Superiority of Interferon-Free Regimens for Chronic Hepatitis C: The Effect on Health-Related Quality of Life and Work Productivity

• Published in: Medicine (Baltimore) Vol. 96; no. 7; p. e5914
• Main Authors: Younossi, Zobair M., Stepanova, Maria, Esteban, Rafael, Jacobson, Ira, Zeuzem, Stefan, Sulkowski, Mark, Henry, Linda, Nader, Fatema, Cable, Rebecca, Afendy, Mariam, Hunt, Sharon
• Format: Journal Article
• Language: English
• Published: United States The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved 01-02-2017; Wolters Kluwer Health
• Subjects: Adult; Antiviral Agents - therapeutic use; Female; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - psychology; Humans; Interferons - therapeutic use; Male; Middle Aged; Observational Study; Quality of Life; Ribavirin - therapeutic use; Sofosbuvir - therapeutic use; Treatment Outcome; Work Performance
• ISSN: 0025-7974; 1536-5964
• DOI: 10.1097/MD.0000000000005914

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.