Effects of sofosbuvir-based treatment, with and without interferon, on outcome and productivity of patients with chronic hepatitis C

Clin Gastroenterol Hepatol. 2014 Aug;12(8):1349-59.e13. doi: 10.1016/j.cgh.2013.11.032. Epub 2013 Dec 6.


Background & aims: 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.

Keywords: CLDQ-HCV; FACIT-F; Hepatitis C; Liver Disease; Quality of Life; WPAI.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antiviral Agents / therapeutic use*
  • Efficiency
  • Genotype
  • Hepacivirus / classification
  • Hepacivirus / genetics
  • Hepacivirus / isolation & purification
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Interferons / therapeutic use*
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Ribavirin / therapeutic use
  • Sofosbuvir
  • Surveys and Questionnaires
  • Treatment Outcome
  • Uridine Monophosphate / analogs & derivatives*
  • Uridine Monophosphate / therapeutic use


  • Antiviral Agents
  • Ribavirin
  • Interferons
  • Uridine Monophosphate
  • Sofosbuvir