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.

Abstract

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.

• Authors: Zobair M Younossi, Maria Stepanova, Nezam Afdhal, Kris V Kowdley, Stefan Zeuzem, Linda Henry, Sharon L Hunt, Patrick Marcellin
• Journal: Journal of hepatology (J Hepatol) Vol. 63 Issue 2 Pg. 337-45 (Aug 2015) ISSN: 1600-0641 [Electronic] Netherlands
• PMID: 25795586 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Chemical References

• Antiviral Agents
• Benzimidazoles
• DNA, Viral
• Fluorenes
• ledipasvir
• Sofosbuvir

Topics

• Antiviral Agents (administration & dosage)
• Benzimidazoles (administration & dosage)
• DNA, Viral (genetics)
• Dose-Response Relationship, Drug
• Drug Therapy, Combination
• Female
• Fluorenes (administration & dosage)
• Hepacivirus (genetics)
• Hepatitis C, Chronic (complications, drug therapy, virology)
• Humans
• Liver Cirrhosis (diagnosis, drug therapy, etiology)
• Male
• Middle Aged
• Quality of Life
• Sofosbuvir (administration & dosage)
• Surveys and Questionnaires