title: Treatment of HCV genotype 2 with sofosbuvir and ribavirin results in lower sustained virological response rates in real life than expected from clinical trials.
abstract: Hepatitis C virus (HCV) infections with genotype 2 (GT2) are generally considered as easy to treat. The current standard therapy is 12 weeks of sofosbuvir and ribavirin. However, sustained virological response (SVR) rates varied substantially in distinct subgroups. Therefore, re-assessing the efficacy of interferon-free therapy in cohorts with larger patient numbers is warranted.
  
  
  
  The German Hepatitis C registry is a national multicenter cohort. Patients are treated at the discretion of the physician. Data are collected by a web-based data system and confirmed by plausibility checks and on-site monitoring.
  
  
  
  A total of 265 (4.3%) of 6034 patients enrolled in the registry were infected with GT2, and 236 had initiated treatment (60% males, 98% Caucasian, median age 54 years). Treatment with sofosbuvir and ribavirin for 12 weeks achieved SVR at week 12 post-treatment (SVR12) in 136/164 (83%) patients. SVR12 rates for this regimen were 80% (35/44) in treatment-experienced patients, 74% (20/27) in cirrhotics and 75% (21/28) in patients with HCV-RNA ≥6 million IU/mL. The overall SVR rate in patients treated with sofosbuvir/ribavirin 12 weeks per protocol (PP), excluding therapy discontinuation or lost to follow-up, was 135/151 (89%). PP SVR12 rates were 91% for treatment naïve, 83% for cirrhotic and 80% for treatment-experienced patients respectively.
  
  
  
  In this large GT2 cohort, sofosbuvir and ribavirin for 12 weeks achieved lower SVR rates compared to treatment outcomes expected from phase 3 trials. These findings highlight the need for establishing alternative treatment strategies for GT2 patients, especially in patients with unfavourable outcome factors.
authors.affiliation: Department of Medicine III, University Hospital Aachen, Aachen, Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Tacke
authors.affiliation: Universitätsklinikum Schleswig-Holstein (UKSH), Kiel, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Günther
authors.affiliation: IFI-Institute for Interdisciplinary Medicine, Hamburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Buggisch
authors.affiliation: University Hospital Würzburg, Würzburg, Germany.
authors.forename: Hartwig
authors.initials: H
authors.lastname: Klinker
authors.affiliation: Hepatologische Praxis, Göttingen, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schober
authors.affiliation: Hepatologische Praxis, Berlin, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: John
authors.affiliation: Infektiologikum, Frankfurt, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Lutz
authors.affiliation: e.factum GmbH, Butzbach, Germany.
authors.forename: Heike
authors.initials: H
authors.lastname: Pfeiffer-Vornkahl
authors.affiliation: St. Josef-Hospital, Katholisches Klinikum Oberhausen, Oberhausen, Germany.
authors.forename: Claus
authors.initials: C
authors.lastname: Niederau
authors.affiliation: Hannover Medical School, Hannover, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Cornberg
authors.affiliation: University Hospital Frankfurt, Frankfurt, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Sarrazin
authors.affiliation: Center for HIV and Hepatogastroenterology, Duesseldorf, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Mauss
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D005858:Germany; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D008103:Liver Cirrhosis / Q000821:virology; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012367:RNA, Viral; D012042:Registries; D012254:Ribavirin / Q000008:administration & dosage*; D000069474:Sofosbuvir / Q000008:administration & dosage*; D000072230:Sustained Virologic Response; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D012367:RNA, Viral; D012254:Ribavirin; D000069474:Sofosbuvir
keywords: 
  HCV
  ; SVR12; cirrhosis; fibrosis; genotype 2; real-life cohort