title: An In-Depth Analysis of Patient-Reported Outcomes in Patients With Chronic Hepatitis C Treated With Different Anti-Viral Regimens.
abstract: OBJECTIVE
  Interferon- and ribavirin (RBV)-containing regimens negatively impact patients' experience. The aim of this study was to quantify the impact of different anti-viral regimens for hepatitis C on patients' work productivity, fatigue, and other patient-reported outcomes (PROs).
  
  
  METHODS
  The PRO data from multicenter multinational phase 3 clinical trials of sofosbuvir with and without interferon or RBV were retrospectively used. Treatment regimens were classified as interferon+RBV-containing, interferon-free RBV-containing, and interferon-free RBV-free. Four PRO instruments (SF-36, CLDQ-HCV, FACIT-F, and WPAI:SHP) were administered to subjects at baseline, during, and up to 24 weeks after treatment.
  
  
  RESULTS
  We included 3,425 subjects with chronic hepatitis C infection with PRO data. Patients were 62.8% male, 62.2% treatment naive, 18.1% with cirrhosis, and 72.9% with HCV genotype 1. Of the study participants, 546 received interferon+RBV+sofosbuvir, 1,721 received sofosbuvir+RBV, and 1,158 received interferon- and RBV-free ledipasvir+sofosbuvir. At baseline, there were no difference in PROs between treatment groups (all P>0.01). During treatment, the decrements in PROs were up to -23.6% for the interferon+RBV group, up to -7.0% in the sofosbuvir+RBV group, whereas there was an improvement of up to +11.6% in the interferon-free RBV-free group (all P<0.0001). In multivariate analysis, the use of interferon was independently associated with up to -26.0% worsening of the PRO scores during treatment and the use of RBV with up to -9.0% worsening. After 12 weeks post-treatment, in patients with sustained virologic response-12, improvements were observed regardless of the regimen, and these improvements continued to increase by week 24 of follow-up.
  
  
  CONCLUSIONS
  The use of interferon- and RBV-free regimens for HCV is associated with better patients' experience and work productivity during treatment.
authors.affiliation: Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia, USA.|Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia, USA.
authors.forename: Zobair M
authors.initials: ZM
authors.lastname: Younossi
authors.affiliation: Center for Outcomes Research in Liver Diseases, Washington DC, USA.
authors.forename: Maria
authors.initials: M
authors.lastname: Stepanova
authors.affiliation: Center for Outcomes Research in Liver Diseases, Washington DC, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Henry
authors.affiliation: Center for Outcomes Research in Liver Diseases, Washington DC, USA.
authors.forename: Fatema
authors.initials: F
authors.lastname: Nader
authors.affiliation: Center for Outcomes Research in Liver Diseases, Washington DC, USA.
authors.forename: Sharon
authors.initials: S
authors.lastname: Hunt
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005449:Fluorenes / Q000627:therapeutic use; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007372:Interferons / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D012189:Retrospective Studies; D012254:Ribavirin / Q000627:therapeutic use; D000069474:Sofosbuvir / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C586541:ledipasvir; D012254:Ribavirin; D007372:Interferons; D000069474:Sofosbuvir