title: The patient's journey with chronic hepatitis C from interferon plus ribavirin to interferon- and ribavirin-free regimens: a study of health-related quality of life.
abstract: BACKGROUND
  Interferon and ribavirin negatively impact health-related quality of life (HRQL) during treatment.
  
  
  OBJECTIVE
  To compare the impact of interferon and/or ribavirin-containing regimens on HRQL to interferon- and ribavirin-free regimens.
  
  
  METHODS
  HRQL data from nine multinational phase 3 clinical trials of sofosbuvir (SOF)-based regimens with and without ledipasvir (LDV), pegylated interferon (IFN) or ribavirin (RBV) were used. The Short Form-36 (SF-36) HRQL questionnaire was administered to subjects prospectively at baseline, during treatment, and 12 and 24 weeks after treatment cessation.
  
  
  RESULTS
  A total of 3460 CH-C with SF-36 data were included (52.2 ± 10.3 years, 62.6% male, 73.6% treatment-naïve, 15.0% cirrhotic, 68.2% HCV genotype 1 and 20.1% genotype 3). Compared to baseline HRQL, at the end of treatment, severe HRQL decrements were noted in IFN + RBV ± SOF regimens (on average, -3.8 to -24.3 on a 0-100 scale for different HRQL domains), while moderate decrements were noted in SOF + RBV ± LDV (-2.8 to -8.6). In contrast, in SOF/LDV without RBV, HRQL improvements were noted during treatment (+2.3 to +5.2). By 12 weeks post-treatment, HRQL returned to baseline in IFN + RBV ± SOF (P > 0.05) and improved in all IFN-free arms (+2.6 to +7.8). In multivariate analysis, a lower end of treatment HRQL was associated with IFN + RBV + SOF and a higher end of treatment HRQL was associated with SOF/LDV. By post-treatment-12, SOF/LDV was additionally associated with higher mental health scores. These improvements in HRQL scores were maintained 24 weeks post-treatment.
  
  
  CONCLUSIONS
  Removing interferon and ribavirin has led to substantial improvement of health-related quality of life during treatment. This may result in better patient experience and higher adherence to treatment regimen.
authors.affiliation: Department of Medicine, Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA, USA.|Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, USA.
authors.forename: Z M
authors.initials: ZM
authors.lastname: Younossi
authors.affiliation: Department of Medicine, Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA, USA.|Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, USA.
authors.forename: M
authors.initials: M
authors.lastname: Stepanova
authors.affiliation: Department of Medicine, Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA, USA.|Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, USA.
authors.forename: F
authors.initials: F
authors.lastname: Nader
authors.affiliation: Department of Medicine, Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA, USA.|Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, USA.
authors.forename: B
authors.initials: B
authors.lastname: Lam
authors.affiliation: Department of Medicine, Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA, USA.|Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, USA.
authors.forename: S
authors.initials: S
authors.lastname: Hunt
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007372:Interferons / Q000627:therapeutic use*; D008297:Male; D008603:Mental Health; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012254:Ribavirin / Q000627:therapeutic use*; D000069474:Sofosbuvir / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D028761:Withholding Treatment
chemical_list: D000998:Antiviral Agents; D012254:Ribavirin; D007372:Interferons; D000069474:Sofosbuvir