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Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study.

Identifieur interne : 004334 ( Ncbi/Curation ); précédent : 004333; suivant : 004335

Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study.

Auteurs : Mark S. Sulkowski [États-Unis] ; Walford J. Fessel [États-Unis] ; Adriano Lazzarin [Italie] ; Juan Berenguer [Espagne] ; Natalia Zakharova [Russie] ; Hugo Cheinquer [Brésil] ; Pierre Côté [Canada] ; Douglas Dieterich [États-Unis] ; Adrian Gadano [Argentine] ; Gail Matthews [Australie] ; Jean-Michel Molina [France] ; Christophe Moreno [Belgique] ; Juan Antonio Pineda [Espagne] ; Federico Pulido [Espagne] ; Antonio Rivero [Espagne] ; Jurgen Rockstroh [Allemagne] ; Dennis Hernandez [États-Unis] ; Fiona Mcphee [États-Unis] ; Timothy Eley [États-Unis] ; Zhaohui Liu [États-Unis] ; Patricia Mendez [États-Unis] ; Eric Hughes [États-Unis] ; Stephanie Noviello [États-Unis] ; Peter Ackerman [États-Unis]

Source :

RBID : pubmed:28210927

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English descriptors

Abstract

Daclatasvir (DCV) is a potent, pangenotypic, hepatitis C virus (HCV) non-structural protein 5A inhibitor with low potential for drug interactions with antiretroviral therapy (ART). We evaluated the safety and efficacy of DCV plus peginterferon alfa-2a/ribavirin (PegIFN/RBV) in HIV-1/HCV genotype-1-coinfected patients.

DOI: 10.1007/s12072-017-9788-z
PubMed: 28210927

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pubmed:28210927

Le document en format XML

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<name sortKey="Zakharova, Natalia" sort="Zakharova, Natalia" uniqKey="Zakharova N" first="Natalia" last="Zakharova">Natalia Zakharova</name>
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<name sortKey="Cheinquer, Hugo" sort="Cheinquer, Hugo" uniqKey="Cheinquer H" first="Hugo" last="Cheinquer">Hugo Cheinquer</name>
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<nlm:affiliation>Servico De Gastroentereologia, Hospital De Clinicas De Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil.</nlm:affiliation>
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<name sortKey="Cote, Pierre" sort="Cote, Pierre" uniqKey="Cote P" first="Pierre" last="Côté">Pierre Côté</name>
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<nlm:affiliation>Clinique Medicale Du Quartier Latin, Montreal, QC, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
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<name sortKey="Dieterich, Douglas" sort="Dieterich, Douglas" uniqKey="Dieterich D" first="Douglas" last="Dieterich">Douglas Dieterich</name>
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<name sortKey="Gadano, Adrian" sort="Gadano, Adrian" uniqKey="Gadano A" first="Adrian" last="Gadano">Adrian Gadano</name>
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<nlm:affiliation>Hospital Italiano De Buenos Aires, Buenos Aires, Argentina.</nlm:affiliation>
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<name sortKey="Matthews, Gail" sort="Matthews, Gail" uniqKey="Matthews G" first="Gail" last="Matthews">Gail Matthews</name>
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<nlm:affiliation>St Vincent's Hospital (NSW), Darlinghurst, NSW, Australia.</nlm:affiliation>
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<name sortKey="Molina, Jean Michel" sort="Molina, Jean Michel" uniqKey="Molina J" first="Jean-Michel" last="Molina">Jean-Michel Molina</name>
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<nlm:affiliation>Hopital Saint Louis, Paris, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
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<region type="region">Île-de-France</region>
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<name sortKey="Moreno, Christophe" sort="Moreno, Christophe" uniqKey="Moreno C" first="Christophe" last="Moreno">Christophe Moreno</name>
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<nlm:affiliation>Hospital Erasme, Brussels, Belgium.</nlm:affiliation>
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<name sortKey="Pineda, Juan Antonio" sort="Pineda, Juan Antonio" uniqKey="Pineda J" first="Juan Antonio" last="Pineda">Juan Antonio Pineda</name>
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<nlm:affiliation>Infectious Diseases and Microbiology Unit, Hospital Universitario de Valme, Seville, Spain.</nlm:affiliation>
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<wicri:noRegion>Seville</wicri:noRegion>
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<name sortKey="Pulido, Federico" sort="Pulido, Federico" uniqKey="Pulido F" first="Federico" last="Pulido">Federico Pulido</name>
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<nlm:affiliation>Hospital Universitario 12 De Octubre, Madrid, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Hospital Universitario 12 De Octubre, Madrid</wicri:regionArea>
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<name sortKey="Rivero, Antonio" sort="Rivero, Antonio" uniqKey="Rivero A" first="Antonio" last="Rivero">Antonio Rivero</name>
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<nlm:affiliation>Hospital Universitario Reina Sofia, Cordoba, Spain.</nlm:affiliation>
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<wicri:regionArea>Hospital Universitario Reina Sofia, Cordoba</wicri:regionArea>
<wicri:noRegion>Cordoba</wicri:noRegion>
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<name sortKey="Rockstroh, Jurgen" sort="Rockstroh, Jurgen" uniqKey="Rockstroh J" first="Jurgen" last="Rockstroh">Jurgen Rockstroh</name>
<affiliation wicri:level="3">
<nlm:affiliation>Universitaetsklinikum Bonn, Medizinische Klinik, Bonn, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Universitaetsklinikum Bonn, Medizinische Klinik, Bonn</wicri:regionArea>
<placeName>
<region type="land" nuts="1">Rhénanie-du-Nord-Westphalie</region>
<region type="district" nuts="2">District de Cologne</region>
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<author>
<name sortKey="Hernandez, Dennis" sort="Hernandez, Dennis" uniqKey="Hernandez D" first="Dennis" last="Hernandez">Dennis Hernandez</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Virology Discovery Biology, Bristol-Myers Squibb Research and Development, Wallingford, CT, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Virology Discovery Biology, Bristol-Myers Squibb Research and Development, Wallingford, CT</wicri:regionArea>
<placeName>
<region type="state">Connecticut</region>
</placeName>
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<author>
<name sortKey="Mcphee, Fiona" sort="Mcphee, Fiona" uniqKey="Mcphee F" first="Fiona" last="Mcphee">Fiona Mcphee</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Virology Discovery Biology, Bristol-Myers Squibb Research and Development, Wallingford, CT, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Virology Discovery Biology, Bristol-Myers Squibb Research and Development, Wallingford, CT</wicri:regionArea>
<placeName>
<region type="state">Connecticut</region>
</placeName>
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<author>
<name sortKey="Eley, Timothy" sort="Eley, Timothy" uniqKey="Eley T" first="Timothy" last="Eley">Timothy Eley</name>
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<nlm:affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Bristol-Myers Squibb, Princeton, NJ</wicri:regionArea>
<placeName>
<region type="state">New Jersey</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Liu, Zhaohui" sort="Liu, Zhaohui" uniqKey="Liu Z" first="Zhaohui" last="Liu">Zhaohui Liu</name>
<affiliation wicri:level="2">
<nlm:affiliation>Bristol-Myers Squibb, Hopewell, Pennington, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
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<region type="state">New Jersey</region>
</placeName>
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<author>
<name sortKey="Mendez, Patricia" sort="Mendez, Patricia" uniqKey="Mendez P" first="Patricia" last="Mendez">Patricia Mendez</name>
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<nlm:affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
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<placeName>
<region type="state">New Jersey</region>
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<author>
<name sortKey="Hughes, Eric" sort="Hughes, Eric" uniqKey="Hughes E" first="Eric" last="Hughes">Eric Hughes</name>
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<nlm:affiliation>Bristol-Myers Squibb, Lawrenceville, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
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<region type="state">New Jersey</region>
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<author>
<name sortKey="Noviello, Stephanie" sort="Noviello, Stephanie" uniqKey="Noviello S" first="Stephanie" last="Noviello">Stephanie Noviello</name>
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<nlm:affiliation>Bristol-Myers Squibb, Lawrenceville, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Bristol-Myers Squibb, Lawrenceville, NJ</wicri:regionArea>
<placeName>
<region type="state">New Jersey</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Ackerman, Peter" sort="Ackerman, Peter" uniqKey="Ackerman P" first="Peter" last="Ackerman">Peter Ackerman</name>
<affiliation wicri:level="2">
<nlm:affiliation>Bristol-Myers Squibb, Wallingford, CT, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Bristol-Myers Squibb, Wallingford, CT</wicri:regionArea>
<placeName>
<region type="state">Connecticut</region>
</placeName>
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<title xml:lang="en">Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study.</title>
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<name sortKey="Sulkowski, Mark S" sort="Sulkowski, Mark S" uniqKey="Sulkowski M" first="Mark S" last="Sulkowski">Mark S. Sulkowski</name>
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<country xml:lang="fr">États-Unis</country>
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<nlm:affiliation>Kaiser Permanente San Francisco Medical Center, San Francisco, CA, USA.</nlm:affiliation>
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<name sortKey="Lazzarin, Adriano" sort="Lazzarin, Adriano" uniqKey="Lazzarin A" first="Adriano" last="Lazzarin">Adriano Lazzarin</name>
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<nlm:affiliation>Unit of Infectious Diseases, Clinica Malattie Infettive, Institute of Hospitalisation and Scientific Care, Milan, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
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<settlement type="city">Milan</settlement>
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<name sortKey="Berenguer, Juan" sort="Berenguer, Juan" uniqKey="Berenguer J" first="Juan" last="Berenguer">Juan Berenguer</name>
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<nlm:affiliation>Unidad de Enfermedades Infecciosas/VIH (4100), Instituto de Investigación Sanitaria Gregorio Marañón, Hospital General Universitario Gregorio Marañón, Madrid, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
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<settlement type="city">Madrid</settlement>
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</affiliation>
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<author>
<name sortKey="Zakharova, Natalia" sort="Zakharova, Natalia" uniqKey="Zakharova N" first="Natalia" last="Zakharova">Natalia Zakharova</name>
<affiliation wicri:level="1">
<nlm:affiliation>St Petersburg AIDS Center, SPT AIDS C 179A OBVODNIY CANAL, Saint Petersburg, Russian Federation.</nlm:affiliation>
<country xml:lang="fr">Russie</country>
<wicri:regionArea>St Petersburg AIDS Center, SPT AIDS C 179A OBVODNIY CANAL, Saint Petersburg</wicri:regionArea>
<wicri:noRegion>Saint Petersburg</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Cheinquer, Hugo" sort="Cheinquer, Hugo" uniqKey="Cheinquer H" first="Hugo" last="Cheinquer">Hugo Cheinquer</name>
<affiliation wicri:level="1">
<nlm:affiliation>Servico De Gastroentereologia, Hospital De Clinicas De Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil.</nlm:affiliation>
<country xml:lang="fr">Brésil</country>
<wicri:regionArea>Servico De Gastroentereologia, Hospital De Clinicas De Porto Alegre, Porto Alegre, Rio Grande Do Sul</wicri:regionArea>
<wicri:noRegion>Rio Grande Do Sul</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Cote, Pierre" sort="Cote, Pierre" uniqKey="Cote P" first="Pierre" last="Côté">Pierre Côté</name>
<affiliation wicri:level="1">
<nlm:affiliation>Clinique Medicale Du Quartier Latin, Montreal, QC, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Clinique Medicale Du Quartier Latin, Montreal, QC</wicri:regionArea>
<wicri:noRegion>QC</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Dieterich, Douglas" sort="Dieterich, Douglas" uniqKey="Dieterich D" first="Douglas" last="Dieterich">Douglas Dieterich</name>
<affiliation wicri:level="2">
<nlm:affiliation>Institute for Liver Disease, Mount Sinai School of Medicine, New York, NY, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Institute for Liver Disease, Mount Sinai School of Medicine, New York, NY</wicri:regionArea>
<placeName>
<region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Gadano, Adrian" sort="Gadano, Adrian" uniqKey="Gadano A" first="Adrian" last="Gadano">Adrian Gadano</name>
<affiliation wicri:level="1">
<nlm:affiliation>Hospital Italiano De Buenos Aires, Buenos Aires, Argentina.</nlm:affiliation>
<country xml:lang="fr">Argentine</country>
<wicri:regionArea>Hospital Italiano De Buenos Aires, Buenos Aires</wicri:regionArea>
<wicri:noRegion>Buenos Aires</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Matthews, Gail" sort="Matthews, Gail" uniqKey="Matthews G" first="Gail" last="Matthews">Gail Matthews</name>
<affiliation wicri:level="1">
<nlm:affiliation>St Vincent's Hospital (NSW), Darlinghurst, NSW, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>St Vincent's Hospital (NSW), Darlinghurst, NSW</wicri:regionArea>
<wicri:noRegion>NSW</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Molina, Jean Michel" sort="Molina, Jean Michel" uniqKey="Molina J" first="Jean-Michel" last="Molina">Jean-Michel Molina</name>
<affiliation wicri:level="3">
<nlm:affiliation>Hopital Saint Louis, Paris, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Hopital Saint Louis, Paris</wicri:regionArea>
<placeName>
<region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Moreno, Christophe" sort="Moreno, Christophe" uniqKey="Moreno C" first="Christophe" last="Moreno">Christophe Moreno</name>
<affiliation wicri:level="3">
<nlm:affiliation>Hospital Erasme, Brussels, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Hospital Erasme, Brussels</wicri:regionArea>
<placeName>
<settlement type="city">Bruxelles</settlement>
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<name sortKey="Rivero, Antonio" sort="Rivero, Antonio" uniqKey="Rivero A" first="Antonio" last="Rivero">Antonio Rivero</name>
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<region type="state">Connecticut</region>
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<name sortKey="Mcphee, Fiona" sort="Mcphee, Fiona" uniqKey="Mcphee F" first="Fiona" last="Mcphee">Fiona Mcphee</name>
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<name sortKey="Eley, Timothy" sort="Eley, Timothy" uniqKey="Eley T" first="Timothy" last="Eley">Timothy Eley</name>
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<name sortKey="Liu, Zhaohui" sort="Liu, Zhaohui" uniqKey="Liu Z" first="Zhaohui" last="Liu">Zhaohui Liu</name>
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<name sortKey="Mendez, Patricia" sort="Mendez, Patricia" uniqKey="Mendez P" first="Patricia" last="Mendez">Patricia Mendez</name>
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<name sortKey="Noviello, Stephanie" sort="Noviello, Stephanie" uniqKey="Noviello S" first="Stephanie" last="Noviello">Stephanie Noviello</name>
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<author>
<name sortKey="Ackerman, Peter" sort="Ackerman, Peter" uniqKey="Ackerman P" first="Peter" last="Ackerman">Peter Ackerman</name>
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<series>
<title level="j">Hepatology international</title>
<idno type="eISSN">1936-0541</idno>
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<date when="2017" type="published">2017</date>
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<term>Antiviral Agents (adverse effects)</term>
<term>Antiviral Agents (therapeutic use)</term>
<term>Coinfection (drug therapy)</term>
<term>Coinfection (virology)</term>
<term>Drug Therapy, Combination</term>
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<term>Hepacivirus (genetics)</term>
<term>Hepatitis C, Chronic (complications)</term>
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<term>Male</term>
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<term>Recombinant Proteins (adverse effects)</term>
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<term>Interféron alpha (effets indésirables)</term>
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<term>Co-infection</term>
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<term>Adulte d'âge moyen</term>
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<front>
<div type="abstract" xml:lang="en">Daclatasvir (DCV) is a potent, pangenotypic, hepatitis C virus (HCV) non-structural protein 5A inhibitor with low potential for drug interactions with antiretroviral therapy (ART). We evaluated the safety and efficacy of DCV plus peginterferon alfa-2a/ribavirin (PegIFN/RBV) in HIV-1/HCV genotype-1-coinfected patients.</div>
</front>
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