PMID- 23725204
OWN - NLM
STAT- MEDLINE
DCOM- 20140128
LR  - 20181203
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Linking)
VI  - 38
IP  - 2
DP  - 2013 Jul
TI  - Health-related quality of life in genotype 1 treatment-naive chronic hepatitis C 
      patients receiving telaprevir combination treatment in the ADVANCE study.
PG  - 124-33
LID - 10.1111/apt.12354 [doi]
AB  - BACKGROUND: Chronic hepatitis C virus (HCV) infection and its treatment impact 
      patients' health-related quality of life (HRQL). AIM: To report on treatment 
      impact and predictors of HRQL among treatment-naive patients with genotype 1 
      chronic HCV infection who received 12-week telaprevir (T) with 24 (T12PR24) or 48 
      weeks (T12PR48) peginterferon alpha-2a/ribavirin (PR), or 48 weeks of PR in the 
      ADVANCE study. METHODS: The EQ-5D-3L (EQ-5D) questionnaire (index range: 0-1) was 
      completed at baseline and weeks 4, 12, 24, 36, 48 and 72. Patients indicated 
      their health state on five dimensions: mobility, self-care, usual activities, 
      pain/discomfort and anxiety/depression. Descriptive statistics for the EQ-5D 
      index and descriptive system and area under the curve from baseline to week 12 
      were calculated. Predictors of EQ-5D index were identified using multivariate 
      analyses. RESULTS: Data from 722 patients were included. The mean EQ-5D index 
      decreased during the first 12 weeks and returned to baseline by week 72 (T12PR24 
      by week 36) across treatments. In multivariate analysis, sustained virological 
      response (SVR) at week 72 was associated (P < 0.0001) with improved EQ-5D index 
      [mean; SVR+ (0.90), SVR- (0.86)], a 4% difference, within the published range of 
      minimal clinically important difference. CONCLUSIONS: Post hoc analyses of data 
      from ADVANCE suggested that HRQL worsened during the first 12 weeks of therapy 
      and returned to baseline by week 72 across treatments. Improvements were observed 
      early following completion of a 24-week treatment (T12PR24). Telaprevir 
      combination therapy was associated with slightly higher reductions in HRQL during 
      the first 12 weeks (vs. PR). SVR was a statistically significant and meaningful 
      predictor of HRQL at week 72.
CI  - (c) 2013 John Wiley & Sons Ltd.
FAU - Vera-Llonch, M
AU  - Vera-Llonch M
AD  - Vertex Pharmaceuticals Incorporated, Cambridge, MA 02139, USA. 
      montserrat_vera-llonch@vrtx.com
FAU - Martin, M
AU  - Martin M
FAU - Aggarwal, J
AU  - Aggarwal J
FAU - Donepudi, M
AU  - Donepudi M
FAU - Bayliss, M
AU  - Bayliss M
FAU - Goss, T
AU  - Goss T
FAU - Younossi, Z
AU  - Younossi Z
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130603
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (Antiviral Agents)
RN  - 0 (Interferon-alpha)
RN  - 0 (Oligopeptides)
RN  - 0 (Recombinant Proteins)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 49717AWG6K (Ribavirin)
RN  - 655M5O3W0U (telaprevir)
RN  - Q46947FE7K (peginterferon alfa-2a)
SB  - IM
MH  - Adult
MH  - Antiviral Agents/*therapeutic use
MH  - Area Under Curve
MH  - Drug Therapy, Combination
MH  - Female
MH  - Genotype
MH  - Health Status
MH  - Hepacivirus/*genetics/isolation & purification
MH  - Hepatitis C, Chronic/*drug therapy/virology
MH  - Humans
MH  - Interferon-alpha/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Oligopeptides/*therapeutic use
MH  - Polyethylene Glycols/*therapeutic use
MH  - Prospective Studies
MH  - *Quality of Life
MH  - Recombinant Proteins/therapeutic use
MH  - Ribavirin/*therapeutic use
MH  - Surveys and Questionnaires
MH  - Time Factors
MH  - Viral Load
EDAT- 2013/06/04 06:00
MHDA- 2014/01/29 06:00
CRDT- 2013/06/04 06:00
PHST- 2013/03/27 00:00 [received]
PHST- 2013/04/03 00:00 [revised]
PHST- 2013/05/08 00:00 [revised]
PHST- 2013/05/09 00:00 [accepted]
PHST- 2013/06/04 06:00 [entrez]
PHST- 2013/06/04 06:00 [pubmed]
PHST- 2014/01/29 06:00 [medline]
AID - 10.1111/apt.12354 [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2013 Jul;38(2):124-33. doi: 10.1111/apt.12354. Epub 2013 
      Jun 3.