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Conference/Presentation Title: | Impact of elbasvir/grazoprevir (EBR/GZR) on health-related quality of life (HRQOL) and fatigue in patients with chronic hepatitis C virus (HCV) infection and inherited blood disorders (IBLD): Data from the C-EDGE IBLD study. | Authors: | Li M.;Morgan L.;Talwani R.;Kwo P.;Arduino J.M.;Vierling J.M.;Sobhonslidsuk A.;Papatheodoridis G.;Assy N.;Rosenberg W.;Guyader D.;Dev A. ;Gordon S.C.;Pol S.;Luketic V.A.;Khemichian S.;Evans B. | Institution: | (Vierling) Baylor College of Medicine, Houston, TX, United States (Sobhonslidsuk) Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (Papatheodoridis) Laiko General Hospital, Athens, Greece (Assy) Galilee Medical Center, Western Galilee, Israel (Rosenberg) Institute for Liver and Digestive Health UCL, London, United Kingdom (Guyader) Hopital Pontchaillou, Rennes, France (Dev) Monash Health, Melbourne, Australia (Gordon) Henry Ford Health System, Detroit, MI, United States (Pol) Hopital Cochin, Paris, France (Luketic) McGuire Research Institute and Virginia Commonwealth University School of Medicine, Richmond, VA, United States (Khemichian) Keck School of Medicine, University of Southern California, Los Angeles, CA, United States (Evans, Morgan, Li, Talwani, Arduino) Merck and Co., Inc., Kenilworth, NJ, United States (Kwo) Stanford University Medical Center, Stanford, CA, United States | Presentation/Conference Date: | 16-Mar-2018 | Copyright year: | 2017 | Publisher: | Elsevier B.V. | Publication information: | Journal of Hepatology. Conference: International Liver Congress 2017 - 52nd Annual Meeting of the European Association for the Study of the Liver. Amsterdam Netherlands. 66 (1 Supplement 1) (pp S521-S522), 2017. Date of Publication: 2017. | Abstract: | Background and Aims: Chronic HCV infection and IBLD are knownto negatively impact patients' HRQOL and cause fatigue. C-EDGE IBLD, a double-blind, placebo-control, Phase 3 trial, randomized patients with HCV genotype 1, 4 or 6 infection and IBLD (hemophilia A/B, von Willebrand disease, beta-thalassemia, or sickle cell anemia) in a 2:1 ratio to either an immediate treatment group (ITG; 12 weeks of EBR/GZR) or deferred treatment group (DTG; 12 weeks of placebo, followed by open-label EBR/GZR). An aim of this study was to compare the HRQOL and fatigue profiles between the EBR/GZR ITG to the placebo DTG. Method(s): Patients completed the SF-36v2RAcute Health Survey and the FACIT-Fatigue Scale. 159 patients were randomized and received >=1 dose of study drug (EBR/GZR: n = 107; placebo: n = 52). Mean change from baseline scores (95% confidence intervals (CI)) and differences between treatment groups' mean change scores (95% CI) were estimated for Physical Functioning (PF), Role-Limitations Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (V), Social Functioning (SF), Role-Limitations Emotional (RE), Mental Health (MH), mental component summary (MCS), physical component summary (PCS) and fatigue. Result(s): Over 96% of patients completed a baseline and >= 1 postbaseline assessment. Baseline mean HRQOL and fatigue scores were similar between EBR/GZR ITG and placebo DTG. During the treatment phase, only GH [TW4: 3.4 (0.7,6.1); TW12: 4.9 (1.5,8.3)] changed significantly in the EBR/GZR ITG and only MH [TW4: -4.5 (-8.3, -0.7)] in the placebo DTG. While the EBR/GZR ITG had better mean change scores than the placebo DTG at TW12, none of the differences were significant. At FW4, The EBR/GZR ITG had significantly improved GH (4.9 (1.4,8.3)) and V (4.4 (0.7,8.1)), which were maintained during follow-up. In contrast, the placebo DTGsignificantly declined in RE (-8.8 (-14.8,-2.9)), MH (-4.3 (-8.4, -0.2)) and MCS (-2.7 (-4.9,-0.4)). EBR/GZR ITG had significantly better mean change scores than the placebo DTG at FW4 [Treatment differences for: PF (5.8 (0.3,11.3)), RP (8.7 (0.3,17.1)), GH (6.1 (0.4,11.8)), RE (8.7 (1.1,16.3)), MH (5.4 (0.1,10.7)), MCS (3.1 (0.5,5.8))]. Fatigue declined significantly in the EBR/GZR ITG at TW4 (-1.5 (-2.8,-0.1)) and the placebo DTG at TW12 (-3.2 (-6.0, -0.4)). Fatigue did not differ between treatment groups during the study period (Figure presented). Conclusion(s): EBR/GZR treatment had a more favorable impact on the HRQOL profile as compared with placebo-treated patients with chronic HCV infection and IBLD. | Conference Start Date: | 2017-04-19 | Conference End Date: | 2017-04-23 | ISSN: | 1600-0641 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/38951 | Type: | Conference Abstract | Subjects: | double blind procedure drug therapy *fatigue female follow up health survey *hemophilia A hemophilia B Hepatitis C virus genotype 1 human major clinical study male mental health nonhuman pain adult *quality of life randomized controlled trial sickle cell anemia social interaction visually impaired person von Willebrand disease *elbasvir plus grazoprevir placebo conference abstract beta thalassemia phase 3 clinical trial *chronic hepatitis C controlled study Hepatitis C virus genotype 1 human major clinical study male mental health nonhuman pain phase 3 clinical trial *quality of life randomized controlled trial sickle cell anemia social interaction visually impaired person von Willebrand disease health survey follow up female *fatigue drug therapy double blind procedure adult hemophilia B controlled study *chronic hepatitis C beta thalassemia *hemophilia A |
Type of Clinical Study or Trial: | Randomised controlled trial |
Appears in Collections: | Conferences |
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