Efficacy and Safety of Ledipasvir/Sofosbuvir With and Without Ribavirin in Patients With Chronic HCV Genotype 1 Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ION Trials.
Identifieur interne : 003A27 ( Ncbi/Merge ); précédent : 003A26; suivant : 003A28Efficacy and Safety of Ledipasvir/Sofosbuvir With and Without Ribavirin in Patients With Chronic HCV Genotype 1 Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ION Trials.
Auteurs : Jason Grebely [Australie] ; Stefan Mauss [Allemagne] ; Ashley Brown [Royaume-Uni] ; Jean-Pierre Bronowicki [France] ; Massimo Puoti [Italie] ; David Wyles [États-Unis] ; Macky Natha [États-Unis] ; Yanni Zhu [États-Unis] ; Junming Yang [États-Unis] ; Bruce Kreter [États-Unis] ; Diana M. Brainard [États-Unis] ; Chohee Yun [États-Unis] ; Val Carr [Royaume-Uni] ; Gregory J. Dore [Australie]Source :
- Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [ 1537-6591 ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Antiviraux (usage thérapeutique), Association de médicaments (effets indésirables), Benzimidazoles (administration et posologie), Benzimidazoles (effets indésirables), Benzimidazoles (usage thérapeutique), Charge virale (), Femelle, Fluorènes (administration et posologie), Fluorènes (effets indésirables), Fluorènes (usage thérapeutique), Génotype, Hepacivirus (), Hepacivirus (génétique), Humains, Hépatite C chronique (génétique), Hépatite C chronique (sang), Hépatite C chronique (traitement médicamenteux), Interprétation statistique de données, Mâle, Ribavirine (administration et posologie), Ribavirine (effets indésirables), Ribavirine (usage thérapeutique), Réponse virologique soutenue, Sofosbuvir (administration et posologie), Sofosbuvir (effets indésirables), Sofosbuvir (usage thérapeutique), Test ELISA, Traitement de substitution aux opiacés, Usagers de drogues, Études rétrospectives.
- MESH :
- administration et posologie : Benzimidazoles, Fluorènes, Ribavirine, Sofosbuvir.
- effets indésirables : Association de médicaments, Benzimidazoles, Fluorènes, Ribavirine, Sofosbuvir.
- génétique : Hepacivirus, Hépatite C chronique.
- sang : Hépatite C chronique.
- traitement médicamenteux : Hépatite C chronique.
- usage thérapeutique : Antiviraux, Benzimidazoles, Fluorènes, Ribavirine, Sofosbuvir.
- Adulte, Adulte d'âge moyen, Charge virale, Femelle, Génotype, Hepacivirus, Humains, Interprétation statistique de données, Mâle, Réponse virologique soutenue, Test ELISA, Traitement de substitution aux opiacés, Usagers de drogues, Études rétrospectives.
English descriptors
- KwdEn :
- Adult, Antiviral Agents (therapeutic use), Benzimidazoles (administration & dosage), Benzimidazoles (adverse effects), Benzimidazoles (therapeutic use), Data Interpretation, Statistical, Drug Therapy, Combination (adverse effects), Drug Users, Enzyme-Linked Immunosorbent Assay, Female, Fluorenes (administration & dosage), Fluorenes (adverse effects), Fluorenes (therapeutic use), Genotype, Hepacivirus (drug effects), Hepacivirus (genetics), Hepatitis C, Chronic (blood), Hepatitis C, Chronic (drug therapy), Hepatitis C, Chronic (genetics), Humans, Male, Middle Aged, Opiate Substitution Treatment, Retrospective Studies, Ribavirin (administration & dosage), Ribavirin (adverse effects), Ribavirin (therapeutic use), Sofosbuvir (administration & dosage), Sofosbuvir (adverse effects), Sofosbuvir (therapeutic use), Sustained Virologic Response, Viral Load (drug effects).
- MESH :
- chemical , administration & dosage : Benzimidazoles, Fluorenes, Ribavirin, Sofosbuvir.
- chemical , adverse effects : Benzimidazoles, Fluorenes, Ribavirin, Sofosbuvir.
- chemical , therapeutic use : Antiviral Agents, Benzimidazoles, Fluorenes, Ribavirin, Sofosbuvir.
- adverse effects : Drug Therapy, Combination.
- blood : Hepatitis C, Chronic.
- drug effects : Hepacivirus, Viral Load.
- drug therapy : Hepatitis C, Chronic.
- genetics : Hepacivirus, Hepatitis C, Chronic.
- Adult, Data Interpretation, Statistical, Drug Users, Enzyme-Linked Immunosorbent Assay, Female, Genotype, Humans, Male, Middle Aged, Opiate Substitution Treatment, Retrospective Studies, Sustained Virologic Response.
Abstract
Interferon-based hepatitis C virus (HCV) therapy is safe and effective among people receiving opioid substitution therapy (OST), but treatment uptake remains low. Our aim was to evaluate the impact of OST and drug use during therapy on completion, adherence, sustained virologic response (SVR12), and safety of ledipasvir/sofosbuvir ± ribavirin.
DOI: 10.1093/cid/ciw580
PubMed: 27553375
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pubmed:27553375Le document en format XML
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Dore</name><affiliation wicri:level="3"><nlm:affiliation>The Kirby Institute, UNSW Australia, Sydney.</nlm:affiliation><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><wicri:orgArea>The Kirby Institute, UNSW Australia</wicri:orgArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:27553375</idno><idno type="pmid">27553375</idno><idno type="doi">10.1093/cid/ciw580</idno><idno type="wicri:Area/PubMed/Corpus">001457</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001457</idno><idno type="wicri:Area/PubMed/Curation">001435</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">001435</idno><idno type="wicri:Area/PubMed/Checkpoint">001435</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" 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wicri:level="3"><nlm:affiliation>Center for HIV and Hepatogastroenterology, Düsseldorf, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Center for HIV and Hepatogastroenterology, Düsseldorf</wicri:regionArea><placeName><region type="land" nuts="1">Rhénanie-du-Nord-Westphalie</region><region type="district" nuts="2">District de Düsseldorf</region><settlement type="city">Düsseldorf</settlement></placeName></affiliation></author><author><name sortKey="Brown, Ashley" sort="Brown, Ashley" uniqKey="Brown A" first="Ashley" last="Brown">Ashley Brown</name><affiliation wicri:level="3"><nlm:affiliation>Liver Unit, Department of Medicine, St Mary's Hospital, London, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Liver Unit, Department of Medicine, St Mary's Hospital, London</wicri:regionArea><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="Bronowicki, Jean Pierre" sort="Bronowicki, Jean Pierre" uniqKey="Bronowicki J" first="Jean-Pierre" last="Bronowicki">Jean-Pierre Bronowicki</name><affiliation wicri:level="3"><nlm:affiliation>INSERM U954, Universitary Hospital of Nancy, University of Lorraine, Vandoeuvre-les-Nancy, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>INSERM U954, Universitary Hospital of Nancy, University of Lorraine, Vandoeuvre-les-Nancy</wicri:regionArea><placeName><region type="region" nuts="2">Grand Est</region><region type="old region" nuts="2">Lorraine (région)</region><settlement type="city">Vandœuvre-lès-Nancy</settlement><settlement type="city" wicri:auto="agglo">Nancy</settlement></placeName></affiliation></author><author><name sortKey="Puoti, Massimo" sort="Puoti, Massimo" uniqKey="Puoti M" first="Massimo" last="Puoti">Massimo Puoti</name><affiliation wicri:level="3"><nlm:affiliation>Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Milan, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Milan</wicri:regionArea><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Wyles, David" sort="Wyles, David" uniqKey="Wyles D" first="David" last="Wyles">David Wyles</name><affiliation wicri:level="3"><nlm:affiliation>Division of Infectious Diseases, University of California, San Diego.</nlm:affiliation><country>États-Unis</country><placeName><settlement type="city">San Diego</settlement><region type="state">Californie</region></placeName><wicri:orgArea>Division of Infectious Diseases, University of California</wicri:orgArea></affiliation></author><author><name sortKey="Natha, Macky" sort="Natha, Macky" uniqKey="Natha M" first="Macky" last="Natha">Macky Natha</name><affiliation wicri:level="2"><nlm:affiliation>Gilead Sciences, Foster City, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Gilead Sciences, Foster City</wicri:cityArea></affiliation></author><author><name sortKey="Zhu, Yanni" sort="Zhu, Yanni" uniqKey="Zhu Y" first="Yanni" last="Zhu">Yanni Zhu</name><affiliation wicri:level="2"><nlm:affiliation>Gilead Sciences, Foster City, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Gilead Sciences, Foster City</wicri:cityArea></affiliation></author><author><name sortKey="Yang, Junming" sort="Yang, Junming" uniqKey="Yang J" first="Junming" last="Yang">Junming Yang</name><affiliation wicri:level="2"><nlm:affiliation>Gilead Sciences, Foster City, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Gilead Sciences, Foster City</wicri:cityArea></affiliation></author><author><name sortKey="Kreter, Bruce" sort="Kreter, Bruce" uniqKey="Kreter B" first="Bruce" last="Kreter">Bruce Kreter</name><affiliation wicri:level="2"><nlm:affiliation>Gilead Sciences, Foster City, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Gilead Sciences, Foster City</wicri:cityArea></affiliation></author><author><name sortKey="Brainard, Diana M" sort="Brainard, Diana M" uniqKey="Brainard D" first="Diana M" last="Brainard">Diana M. Brainard</name><affiliation wicri:level="2"><nlm:affiliation>Gilead Sciences, Foster City, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Gilead Sciences, Foster City</wicri:cityArea></affiliation></author><author><name sortKey="Yun, Chohee" sort="Yun, Chohee" uniqKey="Yun C" first="Chohee" last="Yun">Chohee Yun</name><affiliation wicri:level="2"><nlm:affiliation>Gilead Sciences, Foster City, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Gilead Sciences, Foster City</wicri:cityArea></affiliation></author><author><name sortKey="Carr, Val" sort="Carr, Val" uniqKey="Carr V" first="Val" last="Carr">Val Carr</name><affiliation wicri:level="1"><nlm:affiliation>Gilead Sciences, Stockley Park, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Gilead Sciences, Stockley Park</wicri:regionArea><wicri:noRegion>Stockley Park</wicri:noRegion></affiliation></author><author><name sortKey="Dore, Gregory J" sort="Dore, Gregory J" uniqKey="Dore G" first="Gregory J" last="Dore">Gregory J. Dore</name><affiliation wicri:level="3"><nlm:affiliation>The Kirby Institute, UNSW Australia, Sydney.</nlm:affiliation><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><wicri:orgArea>The Kirby Institute, UNSW Australia</wicri:orgArea></affiliation></author></analytic><series><title level="j">Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</title><idno type="eISSN">1537-6591</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Antiviral Agents (therapeutic use)</term><term>Benzimidazoles (administration & dosage)</term><term>Benzimidazoles (adverse effects)</term><term>Benzimidazoles (therapeutic use)</term><term>Data Interpretation, Statistical</term><term>Drug Therapy, Combination (adverse effects)</term><term>Drug Users</term><term>Enzyme-Linked Immunosorbent Assay</term><term>Female</term><term>Fluorenes (administration & dosage)</term><term>Fluorenes (adverse effects)</term><term>Fluorenes (therapeutic use)</term><term>Genotype</term><term>Hepacivirus (drug effects)</term><term>Hepacivirus (genetics)</term><term>Hepatitis C, Chronic (blood)</term><term>Hepatitis C, Chronic (drug therapy)</term><term>Hepatitis C, Chronic (genetics)</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Opiate Substitution Treatment</term><term>Retrospective Studies</term><term>Ribavirin (administration & dosage)</term><term>Ribavirin (adverse effects)</term><term>Ribavirin (therapeutic use)</term><term>Sofosbuvir (administration & dosage)</term><term>Sofosbuvir (adverse effects)</term><term>Sofosbuvir (therapeutic use)</term><term>Sustained Virologic Response</term><term>Viral Load (drug effects)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Antiviraux (usage thérapeutique)</term><term>Association de médicaments (effets indésirables)</term><term>Benzimidazoles (administration et posologie)</term><term>Benzimidazoles (effets indésirables)</term><term>Benzimidazoles (usage thérapeutique)</term><term>Charge virale ()</term><term>Femelle</term><term>Fluorènes (administration et posologie)</term><term>Fluorènes (effets indésirables)</term><term>Fluorènes (usage thérapeutique)</term><term>Génotype</term><term>Hepacivirus ()</term><term>Hepacivirus (génétique)</term><term>Humains</term><term>Hépatite C chronique (génétique)</term><term>Hépatite C chronique (sang)</term><term>Hépatite C chronique (traitement médicamenteux)</term><term>Interprétation statistique de données</term><term>Mâle</term><term>Ribavirine (administration et posologie)</term><term>Ribavirine (effets indésirables)</term><term>Ribavirine (usage thérapeutique)</term><term>Réponse virologique soutenue</term><term>Sofosbuvir (administration et posologie)</term><term>Sofosbuvir (effets indésirables)</term><term>Sofosbuvir (usage thérapeutique)</term><term>Test ELISA</term><term>Traitement de substitution aux opiacés</term><term>Usagers de drogues</term><term>Études rétrospectives</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Benzimidazoles</term><term>Fluorenes</term><term>Ribavirin</term><term>Sofosbuvir</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Benzimidazoles</term><term>Fluorenes</term><term>Ribavirin</term><term>Sofosbuvir</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>Sofosbuvir</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Benzimidazoles</term><term>Fluorènes</term><term>Ribavirine</term><term>Sofosbuvir</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Drug Therapy, Combination</term></keywords><keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Hepatitis C, Chronic</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Hepacivirus</term><term>Viral Load</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Hepatitis C, Chronic</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Association de médicaments</term><term>Benzimidazoles</term><term>Fluorènes</term><term>Ribavirine</term><term>Sofosbuvir</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Hepacivirus</term><term>Hepatitis C, Chronic</term></keywords><keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>Hepacivirus</term><term>Hépatite C chronique</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Hépatite C chronique</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Hépatite C chronique</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antiviraux</term><term>Benzimidazoles</term><term>Fluorènes</term><term>Ribavirine</term><term>Sofosbuvir</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Data Interpretation, Statistical</term><term>Drug Users</term><term>Enzyme-Linked Immunosorbent Assay</term><term>Female</term><term>Genotype</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Opiate Substitution Treatment</term><term>Retrospective Studies</term><term>Sustained Virologic Response</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Charge virale</term><term>Femelle</term><term>Génotype</term><term>Hepacivirus</term><term>Humains</term><term>Interprétation statistique de données</term><term>Mâle</term><term>Réponse virologique soutenue</term><term>Test ELISA</term><term>Traitement de substitution aux opiacés</term><term>Usagers de drogues</term><term>Études rétrospectives</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"> Interferon-based hepatitis C virus (HCV) therapy is safe and effective among people receiving opioid substitution therapy (OST), but treatment uptake remains low. Our aim was to evaluate the impact of OST and drug use during therapy on completion, adherence, sustained virologic response (SVR12), and safety of ledipasvir/sofosbuvir ± ribavirin.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27553375</PMID><DateCreated><Year>2016</Year><Month>08</Month><Day>24</Day></DateCreated><DateCompleted><Year>2017</Year><Month>10</Month><Day>30</Day></DateCompleted><DateRevised><Year>2017</Year><Month>10</Month><Day>30</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1537-6591</ISSN><JournalIssue CitedMedium="Internet"><Volume>63</Volume><Issue>11</Issue><PubDate><Year>2016</Year><Month>Dec</Month><Day>01</Day></PubDate></JournalIssue><Title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</Title><ISOAbbreviation>Clin. Infect. Dis.</ISOAbbreviation></Journal><ArticleTitle>Efficacy and Safety of Ledipasvir/Sofosbuvir With and Without Ribavirin in Patients With Chronic HCV Genotype 1 Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ION Trials.</ArticleTitle><Pagination><MedlinePgn>1405-1411</MedlinePgn></Pagination><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND"> Interferon-based hepatitis C virus (HCV) therapy is safe and effective among people receiving opioid substitution therapy (OST), but treatment uptake remains low. Our aim was to evaluate the impact of OST and drug use during therapy on completion, adherence, sustained virologic response (SVR12), and safety of ledipasvir/sofosbuvir ± ribavirin.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS"> The phase 3 ION studies evaluated a fixed-dose combination of ledipasvir/sofosbuvir ± ribavirin administered for 8, 12, or 24 weeks in patients with chronic HCV genotype 1. People with clinically significant drug use (prior 12 months) or noncannabinoids detected at screening by urine drug tests (not explained by prescriptions) were ineligible. Stored samples were available from ION-1 for retrospective testing for illicit drugs by enzyme-linked immunosorbent assay.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS"> Among 1952 patients enrolled in the ION studies, 4% (n = 70) were receiving OST. Among those receiving (n = 70) and not receiving OST (n = 1882), there was no difference in treatment completion (97% vs 98%; P = .40), ≥80% adherence (93% vs 92%; P = 1.00), SVR12 (94% vs 97%; P = .28), and serious adverse events (4% vs 3%; P = .43), respectively. Among participants in the ION-1 trial, 23% (n = 196) used illicit drugs during therapy (15% cannabinoids alone; 8% other illicit drugs ± cannabinoids). There was no difference in treatment completion, ≥80% adherence, SVR12, or serious AEs in those with no drug use during treatment compared with those who used cannabinoids and/or other illicit drugs. No cases of HCV reinfection were observed in the 24 weeks following treatment.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS"> OST and drug use during HCV therapy did not impact treatment completion, adherence, SVR12, or safety.</AbstractText><AbstractText Label="CLINICAL TRIALS REGISTRATION" NlmCategory="BACKGROUND"> ION-1 (NCT01701401); ION-2 (NCT01768286); and ION-3 (NCT01851330).</AbstractText><CopyrightInformation>© The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Grebely</LastName><ForeName>Jason</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>The Kirby Institute, UNSW Australia, Sydney.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mauss</LastName><ForeName>Stefan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Center for HIV and Hepatogastroenterology, Düsseldorf, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Brown</LastName><ForeName>Ashley</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Liver Unit, Department of Medicine, St Mary's Hospital, London, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bronowicki</LastName><ForeName>Jean-Pierre</ForeName><Initials>JP</Initials><AffiliationInfo><Affiliation>INSERM U954, Universitary Hospital of Nancy, University of Lorraine, Vandoeuvre-les-Nancy, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Puoti</LastName><ForeName>Massimo</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wyles</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, University of California, San Diego.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Natha</LastName><ForeName>Macky</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhu</LastName><ForeName>Yanni</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yang</LastName><ForeName>Junming</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kreter</LastName><ForeName>Bruce</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Brainard</LastName><ForeName>Diana M</ForeName><Initials>DM</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yun</LastName><ForeName>Chohee</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Carr</LastName><ForeName>Val</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Stockley Park, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dore</LastName><ForeName>Gregory J</ForeName><Initials>GJ</Initials><AffiliationInfo><Affiliation>The Kirby Institute, UNSW Australia, Sydney.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01701401</AccessionNumber><AccessionNumber>NCT01768286</AccessionNumber><AccessionNumber>NCT01851330</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>08</Month><Day>23</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Infect Dis</MedlineTA><NlmUniqueID>9203213</NlmUniqueID><ISSNLinking>1058-4838</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D001562">Benzimidazoles</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D005449">Fluorenes</NameOfSubstance></Chemical><Chemical><RegistryNumber>013TE6E4WV</RegistryNumber><NameOfSubstance UI="C586541">ledipasvir</NameOfSubstance></Chemical><Chemical><RegistryNumber>49717AWG6K</RegistryNumber><NameOfSubstance UI="D012254">Ribavirin</NameOfSubstance></Chemical><Chemical><RegistryNumber>WJ6CA3ZU8B</RegistryNumber><NameOfSubstance UI="D000069474">Sofosbuvir</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000998" MajorTopicYN="N">Antiviral Agents</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001562" MajorTopicYN="N">Benzimidazoles</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003627" MajorTopicYN="N">Data Interpretation, Statistical</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D055030" MajorTopicYN="Y">Drug Users</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004797" MajorTopicYN="N">Enzyme-Linked Immunosorbent Assay</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005449" MajorTopicYN="N">Fluorenes</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005838" MajorTopicYN="N">Genotype</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016174" MajorTopicYN="N">Hepacivirus</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="N">drug effects</QualifierName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D019698" MajorTopicYN="N">Hepatitis C, Chronic</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D058850" MajorTopicYN="Y">Opiate Substitution Treatment</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012189" MajorTopicYN="N">Retrospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012254" MajorTopicYN="N">Ribavirin</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000069474" MajorTopicYN="N">Sofosbuvir</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000072230" MajorTopicYN="N">Sustained Virologic Response</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019562" MajorTopicYN="N">Viral Load</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="N">drug effects</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">DAA</Keyword><Keyword MajorTopicYN="N">PWID</Keyword><Keyword MajorTopicYN="N">drug use</Keyword><Keyword MajorTopicYN="N">hepatitis C virus</Keyword><Keyword MajorTopicYN="N">opioid substitution therapy</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>05</Month><Day>24</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>08</Month><Day>06</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>8</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>10</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>8</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27553375</ArticleId><ArticleId IdType="pii">ciw580</ArticleId><ArticleId IdType="doi">10.1093/cid/ciw580</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>France</li><li>Italie</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Californie</li><li>District de Düsseldorf</li><li>Grand Est</li><li>Grand Londres</li><li>Lombardie</li><li>Lorraine (région)</li><li>Nouvelle-Galles du Sud</li><li>Rhénanie-du-Nord-Westphalie</li></region><settlement><li>Düsseldorf</li><li>Londres</li><li>Milan</li><li>Nancy</li><li>San Diego</li><li>Sydney</li><li>Vandœuvre-lès-Nancy</li></settlement></list><tree><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Grebely, Jason" sort="Grebely, Jason" uniqKey="Grebely J" first="Jason" last="Grebely">Jason Grebely</name></region><name sortKey="Dore, Gregory J" sort="Dore, Gregory J" uniqKey="Dore G" first="Gregory J" last="Dore">Gregory J. Dore</name></country><country name="Allemagne"><region name="Rhénanie-du-Nord-Westphalie"><name sortKey="Mauss, Stefan" sort="Mauss, Stefan" uniqKey="Mauss S" first="Stefan" last="Mauss">Stefan Mauss</name></region></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Brown, Ashley" sort="Brown, Ashley" uniqKey="Brown A" first="Ashley" last="Brown">Ashley Brown</name></region><name sortKey="Carr, Val" sort="Carr, Val" uniqKey="Carr V" first="Val" last="Carr">Val Carr</name></country><country name="France"><region name="Grand Est"><name sortKey="Bronowicki, Jean Pierre" sort="Bronowicki, Jean Pierre" uniqKey="Bronowicki J" first="Jean-Pierre" last="Bronowicki">Jean-Pierre Bronowicki</name></region></country><country name="Italie"><region name="Lombardie"><name sortKey="Puoti, Massimo" sort="Puoti, Massimo" uniqKey="Puoti M" first="Massimo" last="Puoti">Massimo Puoti</name></region></country><country name="États-Unis"><region name="Californie"><name sortKey="Wyles, David" sort="Wyles, David" uniqKey="Wyles D" first="David" last="Wyles">David Wyles</name></region><name sortKey="Brainard, Diana M" sort="Brainard, Diana M" uniqKey="Brainard D" first="Diana M" last="Brainard">Diana M. Brainard</name><name sortKey="Kreter, Bruce" sort="Kreter, Bruce" uniqKey="Kreter B" first="Bruce" last="Kreter">Bruce Kreter</name><name sortKey="Natha, Macky" sort="Natha, Macky" uniqKey="Natha M" first="Macky" last="Natha">Macky Natha</name><name sortKey="Yang, Junming" sort="Yang, Junming" uniqKey="Yang J" first="Junming" last="Yang">Junming Yang</name><name sortKey="Yun, Chohee" sort="Yun, Chohee" uniqKey="Yun C" first="Chohee" last="Yun">Chohee Yun</name><name sortKey="Zhu, Yanni" sort="Zhu, Yanni" uniqKey="Zhu Y" first="Yanni" last="Zhu">Yanni Zhu</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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