title: Long-term outcome of chronic hepatitis C virus infection in a real-world setting: The German LOTOS study.
abstract: There are few large-scale, prospective studies comparing liver-associated events in treated and untreated patients with CHC managed in routine clinical practice.
  
  
  
  Patients with CHC were prospectively enrolled in a non-interventional study. Data from patients with available documentation who had either achieved a sustained virological response, or were non-responders, relapsers, or had virological breakthrough following treatment with peginterferon alfa-2a±ribavirin, or who had been diagnosed but never treated at least 3 years previously, and who remained under medical observation were analyzed. Primary endpoint was liver-associated events (composite of decompensation/liver failure, ascites, hepatocellular carcinoma, or liver transplant/placement on a transplant list).
  
  
  
  In all, 1444 eligible patients were identified. Mean follow-up was 4.7 (standard deviation; SD 1.1) years. Patients with sustained virological response had a lower incidence of liver-associated events vs non-responders, relapsers, or virological breakthrough and never treated patients (1.7% vs 4.7% and 4.7% respectively). The proportion of patients with cirrhosis increased from baseline in the non-responders, relapsers, or virological breakthrough (6.8%-10.5%) and never treated group (3.7%-8.4%), with an associated increase in severity, but was unchanged in the sustained virological response group (2.1%). Event-free survival was significantly higher in sustained virological response patients (P=.0082).
  
  
  
  In this "real-world" cohort, the achievement of sustained virological response almost eliminated liver-related morbidity and mortality compared with patients who failed to achieve sustained virological response and those who were untreated. Overall, the LOTOS cohort highlights the importance of timely and effective treatment for patients with CHC.
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
authors.forename: Heiner
authors.identifier: 0000-0003-2906-0480
authors.initials: H
authors.lastname: Wedemeyer
authors.affiliation: Centre for Interdisciplinary Addiction Research, University of Hamburg, Hamburg, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Reimer
authors.affiliation: Private Practice, Berlin, Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Sandow
authors.affiliation: Center of Gastroenterology, Herne, Germany.
authors.forename: Dietrich
authors.initials: D
authors.lastname: Hueppe
authors.affiliation: Infektiologikum, Frankfurt, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Lutz
authors.affiliation: Practice of Hepatology, Magdeburg, Germany.
authors.forename: Kurt
authors.initials: K
authors.lastname: Gruengreiff
authors.affiliation: Practice Center Kaiserdamm, Berlin, Germany.
authors.forename: Joerg
authors.initials: J
authors.lastname: Goelz
authors.affiliation: Center for Interdisciplinary Medicine (CIM), Muenster, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Christensen
authors.affiliation: e.factum-GmbH, Butzbach, Germany.
authors.forename: Heike
authors.initials: H
authors.lastname: Pfeiffer-Vornkahl
authors.affiliation: Roche Pharma AG, Grenzach-Wyhlen, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Alshuth
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Manns
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000601:surgery / Q000821:virology; D016208:Databases, Factual; D005260:Female; D005858:Germany; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D017093:Liver Failure / Q000401:mortality / Q000601:surgery / Q000821:virology; D008113:Liver Neoplasms / Q000401:mortality / Q000601:surgery / Q000821:virology; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D012008:Recurrence; D012307:Risk Factors; D000072230:Sustained Virologic Response; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a
keywords: cirrhosis; hepatitis C; liver; liver associated events; long-term observation