title: Real-world use, effectiveness and safety of anti-viral treatment in chronic hepatitis C genotype 3 infection.
abstract: Treatment of chronic hepatitis C genotype 3 (GT3) is more challenging compared with other genotypes. Since 2014, several new treatment regimens have been approved but sometimes based on limited data.
  
  
  
  To validate the use, effectiveness and safety of anti-viral treatment in chronic hepatitis C genotype 3 infection under real-word conditions.
  
  
  
  The German Hepatitis C-Registry is a large national non-interventional real-world study for patients with chronic hepatitis C. A total of 1322 GT3 patients were enrolled (211 untreated and 1111 treated patients).
  
  
  
  Between February 2014 and September 2015, five different treatment strategies have been used (PegIFN+RBV, PegIFN+RBV+SOF, SOF+RBV, DCV+SOF±RBV, LDV/SOF±RBV). Treatment uptake and use of treatment concepts changed markedly and rapidly during the study influenced by new approvals, guideline recommendations, and label updates. PegIFN-based therapies constantly declined while DCV-based therapies increased with one interruption after the approval of LDV/SOF, which was frequently used until new guidelines recommended not using this combination for GT3. Per-protocol SVR ranged from 80.9% in the PegIFN+RBV group to 96.1% in PegIFN+RBV+SOF treated patients. Treatment-experienced patients with cirrhosis showed a suboptimal SVR of 68% for SOF+RBV but a high SVR of 90-95% for DCV+SOF±RBV. The safety analysis showed more adverse events and a stronger decline of haemoglobin for RBV containing regimens.
  
  
  
  Real-world data can validate the effectiveness and safety for treatment regimens that had previously been approved with limited data, in particular for specific subgroups of patients. The present study demonstrates how rapid new scientific data, new treatment guidelines, new drug approvals and label changes are implemented into routine clinical practice today.
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany and German Center for Infection Research (DZIF), Partner-site Hannover-Braunschweig, Germany.
authors.forename: M
authors.identifier: 0000-0002-9141-8001
authors.initials: M
authors.lastname: Cornberg
authors.affiliation: IFI-Institute for Interdisciplinary Medicine, Hamburg, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Petersen
authors.affiliation: Hepatologische Praxis, Göttingen, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Schober
authors.affiliation: Center for HIV and Hepatogastroenterology, Duesseldorf, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Mauss
authors.affiliation: Hepatologische Praxis, Hannover, Germany.
authors.forename: K H W
authors.initials: KH
authors.lastname: Böker
authors.affiliation: MVZ Offenburg, Offenburg, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Link
authors.affiliation: Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Günther
authors.affiliation: Leberstiftungs-GmbH Deutschland, Hannover, Germany.
authors.forename: Y
authors.initials: Y
authors.lastname: Serfert
authors.affiliation: e.factum GmbH, Butzbach, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Pfeiffer-Vornkahl
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany and German Center for Infection Research (DZIF), Partner-site Hannover-Braunschweig, Germany.
authors.forename: M P
authors.initials: MP
authors.lastname: Manns
authors.affiliation: St.-Josefs-Hospital Wiesbaden and University Hospital Frankfurt, Frankfurt, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Sarrazin
authors.affiliation: Hepatologische Schwerpunktpraxis Herne, Herne, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Hüppe
authors.affiliation: University Hospital Leipzig, Leipzig, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Berg
authors.affiliation: St. Josef-Hospital Katholisches Klinikum Oberhausen, Oberhausen, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Niederau
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000627:therapeutic use; 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; D012042:Registries; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D012254:Ribavirin