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5. Clinical outcomes after treatment with direct antiviral agents: beyond the virological response in patients with previous HCV-related decompensated cirrhosis

Author

Pageaux, G. (Georges-Philippe), Nzinga, C. (Clovis Lusivika), Ganne, N. (Nathalie), Samuel, D. (Didier), Dorival, C. (Céline), Zoulim, F. (Fabien), Cagnot, C. (Carole), Decaens, T. (Thomas), Thabut, D. (Dominique), Asselah, T. (Tarik), Mathurin, P. (Philippe), Habersetzer, F. (Francois), Bronowicki, J. (Jean-Pierre), Guyader, D. (Dominique), Rosa, I. (Isabelle), Leroy, V. (Vincent), Chazouilleres, O. (Olivier), de Ledinghen, V. (Victor), Bourliere, M. (Marc), Causse, X. (Xavier), Cales, P. (Paul), Metivier, S. (Sophie), Loustaud-Ratti, V. (Véronique), Riachi, G. (Ghassan), Alric, L. (Laurent), Gelu-Simeon, M. (Moana), Minello, A. (Anne), Gournay, J. (Jérôme), Geist, C. (Claire), Tran, A. (Albert), Abergel, A. (Armand), Portal, I. (Isabelle), d'Alteroche, L. (Louis), Raffi, F. (François), Fontaine, H. (Hélène), Carrat, F. (Fabrice), Pol, S. (Stanislas), Baumert, Thomas F., Doffoel, M. (Michel), Mutter, C. (Catherine), Simo-Noumbissie, P. (Pauline), Razi, E. (Esma), Hôpital Saint Eloi (CHRU Montpellier), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Génomique Fonctionnelle des Tumeurs Solides (U1162), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiopathogénèse et Traitement des Maladies du Foie, Hôpital Paul Brousse-Université Paris-Saclay, Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Agence Nationale de Recherches sur le Sida et les Hépatites Virales (ANRS), Institute for Advanced Biosciences / Institut pour l'Avancée des Biosciences (Grenoble) (IAB), Centre Hospitalier Universitaire [Grenoble] (CHU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang - Auvergne-Rhône-Alpes (EFS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA), Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Centre de recherche sur l'Inflammation (CRI (UMR_S_1149 / ERL_8252 / U1149)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Physiopathologie des Maladies Inflammatoires de l'Intestin, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Droit et Santé, Interactions Virus-Hôte et Maladies Hépatiques, Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Virologie, Imagerie Adaptative Diagnostique et Interventionnelle (IADI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Service d'Hépato-gastro-entérologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), CHU Pontchaillou [Rennes], Nutrition, Métabolismes et Cancer (NuMeCan), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), CHI Créteil, Biomécanique cellulaire et respiratoire (BCR), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Centre National de la Recherche Scientifique (CNRS), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Bordeaux Research In Translational Oncology [Bordeaux] (BaRITOn), Université de Bordeaux (UB)-CHU Bordeaux [Bordeaux]-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Saint-Joseph [Marseille], Centre Hospitalier Régional d'Orléans (CHRO), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Université d'Angers (UA), CHU Toulouse [Toulouse], Ciblage individuel et prévention des risques de traitements immunosupresseurs et de la transplantation (IPPRITT), CHU Limoges-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), Nutrition, Inflammation et axe Microbiote-Intestin-Cerveau (ADEN), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Normandie Université (NU)-Normandie Université (NU), Service d'Hépato-Gastroentérologie [CHU Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Pharmacochimie et Biologie pour le Développement (PHARMA-DEV), Institut de Recherche pour le Développement (IRD)-Institut de Chimie de Toulouse (ICT-FR 2599), Institut de Recherche pour le Développement (IRD)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Institut de Recherche pour le Développement (IRD)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées, Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Agro Dijon, Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro), Institut des Maladies de l'Appareil Digestif, Université de Nantes (UN), Centre hospitalier régional Metz-Thionville (CHR Metz-Thionville), Centre Hospitalier Universitaire de Nice (CHU Nice), CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, Institut Pascal (IP), Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA)-Institut national polytechnique Clermont Auvergne (INP Clermont Auvergne), Université Clermont Auvergne (UCA)-Université Clermont Auvergne (UCA), Hôpital de la Timone [CHU - APHM] (TIMONE), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre d’Investigation Clinique de Nantes (CIC Nantes), Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Physiopathologie du système immunitaire (Inserm U1223), Institut Pasteur [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), French ANRS CO22 Hepather Cohort: Delphine Bonnet, Virginie Payssan-Sicart, Chloe Pomes, François Bailly, Marjolaine Beaudoin, Dominique Giboz, Kerstin Hartig-Lavie, Marianne Maynard, Eric Billaud, David Boutoille, Morane Cavellec, Caroline Chevalier, Isabelle Hubert, Pierre Goepfert, Adrien Lannes, Françoise Lunel, Jérôme Boursier, Nathalie Boyer, Nathalie Giuily, Corinne Castelnau, Giovanna Scoazec, Aziza Chibah, Sylvie Keser, Karim Bonardi, Anaïs Vallet-Pichard, Philippe Sogni, Juliette Foucher, Jean-Baptiste Hiriart, Amandine Legendre, Faiza Chermak, Marie Irlès-Depé, Si Nafa Si Ahmed, Christelle Ansaldi, Nisserine Ben Amara, Valérie Oules, Jacqueline Dunette, Rodolphe Anty, Eve Gelsi, Régine Truchi, Elena Luckina, Nadia Messaoudi, Joseph Moussali, Barbara De Dieuleveult, Héloïse Goin, Damien Labarrière, Pascal Potier, Si Nafa Si Ahmed, Véronique Grando-Lemaire, Pierre Nahon, Séverine Brulé, Rym Monard, Caroline Jezequel, Audrey Brener, Anne Laligant, Aline Rabot, Isabelle Renard, Thomas F Baumert, Michel Dofföel, Catherine Mutter, Pauline Simo-Noumbissie, Esma Razi, Hélène Barraud, Mouni Bensenane, Abdelbasset Nani, Sarah Hassani-Nani, Marie-Albertine Bernard, Georges-Philippe Pageaux, Michael Bismuth, Ludovic Caillo, Stéphanie Faure, Marie Pierre Ripault, Christophe Bureau, Sarah Launay, Jean Marie Peron, Marie Angèle Robic, Léa Tarallo, Marine Faure, Bruno Froissart, Marie-Noelle Hilleret, Jean-Pierre Zarski, Odile Goria, Victorien Grard, Hélène Montialoux, Muriel François, Christian Ouedraogo, Christelle Pauleau, Anne Varault, Tony Andreani, Bénédicte Angoulevant, Azeline Chevance, Lawrence Serfaty, Teresa Antonini, Audrey Coilly, Jean-Charles Duclos Vallée, Mariagrazia Tateo, Corinne Bonny, Chanteranne Brigitte, Géraldine Lamblin, Léon Muti, Abdenour Babouri, Virginie Filipe, Camille Barrault, Laurent Costes, Hervé Hagège, Soraya Merbah, Paul Carrier, Maryline Debette-Gratien, Jérémie Jacques, Guillaume Lassailly, Florent Artu, Valérie Canva, Sébastien Dharancy, Alexandre Louvet, Marianne Latournerie, Marc Bardou, Thomas Mouillot, Yannick Bacq, Didier Barbereau, Charlotte Nicolas, Caroline Chevalier, Isabelle Archambeaud, Sarah Habes, Nisserine Ben Amara, Danièle Botta-Fridlund, Eric Saillard, Marie-Josée Lafrance, Carole Cagnot, Alpha Diallo, Lena Wadouachi, Ventzi Petrov-Sanchez, Douae Ammour, Loubna Ayour, Jaouad Benhida, Fabrice Carrat, Frederic Chau, Céline Dorival, Audrey Gilibert, Isabelle Goderel, Warda Hadi, Clovis Luzivika Nzinga, Grégory Pannetier, François Pinot, Odile Stahl, François Téloulé, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Institut de Recherche pour le Développement (IRD)-Institut de Chimie de Toulouse (ICT), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Institut National Polytechnique (Toulouse) (Toulouse INP), Université de Toulouse (UT)-Institut de Recherche pour le Développement (IRD)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Institut Pasteur [Paris] (IP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), and Jonchère, Laurent

Subjects
Liver Cirrhosis, medicine.medical_specialty, Carcinoma, Hepatocellular, Survival, Hepatocellular carcinoma, [SDV]Life Sciences [q-bio], Decompensated cirrhosis, Infectious and parasitic diseases, RC109-216, Hepacivirus, Sciences du Vivant [q-bio]/Médecine humaine et pathologie, complications, drug therapy, Gastroenterology, Antiviral Agents, Virological response, Internal medicine, Medicine, Humans, In patient, business.industry, Hepatitis C virus, Research, Liver Neoplasms, Hepatitis C, [SDV] Life Sciences [q-bio], Sustained virological response, Infectious Diseases, Direst-acting antiviral agents, therapeutic use, business, After treatment
Abstract

Background In HCV-infected patients with advanced liver disease, the direct antiviral agents-associated clinical benefits remain debated. We compared the clinical outcome of patients with a previous history of decompensated cirrhosis following treatment or not with direct antiviral agents from the French ANRS CO22 HEPATHER cohort. Methods We identified HCV patients who had experienced an episode of decompensated cirrhosis. Study outcomes were all-cause mortality, liver-related or non-liver-related deaths, hepatocellular carcinoma, liver transplantation. Secondary study outcomes were sustained virological response and its clinical benefits. Results 559 patients met the identification criteria, of which 483 received direct antiviral agents and 76 remained untreated after inclusion in the cohort. The median follow-up time was 39.7 (IQR: 22.7–51) months. After adjustment for multivariate analysis, exposure to direct antiviral agents was associated with a decrease in all-cause mortality (HR 0.45, 95% CI 0.24–0.84, p = 0.01) and non-liver-related death (HR 0.26, 95% CI 0.08–0.82, p = 0.02), and was not associated with liver-related death, decrease in hepatocellular carcinoma and need for liver transplantation. The sustained virological response was 88%. According to adjusted multivariable analysis, sustained virological response achievement was associated with a decrease in all-cause mortality (HR 0.29, 95% CI 0.15–0.54, p Conclusion Treatment with direct antiviral agents is associated with reduced risk for mortality. The sustained virological response was 88%. Thus, direct antiviral agents treatment should be considered for any patient with HCV-related decompensated cirrhosis. Trial registration: ClinicalTrials.gov registry number: NCT01953458.

Published
2022
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6. Dynamic personalized prediction of the individual liver‐related risk after sustained viral response in HCV patients.

Author

Moreau, Clémence, Roux, Marine, Riou, Jérémie, Canivet, Clémence M., Audureau, Etienne, Lusivika‐Nzinga, Clovis, Nahon, Pierre, Carrat, Fabrice, Boursier, Jérôme, Nahon, P., Layese, R., Audureau, E., Bedossa, P., Bonjour, M., Bourcier, V., Dharancy, S., Durand‐Zaleski, I., Fontaine, H., Guyader, D., and Laurent, A.

Subjects
HEPATITIS C virus, LATENT class analysis (Statistics), CHRONIC hepatitis C, INDIVIDUALIZED medicine, HEPATOCELLULAR carcinoma
Abstract

Sustained viral response (SVR) significantly improves the prognosis in patients with hepatitis C virus (HCV) chronic infection but does not totally alleviate the risk of liver‐related complications (LRC). We aimed to evaluate whether the dynamics of multiple measurements of simple parameters after SVR enable the development of a personalized prediction of prognosis in HCV patients. HCV mono‐infected patients who experienced SVR in two prospective cohorts (ANRS CO12 CirVir cohort: derivation set; ANRS CO22 HEPATHER cohort: validation set) were included. The study outcome was LRC, a composite criterion including decompensation of cirrhosis and/or hepatocellular carcinoma. Joint latent class modelling accounting for both biomarker trajectory and event occurrence during follow‐up was developed in the derivation set to compute individual dynamic predictions, with further evaluation in the validation set. In the derivation set (n = 695; 50 LRC during the median 3.8 [1.6–7.5] years follow‐up), FIB4 was identified as a biomarker associated with LRC occurrence after SVR. Joint modelling used sex and the dynamics of FIB4 and diabetes status to develop a personalized prediction of LRC. In the validation set (n = 7064; 273 LRC during the median 3.6 [2.5–4.9] years follow‐up), individual dynamic predictions from the model accurately stratified the risk of LRC. Time‐dependent Brier Score showed good calibration that improved with the accumulation of visits, justifying our modelling approach considering both baseline and follow‐up measurements. Dynamic modelling using repeated measurements of simple parameters predicts the individual residual risk of LRC and improves personalized medicine after SVR in HCV patients. [ABSTRACT FROM AUTHOR]

Published
2023
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8. A case report of a therapeutic drug monitoring-guided sofosbuvir-velpatasvir crushed treatment

Author

Lalanne, S., Tron, C., Verdier, M. C., Jezequel, C., Mercerolle, M., Pronier, C., Guyader, D., Bellissant, E., Lemaitre, F., CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
[SDV]Life Sciences [q-bio]
Abstract

International audience; Meeting Abstract PS-191

Published
2021

9. Non-invasive assessment of hepatic iron stores by MRI

Author

Gandon, Y., Olivie, D., Guyader, D., Aube, C., Oberti, F., Sebille, V., and Deugnier, Y.

Subjects
Iron in the body -- Measurement, Liver -- Medical examination, Magnetic resonance imaging -- Usage
Published
2004

11. Foie et maladies musculaires

Author

Boisteau, É., Guyader, D., Nutrition, Métabolismes et Cancer (NuMeCan), Institut National de la Recherche Agronomique (INRA)-Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)

Subjects
Creatine phosphokinase, Liver, [SDV]Life Sciences [q-bio], Muscle, Transaminases
Abstract

National audience; Myopathies are rare causes of abnormal liver function tests. Muscular cytolysis, responsible for increase of transaminases predominant on AST, has to be recognized to avoid unnecessary investigations. The abnormalities might also be related to broader spectrum of diseases associating liver and muscular injuries such mitochondrial cytopathy or some metabolic diseases. Therefore, the hepato-gastroenterologist should always consider these extra-hepatic diseases when facing the problem of unexplained raise of transaminases for accurate diagnosis and treatment. © 2019 John Libbey Eurotext. All Rights Reserved.

Published
2019
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13. Lower compliance to prior HCC surveillance and liver function impairment explain the apparent higher HCC incidence under direct antivirals in HCV compensated cirrhotic patients: the French multicenter prospective ANRS CO12 CirVir cohort experience

Author

Nahon, P., primary, Richard, L., additional, Valerie, B., additional, Carole, C., additional, Patrick, M., additional, Guyader, D., additional, Stanislas, P., additional, Larrey, D., additional, Francoise, R., additional, and Audureau, E., additional

Published
2018
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14. Impact of elbasvir/grazoprevir (EBR/GZR) on health-related quality of life (HRQOL) and fatigue in patients with chronic hepatitis C virus (HCV) infection and inherited blood disorders (IBLD): Data from the C-EDGE IBLD study.

Author

Li M., Morgan L., Talwani R., Kwo P., Arduino J.M., Vierling J.M., Sobhonslidsuk A., Papatheodoridis G., Assy N., Rosenberg W., Guyader D., Dev A., Gordon S.C., Pol S., Luketic V.A., Khemichian S., Evans B., Li M., Morgan L., Talwani R., Kwo P., Arduino J.M., Vierling J.M., Sobhonslidsuk A., Papatheodoridis G., Assy N., Rosenberg W., Guyader D., Dev A., Gordon S.C., Pol S., Luketic V.A., Khemichian S., and Evans B.

Abstract

Background and Aims: Chronic HCV infection and IBLD are knownto negatively impact patients' HRQOL and cause fatigue. C-EDGE IBLD, a double-blind, placebo-control, Phase 3 trial, randomized patients with HCV genotype 1, 4 or 6 infection and IBLD (hemophilia A/B, von Willebrand disease, beta-thalassemia, or sickle cell anemia) in a 2:1 ratio to either an immediate treatment group (ITG; 12 weeks of EBR/GZR) or deferred treatment group (DTG; 12 weeks of placebo, followed by open-label EBR/GZR). An aim of this study was to compare the HRQOL and fatigue profiles between the EBR/GZR ITG to the placebo DTG. Method(s): Patients completed the SF-36v2RAcute Health Survey and the FACIT-Fatigue Scale. 159 patients were randomized and received >=1 dose of study drug (EBR/GZR: n = 107; placebo: n = 52). Mean change from baseline scores (95% confidence intervals (CI)) and differences between treatment groups' mean change scores (95% CI) were estimated for Physical Functioning (PF), Role-Limitations Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (V), Social Functioning (SF), Role-Limitations Emotional (RE), Mental Health (MH), mental component summary (MCS), physical component summary (PCS) and fatigue. Result(s): Over 96% of patients completed a baseline and >= 1 postbaseline assessment. Baseline mean HRQOL and fatigue scores were similar between EBR/GZR ITG and placebo DTG. During the treatment phase, only GH [TW4: 3.4 (0.7,6.1); TW12: 4.9 (1.5,8.3)] changed significantly in the EBR/GZR ITG and only MH [TW4: -4.5 (-8.3, -0.7)] in the placebo DTG. While the EBR/GZR ITG had better mean change scores than the placebo DTG at TW12, none of the differences were significant. At FW4, The EBR/GZR ITG had significantly improved GH (4.9 (1.4,8.3)) and V (4.4 (0.7,8.1)), which were maintained during follow-up. In contrast, the placebo DTGsignificantly declined in RE (-8.8 (-14.8,-2.9)), MH (-4.3 (-8.4, -0.2)) and MCS (-2.7 (-4.9,-0.4)). EBR/GZR ITG had significantly better mea

Published
2018

15. Managing drug-drug interaction between Ombitasvir, Paritaprevir/Ritonavir, Dasabuvir and Mycophenolate mofetil

Author

Tron, C., Lemaître, F., Ben Ali, Z., Leven, C., Jezequel, C., Boglione-Kerrien, C., Verdier, M. C., Guyader, D., Bellissant, E, CHU Pontchaillou [Rennes], Service des maladies du foie, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Centre Hospitalier Universitaire [Rennes], Foie, métabolismes et cancer, Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Service des maladies du foie [CHU Rennes], Centre Hospitalier Universitaire [Rennes], Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Jonchère, Laurent

Subjects
[SDV] Life Sciences [q-bio], [SDV]Life Sciences [q-bio]
Abstract

International audience; Meeting Abstract: PS-172, 20e congrès de la Société Française de Pharmacologie et de Thérapeutique, Nancy, 19-21 avril 2016

Published
2016

17. Baseline serum ferritin is an independent predictive factor of mortality in patients with chronic hepatitis C after long term follow-up

Author

Jezequel, C., primary, Ali, Z.B., additional, Pronier, C., additional, Rabot, A., additional, Renard, I., additional, Legros, L., additional, Uguen, T., additional, Bardou-Jacquet, E., additional, Lan, C.L., additional, Moirand, R., additional, Houssel-Debry, P., additional, Michelet, C., additional, Thibault, V., additional, and Guyader, D., additional

Published
2017
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19. Identifying residual risk of hepatocellular carcinoma following hepatitis C virus eradication in compensated cirrhosis: decision-tree and random forest models developed in the French multicenter prospective ANRS CO12 CirVir cohort

Author

Audureau, E., primary, Bourcier, V., additional, Layese, R., additional, Cagnot, C., additional, Marcellin, P., additional, Guyader, D., additional, Pol, S., additional, Larrey, D., additional, Roudot-Thoraval, F., additional, and Nahon, P., additional

Published
2017
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20. Impact of elbasvir/grazoprevir (EBR/GZR) on health-related quality of life (HRQOL) and fatigue in patients with chronic hepatitis C virus (HCV) infection and inherited blood disorders (IBLD): data from the C-EDGE IBLD study

Author

Vierling, J.M., primary, Sobhonslidsuk, A., additional, Papatheodoridis, G., additional, Assy, N., additional, Rosenberg, W., additional, Guyader, D., additional, Dev, A., additional, Gordon, S.C., additional, Pol, S., additional, Luketic, V.A., additional, Khemichian, S., additional, Evans, B., additional, Morgan, L., additional, Li, M., additional, Talwani, R., additional, Arduino, J.M., additional, and Kwo, P., additional

Published
2017
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21. A 2-year multicenter, double-blind, randomized, placebo-controlled study of bezafibrate for the treatment of primary biliary cholangitis in patients with inadequate biochemical response to ursodeoxycholic acid therapy (Bezurso)

Author

Corpechot, C., primary, Chazouillères, O., additional, Rousseau, A., additional, Guyader, D., additional, Habersetzer, F., additional, Mathurin, P., additional, Goria, O., additional, Potier, P., additional, Minello, A., additional, Silvain, C., additional, Abergel, A., additional, Debette-Gratien, M., additional, Larrey, D., additional, Roux, O., additional, Bronowicki, J.-P., additional, Boursier, J., additional, de Ledhingen, V., additional, Heurgue-Berlot, A., additional, Nguyen-Khac, E., additional, Zoulim, F., additional, Ollivier-Hourmand, I., additional, Zarski, J.-P., additional, Nkontchou, G., additional, Gaouar, F., additional, Simon, T., additional, and Poupon, R., additional

Published
2017
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24. A GIS-based Interview Procedure for Mapping Maritime Activity Zones

Author

Le Guyader, D., Gourmelon, Françoise, Fontenelle, Guy, Écologie et santé des écosystèmes (ESE), Institut National de la Recherche Agronomique (INRA)-AGROCAMPUS OUEST, Le Guyader, Damien, Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro), Littoral, Environnement, Télédétection, Géomatique (LETG - Brest), Littoral, Environnement, Télédétection, Géomatique UMR 6554 (LETG), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-Université d'Angers (UA)-École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Université de Brest (UBO)-Université de Rennes 2 (UR2), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Centre National de la Recherche Scientifique (CNRS)-Institut de Géographie et d'Aménagement Régional de l'Université de Nantes (IGARUN), Université de Nantes (UN)-Université de Nantes (UN)-Université de Caen Normandie (UNICAEN), Université de Nantes (UN)-Université de Nantes (UN), AGROCAMPUS OUEST, Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro), and Rad2Brest

Subjects
Participatory Survey, [SDV.SA.STP]Life Sciences [q-bio]/Agricultural sciences/Sciences and technics of fishery, [SDE.ES] Environmental Sciences/Environmental and Society, Mapping of Marine Activities, GIS, [SDE.ES]Environmental Sciences/Environmental and Society, Coastal sea
Abstract

International audience; This contribution presents the methodology of data acquisition concerning human activities in the Bay of Brest (Brittany, France). The objective is to model potential conflicts and potential impacts on renewable resources. A survey method was developed to collect spatial data from stakeholders using GIS as a mediation tool. Thirty-nine semi-structured interviews were carried out with key informants about several activities. A tablet PC enabled them to map their practice areas on a touch screen. These areas complement a multi-layer GIS database and provide maps for organised activities such as commercial fishing, nautical sports (windsurfing, sailing, kayak, rowing, scuba-diving) and maritime transportation (passengers). The use of GIS, and especially its dynamic multi-scale display capacity, also gives us the opportunity to monitor geographic data layers and scales used by stakeholders while disclosing their practice areas. This integrated GIS based methodology allows us to formalise the stakeholders experience and knowledge. Its contribution to a participatory process such as the Integrated Coastal Zone Management is discussed.

Published
2011

26. Extrahepatic Cancer is the Second Cause of Non Liver-Related Death in Patients with Compensated Viral Cirrhosis and is Associated with Viral Replication (ANRS CO12 CirVir Prospective Cohort)

Author

Allaire, M., primary, Bourcier, V., additional, Layese, R., additional, Corvi, L., additional, Petrov-Sanchez, V., additional, Marcellin, P., additional, Guyader, D., additional, Larrey, D., additional, De Lédinghen, V., additional, Ouzan, D., additional, Zoulim, F., additional, Roulot, D., additional, Tran, A., additional, Bronowicki, J.-P., additional, Zarski, J.-P., additional, Riachi, G., additional, Calès, P., additional, Péron, J.-M., additional, Alric, L., additional, Bourlière, M., additional, Mathurin, P., additional, Nahon, P., additional, and Roudot-Thoraval, F., additional

Published
2016
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27. Viral Suppression is Not a risk Factor for CKD in Viral Cirrhosis (ANRS CO12 CirVir Prospective Cohort)

Author

Bagnis, C.I., primary, Layese, R., additional, Divard, G., additional, Cacoub, P., additional, Bourcier, V., additional, Corvi, L., additional, Petro-Sanchez, V., additional, Marcellin, P., additional, Guyader, D., additional, Pol, S., additional, Larrey, D., additional, De Ledingen, V., additional, Ouzan, D., additional, Zoulim, F., additional, Deray, G., additional, Roudot-Thoraval, F., additional, and Nahon, P., additional

Published
2016
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28. The Benefits of Virosuppression on Progression of Portal Hypertension in Patients with Compensated Viral Cirrhosis (ANRS CO12 CirVir Cohort)

Author

Bureau, C., primary, Thabut, D., additional, Layese, R., additional, Bourcier, V., additional, Corvy, L., additional, Petrov-Sanchez, V., additional, Marcellin, P., additional, Guyader, D., additional, Pol, S., additional, Larrey, D., additional, Zoulim, F., additional, Roulot, D., additional, De Ledinghen, V., additional, Ouzan, D., additional, Tran, A., additional, Bronowicki, J.-P., additional, Riachi, G., additional, Cales, P., additional, Peron, J.-M., additional, Alric, L., additional, Bourliere, M., additional, Mathurin, P., additional, Zarski, J.-P., additional, Roudot-Thoraval, F., additional, and Nahon, P., additional

Published
2016
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29. Prospective Evidence That Hepatocellular Carcinoma Surveillance in Patients with Compensated Viral Cirrhosis Increases the Probability of Curative Treatment and Survival Taking into Account Lead-Time Bias (Anrs Co12 Cirvir Cohort)

Author

Costentin, C., primary, Layese, R., additional, Bourcier, V., additional, Corvi, L., additional, Petro-Sanchez, V., additional, Marcellin, P., additional, Guyader, D., additional, Pol, S., additional, Larrey, D., additional, de Ledinghen, V., additional, Ouzan, D., additional, Zoulim, F., additional, zarski, J.P., additional, Roulot, D., additional, Tran, A., additional, Bronowicki, J.-P., additional, Riachi, G., additional, Cales, P., additional, Péron, J.M., additional, Alric, L., additional, Bourlière, M., additional, Mathurin, P., additional, Sutton, A., additional, Letouze, E., additional, Zucman-Rossi, J., additional, Roudot-Thoraval, F., additional, and Nahon, P., additional

Published
2016
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30. AL-335, a Once-Daily Pangenotypic Nucleotide HCV Polymerase Inhibitor, Demonstrates Potent Antiviral Activity over 7 Days in Treatment-Naïve Genotype 1-4 Patients

Author

Berliba, E., primary, Tsertsvadze, T., additional, Ghicavii, N., additional, Guyader, D., additional, Kakabadze, T., additional, Westland, C., additional, Chanda, S., additional, Patat, A., additional, Zhang, Q., additional, Smith, D., additional, Yogaratnam, J., additional, McClure, M., additional, Beigelman, L., additional, Blatt, L., additional, and Fry, J., additional

Published
2016
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31. New Recommendations of Baveno Vi Conference for the Screening of Portal Hypertension: An Independent Sequential Validation in Patients with Compensated Viral Cirrhosis Taking into Account Virological Status (Anrs Co12 Cirvir Cohort)

Author

Thabut, D., primary, Bureau, C., additional, Layese, R., additional, Bourcier, V., additional, Corvy, L., additional, Petrov-Sanchez, V., additional, Marcellin, P., additional, Guyader, D., additional, Pol, S., additional, Larrey, D., additional, Zoulim, F., additional, Roulot, D., additional, De Ledinghen, V., additional, Ouzan, D., additional, Tran, A., additional, Bronowicki, J.-P., additional, Riachi, G., additional, Cales, P., additional, Peron, J.-M., additional, Alric, L., additional, Bourliere, M., additional, Mathurin, P., additional, Zarski, J.-P., additional, Roudot-Thorava, P., additional, and Nahon, P., additional

Published
2016
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32. Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): A randomised, open-label phase 2 trial.

Author

Ghesquiere W., Guyader D., Alric L., Bronowicki J.-P., Lester L., Sund F., Lagging M., Dutko F., Shaughnessy M., Hwang P., Howe A.Y.M., Wahl J., Robertson M., Barr E., Haber B., Lawitz E., Gane E., Pearlman B., Tam E., Sievert W., Ghalib R., Balart L., Ghesquiere W., Guyader D., Alric L., Bronowicki J.-P., Lester L., Sund F., Lagging M., Dutko F., Shaughnessy M., Hwang P., Howe A.Y.M., Wahl J., Robertson M., Barr E., Haber B., Lawitz E., Gane E., Pearlman B., Tam E., Sievert W., Ghalib R., and Balart L.

Abstract

Background There is a high medical need for an interferon-free, all-oral, short-duration therapy for hepatitis C virus (HCV) that is highly effective across diverse patient populations, including patients with cirrhosis or previous null response to pegylated interferon (peginterferon) plus ribavirin (PR-null responders). We aimed to assess the efficacy, safety, and effective treatment duration of grazoprevir (an HCV NS3/4A protease inhibitor) combined with elbasvir (an HCV NS5A inhibitor) with or without ribavirin in patients with HCV genotype 1 infection with baseline characteristics of poor response. Methods The C-WORTHY trial is a randomised, open-label phase 2 trial of grazoprevir plus elbasvir with or without ribavirin; here we report findings for two cohorts of previously untreated patients with cirrhosis (cohort 1) and those with previous PR-null response with or without cirrhosis (cohort 2) enrolled in part B of the study. Eligible patients were adults aged 18 years or older with chronic HCV genotype 1 infection and HCV RNA concentrations of 10 000 IU/mL or higher in peripheral blood. We randomly assigned patients to receive grazoprevir (100 mg daily) and elbasvir (50 mg daily) with or without ribavirin for 12 or 18 weeks. Randomisation was done centrally with an interactive voice response system; patients and study investigators were masked to treatment duration up to week 12 but not to treatment allocation. The primary endpoint was the proportion of patients achieving HCV RNA less than 25 IU/mL at 12 weeks after end of treatment (SVR12), assessed by COBAS TaqMan version 2.0. This study is registered with ClinicalTrials.gov, number NCT01717326. Findings We describe findings for 253 patients enrolled in cohort 1 (n=123) or cohort 2 (n=130). In cohort 1, we randomly assigned 60 patients to the 12-week regimen (31 with ribavirin and 29 with no ribavirin) and 63 to the 18-week regimen (32 with ribavirin and 31 with no ribavirin); in cohort 2, we randomly assign

Published
2015

34. O112 : HBsAg clearance after addition of 48 weeks of pegifn in HBeAg negative CHB patients on nucleos(T)ide therapy with undetectable hbvdna for at least one year: final results from ANRS-HB06 pegan study: multicenter randomized controlled phase III trial

Author

Bourliere, M., primary, Rabiega, P., additional, Ganne-Carrie, N., additional, Serfaty, L., additional, Marcellin, P., additional, Pouget, N., additional, Guyader, D., additional, Hezode, C., additional, Picon, M., additional, Causse, X., additional, Leroy, V., additional, Bronowicki, J.P., additional, Riachi, G., additional, Rosa, I., additional, Attali, P., additional, Molina, J.M., additional, Bacq, Y., additional, Tran, A., additional, Grangé, J.D., additional, Zoulim, F., additional, Fontaine, H., additional, Bertucci, I., additional, Bouvier-Alias, M., additional, Carrat, F., additional, and Benhamou, Y., additional

Published
2015
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35. P0768 : Late mortality in treatment-experienced cirrhotic patients treated with triple therapy including boceprevir or telaprevir in a real-life cohort - ANRS Co 20 cupic

Author

Bronowicki, J.-P., primary, Fontaine, H., additional, Dufour, C., additional, Zoulim, F., additional, Larrey, D., additional, Canva, V., additional, Samuel, D., additional, Poynard, T., additional, Marcellin, P., additional, De Ledinghen, V., additional, Bourlière, M., additional, Alric, L., additional, Zarski, J.-P., additional, Raabe, J.-J., additional, Serfaty, L., additional, Metivier, S., additional, Riachi, G., additional, Abergel, A., additional, Loustaud-Ratti, V., additional, Causse, X., additional, Guyader, D., additional, Bernard, P.-H., additional, Attali, P., additional, Di Martino, V., additional, Cacoub, P., additional, Cales, P., additional, Tran, A., additional, Rosa, I., additional, Grando-Lemaire, V., additional, Portal, I., additional, Dao, T., additional, Lucidarme, D., additional, Fontanges, T., additional, Barthe, Y., additional, Pawlotsky, J.-M., additional, Pol, S., additional, Carrat, F., additional, and Hezode, C., additional

Published
2015
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36. LP05 : Daclatasvir plus sofosbuvir with or without ribavirin in patients with HCV genotype 3 infection: Interim analysis of a french multicenter compassionate use program

Author

Hezode, C., primary, De Ledinghen, V., additional, Fontaine, H., additional, Zoulim, F., additional, Lebray, P., additional, Boyer, N., additional, Larrey, D., additional, Silvain, C., additional, Botta-Fridlund, D., additional, Leroy, V., additional, Bourliere, M., additional, D’Alteroche, L., additional, Hubert-Fouchard, I., additional, Guyader, D., additional, Rosa, I., additional, Nguyen-Khac, E., additional, Di Martino, V., additional, Carrat, F., additional, Fedchuk, L., additional, Akremi, R., additional, Bennai, Y., additional, and Bronowicki, J.-P., additional

Published
2015
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37. P1266 : Human albumin use in cirrhotic patients in France: Results of the national “Albu-live” survey

Author

Garioud, A., primary, Cadranel, J.-F., additional, Pauwels, A., additional, Thévenot, T., additional, Louvet, A., additional, Dao, T., additional, Sogni, P., additional, Talbodec, N., additional, Bureau, C., additional, Thabut, D., additional, Elkrief, L., additional, Jouannaud, V., additional, Macaigne, G., additional, Bernard-Chabert, B., additional, Lison, H., additional, Alric, L., additional, Carbonnel, N., additional, Pageaux, G.-P., additional, Bettan, L., additional, Labadie, H., additional, Nahon, P., additional, Bader, R., additional, Zarski, J.-P., additional, Abergel, A., additional, Pol, S., additional, Pariente, A., additional, Amiot, X., additional, Mathurin, P., additional, Ollivier-Hourmand, I., additional, Bismuth, M., additional, Dupont, K., additional, Rosa-Hézode, I., additional, Lesgourgues, B., additional, Leroy, V., additional, Poynard, T., additional, Causse, X., additional, Chazouillères, O., additional, Valla, D., additional, Zanditenas, D., additional, Renou, C., additional, Trinchet, J.-C., additional, Paupard, T., additional, Ouzan, D., additional, Guyader, D., additional, Fontanges, T., additional, Hanslik, B., additional, De Lédinghen, V., additional, and Denis, J., additional

Published
2015
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40. LP28 : Efficacy of the oral sofosbuvir-based combinations in HCV genotype 4-mono-infected patients from the french observational cohort anrs CO22 hepather

Author

Fontaine, H., primary, Hezode, C., additional, Zoulim, F., additional, Samuel, D., additional, Bourliere, M., additional, Haour, G., additional, Dorival-Mouly, C., additional, Leroy, V., additional, De Ledinghen, V., additional, Lucier, S., additional, Larrey, D., additional, Tran, A., additional, Metivier, S., additional, Benhamou, Y., additional, Hubert-Fouchard, I., additional, Habersetzer, F., additional, Marcellin, P., additional, Mathurin, P., additional, Alric, L., additional, Bronowicki, J.-P., additional, Guyader, D., additional, Loustaud-Ratti, V., additional, Minello, A., additional, Riachi, G., additional, Rosa, I., additional, Simony, M., additional, Diallo, A., additional, Carrat, F., additional, and Pol, S., additional

Published
2015
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41. P0328 : Incidence, characteristics and determinants of primary liver cancer occurring during surveillance of compensated HCV cirrhosis according to sustained virological response (ANRS CO12 CirVir)

Author

Nahon, P., primary, Bourcier, V., additional, Layese, R., additional, Talmat, N., additional, Allam, S., additional, Marcellin, P., additional, Guyader, D., additional, Pol, S., additional, Larrey, D., additional, Zoulim, F., additional, Roulot, D., additional, de Lédinghen, V., additional, Ouzan, D., additional, Zarski, J.-P., additional, Trinchet, J.-C., additional, and Roudot-Thoraval, F., additional

Published
2015
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43. LO3 : Safety and efficacy of the combination daclatasvir-sofosbuvir in HCV genotype 1-mono-infected patients from the french observational cohort ANRS CO22 hepather*

Author

Pol, S., primary, Bourliere, M., additional, Lucier, S., additional, De Ledinghen, V., additional, Zoulim, F., additional, Dorival-Mouly, C., additional, Métivier, S., additional, Larrey, D., additional, Tran, A., additional, Hezode, C., additional, Bronowicki, J.-P., additional, Samuel, D., additional, Marcellin, P., additional, Zarski, J.-P., additional, Minello, A., additional, Alric, L., additional, Trinchet, J.-C., additional, Nahon, P., additional, Guyader, D., additional, Chazouillères, O., additional, Riachi, G., additional, Loustaud-Ratti, V., additional, Causse, X., additional, Mathurin, P., additional, Hubert-Fouchard, I., additional, Rosa, I., additional, Benhamou, Y., additional, Gournay, J., additional, Raabe, J.-J., additional, Raffi, F., additional, Petrov-Sanchez, V., additional, Diallo, A., additional, Fontaine, H., additional, and Carrat, F., additional

Published
2015
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44. Fibrillar Collagen scoring in human liver fibrosis by Second Harmonic Generation Microscopy

Author

Gailhouste, L., Le Grand, Y., Odin, Christophe, Turlin, Bruno, Ezan, Frédéric, Guyader, D., Renault, Anne, Baffet, G., Groupe matière condensée et matériaux (GMCM), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Centre National de la Recherche Scientifique (CNRS), Université de Rennes (UR)-Centre National de la Recherche Scientifique (CNRS), and Brébion, Alice

Subjects
[PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci], [PHYS.COND.CM-MS] Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci]
Published
2007

45. Efficacy and safety of MK-5172 and MK-8742 +/- ribavirin in hepatitis C genotype 1 infected patients with cirrhosis or previous null response: Final results of the C-worthy study (parts a and b).

Author

Dutko F., Haber B.A., Hwang P., Wahl J., Robertson M., Sund F., Lagging M., Howe A.Y., Shaughnessy M., Lawitz E., Gane E.J., Pearlman B., Tam E., Ghesquiere W., Guyader D., Alric L., Bronowicki J.-P., Rossaro L., Sievert W., Ghalib R.H., Balart L.A., Dutko F., Haber B.A., Hwang P., Wahl J., Robertson M., Sund F., Lagging M., Howe A.Y., Shaughnessy M., Lawitz E., Gane E.J., Pearlman B., Tam E., Ghesquiere W., Guyader D., Alric L., Bronowicki J.-P., Rossaro L., Sievert W., Ghalib R.H., and Balart L.A.

Abstract

Purpose: The purpose of this study was to assess the efficacy, safety and effective treatment duration of MK-5172 (hepatitis C virus [HCV] NS3/4A protease inhibitor) in combination with MK-8742 (an HCV NS5A replication complex inhibitor) +/- ribavirin in patients with HCV genotype (GT)1 infection with baseline characteristics of poor response, including either cirrhosis or prior null response to peginterferon /ribavirin (PR null). Method(s): Patients with a prior PR null response +/- cirrhosis or treatment-naive patients with cirrhosis were randomized to receive MK-5172 (100 mg QD) and MK-8742 (50 mg QD) +/- ribavirin (weight-based) for 12 or 18 weeks. Primary endpoint was the proportion of patients achieving HCV RNA<25 IU/mL 12 weeks after end of treatment (SVR12) assessed by COBAS TaqMan v2.0 (lower limit of quantitation <25 IU/mL). The study is ongoing, and all patients will have received 24 weeks of follow-up by November 2014. Result(s):253 patients were enrolled (male, 58%; African American, 6%; GT1a, 65%). Among patients treated for 12 weeks with MK-5172 + MK-8742 without RBV, 94% (28/29) of treatment-naive patients with cirrhosis and 91% (30/33) of prior PR null responders achieved SVR12 (Table). High SVR12 rates were achieved regardless of the use of ribavirin or extending the treatment duration from 12 to 18 weeks (results as of May 1, 2014). Among prior PR null patients with cirrhosis treated for 12 or 18 weeks with MK-5172 + MK-8742 +/- RBV, 95% (41/43) achieved SVR12. Final SVR12 and SVR24 results will be presented. Adverse events reported in >10% of patients were fatigue (25%), headache (24%) and asthenia (14%). Conclusion(s): Treatment with MK-5172 + MK-8742 +/- RBV demonstrated high rates of efficacy in treatment-naive patients with cirrhosis and prior PR null responders. Neither RBV nor extension of treatment duration from 12 to 18 weeks was needed to achieve SVR12 in a high proportion of patients. These results support the ongoing Phase 3 developmen

Published
2014

46. FRI-251 - Impact of elbasvir/grazoprevir (EBR/GZR) on health-related quality of life (HRQOL) and fatigue in patients with chronic hepatitis C virus (HCV) infection and inherited blood disorders (IBLD): data from the C-EDGE IBLD study

Author

Vierling, J.M., Sobhonslidsuk, A., Papatheodoridis, G., Assy, N., Rosenberg, W., Guyader, D., Dev, A., Gordon, S.C., Pol, S., Luketic, V.A., Khemichian, S., Evans, B., Morgan, L., Li, M., Talwani, R., Arduino, J.M., and Kwo, P.

Published
2017
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48. LBO-01 - A 2-year multicenter, double-blind, randomized, placebo-controlled study of bezafibrate for the treatment of primary biliary cholangitis in patients with inadequate biochemical response to ursodeoxycholic acid therapy (Bezurso)

Author

Corpechot, C., Chazouillères, O., Rousseau, A., Guyader, D., Habersetzer, F., Mathurin, P., Goria, O., Potier, P., Minello, A., Silvain, C., Abergel, A., Debette-Gratien, M., Larrey, D., Roux, O., Bronowicki, J.-P., Boursier, J., de Ledhingen, V., Heurgue-Berlot, A., Nguyen-Khac, E., Zoulim, F., Ollivier-Hourmand, I., Zarski, J.-P., Nkontchou, G., Gaouar, F., Simon, T., and Poupon, R.

Published
2017
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