title: Sofosbuvir in Combination with Simeprevir +/- Ribavirin in Genotype 4 Hepatitis C Patients with Advanced Fibrosis or Cirrhosis: A Real-World Experience from Belgium.
abstract: BACKGROUND
  Hepatitis C virus (HCV) is a major global health issue and successful treatment has been associated with a reduction of risk of all-cause mortality. Advancements have been made in HCV treatment through the use of interferon-free regimens. Most trials have been conducted in HCV genotype (GT) 1 and data for interferon-free regimens in GT4 patients are limited. The aim of this study was to evaluate the safety and efficacy of sofosbuvir plus simeprevir in a real-world cohort of HCV GT4 patients with advanced fibrosis.
  
  
  METHODS
  Eighty-seven GT4 treatment-naïve or -Interferon (IFN) ribavirin (RBV) experienced patients treated with sofosbuvir and simeprevir +/- ribavirin (RBV) were enrolled in this cohort study (41% severe fibrosis, 59% cirrhosis).
  
  
  RESULTS
  Patients were 51.7% male, 78.2% IFN/RBV treatment-experienced, and 37.9% received RBV treatment. The overall sustained virologic response at least 12 weeks after treatment (SVR12) rate was 87.4% while patients treated with and without RBV had rates of 87.9% and 87% (p = 0.593), respectively, and patients with advanced fibrosis (F3) and patients with cirrhosis had SVR12 rates of 94.4% and 82.4% (p = 0.087), respectively. SVR12 rates in treatment-naïve patients and in IFN/RBV -experienced patients were 78.9% and 89.7% (p = 0.191), respectively. Treatment failure occurred most commonly in patients with cirrhosis and severe disease. The treatment was well tolerated and no patient died or discontinued treatment due to adverse events.
  
  
  CONCLUSIONS
  Sofosbuvir in combination with simeprevir +/- ribavirin in GT 4 HCV patients with advanced fibrosis achieved high SVR12 rates and was well tolerated. RBV did not appear to increase the rate of SVR12.
authors.affiliation: Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Delphine
authors.initials: D
authors.lastname: Degré
authors.affiliation: Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.|Department of Hepato-Gastroenterology, CHU Saint-Pierre, Brussels, Belgium.
authors.forename: Thomas
authors.initials: T
authors.lastname: Sersté
authors.affiliation: Department of Gastroenterology, Brugmann Hospital, Brussels, Belgium.
authors.forename: Luc
authors.initials: L
authors.lastname: Lasser
authors.affiliation: Department of Hepatogastroenterology, CHU Sart Tilman, University of Liège, Liège, Belgium.
authors.forename: Jean
authors.initials: J
authors.lastname: Delwaide
authors.affiliation: Department of Hepato-Gastroenterology, Clinique Universitaire Saint-Luc, Brussels, Belgium.
authors.forename: Peter
authors.initials: P
authors.lastname: Starkel
authors.affiliation: Department of Gastroenterology and Hepatology, University Hospital Gasthuisberg, Leuven, Belgium.
authors.forename: Wim
authors.initials: W
authors.lastname: Laleman
authors.affiliation: Department of Hepato-Gastroenterology, CHIREC, Brussels, Belgium.
authors.forename: Philippe
authors.initials: P
authors.lastname: Langlet
authors.affiliation: Department of Gastroenterology and Hepatology, VUB, UZ Brussels, Brussels, Belgium.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Reynaert
authors.affiliation: Department of Gastroenterology and Hepatology, ZNA, Antwerp, Belgium.
authors.forename: Stefan
authors.initials: S
authors.lastname: Bourgeois
authors.affiliation: Department of Gastroenterology and Hepatology, Antwerp University Hospital, Edegem, Belgium.|Laboratory of Gastroenterology and Hepatology, Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Thomas
authors.initials: T
authors.lastname: Vanwolleghem
authors.affiliation: Department of Gastroenterology and Hepatology, GHdC, Charleroi, Belgium.
authors.forename: Sergio
authors.initials: S
authors.lastname: Negrin Dastis
authors.affiliation: Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Thierry
authors.initials: T
authors.lastname: Gustot
authors.affiliation: Department of Gastroenterology and Hepatology, University Hospital Ghent, Ghent, Belgium.
authors.forename: Anja
authors.initials: A
authors.lastname: Geerts
authors.affiliation: Department of Gastroenterology and Hepatology, AZ Maria Middelares, Ghent, Belgium.
authors.forename: Christophe
authors.initials: C
authors.lastname: Van Steenkiste
authors.affiliation: Department of Gastroenterology and Hepatology, Hôpitaux IRIS sud, Brussels, Belgium.
authors.forename: Chantal
authors.initials: C
authors.lastname: de Galocsy
authors.affiliation: Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.|Department of Gastroenterology and Hepatology, Hôpitaux IRIS sud, Brussels, Belgium.
authors.forename: Antonia
authors.initials: A
authors.lastname: Lepida
authors.affiliation: Department of Gastroenterology and Hepatology, AZ Bruges, Bruges, Belgium.
authors.forename: Hans
authors.initials: H
authors.lastname: Orlent
authors.affiliation: Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Christophe
authors.initials: C
authors.lastname: Moreno
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000627:therapeutic use*; D001530:Belgium; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral; D012254:Ribavirin / Q000627:therapeutic use*; D000069616:Simeprevir / Q000627:therapeutic use*; D000069474:Sofosbuvir / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D012367:RNA, Viral; D012254:Ribavirin; D000069616:Simeprevir; D000069474:Sofosbuvir