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.

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.