AustralieFrV1, Main, Exploration, bibRecord, 000D38

Elbasvir/Grazoprevir for Patients With Hepatitis C Virus Infection and Inherited Blood Disorders: A Phase III Study.

Identifieur interne : 000D38 ( Main/Exploration ); précédent : 000D37; suivant : 000D39

Elbasvir/Grazoprevir for Patients With Hepatitis C Virus Infection and Inherited Blood Disorders: A Phase III Study.

Auteurs : Christophe Hézode [France] ; Massimo Colombo [Italie] ; Marc Bourlière [France] ; Ulrich Spengler [Allemagne] ; Ziv Ben-Ari [Israël] ; Simone I. Strasser [Australie] ; William M. Lee [États-Unis] ; Leslie Morgan [États-Unis] ; Jingjun Qiu [États-Unis] ; Peggy Hwang [États-Unis] ; Michael Robertson [États-Unis] ; Bach-Yen Nguyen [États-Unis] ; Eliav Barr [États-Unis] ; Janice Wahl [États-Unis] ; Barbara Haber [États-Unis] ; Robert Chase [États-Unis] ; Rohit Talwani [États-Unis] ; Vito Di Marco [Italie]

Source :

Hepatology (Baltimore, Md.) [ 1527-3350 ] ; 2017.

RBID : pubmed:28256747

Descripteurs français

English descriptors

KwdEn :
- Administration, Oral, Adult, Benzofurans (administration & dosage), Biopsy, Needle, Blood Coagulation Disorders, Inherited (complications), Blood Coagulation Disorders, Inherited (diagnosis), Blood Coagulation Disorders, Inherited (drug therapy), Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Therapy, Combination, Female, Follow-Up Studies, Hepacivirus (drug effects), Hepatitis C, Chronic (complications), Hepatitis C, Chronic (diagnosis), Hepatitis C, Chronic (drug therapy), Humans, Imidazoles (administration & dosage), Immunohistochemistry, Liver Function Tests, Male, Middle Aged, Quinoxalines (administration & dosage), Reference Values, Severity of Illness Index, Treatment Outcome.
MESH :
- chemical , administration & dosage : Benzofurans, Imidazoles, Quinoxalines.
- complications : Blood Coagulation Disorders, Inherited, Hepatitis C, Chronic.
- diagnosis : Blood Coagulation Disorders, Inherited, Hepatitis C, Chronic.
- drug effects : Hepacivirus.
- drug therapy : Blood Coagulation Disorders, Inherited, Hepatitis C, Chronic.
- Administration, Oral, Adult, Biopsy, Needle, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Immunohistochemistry, Liver Function Tests, Male, Middle Aged, Reference Values, Severity of Illness Index, Treatment Outcome.

Abstract

Direct-acting antiviral agents have not been studied exclusively in patients with inherited blood disorders and hepatitis C virus (HCV) infection. The objective of the randomized, placebo-controlled, phase III C-EDGE IBLD study was to assess the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) in patients with inherited bleeding disorders and HCV infection. One hundred fifty-nine adults with HCV infection and sickle cell anemia, thalassemia, or hemophilia A/B or von Willebrand disease were enrolled at 31 study sites in the United States, Europe, Australia, Canada, Israel, and Thailand. Patients were given an oral, once-daily, fixed-dose combination of EBR/GZR 50 mg/100 mg for 12 weeks and randomized to the immediate-treatment group (ITG) or deferred-treatment group (DTG; placebo followed by active treatment). The primary endpoints were the proportion of patients in the ITG with unquantifiable HCV RNA 12 weeks posttreatment (sustained virological response 12 weeks after completion of study treatment; SVR12) and the comparison of safety in the ITG and DTG. In the ITG, 100 of 107 patients (93.5%) achieved SVR12, 6 relapsed, and 1 was lost to follow-up. SVR12 was achieved in 94.7% (18 of 19), 97.6% (40 of 41), and 89.4% (42 of 47) of patients with sickle cell disease, β-thalassemia, and hemophilia A/B or von Willebrand disease, respectively. Serious adverse events were reported by 2.8% (n = 3) and 11.5% (n = 6) of patients in the ITG and DTG, respectively. Hemoglobin levels and international normalized ratio values were similar in patients receiving EBR/GZR and placebo; among patients with hemoglobinopathies, change in mean hemoglobin levels was similar in those receiving EBR/GZR compared to those receiving placebo.

DOI: 10.1002/hep.29139
PubMed: 28256747

Affiliations:

Le document en format XML

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<author><name sortKey="Marco, Vito Di" sort="Marco, Vito Di" uniqKey="Marco V" first="Vito Di" last="Marco">Vito Di Marco</name>
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<author><name sortKey="Qiu, Jingjun" sort="Qiu, Jingjun" uniqKey="Qiu J" first="Jingjun" last="Qiu">Jingjun Qiu</name>
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<author><name sortKey="Robertson, Michael" sort="Robertson, Michael" uniqKey="Robertson M" first="Michael" last="Robertson">Michael Robertson</name>
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<author><name sortKey="Nguyen, Bach Yen" sort="Nguyen, Bach Yen" uniqKey="Nguyen B" first="Bach-Yen" last="Nguyen">Bach-Yen Nguyen</name>
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<author><name sortKey="Barr, Eliav" sort="Barr, Eliav" uniqKey="Barr E" first="Eliav" last="Barr">Eliav Barr</name>
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<author><name sortKey="Wahl, Janice" sort="Wahl, Janice" uniqKey="Wahl J" first="Janice" last="Wahl">Janice Wahl</name>
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<author><name sortKey="Chase, Robert" sort="Chase, Robert" uniqKey="Chase R" first="Robert" last="Chase">Robert Chase</name>
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<author><name sortKey="Talwani, Rohit" sort="Talwani, Rohit" uniqKey="Talwani R" first="Rohit" last="Talwani">Rohit Talwani</name>
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<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Marco, Vito Di" sort="Marco, Vito Di" uniqKey="Marco V" first="Vito Di" last="Marco">Vito Di Marco</name>
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<series><title level="j">Hepatology (Baltimore, Md.)</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term>
<term>Adult</term>
<term>Benzofurans (administration & dosage)</term>
<term>Biopsy, Needle</term>
<term>Blood Coagulation Disorders, Inherited (complications)</term>
<term>Blood Coagulation Disorders, Inherited (diagnosis)</term>
<term>Blood Coagulation Disorders, Inherited (drug therapy)</term>
<term>Dose-Response Relationship, Drug</term>
<term>Drug Administration Schedule</term>
<term>Drug Therapy, Combination</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Hepacivirus (drug effects)</term>
<term>Hepatitis C, Chronic (complications)</term>
<term>Hepatitis C, Chronic (diagnosis)</term>
<term>Hepatitis C, Chronic (drug therapy)</term>
<term>Humans</term>
<term>Imidazoles (administration & dosage)</term>
<term>Immunohistochemistry</term>
<term>Liver Function Tests</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Quinoxalines (administration & dosage)</term>
<term>Reference Values</term>
<term>Severity of Illness Index</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Administration par voie orale</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Association de médicaments</term>
<term>Benzofuranes (administration et posologie)</term>
<term>Calendrier d'administration des médicaments</term>
<term>Femelle</term>
<term>Hepacivirus ()</term>
<term>Humains</term>
<term>Hépatite C chronique ()</term>
<term>Hépatite C chronique (diagnostic)</term>
<term>Hépatite C chronique (traitement médicamenteux)</term>
<term>Imidazoles (administration et posologie)</term>
<term>Immunohistochimie</term>
<term>Indice de gravité médicale</term>
<term>Mâle</term>
<term>Ponction-biopsie à l'aiguille</term>
<term>Quinoxalines (administration et posologie)</term>
<term>Relation dose-effet des médicaments</term>
<term>Résultat thérapeutique</term>
<term>Tests de la fonction hépatique</term>
<term>Troubles héréditaires de la coagulation sanguine ()</term>
<term>Troubles héréditaires de la coagulation sanguine (diagnostic)</term>
<term>Troubles héréditaires de la coagulation sanguine (traitement médicamenteux)</term>
<term>Valeurs de référence</term>
<term>Études de suivi</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Benzofurans</term>
<term>Imidazoles</term>
<term>Quinoxalines</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Benzofuranes</term>
<term>Imidazoles</term>
<term>Quinoxalines</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Blood Coagulation Disorders, Inherited</term>
<term>Hepatitis C, Chronic</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Blood Coagulation Disorders, Inherited</term>
<term>Hepatitis C, Chronic</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Hépatite C chronique</term>
<term>Troubles héréditaires de la coagulation sanguine</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>Blood Coagulation Disorders, Inherited</term>
<term>Hepatitis C, Chronic</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Hépatite C chronique</term>
<term>Troubles héréditaires de la coagulation sanguine</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term>
<term>Adult</term>
<term>Biopsy, Needle</term>
<term>Dose-Response Relationship, Drug</term>
<term>Drug Administration Schedule</term>
<term>Drug Therapy, Combination</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Immunohistochemistry</term>
<term>Liver Function Tests</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Reference Values</term>
<term>Severity of Illness Index</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Administration par voie orale</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Association de médicaments</term>
<term>Calendrier d'administration des médicaments</term>
<term>Femelle</term>
<term>Hepacivirus</term>
<term>Humains</term>
<term>Hépatite C chronique</term>
<term>Immunohistochimie</term>
<term>Indice de gravité médicale</term>
<term>Mâle</term>
<term>Ponction-biopsie à l'aiguille</term>
<term>Relation dose-effet des médicaments</term>
<term>Résultat thérapeutique</term>
<term>Tests de la fonction hépatique</term>
<term>Troubles héréditaires de la coagulation sanguine</term>
<term>Valeurs de référence</term>
<term>Études de suivi</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Direct-acting antiviral agents have not been studied exclusively in patients with inherited blood disorders and hepatitis C virus (HCV) infection. The objective of the randomized, placebo-controlled, phase III C-EDGE IBLD study was to assess the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) in patients with inherited bleeding disorders and HCV infection. One hundred fifty-nine adults with HCV infection and sickle cell anemia, thalassemia, or hemophilia A/B or von Willebrand disease were enrolled at 31 study sites in the United States, Europe, Australia, Canada, Israel, and Thailand. Patients were given an oral, once-daily, fixed-dose combination of EBR/GZR 50 mg/100 mg for 12 weeks and randomized to the immediate-treatment group (ITG) or deferred-treatment group (DTG; placebo followed by active treatment). The primary endpoints were the proportion of patients in the ITG with unquantifiable HCV RNA 12 weeks posttreatment (sustained virological response 12 weeks after completion of study treatment; SVR12) and the comparison of safety in the ITG and DTG. In the ITG, 100 of 107 patients (93.5%) achieved SVR12, 6 relapsed, and 1 was lost to follow-up. SVR12 was achieved in 94.7% (18 of 19), 97.6% (40 of 41), and 89.4% (42 of 47) of patients with sickle cell disease, β-thalassemia, and hemophilia A/B or von Willebrand disease, respectively. Serious adverse events were reported by 2.8% (n = 3) and 11.5% (n = 6) of patients in the ITG and DTG, respectively. Hemoglobin levels and international normalized ratio values were similar in patients receiving EBR/GZR and placebo; among patients with hemoglobinopathies, change in mean hemoglobin levels was similar in those receiving EBR/GZR compared to those receiving placebo.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>France</li>
<li>Israël</li>
<li>Italie</li>
<li>États-Unis</li>
</country>
<region><li>District de Cologne</li>
<li>New Jersey</li>
<li>Nouvelle-Galles du Sud</li>
<li>Provence-Alpes-Côte d'Azur</li>
<li>Rhénanie-du-Nord-Westphalie</li>
<li>Texas</li>
<li>Île-de-France</li>
</region>
<settlement><li>Bonn</li>
<li>Marseille</li>
<li>Paris</li>
<li>Sydney</li>
</settlement>
<orgName><li>Université de Sydney</li>
</orgName>
</list>
<tree><country name="France"><region name="Île-de-France"><name sortKey="Hezode, Christophe" sort="Hezode, Christophe" uniqKey="Hezode C" first="Christophe" last="Hézode">Christophe Hézode</name>
</region>
<name sortKey="Bourliere, Marc" sort="Bourliere, Marc" uniqKey="Bourliere M" first="Marc" last="Bourlière">Marc Bourlière</name>
</country>
<country name="Italie"><noRegion><name sortKey="Colombo, Massimo" sort="Colombo, Massimo" uniqKey="Colombo M" first="Massimo" last="Colombo">Massimo Colombo</name>
</noRegion>
<name sortKey="Marco, Vito Di" sort="Marco, Vito Di" uniqKey="Marco V" first="Vito Di" last="Marco">Vito Di Marco</name>
</country>
<country name="Allemagne"><region name="Rhénanie-du-Nord-Westphalie"><name sortKey="Spengler, Ulrich" sort="Spengler, Ulrich" uniqKey="Spengler U" first="Ulrich" last="Spengler">Ulrich Spengler</name>
</region>
</country>
<country name="Israël"><noRegion><name sortKey="Ben Ari, Ziv" sort="Ben Ari, Ziv" uniqKey="Ben Ari Z" first="Ziv" last="Ben-Ari">Ziv Ben-Ari</name>
</noRegion>
</country>
<country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Strasser, Simone I" sort="Strasser, Simone I" uniqKey="Strasser S" first="Simone I" last="Strasser">Simone I. Strasser</name>
</region>
</country>
<country name="États-Unis"><region name="Texas"><name sortKey="Lee, William M" sort="Lee, William M" uniqKey="Lee W" first="William M" last="Lee">William M. Lee</name>
</region>
<name sortKey="Barr, Eliav" sort="Barr, Eliav" uniqKey="Barr E" first="Eliav" last="Barr">Eliav Barr</name>
<name sortKey="Chase, Robert" sort="Chase, Robert" uniqKey="Chase R" first="Robert" last="Chase">Robert Chase</name>
<name sortKey="Haber, Barbara" sort="Haber, Barbara" uniqKey="Haber B" first="Barbara" last="Haber">Barbara Haber</name>
<name sortKey="Hwang, Peggy" sort="Hwang, Peggy" uniqKey="Hwang P" first="Peggy" last="Hwang">Peggy Hwang</name>
<name sortKey="Morgan, Leslie" sort="Morgan, Leslie" uniqKey="Morgan L" first="Leslie" last="Morgan">Leslie Morgan</name>
<name sortKey="Nguyen, Bach Yen" sort="Nguyen, Bach Yen" uniqKey="Nguyen B" first="Bach-Yen" last="Nguyen">Bach-Yen Nguyen</name>
<name sortKey="Qiu, Jingjun" sort="Qiu, Jingjun" uniqKey="Qiu J" first="Jingjun" last="Qiu">Jingjun Qiu</name>
<name sortKey="Robertson, Michael" sort="Robertson, Michael" uniqKey="Robertson M" first="Michael" last="Robertson">Michael Robertson</name>
<name sortKey="Talwani, Rohit" sort="Talwani, Rohit" uniqKey="Talwani R" first="Rohit" last="Talwani">Rohit Talwani</name>
<name sortKey="Wahl, Janice" sort="Wahl, Janice" uniqKey="Wahl J" first="Janice" last="Wahl">Janice Wahl</name>
</country>
</tree>
</affiliations>
</record>

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Elbasvir/Grazoprevir for Patients With Hepatitis C Virus Infection and Inherited Blood Disorders: A Phase III Study.

Elbasvir/Grazoprevir for Patients With Hepatitis C Virus Infection and Inherited Blood Disorders: A Phase III Study.

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