (2:1 ratio) by an interactive voice-response system with a computer-generated random allocation sequence (stratified by cirrhosis status) to receive daclatasvir 60 mg once daily plus asunaprevir 100 mg twice daily or placebo for 12 weeks. Patients and investigator sites were masked to treatment assignment and HCV RNA results to the end of week 12. The treatment-naive group assigned to daclatasvir plus asunaprevir continued open-label treatment to the end of week 24; participants assigned to placebo entered another daclatasvir plus asunaprevir study. Non-responders and ineligible, intolerant, or ineligible and intolerant patients received open-label daclatasvir plus asunaprevir for 24 weeks. The primary endpoint was sustained virological response at post-treatment week 12. Efficacy analyses were restricted to patients given daclatasvir plus asunaprevir.
Affiliations:
- Allemagne, Australie, Corée du Sud, France, Taïwan, États-Unis
- Basse-Saxe, Grand Est, Lorraine (région), Midi-Pyrénées, Occitanie (région administrative), Provence-Alpes-Côte d'Azur, Texas, Île-de-France
- Hanovre, Houston, Marseille, Nancy, Paris, Toulouse, Vandœuvre-lès-Nancy
- Baylor College of Medicine
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Gordon</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Henry Ford Health Systems</s1><s2>Detroit, MI</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Henry Ford Health Systems</wicri:noRegion></affiliation></author><author><name sortKey="Peng, Cheng Yuan" sort="Peng, Cheng Yuan" uniqKey="Peng C" first="Cheng-Yuan" last="Peng">Cheng-Yuan Peng</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>School of Medicine, China Medical University</s1><s2>Taichung</s2><s3>TWN</s3><sZ>6 aut.</sZ></inist:fA14><country>Taïwan</country><wicri:noRegion>Taichung</wicri:noRegion></affiliation></author><author><name sortKey="Chang, Ting Tsung" sort="Chang, Ting Tsung" uniqKey="Chang T" first="Ting-Tsung" last="Chang">Ting-Tsung Chang</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>National Cheng Kung University Hospital</s1><s2>Tainan</s2><s3>TWN</s3><sZ>7 aut.</sZ></inist:fA14><country>Taïwan</country><wicri:noRegion>National Cheng Kung University Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Everson, Gregory T" sort="Everson, Gregory T" uniqKey="Everson G" first="Gregory T." last="Everson">Gregory T. Everson</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>University of Colorado Denver</s1><s2>Aurora, CO</s2><s3>USA</s3><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>University of Colorado Denver</wicri:noRegion></affiliation></author><author><name sortKey="Jeong Heo" sort="Jeong Heo" uniqKey="Jeong Heo" last="Jeong Heo">JEONG HEO</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Internal Medicine, College of Medicine, Pusan National University and Medical Research Institute, Pusan National University Hospital</s1><s2>Busan</s2><s3>KOR</s3><sZ>9 aut.</sZ></inist:fA14><country>Corée du Sud</country><wicri:noRegion>Busan</wicri:noRegion></affiliation></author><author><name sortKey="Gerken, Guido" sort="Gerken, Guido" uniqKey="Gerken G" first="Guido" last="Gerken">Guido Gerken</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>University of Duisburg-Essen</s1><s2>Essen</s2><s3>DEU</s3><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Essen</wicri:noRegion><wicri:noRegion>University of Duisburg-Essen</wicri:noRegion><wicri:noRegion>University of Duisburg-Essen</wicri:noRegion></affiliation></author><author><name sortKey="Yoffe, Boris" sort="Yoffe, Boris" uniqKey="Yoffe B" first="Boris" last="Yoffe">Boris Yoffe</name><affiliation wicri:level="4"><inist:fA14 i1="12"><s1>VAMC, Baylor College of Medicine</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName><orgName type="university">Baylor College of Medicine</orgName></affiliation></author><author><name sortKey="Towner, William J" sort="Towner, William J" uniqKey="Towner W" first="William J." last="Towner">William J. 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VIC</s2><s3>AUS</s3><sZ>16 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Monash Health and Monash University</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"><inist:fA14 i1="18"><s1>INSERM Unité 954, Centre Hospitalier Universitaire de Nancy and Université de Lorraine</s1><s2>Vandoeuvre-lès-Nancy</s2><s3>FRA</s3><sZ>17 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="Thabut, Dominique" sort="Thabut, Dominique" uniqKey="Thabut D" first="Dominique" last="Thabut">Dominique Thabut</name><affiliation wicri:level="3"><inist:fA14 i1="19"><s1>Hôpital Pitié-Salpêtrière</s1><s2>Paris</s2><s3>FRA</s3><sZ>18 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></placeName></affiliation></author><author><name sortKey="Lee, Youn Jae" sort="Lee, Youn Jae" uniqKey="Lee Y" first="Youn-Jae" last="Lee">Youn-Jae Lee</name><affiliation wicri:level="1"><inist:fA14 i1="20"><s1>Inje University Busan Paik Hospital</s1><s2>Busan</s2><s3>KOR</s3><sZ>19 aut.</sZ></inist:fA14><country>Corée du Sud</country><wicri:noRegion>Inje University Busan Paik Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Kao, Jia Horng" sort="Kao, Jia Horng" uniqKey="Kao J" first="Jia-Horng" last="Kao">Jia-Horng Kao</name><affiliation wicri:level="1"><inist:fA14 i1="21"><s1>National Taiwan University Hospital</s1><s2>Taipei</s2><s3>TWN</s3><sZ>20 aut.</sZ></inist:fA14><country>Taïwan</country><wicri:noRegion>National Taiwan University Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Mcphee, Fiona" sort="Mcphee, Fiona" uniqKey="Mcphee F" first="Fiona" last="Mcphee">Fiona Mcphee</name><affiliation wicri:level="1"><inist:fA14 i1="22"><s1>Bristol-Myers Squibb Research and Development</s1><s2>Wallingford, CT</s2><s3>USA</s3><sZ>21 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Bristol-Myers Squibb Research and Development</wicri:noRegion></affiliation></author><author><name sortKey="Kopit, Justin" sort="Kopit, Justin" uniqKey="Kopit J" first="Justin" last="Kopit">Justin Kopit</name><affiliation wicri:level="1"><inist:fA14 i1="22"><s1>Bristol-Myers Squibb Research and Development</s1><s2>Wallingford, CT</s2><s3>USA</s3><sZ>21 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Bristol-Myers Squibb Research and Development</wicri:noRegion></affiliation></author><author><name sortKey="Mendez, Patricia" sort="Mendez, Patricia" uniqKey="Mendez P" first="Patricia" last="Mendez">Patricia Mendez</name><affiliation wicri:level="1"><inist:fA14 i1="23"><s1>Bristol-Myers Squibb Research and Development</s1><s2>Princeton, NJ</s2><s3>USA</s3><sZ>23 aut.</sZ><sZ>24 aut.</sZ><sZ>25 aut.</sZ><sZ>26 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Bristol-Myers Squibb Research and Development</wicri:noRegion></affiliation></author><author><name sortKey="Linaberry, Misti" sort="Linaberry, Misti" uniqKey="Linaberry M" first="Misti" last="Linaberry">Misti Linaberry</name><affiliation wicri:level="1"><inist:fA14 i1="23"><s1>Bristol-Myers Squibb Research and Development</s1><s2>Princeton, NJ</s2><s3>USA</s3><sZ>23 aut.</sZ><sZ>24 aut.</sZ><sZ>25 aut.</sZ><sZ>26 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Bristol-Myers Squibb Research and Development</wicri:noRegion></affiliation></author><author><name sortKey="Hughes, Eric" sort="Hughes, Eric" uniqKey="Hughes E" first="Eric" last="Hughes">Eric Hughes</name><affiliation wicri:level="1"><inist:fA14 i1="23"><s1>Bristol-Myers Squibb Research and Development</s1><s2>Princeton, NJ</s2><s3>USA</s3><sZ>23 aut.</sZ><sZ>24 aut.</sZ><sZ>25 aut.</sZ><sZ>26 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Bristol-Myers Squibb Research and Development</wicri:noRegion></affiliation></author><author><name sortKey="Noviello, Stephanie" sort="Noviello, Stephanie" uniqKey="Noviello S" first="Stephanie" last="Noviello">Stephanie Noviello</name><affiliation wicri:level="1"><inist:fA14 i1="23"><s1>Bristol-Myers Squibb Research and Development</s1><s2>Princeton, NJ</s2><s3>USA</s3><sZ>23 aut.</sZ><sZ>24 aut.</sZ><sZ>25 aut.</sZ><sZ>26 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Bristol-Myers Squibb Research and Development</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">14-0280706</idno><date when="2014">2014</date><idno type="stanalyst">PASCAL 14-0280706 INIST</idno><idno type="RBID">Pascal:14-0280706</idno><idno type="wicri:Area/PascalFrancis/Corpus">000174</idno><idno type="wicri:Area/PascalFrancis/Curation">005C92</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000459</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000459</idno><idno type="wicri:doubleKey">0140-6736:2014:Manns M:all:oral:daclatasvir</idno><idno type="wicri:Area/Main/Merge">004383</idno><idno type="wicri:Area/Main/Curation">004309</idno><idno type="wicri:Area/Main/Exploration">004309</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study</title><author><name sortKey="Manns, Michael" sort="Manns, Michael" uniqKey="Manns M" first="Michael" last="Manns">Michael Manns</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Hannover Medical School</s1><s2>Hannover</s2><s3>DEU</s3><sZ>1 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="2">Basse-Saxe</region><settlement type="city">Hanovre</settlement></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>German Centerfor Infection Research (DZIF)</s1><s2>Hannover-Braunschweig</s2><s3>DEU</s3><sZ>1 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Hannover-Braunschweig</wicri:noRegion><wicri:noRegion>German Centerfor Infection Research (DZIF)</wicri:noRegion><wicri:noRegion>German Centerfor Infection Research (DZIF)</wicri:noRegion></affiliation></author><author><name sortKey="Pol, Stanislas" sort="Pol, Stanislas" uniqKey="Pol S" first="Stanislas" last="Pol">Stanislas Pol</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Hôpital Cochin</s1><s2>Paris</s2><s3>FRA</s3><sZ>2 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></placeName></affiliation></author><author><name sortKey="Jacobson, Ira M" sort="Jacobson, Ira M" uniqKey="Jacobson I" first="Ira M." last="Jacobson">Ira M. Jacobson</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Weill Cornell Medical College</s1><s2>New York, NY</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Weill Cornell Medical College</wicri:noRegion></affiliation></author><author><name sortKey="Marcellin, Patrick" sort="Marcellin, Patrick" uniqKey="Marcellin P" first="Patrick" last="Marcellin">Patrick Marcellin</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Hôpital Beaujon</s1><s2>Clichy</s2><s3>FRA</s3><sZ>4 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Clichy</wicri:noRegion><wicri:noRegion>Hôpital Beaujon</wicri:noRegion><wicri:noRegion>Hôpital Beaujon</wicri:noRegion></affiliation></author><author><name sortKey="Gordon, Stuart C" sort="Gordon, Stuart C" uniqKey="Gordon S" first="Stuart C." last="Gordon">Stuart C. Gordon</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Henry Ford Health Systems</s1><s2>Detroit, MI</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Henry Ford Health Systems</wicri:noRegion></affiliation></author><author><name sortKey="Peng, Cheng Yuan" sort="Peng, Cheng Yuan" uniqKey="Peng C" first="Cheng-Yuan" last="Peng">Cheng-Yuan Peng</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>School of Medicine, China Medical University</s1><s2>Taichung</s2><s3>TWN</s3><sZ>6 aut.</sZ></inist:fA14><country>Taïwan</country><wicri:noRegion>Taichung</wicri:noRegion></affiliation></author><author><name sortKey="Chang, Ting Tsung" sort="Chang, Ting Tsung" uniqKey="Chang T" first="Ting-Tsung" last="Chang">Ting-Tsung Chang</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>National Cheng Kung University Hospital</s1><s2>Tainan</s2><s3>TWN</s3><sZ>7 aut.</sZ></inist:fA14><country>Taïwan</country><wicri:noRegion>National Cheng Kung University Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Everson, Gregory T" sort="Everson, Gregory T" uniqKey="Everson G" first="Gregory T." last="Everson">Gregory T. Everson</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>University of Colorado Denver</s1><s2>Aurora, CO</s2><s3>USA</s3><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>University of Colorado Denver</wicri:noRegion></affiliation></author><author><name sortKey="Jeong Heo" sort="Jeong Heo" uniqKey="Jeong Heo" last="Jeong Heo">JEONG HEO</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Internal Medicine, College of Medicine, Pusan National University and Medical Research Institute, Pusan National University Hospital</s1><s2>Busan</s2><s3>KOR</s3><sZ>9 aut.</sZ></inist:fA14><country>Corée du Sud</country><wicri:noRegion>Busan</wicri:noRegion></affiliation></author><author><name sortKey="Gerken, Guido" sort="Gerken, Guido" uniqKey="Gerken G" first="Guido" last="Gerken">Guido Gerken</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>University of Duisburg-Essen</s1><s2>Essen</s2><s3>DEU</s3><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Essen</wicri:noRegion><wicri:noRegion>University of Duisburg-Essen</wicri:noRegion><wicri:noRegion>University of Duisburg-Essen</wicri:noRegion></affiliation></author><author><name sortKey="Yoffe, Boris" sort="Yoffe, Boris" uniqKey="Yoffe B" first="Boris" last="Yoffe">Boris Yoffe</name><affiliation wicri:level="4"><inist:fA14 i1="12"><s1>VAMC, Baylor College of Medicine</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName><orgName type="university">Baylor College of Medicine</orgName></affiliation></author><author><name sortKey="Towner, William J" sort="Towner, William J" uniqKey="Towner W" first="William J." last="Towner">William J. Towner</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Kaiser Permanente</s1><s2>Los Angeles, CA</s2><s3>USA</s3><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Kaiser Permanente</wicri:noRegion></affiliation></author><author><name sortKey="Bourliere, Marc" sort="Bourliere, Marc" uniqKey="Bourliere M" first="Marc" last="Bourliere">Marc Bourliere</name><affiliation wicri:level="3"><inist:fA14 i1="14"><s1>Hôpital Saint Joseph</s1><s2>Marseille</s2><s3>FRA</s3><sZ>13 aut.</sZ></inist:fA14><country>France</country><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="Metivier, Sophie" sort="Metivier, Sophie" uniqKey="Metivier S" first="Sophie" last="Metivier">Sophie Metivier</name><affiliation wicri:level="3"><inist:fA14 i1="15"><s1>CHU Purpan</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>14 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Chu, Chi Jen" sort="Chu, Chi Jen" uniqKey="Chu C" first="Chi-Jen" last="Chu">Chi-Jen Chu</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Taipei Veterans General Hospital and National Yang-Ming University</s1><s2>Taipei</s2><s3>TWN</s3><sZ>15 aut.</sZ></inist:fA14><country>Taïwan</country><wicri:noRegion>Taipei Veterans General Hospital and National Yang-Ming University</wicri:noRegion></affiliation></author><author><name sortKey="Sievert, William" sort="Sievert, William" uniqKey="Sievert W" first="William" last="Sievert">William Sievert</name><affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Monash Health and Monash University</s1><s2>Melbourne, VIC</s2><s3>AUS</s3><sZ>16 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Monash Health and Monash University</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"><inist:fA14 i1="18"><s1>INSERM Unité 954, Centre Hospitalier Universitaire de Nancy and Université de Lorraine</s1><s2>Vandoeuvre-lès-Nancy</s2><s3>FRA</s3><sZ>17 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="Thabut, Dominique" sort="Thabut, Dominique" uniqKey="Thabut D" first="Dominique" last="Thabut">Dominique Thabut</name><affiliation wicri:level="3"><inist:fA14 i1="19"><s1>Hôpital Pitié-Salpêtrière</s1><s2>Paris</s2><s3>FRA</s3><sZ>18 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></placeName></affiliation></author><author><name sortKey="Lee, Youn Jae" sort="Lee, Youn Jae" uniqKey="Lee Y" first="Youn-Jae" last="Lee">Youn-Jae Lee</name><affiliation wicri:level="1"><inist:fA14 i1="20"><s1>Inje University Busan Paik Hospital</s1><s2>Busan</s2><s3>KOR</s3><sZ>19 aut.</sZ></inist:fA14><country>Corée du Sud</country><wicri:noRegion>Inje University Busan Paik Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Kao, Jia Horng" sort="Kao, Jia Horng" uniqKey="Kao J" first="Jia-Horng" last="Kao">Jia-Horng Kao</name><affiliation wicri:level="1"><inist:fA14 i1="21"><s1>National Taiwan University Hospital</s1><s2>Taipei</s2><s3>TWN</s3><sZ>20 aut.</sZ></inist:fA14><country>Taïwan</country><wicri:noRegion>National Taiwan University Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Mcphee, Fiona" sort="Mcphee, Fiona" uniqKey="Mcphee F" first="Fiona" last="Mcphee">Fiona Mcphee</name><affiliation wicri:level="1"><inist:fA14 i1="22"><s1>Bristol-Myers Squibb Research and Development</s1><s2>Wallingford, CT</s2><s3>USA</s3><sZ>21 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Bristol-Myers Squibb Research and Development</wicri:noRegion></affiliation></author><author><name sortKey="Kopit, Justin" sort="Kopit, Justin" uniqKey="Kopit J" first="Justin" last="Kopit">Justin Kopit</name><affiliation wicri:level="1"><inist:fA14 i1="22"><s1>Bristol-Myers Squibb Research and Development</s1><s2>Wallingford, CT</s2><s3>USA</s3><sZ>21 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Bristol-Myers Squibb Research and Development</wicri:noRegion></affiliation></author><author><name sortKey="Mendez, Patricia" sort="Mendez, Patricia" uniqKey="Mendez P" first="Patricia" last="Mendez">Patricia Mendez</name><affiliation wicri:level="1"><inist:fA14 i1="23"><s1>Bristol-Myers Squibb Research and Development</s1><s2>Princeton, NJ</s2><s3>USA</s3><sZ>23 aut.</sZ><sZ>24 aut.</sZ><sZ>25 aut.</sZ><sZ>26 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Bristol-Myers Squibb Research and Development</wicri:noRegion></affiliation></author><author><name sortKey="Linaberry, Misti" sort="Linaberry, Misti" uniqKey="Linaberry M" first="Misti" last="Linaberry">Misti Linaberry</name><affiliation wicri:level="1"><inist:fA14 i1="23"><s1>Bristol-Myers Squibb Research and Development</s1><s2>Princeton, NJ</s2><s3>USA</s3><sZ>23 aut.</sZ><sZ>24 aut.</sZ><sZ>25 aut.</sZ><sZ>26 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Bristol-Myers Squibb Research and Development</wicri:noRegion></affiliation></author><author><name sortKey="Hughes, Eric" sort="Hughes, Eric" uniqKey="Hughes E" first="Eric" last="Hughes">Eric Hughes</name><affiliation wicri:level="1"><inist:fA14 i1="23"><s1>Bristol-Myers Squibb Research and Development</s1><s2>Princeton, NJ</s2><s3>USA</s3><sZ>23 aut.</sZ><sZ>24 aut.</sZ><sZ>25 aut.</sZ><sZ>26 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Bristol-Myers Squibb Research and Development</wicri:noRegion></affiliation></author><author><name sortKey="Noviello, Stephanie" sort="Noviello, Stephanie" uniqKey="Noviello S" first="Stephanie" last="Noviello">Stephanie Noviello</name><affiliation wicri:level="1"><inist:fA14 i1="23"><s1>Bristol-Myers Squibb Research and Development</s1><s2>Princeton, NJ</s2><s3>USA</s3><sZ>23 aut.</sZ><sZ>24 aut.</sZ><sZ>25 aut.</sZ><sZ>26 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Bristol-Myers Squibb Research and Development</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Lancet : (British edition)</title><title level="j" type="abbreviated">Lancet : (Br. ed.)</title><idno type="ISSN">0140-6736</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Lancet : (British edition)</title><title level="j" type="abbreviated">Lancet : (Br. ed.)</title><idno type="ISSN">0140-6736</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiviral</term><term>Asunaprevir</term><term>Chemotherapy</term><term>Daclatasvir</term><term>Drug combination</term><term>Genotype</term><term>Hepatitis C virus</term><term>Human</term><term>Medicine</term><term>Oral administration</term><term>Phase III trial</term><term>Typing</term><term>Viral hepatitis C</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Hépatite virale C</term><term>Voie orale</term><term>Association médicamenteuse</term><term>Essai clinique phase III</term><term>Virus hépatite C</term><term>Génotype</term><term>Antiviral</term><term>Typage</term><term>Médecine</term><term>Chimiothérapie</term><term>Homme</term><term>Daclatasvir</term><term>Asunaprévir</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Médecine</term><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background An unmet need exists for interferon-free and ribavirin-free treatments for chronic hepatitis C virus (HCV) infection. In this study, we assessed all-oral therapy with daclatasvir (NS5A replication complex inhibitor) plus asunaprevir (NS3 protease inhibitor) in patients with genotype 1b infection, including those with high unmet needs or cirrhosis, or both. Methods We did this phase 3, multicohort study (HALLMARK-DUAL) at 116 sites in 18 countries between May 11, 2012, and Oct 9, 2013. Patients were adults with chronic HCV genotype 1b infection who were treatment-naive; previous non-responders to peginterferon alfa plus ribavirin; or medically ineligible for, previously intolerant of, or ineligible for and intolerant of peginterferon alfa plus ribavirin. Treatment-naive patients were randomly assigned (2:1 ratio) by an interactive voice-response system with a computer-generated random allocation sequence (stratified by cirrhosis status) to receive daclatasvir 60 mg once daily plus asunaprevir 100 mg twice daily or placebo for 12 weeks. Patients and investigator sites were masked to treatment assignment and HCV RNA results to the end of week 12. The treatment-naive group assigned to daclatasvir plus asunaprevir continued open-label treatment to the end of week 24; participants assigned to placebo entered another daclatasvir plus asunaprevir study. Non-responders and ineligible, intolerant, or ineligible and intolerant patients received open-label daclatasvir plus asunaprevir for 24 weeks. The primary endpoint was sustained virological response at post-treatment week 12. Efficacy analyses were restricted to patients given daclatasvir plus asunaprevir.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Corée du Sud</li><li>France</li><li>Taïwan</li><li>États-Unis</li></country><region><li>Basse-Saxe</li><li>Grand Est</li><li>Lorraine (région)</li><li>Midi-Pyrénées</li><li>Occitanie (région administrative)</li><li>Provence-Alpes-Côte d'Azur</li><li>Texas</li><li>Île-de-France</li></region><settlement><li>Hanovre</li><li>Houston</li><li>Marseille</li><li>Nancy</li><li>Paris</li><li>Toulouse</li><li>Vandœuvre-lès-Nancy</li></settlement><orgName><li>Baylor College of Medicine</li></orgName></list><tree><country name="Allemagne"><region name="Basse-Saxe"><name sortKey="Manns, Michael" sort="Manns, Michael" uniqKey="Manns M" first="Michael" last="Manns">Michael Manns</name></region><name sortKey="Gerken, Guido" sort="Gerken, Guido" uniqKey="Gerken G" first="Guido" last="Gerken">Guido Gerken</name><name sortKey="Manns, Michael" sort="Manns, Michael" uniqKey="Manns M" first="Michael" last="Manns">Michael Manns</name></country><country name="France"><region name="Île-de-France"><name sortKey="Pol, Stanislas" sort="Pol, Stanislas" uniqKey="Pol S" first="Stanislas" last="Pol">Stanislas Pol</name></region><name sortKey="Bourliere, Marc" sort="Bourliere, Marc" uniqKey="Bourliere M" first="Marc" last="Bourliere">Marc Bourliere</name><name sortKey="Bronowicki, Jean Pierre" sort="Bronowicki, Jean Pierre" uniqKey="Bronowicki J" first="Jean-Pierre" last="Bronowicki">Jean-Pierre Bronowicki</name><name sortKey="Marcellin, Patrick" sort="Marcellin, Patrick" uniqKey="Marcellin P" first="Patrick" last="Marcellin">Patrick Marcellin</name><name sortKey="Metivier, Sophie" sort="Metivier, Sophie" uniqKey="Metivier S" first="Sophie" last="Metivier">Sophie Metivier</name><name sortKey="Thabut, Dominique" sort="Thabut, Dominique" uniqKey="Thabut D" first="Dominique" last="Thabut">Dominique Thabut</name></country><country name="États-Unis"><noRegion><name sortKey="Jacobson, Ira M" sort="Jacobson, Ira M" uniqKey="Jacobson I" first="Ira M." last="Jacobson">Ira M. Jacobson</name></noRegion><name sortKey="Everson, Gregory T" sort="Everson, Gregory T" uniqKey="Everson G" first="Gregory T." last="Everson">Gregory T. Everson</name><name sortKey="Gordon, Stuart C" sort="Gordon, Stuart C" uniqKey="Gordon S" first="Stuart C." last="Gordon">Stuart C. Gordon</name><name sortKey="Hughes, Eric" sort="Hughes, Eric" uniqKey="Hughes E" first="Eric" last="Hughes">Eric Hughes</name><name sortKey="Kopit, Justin" sort="Kopit, Justin" uniqKey="Kopit J" first="Justin" last="Kopit">Justin Kopit</name><name sortKey="Linaberry, Misti" sort="Linaberry, Misti" uniqKey="Linaberry M" first="Misti" last="Linaberry">Misti Linaberry</name><name sortKey="Mcphee, Fiona" sort="Mcphee, Fiona" uniqKey="Mcphee F" first="Fiona" last="Mcphee">Fiona Mcphee</name><name sortKey="Mendez, Patricia" sort="Mendez, Patricia" uniqKey="Mendez P" first="Patricia" last="Mendez">Patricia Mendez</name><name sortKey="Noviello, Stephanie" sort="Noviello, Stephanie" uniqKey="Noviello S" first="Stephanie" last="Noviello">Stephanie Noviello</name><name sortKey="Towner, William J" sort="Towner, William J" uniqKey="Towner W" first="William J." last="Towner">William J. Towner</name><name sortKey="Yoffe, Boris" sort="Yoffe, Boris" uniqKey="Yoffe B" first="Boris" last="Yoffe">Boris Yoffe</name></country><country name="Taïwan"><noRegion><name sortKey="Peng, Cheng Yuan" sort="Peng, Cheng Yuan" uniqKey="Peng C" first="Cheng-Yuan" last="Peng">Cheng-Yuan Peng</name></noRegion><name sortKey="Chang, Ting Tsung" sort="Chang, Ting Tsung" uniqKey="Chang T" first="Ting-Tsung" last="Chang">Ting-Tsung Chang</name><name sortKey="Chu, Chi Jen" sort="Chu, Chi Jen" uniqKey="Chu C" first="Chi-Jen" last="Chu">Chi-Jen Chu</name><name sortKey="Kao, Jia Horng" sort="Kao, Jia Horng" uniqKey="Kao J" first="Jia-Horng" last="Kao">Jia-Horng Kao</name></country><country name="Corée du Sud"><noRegion><name sortKey="Jeong Heo" sort="Jeong Heo" uniqKey="Jeong Heo" last="Jeong Heo">JEONG HEO</name></noRegion><name sortKey="Lee, Youn Jae" sort="Lee, Youn Jae" uniqKey="Lee Y" first="Youn-Jae" last="Lee">Youn-Jae Lee</name></country><country name="Australie"><noRegion><name sortKey="Sievert, William" sort="Sievert, William" uniqKey="Sievert W" first="William" last="Sievert">William Sievert</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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