title: Effects of sofosbuvir-based treatment, with and without interferon, on outcome and productivity of patients with chronic hepatitis C.
abstract: OBJECTIVE
  Interferon-based treatment of chronic hepatitis C virus (HCV) infection can negatively affect patient-reported outcomes (PROs) and work productivity (WP). We assessed these factors in patients with chronic hepatitis C treated with sofosbuvir and ribavirin, with or without pegylated interferon.
  
  
  METHODS
  The HCV-specific Quality of Life (Chronic Liver Disease Questionnaire-HCV version [CLDQ-HCV]), Functional Assessment of Chronic Illness Therapy-Fatigue, and Work Productivity and Activity Index: Specific Health Problem questionnaires were completed before, during, and after treatment of patients infected with HCV genotypes 2 or 3 who received sofosbuvir and ribavirin for 16 or 12 weeks (the FUSION study, n = 201) or patients infected with HCV genotype 1 who received pegylated interferon, sofosbuvir, and ribavirin for 12 weeks (the NEUTRINO study, n = 327).
  
  
  RESULTS
  Patients in each group of the FUSION study had similar PRO and WP scores at each time point (all comparisons, P > .05). Compared with baseline, patients had modest reductions in fatigue, HCV-specific quality of life, and WP and Activity Index scores during treatment (P = .02 to <.0001). However, by 4 weeks after treatment, all scores returned to baseline levels or higher. Subjects in the NEUTRINO study had greater reductions in these scores during treatment; most remained significant through 4 weeks after treatment (P < .05). Significant improvements in PROs were observed among patients with sustained virologic responses 12 weeks after treatment in the FUSION and NEUTRINO studies (all P < .05). In multivariate analyses after adjustment for confounders, interferon therapy was independently associated with worse PROs after 12 weeks of treatment.
  
  
  CONCLUSIONS
  On the basis of an analysis of 2 large clinical trials (FUSION and NEUTRINO), patient outcome and productivity are more negatively affected by the inclusion of pegylated interferon in treatment than by interferon-free regimens. Patients with sustained virologic responses 12 weeks after treatment had significant improvements in PROs in both studies.
authors: Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia. Electronic address: zobair.younossi@inova.org.
authors: Zobair M
authors: ZM
authors: Younossi
authors: Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia.
authors: Maria
authors: M
authors: Stepanova
authors: Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia.
authors: Linda
authors: L
authors: Henry
authors: Auckland City Hospital, Auckland, New Zealand.
authors: Edward
authors: E
authors: Gane
authors: Weill Cornell Medical College, New York, New York.
authors: Ira M
authors: IM
authors: Jacobson
authors: Texas Liver Institute, University of Texas Health Science Center, San Antonio, Texas.
authors: Eric
authors: E
authors: Lawitz
authors: University of Florida, Gainesville, Florida.
authors: David
authors: D
authors: Nelson
authors: Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia.
authors: Lynn
authors: L
authors: Gerber
authors: Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia.
authors: Fatema
authors: F
authors: Nader
authors: Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia.
authors: Sharon
authors: S
authors: Hunt
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D004526:Efficiency; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007372:Interferons / Q000627:therapeutic use*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012254:Ribavirin / Q000627:therapeutic use; D000069474:Sofosbuvir; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014542:Uridine Monophosphate / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D012254:Ribavirin; D007372:Interferons; D014542:Uridine Monophosphate; D000069474:Sofosbuvir
keywords: CLDQ-HCV; FACIT-F; Hepatitis C; Liver Disease; Quality of Life; WPAI