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 0.024–0.103
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.
Graphical abstract
Graphical Abstract
Abbreviations:
HRQL (health-related quality of life), CLDQ-HCV (Chronic Liver Disease Questionnaire-Hepatitis C Virus), SF-36 (Short Form-36), FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue), WPAI:SHP (Work Productivity and Activity Index:Specific Health Problem), CH-C (chronic hepatitis C), HCV (hepatitis C virus), SOF (sofosbuvir), LDV (ledipasvir), RBV (ribavirin), SVR (sustained virologic response), PF (physical functioning), RP (role physical), BP (bodily pain), GH (general health), VT (vitality), SF (social functioning), RE (role emotional), MH (mental health), PCS (physical component summary), MCS (mental component summary), PWB (physical well-being), EWB (emotional well-being), SWB (social well-being), FWB (functional well-being), FS (fatigue scale), AE (activity/energy scale), EM (emotional scale), WO (worry scale), SY (systemic scale), WI (work productivity impairment), AI (activity impairment), HU (health utility)Keywords
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Article info
Publication history
Published online: March 18, 2015
Accepted:
March 3,
2015
Received in revised form:
February 6,
2015
Received:
October 7,
2014
See Editorial, pages 300–302Identification
Copyright
© 2015 European Association for the Study of the Liver. Published by Elsevier Inc. All rights reserved.
