title: Superiority of Interferon-Free Regimens for Chronic Hepatitis C: The Effect on Health-Related Quality of Life and Work Productivity.
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.
authors.affiliation: 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.
authors.forename: Zobair M
authors.initials: ZM
authors.lastname: Younossi
authors.forename: Maria
authors.initials: M
authors.lastname: Stepanova
authors.forename: Rafael
authors.initials: R
authors.lastname: Esteban
authors.forename: Ira
authors.initials: I
authors.lastname: Jacobson
authors.forename: Stefan
authors.initials: S
authors.lastname: Zeuzem
authors.forename: Mark
authors.initials: M
authors.lastname: Sulkowski
authors.forename: Linda
authors.initials: L
authors.lastname: Henry
authors.forename: Fatema
authors.initials: F
authors.lastname: Nader
authors.forename: Rebecca
authors.initials: R
authors.lastname: Cable
authors.forename: Mariam
authors.initials: M
authors.lastname: Afendy
authors.forename: Sharon
authors.initials: S
authors.lastname: Hunt
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D007372:Interferons / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012254:Ribavirin / Q000627:therapeutic use*; D000069474:Sofosbuvir / Q000627:therapeutic use*; D016896:Treatment Outcome; D000066477:Work Performance
chemical_list: D000998:Antiviral Agents; D012254:Ribavirin; D007372:Interferons; D000069474:Sofosbuvir