Telaprevir-based therapy in patients coinfected with chronic hepatitis C virus infection and HIV: INSIGHT study.
Identifieur interne : 002538 ( PubMed/Corpus ); précédent : 002537; suivant : 002539Telaprevir-based therapy in patients coinfected with chronic hepatitis C virus infection and HIV: INSIGHT study.
Auteurs : Maria Luisa Montes ; Mark Nelson ; Pierre-Marie Girard ; Joe Sasadeusz ; Andrzej Horban ; Beatriz Grinsztejn ; Natalia Zakharova ; Antonio Rivero ; Jacques Durant ; Enrique Ortega-Gonzalez ; Erkki Lathouwers ; Katrien Janssen ; Sivi Ouwerkerk-Mahadevan ; James Witek ; Juan González-GarcíaSource :
- The Journal of antimicrobial chemotherapy [ 1460-2091 ] ; 2016.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Antiviral Agents (administration & dosage), Antiviral Agents (adverse effects), Antiviral Agents (pharmacokinetics), Coinfection (drug therapy), Drug-Related Side Effects and Adverse Reactions (epidemiology), Drug-Related Side Effects and Adverse Reactions (pathology), Female, HIV Infections (complications), HIV Infections (drug therapy), Hepatitis C, Chronic (complications), Hepatitis C, Chronic (drug therapy), Humans, Interferon-alpha (administration & dosage), Interferon-alpha (adverse effects), Interferon-alpha (pharmacokinetics), Male, Middle Aged, Oligopeptides (administration & dosage), Oligopeptides (adverse effects), Oligopeptides (pharmacokinetics), Polyethylene Glycols (administration & dosage), Polyethylene Glycols (adverse effects), Polyethylene Glycols (pharmacokinetics), Recombinant Proteins (administration & dosage), Recombinant Proteins (adverse effects), Recombinant Proteins (pharmacokinetics), Ribavirin (administration & dosage), Ribavirin (adverse effects), Ribavirin (pharmacokinetics), Treatment Outcome, Young Adult.
- MESH :
- chemical , administration & dosage : Antiviral Agents, Interferon-alpha, Oligopeptides, Polyethylene Glycols, Recombinant Proteins, Ribavirin.
- chemical , adverse effects : Antiviral Agents, Interferon-alpha, Oligopeptides, Polyethylene Glycols, Recombinant Proteins, Ribavirin.
- chemical , pharmacokinetics : Antiviral Agents, Interferon-alpha, Oligopeptides, Polyethylene Glycols, Recombinant Proteins, Ribavirin.
- complications : HIV Infections, Hepatitis C, Chronic.
- drug therapy : Coinfection, HIV Infections, Hepatitis C, Chronic.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- pathology : Drug-Related Side Effects and Adverse Reactions.
- Adolescent, Adult, Aged, Female, Humans, Male, Middle Aged, Treatment Outcome, Young Adult.
Abstract
INSIGHT (ClinicalTrials.gov NCT01513941) evaluated the efficacy, safety and pharmacokinetics of telaprevir-based therapy and specific antiretroviral agents in hepatitis C virus genotype 1 (HCV-1)/HIV-1-coinfected patients.
DOI: 10.1093/jac/dkv323
PubMed: 26483516
Links to Exploration step
pubmed:26483516Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Telaprevir-based therapy in patients coinfected with chronic hepatitis C virus infection and HIV: INSIGHT study.</title><author><name sortKey="Montes, Maria Luisa" sort="Montes, Maria Luisa" uniqKey="Montes M" first="Maria Luisa" last="Montes">Maria Luisa Montes</name><affiliation><nlm:affiliation>Servicio de Medicina Interna, Unidad de VIH, IdiPAZ, Hospital Universitario La Paz, Madrid, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Nelson, Mark" sort="Nelson, Mark" uniqKey="Nelson M" first="Mark" last="Nelson">Mark Nelson</name><affiliation><nlm:affiliation>Chelsea and Westminster Hospital, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Girard, Pierre Marie" sort="Girard, Pierre Marie" uniqKey="Girard P" first="Pierre-Marie" last="Girard">Pierre-Marie Girard</name><affiliation><nlm:affiliation>Hôpital St Antoine and INSERM, UMR S1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Sasadeusz, Joe" sort="Sasadeusz, Joe" uniqKey="Sasadeusz J" first="Joe" last="Sasadeusz">Joe Sasadeusz</name><affiliation><nlm:affiliation>Victorian Infectious Diseases Service, Royal Melbourne Hospital, Melbourne, Victoria, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Horban, Andrzej" sort="Horban, Andrzej" uniqKey="Horban A" first="Andrzej" last="Horban">Andrzej Horban</name><affiliation><nlm:affiliation>Warsaw Medical University and Hospital of Infectious Diseases, Warsaw, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Grinsztejn, Beatriz" sort="Grinsztejn, Beatriz" uniqKey="Grinsztejn B" first="Beatriz" last="Grinsztejn">Beatriz Grinsztejn</name><affiliation><nlm:affiliation>STD/AIDS Clinical Research Laboratory, Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro, Brazil.</nlm:affiliation></affiliation></author><author><name sortKey="Zakharova, Natalia" sort="Zakharova, Natalia" uniqKey="Zakharova N" first="Natalia" last="Zakharova">Natalia Zakharova</name><affiliation><nlm:affiliation>Saint-Petersburg AIDS Center, St Petersburg, Russian Federation.</nlm:affiliation></affiliation></author><author><name sortKey="Rivero, Antonio" sort="Rivero, Antonio" uniqKey="Rivero A" first="Antonio" last="Rivero">Antonio Rivero</name><affiliation><nlm:affiliation>Unidad de Enfermedades Infecciosas, Hospital Universitario Reina Sofía/IMIBIC, Córdoba, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Durant, Jacques" sort="Durant, Jacques" uniqKey="Durant J" first="Jacques" last="Durant">Jacques Durant</name><affiliation><nlm:affiliation>Infectious Diseases Department, L'Archet Hospital, University of Nice, Nice, France.</nlm:affiliation></affiliation></author><author><name sortKey="Ortega Gonzalez, Enrique" sort="Ortega Gonzalez, Enrique" uniqKey="Ortega Gonzalez E" first="Enrique" last="Ortega-Gonzalez">Enrique Ortega-Gonzalez</name><affiliation><nlm:affiliation>Unidad de Enfermedades Infecciosas, Hospital General Universitario, Valencia, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Lathouwers, Erkki" sort="Lathouwers, Erkki" uniqKey="Lathouwers E" first="Erkki" last="Lathouwers">Erkki Lathouwers</name><affiliation><nlm:affiliation>Janssen Infectious Diseases BVBA, Beerse, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Janssen, Katrien" sort="Janssen, Katrien" uniqKey="Janssen K" first="Katrien" last="Janssen">Katrien Janssen</name><affiliation><nlm:affiliation>Janssen Infectious Diseases BVBA, Beerse, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Ouwerkerk Mahadevan, Sivi" sort="Ouwerkerk Mahadevan, Sivi" uniqKey="Ouwerkerk Mahadevan S" first="Sivi" last="Ouwerkerk-Mahadevan">Sivi Ouwerkerk-Mahadevan</name><affiliation><nlm:affiliation>Janssen Infectious Diseases BVBA, Beerse, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Witek, James" sort="Witek, James" uniqKey="Witek J" first="James" last="Witek">James Witek</name><affiliation><nlm:affiliation>Janssen Research & Development LLC, Titusville, NJ, USA jwitek@its.jnj.com.</nlm:affiliation></affiliation></author><author><name sortKey="Gonzalez Garcia, Juan" sort="Gonzalez Garcia, Juan" uniqKey="Gonzalez Garcia J" first="Juan" last="González-García">Juan González-García</name><affiliation><nlm:affiliation>Servicio de Medicina Interna, Unidad de VIH, IdiPAZ, Hospital Universitario La Paz, Madrid, Spain.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:26483516</idno><idno type="pmid">26483516</idno><idno type="doi">10.1093/jac/dkv323</idno><idno type="wicri:Area/PubMed/Corpus">002538</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002538</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Telaprevir-based therapy in patients coinfected with chronic hepatitis C virus infection and HIV: INSIGHT study.</title><author><name sortKey="Montes, Maria Luisa" sort="Montes, Maria Luisa" uniqKey="Montes M" first="Maria Luisa" last="Montes">Maria Luisa Montes</name><affiliation><nlm:affiliation>Servicio de Medicina Interna, Unidad de VIH, IdiPAZ, Hospital Universitario La Paz, Madrid, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Nelson, Mark" sort="Nelson, Mark" uniqKey="Nelson M" first="Mark" last="Nelson">Mark Nelson</name><affiliation><nlm:affiliation>Chelsea and Westminster Hospital, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Girard, Pierre Marie" sort="Girard, Pierre Marie" uniqKey="Girard P" first="Pierre-Marie" last="Girard">Pierre-Marie Girard</name><affiliation><nlm:affiliation>Hôpital St Antoine and INSERM, UMR S1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Sasadeusz, Joe" sort="Sasadeusz, Joe" uniqKey="Sasadeusz J" first="Joe" last="Sasadeusz">Joe Sasadeusz</name><affiliation><nlm:affiliation>Victorian Infectious Diseases Service, Royal Melbourne Hospital, Melbourne, Victoria, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Horban, Andrzej" sort="Horban, Andrzej" uniqKey="Horban A" first="Andrzej" last="Horban">Andrzej Horban</name><affiliation><nlm:affiliation>Warsaw Medical University and Hospital of Infectious Diseases, Warsaw, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Grinsztejn, Beatriz" sort="Grinsztejn, Beatriz" uniqKey="Grinsztejn B" first="Beatriz" last="Grinsztejn">Beatriz Grinsztejn</name><affiliation><nlm:affiliation>STD/AIDS Clinical Research Laboratory, Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro, Brazil.</nlm:affiliation></affiliation></author><author><name sortKey="Zakharova, Natalia" sort="Zakharova, Natalia" uniqKey="Zakharova N" first="Natalia" last="Zakharova">Natalia Zakharova</name><affiliation><nlm:affiliation>Saint-Petersburg AIDS Center, St Petersburg, Russian Federation.</nlm:affiliation></affiliation></author><author><name sortKey="Rivero, Antonio" sort="Rivero, Antonio" uniqKey="Rivero A" first="Antonio" last="Rivero">Antonio Rivero</name><affiliation><nlm:affiliation>Unidad de Enfermedades Infecciosas, Hospital Universitario Reina Sofía/IMIBIC, Córdoba, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Durant, Jacques" sort="Durant, Jacques" uniqKey="Durant J" first="Jacques" last="Durant">Jacques Durant</name><affiliation><nlm:affiliation>Infectious Diseases Department, L'Archet Hospital, University of Nice, Nice, France.</nlm:affiliation></affiliation></author><author><name sortKey="Ortega Gonzalez, Enrique" sort="Ortega Gonzalez, Enrique" uniqKey="Ortega Gonzalez E" first="Enrique" last="Ortega-Gonzalez">Enrique Ortega-Gonzalez</name><affiliation><nlm:affiliation>Unidad de Enfermedades Infecciosas, Hospital General Universitario, Valencia, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Lathouwers, Erkki" sort="Lathouwers, Erkki" uniqKey="Lathouwers E" first="Erkki" last="Lathouwers">Erkki Lathouwers</name><affiliation><nlm:affiliation>Janssen Infectious Diseases BVBA, Beerse, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Janssen, Katrien" sort="Janssen, Katrien" uniqKey="Janssen K" first="Katrien" last="Janssen">Katrien Janssen</name><affiliation><nlm:affiliation>Janssen Infectious Diseases BVBA, Beerse, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Ouwerkerk Mahadevan, Sivi" sort="Ouwerkerk Mahadevan, Sivi" uniqKey="Ouwerkerk Mahadevan S" first="Sivi" last="Ouwerkerk-Mahadevan">Sivi Ouwerkerk-Mahadevan</name><affiliation><nlm:affiliation>Janssen Infectious Diseases BVBA, Beerse, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Witek, James" sort="Witek, James" uniqKey="Witek J" first="James" last="Witek">James Witek</name><affiliation><nlm:affiliation>Janssen Research & Development LLC, Titusville, NJ, USA jwitek@its.jnj.com.</nlm:affiliation></affiliation></author><author><name sortKey="Gonzalez Garcia, Juan" sort="Gonzalez Garcia, Juan" uniqKey="Gonzalez Garcia J" first="Juan" last="González-García">Juan González-García</name><affiliation><nlm:affiliation>Servicio de Medicina Interna, Unidad de VIH, IdiPAZ, Hospital Universitario La Paz, Madrid, Spain.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The Journal of antimicrobial chemotherapy</title><idno type="eISSN">1460-2091</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Antiviral Agents (administration & dosage)</term><term>Antiviral Agents (adverse effects)</term><term>Antiviral Agents (pharmacokinetics)</term><term>Coinfection (drug therapy)</term><term>Drug-Related Side Effects and Adverse Reactions (epidemiology)</term><term>Drug-Related Side Effects and Adverse Reactions (pathology)</term><term>Female</term><term>HIV Infections (complications)</term><term>HIV Infections (drug therapy)</term><term>Hepatitis C, Chronic (complications)</term><term>Hepatitis C, Chronic (drug therapy)</term><term>Humans</term><term>Interferon-alpha (administration & dosage)</term><term>Interferon-alpha (adverse effects)</term><term>Interferon-alpha (pharmacokinetics)</term><term>Male</term><term>Middle Aged</term><term>Oligopeptides (administration & dosage)</term><term>Oligopeptides (adverse effects)</term><term>Oligopeptides (pharmacokinetics)</term><term>Polyethylene Glycols (administration & dosage)</term><term>Polyethylene Glycols (adverse effects)</term><term>Polyethylene Glycols (pharmacokinetics)</term><term>Recombinant Proteins (administration & dosage)</term><term>Recombinant Proteins (adverse effects)</term><term>Recombinant Proteins (pharmacokinetics)</term><term>Ribavirin (administration & dosage)</term><term>Ribavirin (adverse effects)</term><term>Ribavirin (pharmacokinetics)</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiviral Agents</term><term>Interferon-alpha</term><term>Oligopeptides</term><term>Polyethylene Glycols</term><term>Recombinant Proteins</term><term>Ribavirin</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiviral Agents</term><term>Interferon-alpha</term><term>Oligopeptides</term><term>Polyethylene Glycols</term><term>Recombinant Proteins</term><term>Ribavirin</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en"><term>Antiviral Agents</term><term>Interferon-alpha</term><term>Oligopeptides</term><term>Polyethylene Glycols</term><term>Recombinant Proteins</term><term>Ribavirin</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>HIV Infections</term><term>Hepatitis C, Chronic</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Coinfection</term><term>HIV Infections</term><term>Hepatitis C, Chronic</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">INSIGHT (ClinicalTrials.gov NCT01513941) evaluated the efficacy, safety and pharmacokinetics of telaprevir-based therapy and specific antiretroviral agents in hepatitis C virus genotype 1 (HCV-1)/HIV-1-coinfected patients.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26483516</PMID><DateCreated><Year>2015</Year><Month>12</Month><Day>17</Day></DateCreated><DateCompleted><Year>2016</Year><Month>10</Month><Day>05</Day></DateCompleted><DateRevised><Year>2017</Year><Month>01</Month><Day>03</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1460-2091</ISSN><JournalIssue CitedMedium="Internet"><Volume>71</Volume><Issue>1</Issue><PubDate><Year>2016</Year><Month>Jan</Month></PubDate></JournalIssue><Title>The Journal of antimicrobial chemotherapy</Title><ISOAbbreviation>J. Antimicrob. Chemother.</ISOAbbreviation></Journal><ArticleTitle>Telaprevir-based therapy in patients coinfected with chronic hepatitis C virus infection and HIV: INSIGHT study.</ArticleTitle><Pagination><MedlinePgn>244-50</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1093/jac/dkv323</ELocationID><Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">INSIGHT (ClinicalTrials.gov NCT01513941) evaluated the efficacy, safety and pharmacokinetics of telaprevir-based therapy and specific antiretroviral agents in hepatitis C virus genotype 1 (HCV-1)/HIV-1-coinfected patients.</AbstractText><AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS">Open-label, Phase IIIb, multicentre study of telaprevir with pegylated-IFN (Peg-IFN) α2a and ribavirin in treatment-naive or -experienced HCV-1/HIV-1-coinfected patients on stable HIV HAART comprising efavirenz, atazanavir/ritonavir, darunavir/ritonavir, raltegravir, etravirine or rilpivirine with two nucleos(t)ide analogues. Patients received 750 mg telaprevir (1125 mg, if on efavirenz) every 8 h plus 180 μg/week Peg-IFNα2a and 800 mg/day ribavirin for 12 weeks, followed by Peg-IFNα2a and ribavirin alone for 12 weeks (HCV treatment naive and relapsers without cirrhosis, with extended rapid virological response) or 36 weeks (all others).</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Overall, 162 patients (median age of 46 years, 78% male, 92% Caucasian and mean CD4 count of 687 cells/mm(3)) were treated; 13% had cirrhosis. One-hundred-and-thirty-two patients (81%) completed telaprevir; 14 (9%) discontinued due to an adverse event (AE). Sustained virological response (SVR) 12 rates (<25 IU/mL HCV RNA 12 weeks after the last planned treatment dose) in treatment-naive patients, relapsers and non-responders were 64% (41 of 64), 62% (18 of 29) and 49% (34 of 69), respectively. SVR12 rates ranged from 51% (33 of 65) (patients receiving efavirenz) to 77% (13 of 17) (patients receiving raltegravir). Most frequently reported AEs during telaprevir treatment were pruritus (43%) and rash (34%) special search categories. Anaemia special search category occurred in 15% of patients; 6% of patients reported a serious AE.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">In treatment-naive/-experienced HCV-1/HIV-1 patients there were significantly higher SVR rates with telaprevir-based therapy compared with pre-specified historical controls, and safety comparable to that in HCV-monoinfected patients.</AbstractText><CopyrightInformation>© The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Montes</LastName><ForeName>Maria Luisa</ForeName><Initials>ML</Initials><AffiliationInfo><Affiliation>Servicio de Medicina Interna, Unidad de VIH, IdiPAZ, Hospital Universitario La Paz, Madrid, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nelson</LastName><ForeName>Mark</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Chelsea and Westminster Hospital, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Girard</LastName><ForeName>Pierre-Marie</ForeName><Initials>PM</Initials><AffiliationInfo><Affiliation>Hôpital St Antoine and INSERM, UMR S1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sasadeusz</LastName><ForeName>Joe</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Victorian Infectious Diseases Service, Royal Melbourne Hospital, Melbourne, Victoria, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Horban</LastName><ForeName>Andrzej</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Warsaw Medical University and Hospital of Infectious Diseases, Warsaw, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Grinsztejn</LastName><ForeName>Beatriz</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>STD/AIDS Clinical Research Laboratory, Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zakharova</LastName><ForeName>Natalia</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Saint-Petersburg AIDS Center, St Petersburg, Russian Federation.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rivero</LastName><ForeName>Antonio</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Unidad de Enfermedades Infecciosas, Hospital Universitario Reina Sofía/IMIBIC, Córdoba, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Durant</LastName><ForeName>Jacques</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Infectious Diseases Department, L'Archet Hospital, University of Nice, Nice, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ortega-Gonzalez</LastName><ForeName>Enrique</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Unidad de Enfermedades Infecciosas, Hospital General Universitario, Valencia, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lathouwers</LastName><ForeName>Erkki</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Janssen Infectious Diseases BVBA, Beerse, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Janssen</LastName><ForeName>Katrien</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Janssen Infectious Diseases BVBA, Beerse, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ouwerkerk-Mahadevan</LastName><ForeName>Sivi</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Janssen Infectious Diseases BVBA, Beerse, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Witek</LastName><ForeName>James</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Janssen Research & Development LLC, Titusville, NJ, USA jwitek@its.jnj.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>González-García</LastName><ForeName>Juan</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Servicio de Medicina Interna, Unidad de VIH, IdiPAZ, Hospital Universitario La Paz, Madrid, Spain.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01513941</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="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>10</Month><Day>19</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>J Antimicrob Chemother</MedlineTA><NlmUniqueID>7513617</NlmUniqueID><ISSNLinking>0305-7453</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D016898">Interferon-alpha</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D009842">Oligopeptides</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011994">Recombinant Proteins</NameOfSubstance></Chemical><Chemical><RegistryNumber>30IQX730WE</RegistryNumber><NameOfSubstance UI="D011092">Polyethylene Glycols</NameOfSubstance></Chemical><Chemical><RegistryNumber>49717AWG6K</RegistryNumber><NameOfSubstance UI="D012254">Ribavirin</NameOfSubstance></Chemical><Chemical><RegistryNumber>655M5O3W0U</RegistryNumber><NameOfSubstance UI="C486464">telaprevir</NameOfSubstance></Chemical><Chemical><RegistryNumber>Q46947FE7K</RegistryNumber><NameOfSubstance UI="C100416">peginterferon alfa-2a</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName 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