Telaprevir for Previously Untreated Chronic Hepatitis C Virus Infection
Identifieur interne : 006671 ( Main/Exploration ); précédent : 006670; suivant : 006672Telaprevir for Previously Untreated Chronic Hepatitis C Virus Infection
Auteurs : Ira M. Jacobson [États-Unis] ; John G. Mchutchison [États-Unis] ; Geoffrey Dusheiko [Royaume-Uni] ; Adrian M. Di Bisceglie [États-Unis] ; K. Rajender Reddy [États-Unis] ; Natalie H. Bzowej [États-Unis] ; Patrick Marcellin [France] ; Andrew J. Muir [États-Unis] ; Peter Ferenci [Autriche] ; Robert Flisiak [Pologne] ; Jacob George [Australie] ; Mario Rizzetto [Italie] ; Daniel Shouval [Israël] ; Ricard Sola [Espagne] ; Ruben A. Terg [Royaume-Uni] ; Eric M. Yoshida [Canada] ; Nathalie Adda [États-Unis] ; Leif Bengtsson [États-Unis] ; Abdul J. Sankoh [États-Unis] ; Tara L. Kieffer [États-Unis] ; Shelley George [États-Unis] ; Robert S. Kauffman [États-Unis] ; Stefan Zeuzem [Allemagne]Source :
- The New England journal of medicine [ 0028-4793 ] ; 2011.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Médecine.
English descriptors
- KwdEn :
Abstract
BACKGROUND In phase 2 trials, telaprevir, a hepatitis C virus (HCV) genotype 1 protease inhibitor, in combination with peginterferon-ribavirin, as compared with peginterferon-ribavirin alone, has shown improved efficacy, with potential for shortening the duration of treatment in a majority of patients. METHODS In this international, phase 3, randomized, double-blind, placebo-controlled trial, we assigned 1088 patients with HCV genotype 1 infection who had not received previous treatment for the infection to one of three groups: a group receiving telaprevir combined with peginterferon alfa-2a and ribavirin for 12 weeks (T12PR group), followed by peginterferon-ribavirin alone for 12 weeks if HCV RNA was undetectable at weeks 4 and 12 or for 36 weeks if HCV RNA was detectable at either time point; a group receiving telaprevir with peginterferon-ribavirin for 8 weeks and placebo with peginterferon-ribavirin for 4 weeks (T8PR group), followed by 12 or 36 weeks of peginterferon-ribavirin on the basis of the same HCV RNA criteria; or a group receiving placebo with peginterferon-ribavirin for 12 weeks, followed by 36 weeks of peginterferon-ribavirin (PR group). The primary end point was the proportion of patients who had undetectable plasma HCV RNA 24 weeks after the last planned dose of study treatment (sustained virologic response). RESULTS Significantly more patients in the T12PR or T8PR group than in the PR group had a sustained virologic response (75% and 69%, respectively, vs. 44%; P<0.001 for the comparison of the T12PR or T8PR group with the PR group). A total of 58% of the patients treated with telaprevir were eligible to receive 24 weeks of total treatment. Anemia, gastrointestinal side effects, and skin rashes occurred at a higher incidence among patients receiving telaprevir than among those receiving peginterferon-ribavirin alone. The overall rate of discontinuation of the treatment regimen owing to adverse events was 10% in the T12PR and T8PR groups and 7% in the PR group. Telaprevir with peginterferon-ribavirin, as compared with peginterferon-ribavirin alone, was associated with significantly improved rates of sustained virologic response in patients with HCV genotype 1 infection who had not received previous treatment, with only 24 weeks of therapy administered in the majority of patients. (Funded by Vertex Pharmaceuticals and Tibotec; ADVANCE ClinicalTrials.gov number, NCT00627926.).
Affiliations:
- Allemagne, Australie, Autriche, Canada, Espagne, France, Israël, Italie, Pologne, Royaume-Uni, États-Unis
- Angleterre, Californie, Catalogne, District de Darmstadt, Grand Londres, Hesse (Land), Nouvelle-Galles du Sud, Pennsylvanie, Piémont, Vienne (Autriche), État de New York
- Barcelone, Francfort-sur-le-Main, Londres, Philadelphie, San Francisco, Sydney, Turin, Vienne (Autriche)
- Université autonome de Barcelone, Université de Sydney
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Bzowej</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>California Pacific Medical Center</s1><s2>San Francisco</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">San Francisco</settlement><region type="state">Californie</region></placeName></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="07"><s1>Hôpital Beaujon, Service d'Hépatologie and INSERM CRB3</s1><s2>Clichy</s2><s3>FRA</s3><sZ>7 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Clichy</wicri:noRegion><wicri:noRegion>Service d'Hépatologie and INSERM CRB3</wicri:noRegion><wicri:noRegion>Clichy</wicri:noRegion></affiliation></author><author><name sortKey="Muir, Andrew J" sort="Muir, Andrew J" uniqKey="Muir A" first="Andrew J." last="Muir">Andrew J. Muir</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Duke Clinical Research Institute and Division of Gastroenterology, Duke University Medical Center</s1><s2>Durham, NC</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Durham, NC</wicri:noRegion></affiliation></author><author><name sortKey="Ferenci, Peter" sort="Ferenci, Peter" uniqKey="Ferenci P" first="Peter" last="Ferenci">Peter Ferenci</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>University of Vienna</s1><s2>Vienna</s2><s3>AUT</s3><sZ>9 aut.</sZ></inist:fA14><country>Autriche</country><placeName><settlement type="city">Vienne (Autriche)</settlement><region nuts="2" type="province">Vienne (Autriche)</region></placeName></affiliation></author><author><name sortKey="Flisiak, Robert" sort="Flisiak, Robert" uniqKey="Flisiak R" first="Robert" last="Flisiak">Robert Flisiak</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Infectious Diseases and Hepatology, Medical University of Bialystok</s1><s2>Bialystok</s2><s3>POL</s3><sZ>10 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Bialystok</wicri:noRegion></affiliation></author><author><name sortKey="George, Jacob" sort="George, Jacob" uniqKey="George J" first="Jacob" last="George">Jacob George</name><affiliation wicri:level="4"><inist:fA14 i1="10"><s1>Storr Liver Unit, Westmead Millennium Institute for Medical Research and Westmead Hospital, University of Sydney</s1><s2>Westmead, NSW</s2><s3>AUS</s3><sZ>11 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation></author><author><name sortKey="Rizzetto, Mario" sort="Rizzetto, Mario" uniqKey="Rizzetto M" first="Mario" last="Rizzetto">Mario Rizzetto</name><affiliation wicri:level="3"><inist:fA14 i1="11"><s1>Department of Gastroenterology, University ofTurin</s1><s2>Turin</s2><s3>ITA</s3><sZ>12 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Turin</settlement><region type="région" nuts="2">Piémont</region></placeName></affiliation></author><author><name sortKey="Shouval, Daniel" sort="Shouval, Daniel" uniqKey="Shouval D" first="Daniel" last="Shouval">Daniel Shouval</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Liver Unit, Hadassah-Hebrew University Hospital</s1><s2>Jerusalem</s2><s3>ISR</s3><sZ>13 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Jerusalem</wicri:noRegion></affiliation></author><author><name sortKey="Sola, Ricard" sort="Sola, Ricard" uniqKey="Sola R" first="Ricard" last="Sola">Ricard Sola</name><affiliation wicri:level="4"><inist:fA14 i1="13"><s1>Hospital del Mar, Institut Municipal d'Investigació Médica, Universitat Autónoma de Barcelona</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>14 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region><settlement type="city">Barcelone</settlement></placeName><orgName type="university">Université autonome de Barcelone</orgName></affiliation></author><author><name sortKey="Terg, Ruben A" sort="Terg, Ruben A" uniqKey="Terg R" first="Ruben A." last="Terg">Ruben A. 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Yoshida</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>University of British Columbia and Vancouver General Hospital</s1><s2>Vancouver, BC</s2><s3>CAN</s3><sZ>16 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>University of British Columbia and Vancouver General Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Adda, Nathalie" sort="Adda, Nathalie" uniqKey="Adda N" first="Nathalie" last="Adda">Nathalie Adda</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Vertex Pharmaceuticals</s1><s2>Cambridge, MA</s2><s3>USA</s3><sZ>17 aut.</sZ><sZ>18 aut.</sZ><sZ>19 aut.</sZ><sZ>20 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Vertex Pharmaceuticals</wicri:noRegion></affiliation></author><author><name sortKey="Bengtsson, Leif" sort="Bengtsson, Leif" uniqKey="Bengtsson L" first="Leif" last="Bengtsson">Leif Bengtsson</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Vertex Pharmaceuticals</s1><s2>Cambridge, MA</s2><s3>USA</s3><sZ>17 aut.</sZ><sZ>18 aut.</sZ><sZ>19 aut.</sZ><sZ>20 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Vertex Pharmaceuticals</wicri:noRegion></affiliation></author><author><name sortKey="Sankoh, Abdul J" sort="Sankoh, Abdul J" uniqKey="Sankoh A" first="Abdul J." last="Sankoh">Abdul J. Sankoh</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Vertex Pharmaceuticals</s1><s2>Cambridge, MA</s2><s3>USA</s3><sZ>17 aut.</sZ><sZ>18 aut.</sZ><sZ>19 aut.</sZ><sZ>20 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Vertex Pharmaceuticals</wicri:noRegion></affiliation></author><author><name sortKey="Kieffer, Tara L" sort="Kieffer, Tara L" uniqKey="Kieffer T" first="Tara L." last="Kieffer">Tara L. 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Kauffman</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Vertex Pharmaceuticals</s1><s2>Cambridge, MA</s2><s3>USA</s3><sZ>17 aut.</sZ><sZ>18 aut.</sZ><sZ>19 aut.</sZ><sZ>20 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Vertex Pharmaceuticals</wicri:noRegion></affiliation></author><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="17"><s1>Department of Internal Medicine, Johann Wolfgang Goethe University Medical Center</s1><s2>Frankfurt am Main</s2><s3>DEU</s3><sZ>23 aut.</sZ></inist:fA14><country>Allemagne</country><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></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">11-0444848</idno><date when="2011">2011</date><idno type="stanalyst">PASCAL 11-0444848 INIST</idno><idno type="RBID">Pascal:11-0444848</idno><idno type="wicri:Area/PascalFrancis/Corpus">001918</idno><idno type="wicri:Area/PascalFrancis/Curation">004638</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">001621</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">001621</idno><idno type="wicri:doubleKey">0028-4793:2011:Jacobson I:telaprevir:for:previously</idno><idno type="wicri:Area/Main/Merge">006A72</idno><idno type="wicri:Area/Main/Curation">006671</idno><idno type="wicri:Area/Main/Exploration">006671</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Telaprevir for Previously Untreated Chronic Hepatitis C Virus Infection</title><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="2"><inist:fA14 i1="01"><s1>Weill Cornell Medical College and Center for the Study of Hepatitis C</s1><s2>New York</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Mchutchison, John G" sort="Mchutchison, John G" uniqKey="Mchutchison J" first="John G." last="Mchutchison">John G. Mchutchison</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Duke Clinical Research Institute and Division of Gastroenterology, Duke University Medical Center</s1><s2>Durham, NC</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Durham, NC</wicri:noRegion></affiliation></author><author><name sortKey="Dusheiko, Geoffrey" sort="Dusheiko, Geoffrey" uniqKey="Dusheiko G" first="Geoffrey" last="Dusheiko">Geoffrey Dusheiko</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Royal Free Hospital, Centre for Hepatology</s1><s2>London</s2><s3>GBR</s3><sZ>3 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Di Bisceglie, Adrian M" sort="Di Bisceglie, Adrian M" uniqKey="Di Bisceglie A" first="Adrian M." last="Di Bisceglie">Adrian M. Di Bisceglie</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Saint Louis University School of Medicine</s1><s2>St. Louis</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Saint Louis University School of Medicine</wicri:noRegion></affiliation></author><author><name sortKey="Rajender Reddy, K" sort="Rajender Reddy, K" uniqKey="Rajender Reddy K" first="K." last="Rajender Reddy">K. Rajender Reddy</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Division of Gastroenterology, University of Pennsylvania</s1><s2>Philadelphia</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Philadelphie</settlement><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Bzowej, Natalie H" sort="Bzowej, Natalie H" uniqKey="Bzowej N" first="Natalie H." last="Bzowej">Natalie H. Bzowej</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>California Pacific Medical Center</s1><s2>San Francisco</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">San Francisco</settlement><region type="state">Californie</region></placeName></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="07"><s1>Hôpital Beaujon, Service d'Hépatologie and INSERM CRB3</s1><s2>Clichy</s2><s3>FRA</s3><sZ>7 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Clichy</wicri:noRegion><wicri:noRegion>Service d'Hépatologie and INSERM CRB3</wicri:noRegion><wicri:noRegion>Clichy</wicri:noRegion></affiliation></author><author><name sortKey="Muir, Andrew J" sort="Muir, Andrew J" uniqKey="Muir A" first="Andrew J." last="Muir">Andrew J. Muir</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Duke Clinical Research Institute and Division of Gastroenterology, Duke University Medical Center</s1><s2>Durham, NC</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Durham, NC</wicri:noRegion></affiliation></author><author><name sortKey="Ferenci, Peter" sort="Ferenci, Peter" uniqKey="Ferenci P" first="Peter" last="Ferenci">Peter Ferenci</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>University of Vienna</s1><s2>Vienna</s2><s3>AUT</s3><sZ>9 aut.</sZ></inist:fA14><country>Autriche</country><placeName><settlement type="city">Vienne (Autriche)</settlement><region nuts="2" type="province">Vienne (Autriche)</region></placeName></affiliation></author><author><name sortKey="Flisiak, Robert" sort="Flisiak, Robert" uniqKey="Flisiak R" first="Robert" last="Flisiak">Robert Flisiak</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Infectious Diseases and Hepatology, Medical University of Bialystok</s1><s2>Bialystok</s2><s3>POL</s3><sZ>10 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Bialystok</wicri:noRegion></affiliation></author><author><name sortKey="George, Jacob" sort="George, Jacob" uniqKey="George J" first="Jacob" last="George">Jacob George</name><affiliation wicri:level="4"><inist:fA14 i1="10"><s1>Storr Liver Unit, Westmead Millennium Institute for Medical Research and Westmead Hospital, University of Sydney</s1><s2>Westmead, NSW</s2><s3>AUS</s3><sZ>11 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation></author><author><name sortKey="Rizzetto, Mario" sort="Rizzetto, Mario" uniqKey="Rizzetto M" first="Mario" last="Rizzetto">Mario Rizzetto</name><affiliation wicri:level="3"><inist:fA14 i1="11"><s1>Department of Gastroenterology, University ofTurin</s1><s2>Turin</s2><s3>ITA</s3><sZ>12 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Turin</settlement><region type="région" nuts="2">Piémont</region></placeName></affiliation></author><author><name sortKey="Shouval, Daniel" sort="Shouval, Daniel" uniqKey="Shouval D" first="Daniel" last="Shouval">Daniel Shouval</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Liver Unit, Hadassah-Hebrew University Hospital</s1><s2>Jerusalem</s2><s3>ISR</s3><sZ>13 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Jerusalem</wicri:noRegion></affiliation></author><author><name sortKey="Sola, Ricard" sort="Sola, Ricard" uniqKey="Sola R" first="Ricard" last="Sola">Ricard Sola</name><affiliation wicri:level="4"><inist:fA14 i1="13"><s1>Hospital del Mar, Institut Municipal d'Investigació Médica, Universitat Autónoma de Barcelona</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>14 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region><settlement type="city">Barcelone</settlement></placeName><orgName type="university">Université autonome de Barcelone</orgName></affiliation></author><author><name sortKey="Terg, Ruben A" sort="Terg, Ruben A" uniqKey="Terg R" first="Ruben A." last="Terg">Ruben A. Terg</name><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Hospital de Gastroenterología Dr. Bonorino Udaondo</s1><s2>Buenos Aires</s2><s3>GBR</s3><sZ>15 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Hospital de Gastroenterología Dr. Bonorino Udaondo</wicri:noRegion></affiliation></author><author><name sortKey="Yoshida, Eric M" sort="Yoshida, Eric M" uniqKey="Yoshida E" first="Eric M." last="Yoshida">Eric M. Yoshida</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>University of British Columbia and Vancouver General Hospital</s1><s2>Vancouver, BC</s2><s3>CAN</s3><sZ>16 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>University of British Columbia and Vancouver General Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Adda, Nathalie" sort="Adda, Nathalie" uniqKey="Adda N" first="Nathalie" last="Adda">Nathalie Adda</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Vertex Pharmaceuticals</s1><s2>Cambridge, MA</s2><s3>USA</s3><sZ>17 aut.</sZ><sZ>18 aut.</sZ><sZ>19 aut.</sZ><sZ>20 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Vertex Pharmaceuticals</wicri:noRegion></affiliation></author><author><name sortKey="Bengtsson, Leif" sort="Bengtsson, Leif" uniqKey="Bengtsson L" first="Leif" last="Bengtsson">Leif Bengtsson</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Vertex Pharmaceuticals</s1><s2>Cambridge, MA</s2><s3>USA</s3><sZ>17 aut.</sZ><sZ>18 aut.</sZ><sZ>19 aut.</sZ><sZ>20 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Vertex Pharmaceuticals</wicri:noRegion></affiliation></author><author><name sortKey="Sankoh, Abdul J" sort="Sankoh, Abdul J" uniqKey="Sankoh A" first="Abdul J." last="Sankoh">Abdul J. Sankoh</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Vertex Pharmaceuticals</s1><s2>Cambridge, MA</s2><s3>USA</s3><sZ>17 aut.</sZ><sZ>18 aut.</sZ><sZ>19 aut.</sZ><sZ>20 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Vertex Pharmaceuticals</wicri:noRegion></affiliation></author><author><name sortKey="Kieffer, Tara L" sort="Kieffer, Tara L" uniqKey="Kieffer T" first="Tara L." last="Kieffer">Tara L. Kieffer</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Vertex Pharmaceuticals</s1><s2>Cambridge, MA</s2><s3>USA</s3><sZ>17 aut.</sZ><sZ>18 aut.</sZ><sZ>19 aut.</sZ><sZ>20 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Vertex Pharmaceuticals</wicri:noRegion></affiliation></author><author><name sortKey="George, Shelley" sort="George, Shelley" uniqKey="George S" first="Shelley" last="George">Shelley George</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Vertex Pharmaceuticals</s1><s2>Cambridge, MA</s2><s3>USA</s3><sZ>17 aut.</sZ><sZ>18 aut.</sZ><sZ>19 aut.</sZ><sZ>20 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Vertex Pharmaceuticals</wicri:noRegion></affiliation></author><author><name sortKey="Kauffman, Robert S" sort="Kauffman, Robert S" uniqKey="Kauffman R" first="Robert S." last="Kauffman">Robert S. Kauffman</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Vertex Pharmaceuticals</s1><s2>Cambridge, MA</s2><s3>USA</s3><sZ>17 aut.</sZ><sZ>18 aut.</sZ><sZ>19 aut.</sZ><sZ>20 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Vertex Pharmaceuticals</wicri:noRegion></affiliation></author><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="17"><s1>Department of Internal Medicine, Johann Wolfgang Goethe University Medical Center</s1><s2>Frankfurt am Main</s2><s3>DEU</s3><sZ>23 aut.</sZ></inist:fA14><country>Allemagne</country><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></analytic><series><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno><imprint><date when="2011">2011</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiviral</term><term>Medicine</term><term>Telaprevir</term><term>Viral hepatitis C</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Télaprévir</term><term>Hépatite virale C</term><term>Médecine</term><term>Antiviral</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Médecine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND In phase 2 trials, telaprevir, a hepatitis C virus (HCV) genotype 1 protease inhibitor, in combination with peginterferon-ribavirin, as compared with peginterferon-ribavirin alone, has shown improved efficacy, with potential for shortening the duration of treatment in a majority of patients. METHODS In this international, phase 3, randomized, double-blind, placebo-controlled trial, we assigned 1088 patients with HCV genotype 1 infection who had not received previous treatment for the infection to one of three groups: a group receiving telaprevir combined with peginterferon alfa-2a and ribavirin for 12 weeks (T12PR group), followed by peginterferon-ribavirin alone for 12 weeks if HCV RNA was undetectable at weeks 4 and 12 or for 36 weeks if HCV RNA was detectable at either time point; a group receiving telaprevir with peginterferon-ribavirin for 8 weeks and placebo with peginterferon-ribavirin for 4 weeks (T8PR group), followed by 12 or 36 weeks of peginterferon-ribavirin on the basis of the same HCV RNA criteria; or a group receiving placebo with peginterferon-ribavirin for 12 weeks, followed by 36 weeks of peginterferon-ribavirin (PR group). The primary end point was the proportion of patients who had undetectable plasma HCV RNA 24 weeks after the last planned dose of study treatment (sustained virologic response). RESULTS Significantly more patients in the T12PR or T8PR group than in the PR group had a sustained virologic response (75% and 69%, respectively, vs. 44%; P<0.001 for the comparison of the T12PR or T8PR group with the PR group). A total of 58% of the patients treated with telaprevir were eligible to receive 24 weeks of total treatment. Anemia, gastrointestinal side effects, and skin rashes occurred at a higher incidence among patients receiving telaprevir than among those receiving peginterferon-ribavirin alone. The overall rate of discontinuation of the treatment regimen owing to adverse events was 10% in the T12PR and T8PR groups and 7% in the PR group. Telaprevir with peginterferon-ribavirin, as compared with peginterferon-ribavirin alone, was associated with significantly improved rates of sustained virologic response in patients with HCV genotype 1 infection who had not received previous treatment, with only 24 weeks of therapy administered in the majority of patients. (Funded by Vertex Pharmaceuticals and Tibotec; ADVANCE ClinicalTrials.gov number, NCT00627926.).</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Autriche</li><li>Canada</li><li>Espagne</li><li>France</li><li>Israël</li><li>Italie</li><li>Pologne</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Californie</li><li>Catalogne</li><li>District de Darmstadt</li><li>Grand Londres</li><li>Hesse (Land)</li><li>Nouvelle-Galles du Sud</li><li>Pennsylvanie</li><li>Piémont</li><li>Vienne (Autriche)</li><li>État de New York</li></region><settlement><li>Barcelone</li><li>Francfort-sur-le-Main</li><li>Londres</li><li>Philadelphie</li><li>San Francisco</li><li>Sydney</li><li>Turin</li><li>Vienne (Autriche)</li></settlement><orgName><li>Université autonome de Barcelone</li><li>Université de Sydney</li></orgName></list><tree><country name="États-Unis"><region name="État de New York"><name sortKey="Jacobson, Ira M" sort="Jacobson, Ira M" uniqKey="Jacobson I" first="Ira M." last="Jacobson">Ira M. Jacobson</name></region><name sortKey="Adda, Nathalie" sort="Adda, Nathalie" uniqKey="Adda N" first="Nathalie" last="Adda">Nathalie Adda</name><name sortKey="Bengtsson, Leif" sort="Bengtsson, Leif" uniqKey="Bengtsson L" first="Leif" last="Bengtsson">Leif Bengtsson</name><name sortKey="Bzowej, Natalie H" sort="Bzowej, Natalie H" uniqKey="Bzowej N" first="Natalie H." last="Bzowej">Natalie H. Bzowej</name><name sortKey="Di Bisceglie, Adrian M" sort="Di Bisceglie, Adrian M" uniqKey="Di Bisceglie A" first="Adrian M." last="Di Bisceglie">Adrian M. Di Bisceglie</name><name sortKey="George, Shelley" sort="George, Shelley" uniqKey="George S" first="Shelley" last="George">Shelley George</name><name sortKey="Kauffman, Robert S" sort="Kauffman, Robert S" uniqKey="Kauffman R" first="Robert S." last="Kauffman">Robert S. Kauffman</name><name sortKey="Kieffer, Tara L" sort="Kieffer, Tara L" uniqKey="Kieffer T" first="Tara L." last="Kieffer">Tara L. Kieffer</name><name sortKey="Mchutchison, John G" sort="Mchutchison, John G" uniqKey="Mchutchison J" first="John G." last="Mchutchison">John G. Mchutchison</name><name sortKey="Muir, Andrew J" sort="Muir, Andrew J" uniqKey="Muir A" first="Andrew J." last="Muir">Andrew J. Muir</name><name sortKey="Rajender Reddy, K" sort="Rajender Reddy, K" uniqKey="Rajender Reddy K" first="K." last="Rajender Reddy">K. Rajender Reddy</name><name sortKey="Sankoh, Abdul J" sort="Sankoh, Abdul J" uniqKey="Sankoh A" first="Abdul J." last="Sankoh">Abdul J. Sankoh</name></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Dusheiko, Geoffrey" sort="Dusheiko, Geoffrey" uniqKey="Dusheiko G" first="Geoffrey" last="Dusheiko">Geoffrey Dusheiko</name></region><name sortKey="Terg, Ruben A" sort="Terg, Ruben A" uniqKey="Terg R" first="Ruben A." last="Terg">Ruben A. Terg</name></country><country name="France"><noRegion><name sortKey="Marcellin, Patrick" sort="Marcellin, Patrick" uniqKey="Marcellin P" first="Patrick" last="Marcellin">Patrick Marcellin</name></noRegion></country><country name="Autriche"><region name="Vienne (Autriche)"><name sortKey="Ferenci, Peter" sort="Ferenci, Peter" uniqKey="Ferenci P" first="Peter" last="Ferenci">Peter Ferenci</name></region></country><country name="Pologne"><noRegion><name sortKey="Flisiak, Robert" sort="Flisiak, Robert" uniqKey="Flisiak R" first="Robert" last="Flisiak">Robert Flisiak</name></noRegion></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="George, Jacob" sort="George, Jacob" uniqKey="George J" first="Jacob" last="George">Jacob George</name></region></country><country name="Italie"><region name="Piémont"><name sortKey="Rizzetto, Mario" sort="Rizzetto, Mario" uniqKey="Rizzetto M" first="Mario" last="Rizzetto">Mario Rizzetto</name></region></country><country name="Israël"><noRegion><name sortKey="Shouval, Daniel" sort="Shouval, Daniel" uniqKey="Shouval D" first="Daniel" last="Shouval">Daniel Shouval</name></noRegion></country><country name="Espagne"><region name="Catalogne"><name sortKey="Sola, Ricard" sort="Sola, Ricard" uniqKey="Sola R" first="Ricard" last="Sola">Ricard Sola</name></region></country><country name="Canada"><noRegion><name sortKey="Yoshida, Eric M" sort="Yoshida, Eric M" uniqKey="Yoshida E" first="Eric M." last="Yoshida">Eric M. Yoshida</name></noRegion></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></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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