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      Ledipasvir-sofosbuvir with or without ribavirin to treat patients with HCV genotype 1 infection and cirrhosis non-responsive to previous protease-inhibitor therapy: a randomised, double-blind, phase 2 trial (SIRIUS).

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          Abstract

          Patients with cirrhosis resulting from chronic hepatitis C virus (HCV) infection are at risk of life-threatening complications, but consistently achieve lower sustained virological response (SVR) than patients without cirrhosis, especially if treatment has previously failed. We assessed the efficacy and safety of the NS5A inhibitor ledipasvir and the nucleotide polymerase inhibitor sofosbuvir, with and without ribavirin.

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          Author and article information

          Journal
          Lancet Infect Dis
          The Lancet. Infectious diseases
          1474-4457
          1473-3099
          Apr 2015
          : 15
          : 4
          Affiliations
          [1 ] Hépato-Gastroentérologie, Hôpital Saint Joseph, Marseilles, France. Electronic address: mbourliere@hopital-saint-joseph.fr.
          [2 ] Hépato-Gastroentérologie, INSERM, U954, Centre Hosptialier Universitaire de Nancy, Université de Lorraine, Vandoeuvre-lès-Nancy, France.
          [3 ] Service d'Hépato-Gastro-Entérologie et d'Oncologie Digestive, CHU de Bordeaux, Pessac, France.
          [4 ] Hépato-Gastro-Entérologie, Hôpital Henri Mondor, Université Paris-Est, INSERM U 955, Créteil, France.
          [5 ] Hépato-Gastro-Entérologie, Hôpital de La Croix Rousse, Lyon, France.
          [6 ] Services des Maladies de l'Appareil Digestif, CHRU Lille, Lille, France.
          [7 ] Hépatologie, INSERM, U1065 and CHU de Nice, Nice, France.
          [8 ] Service d'Hépato-Gastroentérologie, Hôpital Saint Eloi, Montpellier, France.
          [9 ] Hépato-Gastro-Entérologie, Hôpital de la Pitié Salpétrière, Paris, France.
          [10 ] Médecine Interne-Pôle Digestif, CHU Purpan, UMR 152 IRD Toulouse 3 University, Toulouse, France.
          [11 ] Liver Disease Therapeutic Area, Gilead Sciences, Foster City, CA, USA.
          [12 ] Service d'Hépatologie, Hôpital Beaujon, Clichy, France.
          [13 ] Hôpitaux Universitaires de Strasbourg, Inserm U 1110, LabEx HepSYS, Université de Strasbourg, Strasbourg, France.
          [14 ] Service de Maladies du Foie, Hôpital Pontchaillou, Rennes, France.
          [15 ] Hépato-Gastro-Entérologie, Hôpital Tenon, Paris, France.
          [16 ] Recherche Clinique et de l'Innovation, CHU de Limoges and Inserm UMR 1092, Université de Limoges, Limoges, France.
          [17 ] Hépatologie, Hôpital Saint Antoine, Paris, France.
          [18 ] Service d'Hépato Gastro Entérologie, Hôpital Purpan, Toulouse, France.
          [19 ] Hépato-Gastroentérologie, CHU de Grenoble, Grenoble, France.
          [20 ] Médecine Digestive, CHU Estaing, Clermont-Ferrand, France.
          [21 ] Hépatologie, Université Paris Descartes, Inserm UMS20, Institut Pasteur, Hôpital Cochin, Paris, France.
          Article
          S1473-3099(15)70050-2
          10.1016/S1473-3099(15)70050-2
          25773757
          Copyright © 2015 Elsevier Ltd. All rights reserved.

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