Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: A randomized phase III study (ALLY-3+).
Identifieur interne : 002131 ( Main/Exploration ); précédent : 002130; suivant : 002132Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: A randomized phase III study (ALLY-3+).
Auteurs : Vincent Leroy [France] ; Peter Angus [Australie] ; Jean-Pierre Bronowicki [France] ; Gregory J. Dore [Australie] ; Christophe Hezode [France] ; Stephen Pianko [Australie] ; Stanislas Pol [France] ; Katherine Stuart [Australie] ; Edmund Tse [Australie] ; Fiona Mcphee [États-Unis] ; Rafia Bhore [États-Unis] ; Maria Jesus Jimenez-Exposito [États-Unis] ; Alexander J. Thompson [Australie]Source :
- Hepatology (Baltimore, Md.) [ 1527-3350 ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Antiviraux (administration et posologie), Association de médicaments, Cirrhose du foie (étiologie), Femelle, Génotype, Hepacivirus (), Hepacivirus (génétique), Humains, Hépatite C chronique (), Hépatite C chronique (traitement médicamenteux), Hépatite C chronique (virologie), Imidazoles (administration et posologie), Imidazoles (effets indésirables), Mâle, Ribavirine (administration et posologie), Ribavirine (effets indésirables), Résistance virale aux médicaments, Sofosbuvir (administration et posologie), Sofosbuvir (effets indésirables), Sujet âgé.
- MESH :
- administration et posologie : Antiviraux, Imidazoles, Ribavirine, Sofosbuvir.
- effets indésirables : Imidazoles, Ribavirine, Sofosbuvir.
- génétique : Hepacivirus.
- traitement médicamenteux : Hépatite C chronique.
- virologie : Hépatite C chronique.
- étiologie : Cirrhose du foie.
- Adulte, Adulte d'âge moyen, Association de médicaments, Femelle, Génotype, Hepacivirus, Humains, Hépatite C chronique, Mâle, Résistance virale aux médicaments, Sujet âgé.
English descriptors
- KwdEn :
- Adult, Aged, Antiviral Agents (administration & dosage), Drug Resistance, Viral, Drug Therapy, Combination, Female, Genotype, Hepacivirus (classification), Hepacivirus (genetics), Hepatitis C, Chronic (complications), Hepatitis C, Chronic (drug therapy), Hepatitis C, Chronic (virology), Humans, Imidazoles (administration & dosage), Imidazoles (adverse effects), Liver Cirrhosis (etiology), Male, Middle Aged, Ribavirin (administration & dosage), Ribavirin (adverse effects), Sofosbuvir (administration & dosage), Sofosbuvir (adverse effects).
- MESH :
- chemical , administration & dosage : Antiviral Agents, Imidazoles, Ribavirin, Sofosbuvir.
- chemical , adverse effects : Imidazoles, Ribavirin, Sofosbuvir.
- classification : Hepacivirus.
- complications : Hepatitis C, Chronic.
- drug therapy : Hepatitis C, Chronic.
- etiology : Liver Cirrhosis.
- genetics : Hepacivirus.
- virology : Hepatitis C, Chronic.
- Adult, Aged, Drug Resistance, Viral, Drug Therapy, Combination, Female, Genotype, Humans, Male, Middle Aged.
Abstract
Patients with hepatitis C virus (HCV) genotype 3 infection, especially those with advanced liver disease, are a challenging population in urgent need of optimally effective therapies. The combination of daclatasvir (DCV; pangenotypic nonstructural protein 5A inhibitor) and sofosbuvir (SOF; nucleotide nonstructural protein 5B inhibitor) for 12 weeks previously showed high efficacy (96%) in noncirrhotic genotype 3 infection. The phase III ALLY-3+ study (N = 50) evaluated DCV-SOF with ribavirin (RBV) in treatment-naïve (n = 13) or treatment-experienced (n = 37) genotype 3-infected patients with advanced fibrosis (n = 14) or compensated cirrhosis (n = 36). Patients were randomized 1:1 to receive open-label DCV-SOF (60 + 400 mg daily) with weight-based RBV for 12 or 16 weeks. The primary endpoint was sustained virological response at post-treatment week 12 (SVR12). SVR12 (intention-to-treat) was 90% overall (45 of 50): 88% (21 of 24) in the 12-week (91% observed) and 92% (24 of 26) in the 16-week group. All patients with advanced fibrosis achieved SVR12. SVR12 in patients with cirrhosis was 86% overall (31 of 36): 83% (15 of 18) in the 12-week (88% observed) and 89% (16 of 18) in the 16-week group; for treatment-experienced patients with cirrhosis, these values were 87% (26 of 30), 88% (14 of 16; 93% observed), and 86% (12 of 14), respectively. One patient (12-week group) did not enter post-treatment follow-up (death unrelated to treatment). There were 4 relapses (2 per group) and no virological breakthroughs. The most common adverse events (AEs) were insomnia, fatigue, and headache. There were no discontinuations for AEs and no treatment-related serious AEs.
DOI: 10.1002/hep.28473
PubMed: 26822022
Affiliations:
- Australie, France, États-Unis
- Auvergne-Rhône-Alpes, Connecticut, Grand Est, Lorraine (région), New Jersey, Nouvelle-Galles du Sud, Rhône-Alpes, Victoria (État), Île-de-France
- Créteil, Grenoble, Melbourne, Nancy, Paris, Sydney
- Université de Lorraine, Université de Melbourne
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Le document en format XML
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Dore</name><affiliation wicri:level="3"><nlm:affiliation>St. Vincent's Hospital and Kirby Institute, UNSW Australia, Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>St. Vincent's Hospital and Kirby Institute, UNSW Australia, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Hezode, Christophe" sort="Hezode, Christophe" uniqKey="Hezode C" first="Christophe" last="Hezode">Christophe Hezode</name><affiliation wicri:level="3"><nlm:affiliation>CHU Henri Mondor, Créteil, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>CHU Henri Mondor, Créteil</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Créteil</settlement></placeName></affiliation></author><author><name sortKey="Pianko, Stephen" sort="Pianko, Stephen" uniqKey="Pianko S" first="Stephen" last="Pianko">Stephen Pianko</name><affiliation wicri:level="1"><nlm:affiliation>Monash Medical Centre, Clayton, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Monash Medical Centre, Clayton</wicri:regionArea><wicri:noRegion>Clayton</wicri:noRegion></affiliation></author><author><name sortKey="Pol, Stanislas" sort="Pol, Stanislas" uniqKey="Pol S" first="Stanislas" last="Pol">Stanislas Pol</name><affiliation wicri:level="3"><nlm:affiliation>Hôpital Cochin, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Cochin, 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="Stuart, Katherine" sort="Stuart, Katherine" uniqKey="Stuart K" first="Katherine" last="Stuart">Katherine Stuart</name><affiliation wicri:level="1"><nlm:affiliation>Gallipoli Medical Research Foundation, Greenslopes, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Gallipoli Medical Research Foundation, Greenslopes</wicri:regionArea><wicri:noRegion>Greenslopes</wicri:noRegion></affiliation></author><author><name sortKey="Tse, Edmund" sort="Tse, Edmund" uniqKey="Tse E" first="Edmund" last="Tse">Edmund Tse</name><affiliation wicri:level="1"><nlm:affiliation>South Australia Health, Adelaide, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>South Australia Health, Adelaide</wicri:regionArea><wicri:noRegion>Adelaide</wicri:noRegion></affiliation></author><author><name sortKey="Mcphee, Fiona" sort="Mcphee, Fiona" uniqKey="Mcphee F" first="Fiona" last="Mcphee">Fiona Mcphee</name><affiliation wicri:level="2"><nlm:affiliation>Bristol-Myers Squibb Research & Development, Wallingford, CT.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Connecticut</region></placeName><wicri:cityArea>Bristol-Myers Squibb Research & Development, Wallingford</wicri:cityArea></affiliation></author><author><name sortKey="Bhore, Rafia" sort="Bhore, Rafia" uniqKey="Bhore R" first="Rafia" last="Bhore">Rafia Bhore</name><affiliation wicri:level="2"><nlm:affiliation>Bristol-Myers Squibb Research & Development, Princeton, NJ.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">New Jersey</region></placeName><wicri:cityArea>Bristol-Myers Squibb Research & Development, Princeton</wicri:cityArea></affiliation></author><author><name sortKey="Jimenez Exposito, Maria Jesus" sort="Jimenez Exposito, Maria Jesus" uniqKey="Jimenez Exposito M" first="Maria Jesus" last="Jimenez-Exposito">Maria Jesus Jimenez-Exposito</name><affiliation wicri:level="2"><nlm:affiliation>Bristol-Myers Squibb Research & Development, Princeton, NJ.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">New Jersey</region></placeName><wicri:cityArea>Bristol-Myers Squibb Research & Development, Princeton</wicri:cityArea></affiliation></author><author><name sortKey="Thompson, Alexander J" sort="Thompson, Alexander J" uniqKey="Thompson A" first="Alexander J" last="Thompson">Alexander J. Thompson</name><affiliation wicri:level="4"><nlm:affiliation>St Vincent's Hospital and the University of Melbourne, Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>St Vincent's Hospital and the University of Melbourne, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region><settlement type="city">Melbourne</settlement></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author></analytic><series><title level="j">Hepatology (Baltimore, Md.)</title><idno type="eISSN">1527-3350</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>Aged</term><term>Antiviral Agents (administration & dosage)</term><term>Drug Resistance, Viral</term><term>Drug Therapy, Combination</term><term>Female</term><term>Genotype</term><term>Hepacivirus (classification)</term><term>Hepacivirus (genetics)</term><term>Hepatitis C, Chronic (complications)</term><term>Hepatitis C, Chronic (drug therapy)</term><term>Hepatitis C, Chronic (virology)</term><term>Humans</term><term>Imidazoles (administration & dosage)</term><term>Imidazoles (adverse effects)</term><term>Liver Cirrhosis (etiology)</term><term>Male</term><term>Middle Aged</term><term>Ribavirin (administration & dosage)</term><term>Ribavirin (adverse effects)</term><term>Sofosbuvir (administration & dosage)</term><term>Sofosbuvir (adverse effects)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Antiviraux (administration et posologie)</term><term>Association de médicaments</term><term>Cirrhose du foie (étiologie)</term><term>Femelle</term><term>Génotype</term><term>Hepacivirus ()</term><term>Hepacivirus (génétique)</term><term>Humains</term><term>Hépatite C chronique ()</term><term>Hépatite C chronique (traitement médicamenteux)</term><term>Hépatite C chronique (virologie)</term><term>Imidazoles (administration et posologie)</term><term>Imidazoles (effets indésirables)</term><term>Mâle</term><term>Ribavirine (administration et posologie)</term><term>Ribavirine (effets indésirables)</term><term>Résistance virale aux médicaments</term><term>Sofosbuvir (administration et posologie)</term><term>Sofosbuvir (effets indésirables)</term><term>Sujet âgé</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiviral Agents</term><term>Imidazoles</term><term>Ribavirin</term><term>Sofosbuvir</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Imidazoles</term><term>Ribavirin</term><term>Sofosbuvir</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Antiviraux</term><term>Imidazoles</term><term>Ribavirine</term><term>Sofosbuvir</term></keywords><keywords scheme="MESH" qualifier="classification" xml:lang="en"><term>Hepacivirus</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Hepatitis C, Chronic</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Hepatitis C, Chronic</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Imidazoles</term><term>Ribavirine</term><term>Sofosbuvir</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Liver Cirrhosis</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Hepacivirus</term></keywords><keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>Hepacivirus</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Hépatite C chronique</term></keywords><keywords scheme="MESH" qualifier="virologie" xml:lang="fr"><term>Hépatite C chronique</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Hepatitis C, Chronic</term></keywords><keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Cirrhose du foie</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Drug Resistance, Viral</term><term>Drug Therapy, Combination</term><term>Female</term><term>Genotype</term><term>Humans</term><term>Male</term><term>Middle Aged</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Association de médicaments</term><term>Femelle</term><term>Génotype</term><term>Hepacivirus</term><term>Humains</term><term>Hépatite C chronique</term><term>Mâle</term><term>Résistance virale aux médicaments</term><term>Sujet âgé</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Patients with hepatitis C virus (HCV) genotype 3 infection, especially those with advanced liver disease, are a challenging population in urgent need of optimally effective therapies. The combination of daclatasvir (DCV; pangenotypic nonstructural protein 5A inhibitor) and sofosbuvir (SOF; nucleotide nonstructural protein 5B inhibitor) for 12 weeks previously showed high efficacy (96%) in noncirrhotic genotype 3 infection. The phase III ALLY-3+ study (N = 50) evaluated DCV-SOF with ribavirin (RBV) in treatment-naïve (n = 13) or treatment-experienced (n = 37) genotype 3-infected patients with advanced fibrosis (n = 14) or compensated cirrhosis (n = 36). Patients were randomized 1:1 to receive open-label DCV-SOF (60 + 400 mg daily) with weight-based RBV for 12 or 16 weeks. The primary endpoint was sustained virological response at post-treatment week 12 (SVR12). SVR12 (intention-to-treat) was 90% overall (45 of 50): 88% (21 of 24) in the 12-week (91% observed) and 92% (24 of 26) in the 16-week group. All patients with advanced fibrosis achieved SVR12. SVR12 in patients with cirrhosis was 86% overall (31 of 36): 83% (15 of 18) in the 12-week (88% observed) and 89% (16 of 18) in the 16-week group; for treatment-experienced patients with cirrhosis, these values were 87% (26 of 30), 88% (14 of 16; 93% observed), and 86% (12 of 14), respectively. One patient (12-week group) did not enter post-treatment follow-up (death unrelated to treatment). There were 4 relapses (2 per group) and no virological breakthroughs. The most common adverse events (AEs) were insomnia, fatigue, and headache. There were no discontinuations for AEs and no treatment-related serious AEs.</div></front></TEI><affiliations><list><country><li>Australie</li><li>France</li><li>États-Unis</li></country><region><li>Auvergne-Rhône-Alpes</li><li>Connecticut</li><li>Grand Est</li><li>Lorraine (région)</li><li>New Jersey</li><li>Nouvelle-Galles du Sud</li><li>Rhône-Alpes</li><li>Victoria (État)</li><li>Île-de-France</li></region><settlement><li>Créteil</li><li>Grenoble</li><li>Melbourne</li><li>Nancy</li><li>Paris</li><li>Sydney</li></settlement><orgName><li>Université de Lorraine</li><li>Université de Melbourne</li></orgName></list><tree><country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Leroy, Vincent" sort="Leroy, Vincent" uniqKey="Leroy V" first="Vincent" last="Leroy">Vincent Leroy</name></region><name sortKey="Bronowicki, Jean Pierre" sort="Bronowicki, Jean Pierre" uniqKey="Bronowicki J" first="Jean-Pierre" last="Bronowicki">Jean-Pierre Bronowicki</name><name sortKey="Hezode, Christophe" sort="Hezode, Christophe" uniqKey="Hezode C" first="Christophe" last="Hezode">Christophe Hezode</name><name sortKey="Pol, Stanislas" sort="Pol, Stanislas" uniqKey="Pol S" first="Stanislas" last="Pol">Stanislas Pol</name></country><country name="Australie"><noRegion><name sortKey="Angus, Peter" sort="Angus, Peter" uniqKey="Angus P" first="Peter" last="Angus">Peter Angus</name></noRegion><name sortKey="Dore, Gregory J" sort="Dore, Gregory J" uniqKey="Dore G" first="Gregory J" last="Dore">Gregory J. Dore</name><name sortKey="Pianko, Stephen" sort="Pianko, Stephen" uniqKey="Pianko S" first="Stephen" last="Pianko">Stephen Pianko</name><name sortKey="Stuart, Katherine" sort="Stuart, Katherine" uniqKey="Stuart K" first="Katherine" last="Stuart">Katherine Stuart</name><name sortKey="Thompson, Alexander J" sort="Thompson, Alexander J" uniqKey="Thompson A" first="Alexander J" last="Thompson">Alexander J. Thompson</name><name sortKey="Tse, Edmund" sort="Tse, Edmund" uniqKey="Tse E" first="Edmund" last="Tse">Edmund Tse</name></country><country name="États-Unis"><region name="Connecticut"><name sortKey="Mcphee, Fiona" sort="Mcphee, Fiona" uniqKey="Mcphee F" first="Fiona" last="Mcphee">Fiona Mcphee</name></region><name sortKey="Bhore, Rafia" sort="Bhore, Rafia" uniqKey="Bhore R" first="Rafia" last="Bhore">Rafia Bhore</name><name sortKey="Jimenez Exposito, Maria Jesus" sort="Jimenez Exposito, Maria Jesus" uniqKey="Jimenez Exposito M" first="Maria Jesus" last="Jimenez-Exposito">Maria Jesus Jimenez-Exposito</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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