• Zobair M Younossi, Maria Stepanova, Rafael Esteban, Ira Jacobson, Stefan Zeuzem, Mark Sulkowski, Linda Henry, Fatema Nader, Rebecca Cable, Mariam Afendy, and Sharon Hunt.
• Department of Medicine, Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA Center for Outcomes Research in Liver Diseases (COR-LD), Washington, DC Internal Medicine, Hepatology, and Liver Unit, Universitari Vall D' Hebron, Barcelona, Spain Department of Medicine, Mount Sinai Medical Center, New York, NY Department of Internal Medicine, Goethe University Hospital, Frankfurt, Germany Department of Medicine, Johns Hopkins University, Baltimore, MD.
• Medicine (Baltimore). 2017 Feb 1; 96 (7): e5914.

AbstractPatient-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.

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