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-naïve patients with genotype 1 chronic HCV infection who received 12-weektelaprevir (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.
RCT Entities:
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-naïve 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.
Authors: Kevin P Vo; Philip Vutien; Matthew J Akiyama; Vinh D Vu; Nghiem B Ha; Joy I Piotrowski; James Wantuck; Marina M Roytman; Naoky Tsai; Ramsey Cheung; Jiayi Li; Mindie H Nguyen Journal: Dig Dis Sci Date: 2015-03-28 Impact factor: 3.199
Authors: Zobair M Younossi; Maria Stepanova; Mark Sulkowski; Graham R Foster; Nancy Reau; Alessandra Mangia; Keyur Patel; Norbert Bräu; Stuart K Roberts; Nezam Afdhal; Fatema Nader; Linda Henry; Sharon Hunt Journal: Clin Infect Dis Date: 2016-07-20 Impact factor: 9.079
Authors: Benjamin P Linas; Devra M Barter; Jake R Morgan; Mai T Pho; Jared A Leff; Bruce R Schackman; C Robert Horsburgh; Sabrina A Assoumou; Joshua A Salomon; Milton C Weinstein; Kenneth A Freedberg; Arthur Y Kim Journal: Ann Intern Med Date: 2015-05-05 Impact factor: 51.598
Authors: Benjamin P Linas; Devra M Barter; Jared A Leff; Madeline DiLorenzo; Bruce R Schackman; Charles R Horsburgh; Sabrina A Assoumou; Joshua A Salomon; Milton C Weinstein; Arthur Y Kim; Kenneth A Freedberg Journal: AIDS Date: 2014-01-28 Impact factor: 4.632
Authors: Benjamin P Linas; Devra M Barter; Jared A Leff; Sabrina A Assoumou; Joshua A Salomon; Milton C Weinstein; Arthur Y Kim; Bruce R Schackman Journal: PLoS One Date: 2014-05-19 Impact factor: 3.752