Burden of disease in patients with chronic hepatitisC in the Austrian REAL study.

Abstract

The direct-acting antiviral regimen of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± ribavirin (RBV) is approved to treat patients with chronic hepatitisC (CHC) infection genotypes1 or 4, including compensated cirrhosis. The aim of the prospective, multicenter, observational REAL study was to provide evidence of the effectiveness of this regimen in an Austrian real-world setting and to determine the impact on patient-reported outcomes (PROs). Effectiveness was defined as sustained virologic response 12weeks after the end of treatment (SVR12). EuroQol5 Dimension 5Level (EQ-5D-5L) and Work Productivity and Activity Impairment HepC v2.0 (WPAI) questionnaires were used to assess PROs. Atotal of 173 patients were enrolled. The SVR12 was 95.9% (140/146) in the core population with sufficient follow-up (i. e. patients without SVR12 data not due to efficacy/safety reasons, such as lost to follow-up, were excluded) and 84.8% (140/165) in the core population (CP). Data at all timepoints for the EQ-5D-5L index score and visual analog scale and the total activity impairment score of the WPAI were available for 88, 95 and 72patients, respectively. All PROs remained generally unaltered during treatment with OBV/PTV/r ± DSV ± RBV but showed astatistically significant (p < 0.01) improvement 12weeks after the end of treatment versus baseline. These are the first data on PROs in areal-world setting with OBV/PTV/r ± DSV ± RBV treatment; this study demonstrated that treatment did not negatively impact quality of life. Results from the Austrian REAL study support the effectiveness of OBV/PTV/r ± DSV ± RBV in patients with CHC genotype1 and 4 in everyday clinical practice.