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Simeprevir added to peginterferon and ribavirin lessens time with fatigue, depressive symptoms and functional limitations in patients with chronic hepatitis C compared with peginterferon and ribavirin: results from 1161 patients in the QUEST-1, QUEST-2 and PROMISE studies.
- Source :
-
Journal of viral hepatitis [J Viral Hepat] 2015 Aug; Vol. 22 (8), pp. 639-50. Date of Electronic Publication: 2014 Dec 09. - Publication Year :
- 2015
-
Abstract
- The value of adding simeprevir (SMV) vs placebo (PBO) to peginterferon and ribavirin (PR) for treatment of chronic hepatitis C virus infection was examined using patient-reported outcomes (PROs); further, concordance of PROs with virology endpoints and adverse events (AEs) was explored. Patients (n = 768 SMV/PR, n = 393 PBO/PR) rated fatigue (FSS), depressive symptoms (CES-D) and functional impairment (WPAI: Hepatitis C Productivity, Daily Activity and Absenteeism) at baseline and throughout treatment in three randomised, double-blind trials comparing the addition of SMV or PBO during initial 12 weeks of PR. PR was administered for 48 weeks (PBO group) and 24/48 weeks (SMV group) using a response-guided therapy (RGT) approach. Mean PRO scores (except Absenteeism) worsened from baseline to Week 4 to the same extent in both groups but reverted after Week 24 for SMV/PR and only after Week 48 for PBO/PR. Accordingly, there was a significantly lower area under the curve (baseline-Week 60, AUC60 ) and fewer weeks with clinically important worsening of scores in the SMV/PR group at any time point. Incidences of patients with fatigue and anaemia AEs were similar in both groups, but FSS scores showed that clinically important increases in fatigue lasted a mean of 6.9 weeks longer with PBO/PR (P < 0.001). PRO score subgroup analysis indicated better outcomes for patients who met the criteria for RGT or achieved sustained virological response 12 weeks post-treatment (SVR12); differences in mean PRO scores associated with fibrosis level were only observed with PBO/PR. Greater efficacy of SMV/PR enabled reduced treatment duration and reduced time with PR-related AEs without adding to AE severity.<br /> (© 2014 The Authors. Journal of Viral Hepatitis published by John Wiley & Sons Ltd.)
- Subjects :
- Adolescent
Adult
Aged
Anemia epidemiology
Double-Blind Method
Drug-Related Side Effects and Adverse Reactions epidemiology
Female
Hepatitis C, Chronic complications
Humans
Incidence
Interferons adverse effects
Liver pathology
Male
Middle Aged
Placebos administration & dosage
Ribavirin adverse effects
Simeprevir adverse effects
Treatment Outcome
Viral Load
Young Adult
Depression epidemiology
Fatigue epidemiology
Hepatitis C, Chronic drug therapy
Interferons administration & dosage
Ribavirin administration & dosage
Simeprevir administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1365-2893
- Volume :
- 22
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Journal of viral hepatitis
- Publication Type :
- Academic Journal
- Accession number :
- 25487355
- Full Text :
- https://doi.org/10.1111/jvh.12365