title: Hepatitis C virus treatment in the 'real-world': how well do 'real' patients respond?
abstract: BACKGROUND
  Published clinical trials of the treatment of HCV are largely multicentre prospective pharmaceutical trials. Patients in clinical trials tend to have more favorable outcomes than patients in the 'real-world', due to strict patient selection and differences in treatment conditions and available resources.
  
  
  OBJECTIVE
  To assess the outcomes of Hepatitis C infected patients treated at the Barwon Health Liver Clinic with combination Pegylated interferon (PEG-IFN) and Ribavirin (RBV) therapy and to determine factors associated with a treatment response.
  
  
  METHODS
  Retrospective review of patients who received treatment for Hepatitis C at our institution's Liver Clinic from January 2001-September 2011. Patient demographics, comorbidities, treatment-related parameters and side effects were extracted from medical records and analyzed.
  
  
  RESULTS
  A total of 190 patients (120 male, 70 female) with a mean age of 42.8 years (range 20-68 years) commenced treatment. The most common genotype was genotype 3 (48.9%), followed by genotype 1 (42.6%). 150 of 190 patients (78.9%) completed treatment and had end of treatment data available. 107 of 182 patients, (58.8%) for whom sustained virologic response (SVR) rate data was available achieved an SVR. Overall response rates were; 46.9%, 68.8% and 62.4% in genotypes 1, 2 and 3 respectively. The response rate was significantly lower in 29 patients with documented cirrhosis (20.7%). Age, diabetes and alcohol abuse did not predict treatment response in our cohort. Side effects reported in 81.6% of patients included general malaise, hematological disturbance and psychiatric issues, and necessitated cessation of therapy in 16 patients (8.4%) and dose reduction in 26 patients (13.7%).
  
  
  CONCLUSIONS
  Response rates to combination PEG-IFN and RBV therapy at our institution are comparable to other 'real-world' and pharmaceutical registration trials. Side effects of combination therapy were prominent but resulted in fewer discontinuations of therapy compared to pharmaceutical trials.
authors.affiliation: Department of Infectious Diseases, Geelong, Victoria, Australia ; Department of Medicine, Geelong, Victoria, Australia.
authors.forename: N
authors.initials: N
authors.lastname: Deborah Friedman
authors.affiliation: Deakin University School of Medicine, Geelong, Victoria, Australia.
authors.forename: Joanne H
authors.initials: JH
authors.lastname: Green
authors.affiliation: Deakin University School of Medicine, Geelong, Victoria, Australia.
authors.forename: Hanna M
authors.initials: HM
authors.lastname: Weber
authors.affiliation: Deakin University School of Medicine, Geelong, Victoria, Australia.
authors.forename: Shiny
authors.initials: S
authors.lastname: Stephen
authors.affiliation: Department of Medicine, Geelong, Victoria, Australia ; Deakin University School of Medicine, Geelong, Victoria, Australia.
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Lane
authors.affiliation: Department of Gastroenterology, Barwon Health, Geelong, Victoria, Australia.
authors.forename: Alvin Y
authors.initials: AY
authors.lastname: Ting
authors.affiliation: Department of Medicine, Geelong, Victoria, Australia ; Department of Gastroenterology, Barwon Health, Geelong, Victoria, Australia ; Deakin University School of Medicine, Geelong, Victoria, Australia.
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Watson
keywords: DAAs, directly acting agents; ETR, end of treatment response; HCV, hepatitis C virus; IVDU, intravenous drug use; NSW, new South Wales; PCR, polymerase chain reaction; PEG-IFN, pegylated interferon; RBV, ribavirin; RNA, ribonucleic acid; SVR, sustained virologic response; hepatitis C; peginterferon alfa-2a; peginterferon alfa-2b; ribavirin