Improvement of health-related quality of life and work productivity in chronic hepatitis C patients with early and advanced fibrosis treated with ledipasvir and sofosbuvir

Background & Aims: New interferon-free anti-HCV regimens are highly efficacious with a favorable safety profile. We assessed health-related quality of life (HRQL) and work productivity in patients with different stages of hepatic fibrosis treated with sofosbuvir + ledipasvir. Methods: Four questionnaires [Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV), Short Form-36 (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Work Productivity and Activity Index: Specific Health Problem (WPAI: SHP)] were administered at baseline, during, and after treatment with sofosbuvir + ledipasvir + ribavirin or sofosbuvir + ledipasvir (ION-1,2,3 clinical trials). Metavir fibrosis stage was determined from pre-treatment liver biopsies. Results: There were 1005 patients included (stage F0: n = 94; F1: n = 311; F2: n = 301; F3: n = 197; F4: n = 102). At baseline, patients with more advanced fibrosis had more HRQL impairments, predominantly related to physical functioning (stage 0 vs. stage 4 by up to 0.126 on a normalized 0-1 scale p < 0.0001). During and post-treatment, HRQL remained lower in patients with advanced fibrosis. After achieving sustained virologic response, significant improvements from baseline in most HRQL domains were observed regardless of fibrosis stage (by 0.0240.103 on a 0-1 scale; all p > 0.05 across fibrosis stages). In multivariate analysis, advanced fibrosis was independently associated with impairment of HRQL and work productivity (beta up to -0.056 in comparison with none-to-mild fibrosis, p < 0.05). However, improvement of HRQL and work productivity after viral clearance was not related to the stage of fibrosis (all p > 0.05). Conclusions: Although advanced hepatic fibrosis is associated with HRQL and work productivity impairment, viral eradication with sofosbuvir + ledipasvir leads to HRQL improvement regardless of fibrosis stage. HCV patients with early fibrosis experience similar improvement of patient reported outcomes as those with advanced fibrosis. (C) 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.