Effects of Sofosbuvir-Based Treatment, With and Without Interferon, on Outcome and Productivity of Patients With Chronic Hepatitis C

Zobair M. Younossi, Maria Stepanova, Linda Henry, Edward Gane, Ira M. Jacobson, Eric Lawitz, David Nelson, Lynn Gerber, Fatema Nader, Sharon Hunt

Research output: Contribution to journalArticlepeer-review

76 Scopus citations

Abstract

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 12weeks after treatment had significant improvements in PROs in both studies.

Original languageEnglish (US)
Pages (from-to)1349-1359.e13
JournalClinical Gastroenterology and Hepatology
Volume12
Issue number8
DOIs
StatePublished - Aug 2014

Keywords

  • CLDQ-HCV
  • FACIT-F
  • Hepatitis C
  • Liver Disease
  • Quality of Life
  • WPAI

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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