Superiority of interferon-free regimens for chronic hepatitis C: The effect on health-related quality of life and work productivity

Zobair M. Younossi, Maria Stepanova, Rafael Esteban, Ira Jacobson, Stefan Zeuzem, Mark Sulkowski, Linda Henry, Fatema Nader, Rebecca Cable, Mariam Afendy, Sharon Hunt

Research output: Contribution to journalArticle

Abstract

Patient-reported outcomes (PROs) such as quality of life and work productivity are important for measuring patient's experience. We assessed PROs during and after treatment of hepatitis C virus (HCV) patients. Data were obtained from a phase 3 open label study of sofosbuvir and ribavirin (SOF + RBV) with and without interferon (IFN). Patients completed 4 PRO assessment instruments (SF-36, Functional Assessment of Chronic Illness Therapy-Fatigue, Chronic Liver Disease Questionnaire- HCV, Work Productivity and Activity-Specific Health Problem) before, during, and after treatment. A total of 533 patients with chronic HCV were enrolled; 28.9% treatment-naïve, 23.1% cirrhotic, 219 received IFN + SOF + RBV and 314 received IFN-free SOF + RBV. At baseline, there were no differences in PROs between the IFN-free and IFN-containing treatment arms (all P>0.05). During treatment, patients receiving IFN + SOF + RBV had a substantial impairment in their PROs (up to -24.4% by treatment week 12, up to -8.3% at week 4 post-treatment). The PRO decrements seen in the SOF + RBV arm were smaller in magnitude (up to -7.1% by treatment week 12), and all returned to baseline or improved by post-treatment week 4. By 12 weeks after treatment cessation, patients who achieved sustained viral response-12 showed some improvement of PRO scores regardless of the regimen (up to +7.1%, P<0.0001) or previous treatment experience. In multivariate analysis, the use of IFN was independently associated with lower PROs. IFN-based regimens have a profoundly negative impact to PROs. By contrast, the impact of RBV on these PROs is relatively modest. Achieving HCV cure is associated with improvement of most of the PRO scores.

Original languageEnglish (US)
Article numbere5914
JournalMedicine (United States)
Volume96
Issue number7
DOIs
StatePublished - 2017

Keywords

  • Direct-acting antivirals
  • Fatigue
  • Work productivity

ASJC Scopus subject areas

  • Medicine(all)

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    Younossi, Z. M., Stepanova, M., Esteban, R., Jacobson, I., Zeuzem, S., Sulkowski, M., Henry, L., Nader, F., Cable, R., Afendy, M., & Hunt, S. (2017). Superiority of interferon-free regimens for chronic hepatitis C: The effect on health-related quality of life and work productivity. Medicine (United States), 96(7), [e5914]. https://doi.org/10.1097/MD.0000000000005914