Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial.
Identifieur interne : 001E20 ( PubMed/Corpus ); précédent : 001E19; suivant : 001E21Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial.
Auteurs : Michael Manns ; Didier Samuel ; Edward J. Gane ; David Mutimer ; Geoff Mccaughan ; Maria Buti ; Martín Prieto ; José Luis Calleja ; Markus Peck-Radosavljevic ; Beat Müllhaupt ; Kosh Agarwal ; Peter Angus ; Eric M. Yoshida ; Massimo Colombo ; Mario Rizzetto ; Hadas Dvory-Sobol ; Jill Denning ; Sarah Arterburn ; Phillip S. Pang ; Diana Brainard ; John G. Mchutchison ; Jean-François Dufour ; Hans Van Vlierberghe ; Bart Van Hoek ; Xavier FornsSource :
- The Lancet. Infectious diseases [ 1474-4457 ] ; 2016.
English descriptors
- KwdEn :
- Antiviral Agents (therapeutic use), Benzimidazoles (therapeutic use), Drug Therapy, Combination, Female, Fluorenes (therapeutic use), Genotype, Global Health, Hepacivirus (classification), Hepacivirus (drug effects), Hepacivirus (genetics), Hepatitis C, Chronic (complications), Hepatitis C, Chronic (drug therapy), Hepatitis C, Chronic (mortality), Humans, Liver Cirrhosis (drug therapy), Liver Cirrhosis (mortality), Liver Cirrhosis (virology), Male, Middle Aged, RNA, Viral, Ribavirin (therapeutic use), Time Factors, Treatment Outcome, Uridine Monophosphate (analogs & derivatives), Uridine Monophosphate (therapeutic use), Viral Load.
- MESH :
- chemical , analogs & derivatives : Uridine Monophosphate.
- chemical , therapeutic use : Antiviral Agents, Benzimidazoles, Fluorenes, Ribavirin, Uridine Monophosphate.
- classification : Hepacivirus.
- complications : Hepatitis C, Chronic.
- drug effects : Hepacivirus.
- drug therapy : Hepatitis C, Chronic, Liver Cirrhosis.
- genetics : Hepacivirus.
- mortality : Hepatitis C, Chronic, Liver Cirrhosis.
- virology : Liver Cirrhosis.
- Drug Therapy, Combination, Female, Genotype, Global Health, Humans, Male, Middle Aged, RNA, Viral, Time Factors, Treatment Outcome, Viral Load.
Abstract
Treatment options are limited for patients infected by hepatitis C virus (HCV) with advanced liver disease. We assessed the safety and efficacy of ledipasvir, sofosbuvir, and ribavirin in patients with HCV genotype 1 or 4 and advanced liver disease.
DOI: 10.1016/S1473-3099(16)00052-9
PubMed: 26907736
Links to Exploration step
pubmed:26907736Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial.</title><author><name sortKey="Manns, Michael" sort="Manns, Michael" uniqKey="Manns M" first="Michael" last="Manns">Michael Manns</name><affiliation><nlm:affiliation>Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; German Center of Infection Research (DZIF), Hannover-Braunschweig, Germany. Electronic address: manns.michael@mh-hannover.de.</nlm:affiliation></affiliation></author><author><name sortKey="Samuel, Didier" sort="Samuel, Didier" uniqKey="Samuel D" first="Didier" last="Samuel">Didier Samuel</name><affiliation><nlm:affiliation>Centre Hepatobiliaire, Hôpital Paul Brousse, and Université Paris Sud, Villejuif, France.</nlm:affiliation></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><nlm:affiliation>New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand.</nlm:affiliation></affiliation></author><author><name sortKey="Mutimer, David" sort="Mutimer, David" uniqKey="Mutimer D" first="David" last="Mutimer">David Mutimer</name><affiliation><nlm:affiliation>Queen Elizabeth Hospital and NIHR Liver Biomedical Research Unit, Birmingham, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Mccaughan, Geoff" sort="Mccaughan, Geoff" uniqKey="Mccaughan G" first="Geoff" last="Mccaughan">Geoff Mccaughan</name><affiliation><nlm:affiliation>Australian Liver Transplant Unit, Centenary Research Institute, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Buti, Maria" sort="Buti, Maria" uniqKey="Buti M" first="Maria" last="Buti">Maria Buti</name><affiliation><nlm:affiliation>Internal Medicine and Hepatology, CIBERHED Vall d'Hebron University Hospital, Barcelona, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Prieto, Martin" sort="Prieto, Martin" uniqKey="Prieto M" first="Martín" last="Prieto">Martín Prieto</name><affiliation><nlm:affiliation>Digestive Diseases Service, Hospital Universitario y Politécnico La Fe, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Valencia, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Calleja, Jose Luis" sort="Calleja, Jose Luis" uniqKey="Calleja J" first="José Luis" last="Calleja">José Luis Calleja</name><affiliation><nlm:affiliation>Servicio de Gastroenterología y Hepatología Hospital Universitario Puerta de Hierro Universidad Autonoma, Madrid, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Peck Radosavljevic, Markus" sort="Peck Radosavljevic, Markus" uniqKey="Peck Radosavljevic M" first="Markus" last="Peck-Radosavljevic">Markus Peck-Radosavljevic</name><affiliation><nlm:affiliation>Department of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Mullhaupt, Beat" sort="Mullhaupt, Beat" uniqKey="Mullhaupt B" first="Beat" last="Müllhaupt">Beat Müllhaupt</name><affiliation><nlm:affiliation>Department for Gastroenterology and Hepatology UniversitätsSpital Zürich, Zürich, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Agarwal, Kosh" sort="Agarwal, Kosh" uniqKey="Agarwal K" first="Kosh" last="Agarwal">Kosh Agarwal</name><affiliation><nlm:affiliation>Institute of Liver Studies, King's College Hospital Foundation Trust, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Angus, Peter" sort="Angus, Peter" uniqKey="Angus P" first="Peter" last="Angus">Peter Angus</name><affiliation><nlm:affiliation>Liver Transplant Unit, Austin Hospital, Heidelberg, VIC, Australia.</nlm:affiliation></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><nlm:affiliation>Division of Gastroenterology, Vancouver General Hospital and University of British Columbia, Vancouver, BC, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Colombo, Massimo" sort="Colombo, Massimo" uniqKey="Colombo M" first="Massimo" last="Colombo">Massimo Colombo</name><affiliation><nlm:affiliation>Department of Gastroenterology, IRCCS Maggiore Hospital University of Milan, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Rizzetto, Mario" sort="Rizzetto, Mario" uniqKey="Rizzetto M" first="Mario" last="Rizzetto">Mario Rizzetto</name><affiliation><nlm:affiliation>Azienda Ospedaliero-Universitaria, Torino, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Dvory Sobol, Hadas" sort="Dvory Sobol, Hadas" uniqKey="Dvory Sobol H" first="Hadas" last="Dvory-Sobol">Hadas Dvory-Sobol</name><affiliation><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Denning, Jill" sort="Denning, Jill" uniqKey="Denning J" first="Jill" last="Denning">Jill Denning</name><affiliation><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Arterburn, Sarah" sort="Arterburn, Sarah" uniqKey="Arterburn S" first="Sarah" last="Arterburn">Sarah Arterburn</name><affiliation><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Pang, Phillip S" sort="Pang, Phillip S" uniqKey="Pang P" first="Phillip S" last="Pang">Phillip S. Pang</name><affiliation><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Brainard, Diana" sort="Brainard, Diana" uniqKey="Brainard D" first="Diana" last="Brainard">Diana Brainard</name><affiliation><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></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><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Dufour, Jean Francois" sort="Dufour, Jean Francois" uniqKey="Dufour J" first="Jean-François" last="Dufour">Jean-François Dufour</name><affiliation><nlm:affiliation>Department of Hepatology, University of Bern, Bern, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Van Vlierberghe, Hans" sort="Van Vlierberghe, Hans" uniqKey="Van Vlierberghe H" first="Hans" last="Van Vlierberghe">Hans Van Vlierberghe</name><affiliation><nlm:affiliation>Ghent University Hospital, Ghent, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Van Hoek, Bart" sort="Van Hoek, Bart" uniqKey="Van Hoek B" first="Bart" last="Van Hoek">Bart Van Hoek</name><affiliation><nlm:affiliation>Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Forns, Xavier" sort="Forns, Xavier" uniqKey="Forns X" first="Xavier" last="Forns">Xavier Forns</name><affiliation><nlm:affiliation>Liver Unit, Hospital Clinic, CIBEREHD, IDIBAPS, University of Barcelona, Barcelona, Spain.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:26907736</idno><idno type="pmid">26907736</idno><idno type="doi">10.1016/S1473-3099(16)00052-9</idno><idno type="wicri:Area/PubMed/Corpus">001E20</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001E20</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial.</title><author><name sortKey="Manns, Michael" sort="Manns, Michael" uniqKey="Manns M" first="Michael" last="Manns">Michael Manns</name><affiliation><nlm:affiliation>Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; German Center of Infection Research (DZIF), Hannover-Braunschweig, Germany. Electronic address: manns.michael@mh-hannover.de.</nlm:affiliation></affiliation></author><author><name sortKey="Samuel, Didier" sort="Samuel, Didier" uniqKey="Samuel D" first="Didier" last="Samuel">Didier Samuel</name><affiliation><nlm:affiliation>Centre Hepatobiliaire, Hôpital Paul Brousse, and Université Paris Sud, Villejuif, France.</nlm:affiliation></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><nlm:affiliation>New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand.</nlm:affiliation></affiliation></author><author><name sortKey="Mutimer, David" sort="Mutimer, David" uniqKey="Mutimer D" first="David" last="Mutimer">David Mutimer</name><affiliation><nlm:affiliation>Queen Elizabeth Hospital and NIHR Liver Biomedical Research Unit, Birmingham, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Mccaughan, Geoff" sort="Mccaughan, Geoff" uniqKey="Mccaughan G" first="Geoff" last="Mccaughan">Geoff Mccaughan</name><affiliation><nlm:affiliation>Australian Liver Transplant Unit, Centenary Research Institute, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Buti, Maria" sort="Buti, Maria" uniqKey="Buti M" first="Maria" last="Buti">Maria Buti</name><affiliation><nlm:affiliation>Internal Medicine and Hepatology, CIBERHED Vall d'Hebron University Hospital, Barcelona, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Prieto, Martin" sort="Prieto, Martin" uniqKey="Prieto M" first="Martín" last="Prieto">Martín Prieto</name><affiliation><nlm:affiliation>Digestive Diseases Service, Hospital Universitario y Politécnico La Fe, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Valencia, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Calleja, Jose Luis" sort="Calleja, Jose Luis" uniqKey="Calleja J" first="José Luis" last="Calleja">José Luis Calleja</name><affiliation><nlm:affiliation>Servicio de Gastroenterología y Hepatología Hospital Universitario Puerta de Hierro Universidad Autonoma, Madrid, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Peck Radosavljevic, Markus" sort="Peck Radosavljevic, Markus" uniqKey="Peck Radosavljevic M" first="Markus" last="Peck-Radosavljevic">Markus Peck-Radosavljevic</name><affiliation><nlm:affiliation>Department of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Mullhaupt, Beat" sort="Mullhaupt, Beat" uniqKey="Mullhaupt B" first="Beat" last="Müllhaupt">Beat Müllhaupt</name><affiliation><nlm:affiliation>Department for Gastroenterology and Hepatology UniversitätsSpital Zürich, Zürich, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Agarwal, Kosh" sort="Agarwal, Kosh" uniqKey="Agarwal K" first="Kosh" last="Agarwal">Kosh Agarwal</name><affiliation><nlm:affiliation>Institute of Liver Studies, King's College Hospital Foundation Trust, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Angus, Peter" sort="Angus, Peter" uniqKey="Angus P" first="Peter" last="Angus">Peter Angus</name><affiliation><nlm:affiliation>Liver Transplant Unit, Austin Hospital, Heidelberg, VIC, Australia.</nlm:affiliation></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><nlm:affiliation>Division of Gastroenterology, Vancouver General Hospital and University of British Columbia, Vancouver, BC, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Colombo, Massimo" sort="Colombo, Massimo" uniqKey="Colombo M" first="Massimo" last="Colombo">Massimo Colombo</name><affiliation><nlm:affiliation>Department of Gastroenterology, IRCCS Maggiore Hospital University of Milan, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Rizzetto, Mario" sort="Rizzetto, Mario" uniqKey="Rizzetto M" first="Mario" last="Rizzetto">Mario Rizzetto</name><affiliation><nlm:affiliation>Azienda Ospedaliero-Universitaria, Torino, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Dvory Sobol, Hadas" sort="Dvory Sobol, Hadas" uniqKey="Dvory Sobol H" first="Hadas" last="Dvory-Sobol">Hadas Dvory-Sobol</name><affiliation><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Denning, Jill" sort="Denning, Jill" uniqKey="Denning J" first="Jill" last="Denning">Jill Denning</name><affiliation><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Arterburn, Sarah" sort="Arterburn, Sarah" uniqKey="Arterburn S" first="Sarah" last="Arterburn">Sarah Arterburn</name><affiliation><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Pang, Phillip S" sort="Pang, Phillip S" uniqKey="Pang P" first="Phillip S" last="Pang">Phillip S. Pang</name><affiliation><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Brainard, Diana" sort="Brainard, Diana" uniqKey="Brainard D" first="Diana" last="Brainard">Diana Brainard</name><affiliation><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></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><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Dufour, Jean Francois" sort="Dufour, Jean Francois" uniqKey="Dufour J" first="Jean-François" last="Dufour">Jean-François Dufour</name><affiliation><nlm:affiliation>Department of Hepatology, University of Bern, Bern, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Van Vlierberghe, Hans" sort="Van Vlierberghe, Hans" uniqKey="Van Vlierberghe H" first="Hans" last="Van Vlierberghe">Hans Van Vlierberghe</name><affiliation><nlm:affiliation>Ghent University Hospital, Ghent, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Van Hoek, Bart" sort="Van Hoek, Bart" uniqKey="Van Hoek B" first="Bart" last="Van Hoek">Bart Van Hoek</name><affiliation><nlm:affiliation>Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Forns, Xavier" sort="Forns, Xavier" uniqKey="Forns X" first="Xavier" last="Forns">Xavier Forns</name><affiliation><nlm:affiliation>Liver Unit, Hospital Clinic, CIBEREHD, IDIBAPS, University of Barcelona, Barcelona, Spain.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The Lancet. Infectious diseases</title><idno type="eISSN">1474-4457</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiviral Agents (therapeutic use)</term><term>Benzimidazoles (therapeutic use)</term><term>Drug Therapy, Combination</term><term>Female</term><term>Fluorenes (therapeutic use)</term><term>Genotype</term><term>Global Health</term><term>Hepacivirus (classification)</term><term>Hepacivirus (drug effects)</term><term>Hepacivirus (genetics)</term><term>Hepatitis C, Chronic (complications)</term><term>Hepatitis C, Chronic (drug therapy)</term><term>Hepatitis C, Chronic (mortality)</term><term>Humans</term><term>Liver Cirrhosis (drug therapy)</term><term>Liver Cirrhosis (mortality)</term><term>Liver Cirrhosis (virology)</term><term>Male</term><term>Middle Aged</term><term>RNA, Viral</term><term>Ribavirin (therapeutic use)</term><term>Time Factors</term><term>Treatment Outcome</term><term>Uridine Monophosphate (analogs & derivatives)</term><term>Uridine Monophosphate (therapeutic use)</term><term>Viral Load</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Uridine Monophosphate</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiviral Agents</term><term>Benzimidazoles</term><term>Fluorenes</term><term>Ribavirin</term><term>Uridine Monophosphate</term></keywords><keywords scheme="MESH" qualifier="classification" xml:lang="en"><term>Hepacivirus</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Hepatitis C, Chronic</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Hepacivirus</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="genetics" xml:lang="en"><term>Hepacivirus</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Hepatitis C, Chronic</term><term>Liver Cirrhosis</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Liver Cirrhosis</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Drug Therapy, Combination</term><term>Female</term><term>Genotype</term><term>Global Health</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>RNA, Viral</term><term>Time Factors</term><term>Treatment Outcome</term><term>Viral Load</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Treatment options are limited for patients infected by hepatitis C virus (HCV) with advanced liver disease. We assessed the safety and efficacy of ledipasvir, sofosbuvir, and ribavirin in patients with HCV genotype 1 or 4 and advanced liver disease.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26907736</PMID><DateCreated><Year>2016</Year><Month>06</Month><Day>15</Day></DateCreated><DateCompleted><Year>2017</Year><Month>06</Month><Day>05</Day></DateCompleted><DateRevised><Year>2017</Year><Month>08</Month><Day>23</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-4457</ISSN><JournalIssue CitedMedium="Internet"><Volume>16</Volume><Issue>6</Issue><PubDate><Year>2016</Year><Month>Jun</Month></PubDate></JournalIssue><Title>The Lancet. Infectious diseases</Title><ISOAbbreviation>Lancet Infect Dis</ISOAbbreviation></Journal><ArticleTitle>Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial.</ArticleTitle><Pagination><MedlinePgn>685-697</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1473-3099(16)00052-9</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1473-3099(16)00052-9</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Treatment options are limited for patients infected by hepatitis C virus (HCV) with advanced liver disease. We assessed the safety and efficacy of ledipasvir, sofosbuvir, and ribavirin in patients with HCV genotype 1 or 4 and advanced liver disease.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">We did an open-label study at 34 sites in Europe, Canada, Australia, and New Zealand. Cohort A included patients with Child-Turcotte-Pugh class B (CTP-B) or CTP-C cirrhosis who had not undergone liver transplantation. Cohort B included post-transplantation patients who had either no cirrhosis; CTP-A, CTP-B, or CTP-C cirrhosis; or fibrosing cholestatic hepatitis. Patients in each group were randomly assigned (1:1) using a computer-generated randomisation sequence to receive 12 or 24 weeks of ledipasvir (90 mg) and sofosbuvir (400 mg) once daily (combination tablet), plus ribavirin (600-1200 mg daily). The primary endpoint was the proportion of patients achieving a sustained virological response 12 weeks after treatment (SVR12). All patients who received at least one dose of study drug were included in the safety analysis and all patients who received at least one dose of study drug and did not undergo liver transplantation during treatment were included in the efficacy analyses. Estimates of SVR12 and relapse rates and their two-sided 90% CI (Clopper-Pearson method) were provided. This exploratory phase 2 study was not powered for formal comparisons among treatment groups; no statistical hypothesis testing was planned or conducted. The trial is registered with EudraCT (number 2013-002802-30) and ClinicalTrials.gov (number NCT02010255).</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between Jan 14, 2014, and Aug 19, 2014, 398 patients were screened. Of 333 patients who received treatment, 296 had genotype 1 HCV and 37 had genotype 4 HCV. In cohort A, among patients with genotype 1 HCV, SVR12 was achieved by 20 (87%, 90% CI 70-96) of 23 CTP-B patients with 12 weeks of treatment; 22 (96%, 81-100) of 23 CTP-B patients with 24 weeks of treatment; 17 (85%, 66-96) of 20 CTP-C patients (12 weeks treatment); and 18 (78%, 60-91) of 23 CTP-C patients (24 weeks treatment). In cohort B, among patients with genotype 1 HCV, SVR12 was achieved by 42 (93%, 84-98) of 45 patients without cirrhosis (12 weeks treatment); 44 (100%, 93-100) of 44 patients without cirrhosis (24 weeks treatment); 30 (100%, 91-100) of 30 CTP-A patients (12 weeks treatment); 27 (96%, 84-100) of 28 CTP-A patients (24 weeks treatment); 19 (95%, 78-100) of 20 CTP-B patients (12 weeks treatment); 20 (100%, 86-100) of 20 CTP-B patients (24 weeks treatment); one (50%, 3-98) of two CTP-C patients (12 weeks treatment); and four (80%, 34-99) of five CTP-C patients (24 weeks treatment). All five patients with fibrosing cholestatic hepatitis achieved SVR12 (100%, 90% CI 55-100). Among all patients with genotype 4 HCV, SVR12 was achieved by 14 (78%, 56-92) of 18 patients (12 weeks treatment) and 16 (94%, 75-100) of 17 patients (24 weeks treatment). Seven patients (2%) discontinued ledipasvir-sofosbuvir prematurely due to adverse events. 17 patients died, mainly from complications of hepatic decompensation.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Ledipasvir-sofosbuvir and ribavirin provided high rates of SVR12 for patients with advanced liver disease, including those with decompensated cirrhosis before or after liver transplantation.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Gilead Sciences.</AbstractText><CopyrightInformation>Copyright © 2016 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Manns</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; German Center of Infection Research (DZIF), Hannover-Braunschweig, Germany. Electronic address: manns.michael@mh-hannover.de.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Samuel</LastName><ForeName>Didier</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Centre Hepatobiliaire, Hôpital Paul Brousse, and Université Paris Sud, Villejuif, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gane</LastName><ForeName>Edward J</ForeName><Initials>EJ</Initials><AffiliationInfo><Affiliation>New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mutimer</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Queen Elizabeth Hospital and NIHR Liver Biomedical Research Unit, Birmingham, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McCaughan</LastName><ForeName>Geoff</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Australian Liver Transplant Unit, Centenary Research Institute, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Buti</LastName><ForeName>Maria</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Internal Medicine and Hepatology, CIBERHED Vall d'Hebron University Hospital, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Prieto</LastName><ForeName>Martín</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Digestive Diseases Service, Hospital Universitario y Politécnico La Fe, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Valencia, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Calleja</LastName><ForeName>José Luis</ForeName><Initials>JL</Initials><AffiliationInfo><Affiliation>Servicio de Gastroenterología y Hepatología Hospital Universitario Puerta de Hierro Universidad Autonoma, Madrid, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Peck-Radosavljevic</LastName><ForeName>Markus</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Müllhaupt</LastName><ForeName>Beat</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Department for Gastroenterology and Hepatology UniversitätsSpital Zürich, Zürich, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Agarwal</LastName><ForeName>Kosh</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Institute of Liver Studies, King's College Hospital Foundation Trust, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Angus</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Liver Transplant Unit, Austin Hospital, Heidelberg, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yoshida</LastName><ForeName>Eric M</ForeName><Initials>EM</Initials><AffiliationInfo><Affiliation>Division of Gastroenterology, Vancouver General Hospital and University of British Columbia, Vancouver, BC, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Colombo</LastName><ForeName>Massimo</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Gastroenterology, IRCCS Maggiore Hospital University of Milan, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rizzetto</LastName><ForeName>Mario</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Azienda Ospedaliero-Universitaria, Torino, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dvory-Sobol</LastName><ForeName>Hadas</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Denning</LastName><ForeName>Jill</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Arterburn</LastName><ForeName>Sarah</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pang</LastName><ForeName>Phillip S</ForeName><Initials>PS</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Brainard</LastName><ForeName>Diana</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McHutchison</LastName><ForeName>John G</ForeName><Initials>JG</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dufour</LastName><ForeName>Jean-François</ForeName><Initials>JF</Initials><AffiliationInfo><Affiliation>Department of Hepatology, University of Bern, Bern, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Van Vlierberghe</LastName><ForeName>Hans</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Ghent University Hospital, Ghent, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van Hoek</LastName><ForeName>Bart</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Forns</LastName><ForeName>Xavier</ForeName><Initials>X</Initials><AffiliationInfo><Affiliation>Liver 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UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D019562" MajorTopicYN="N">Viral Load</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>11</Month><Day>04</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>01</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>01</Month><Day>19</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>2</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>2</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>6</Month><Day>6</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26907736</ArticleId><ArticleId IdType="pii">S1473-3099(16)00052-9</ArticleId><ArticleId IdType="doi">10.1016/S1473-3099(16)00052-9</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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