PMID- 25487355
OWN - NLM
STAT- MEDLINE
DCOM- 20160322
LR  - 20171124
IS  - 1365-2893 (Electronic)
IS  - 1352-0504 (Linking)
VI  - 22
IP  - 8
DP  - 2015 Aug
TI  - 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.
PG  - 639-50
LID - 10.1111/jvh.12365 [doi]
AB  - 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.
CI  - (c) 2014 The Authors. Journal of Viral Hepatitis published by John Wiley & Sons 
      Ltd.
FAU - Scott, J
AU  - Scott J
AD  - Janssen Global Services, LLC, High Wycombe, UK.
FAU - Gilles, L
AU  - Gilles L
AD  - Janssen Research and Development, Beerse, Belgium.
FAU - Fu, M
AU  - Fu M
AD  - Janssen Research and Development, Raritan, NJ, USA.
FAU - Brohan, E
AU  - Brohan E
AD  - Adelphi Values, Bollington, UK.
FAU - Panter, C
AU  - Panter C
AD  - Adelphi Values, Bollington, UK.
FAU - Arbuckle, R
AU  - Arbuckle R
AD  - Adelphi Values, Bollington, UK.
FAU - Jessner, W
AU  - Jessner W
AD  - Janssen Research and Development, Beerse, Belgium.
FAU - Beumont, M
AU  - Beumont M
AD  - Janssen Research and Development, Beerse, Belgium.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20141209
PL  - England
TA  - J Viral Hepat
JT  - Journal of viral hepatitis
JID - 9435672
RN  - 0 (Placebos)
RN  - 49717AWG6K (Ribavirin)
RN  - 9008-11-1 (Interferons)
RN  - 9WS5RD66HZ (Simeprevir)
SB  - IM
EIN - J Viral Hepat. 2016 Jun;23(6):487-91. PMID: 27122164
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anemia/epidemiology
MH  - Depression/*epidemiology
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Fatigue/*epidemiology
MH  - Female
MH  - Hepatitis C, Chronic/complications/*drug therapy
MH  - Humans
MH  - Incidence
MH  - Interferons/*administration & dosage/adverse effects
MH  - Liver/pathology
MH  - Male
MH  - Middle Aged
MH  - Placebos/administration & dosage
MH  - Ribavirin/*administration & dosage/adverse effects
MH  - Simeprevir/*administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Viral Load
MH  - Young Adult
OTO - NOTNLM
OT  - chronic hepatitis C
OT  - daily functioning
OT  - depressive symptoms
OT  - fatigue
OT  - health-related quality of life
OT  - simeprevir
EDAT- 2014/12/10 06:00
MHDA- 2016/03/24 06:00
CRDT- 2014/12/10 06:00
PHST- 2014/05/16 00:00 [received]
PHST- 2014/10/06 00:00 [accepted]
PHST- 2014/12/10 06:00 [entrez]
PHST- 2014/12/10 06:00 [pubmed]
PHST- 2016/03/24 06:00 [medline]
AID - 10.1111/jvh.12365 [doi]
PST - ppublish
SO  - J Viral Hepat. 2015 Aug;22(8):639-50. doi: 10.1111/jvh.12365. Epub 2014 Dec 9.