Burden of disease in patients with chronic hepatitis C in the Austrian REAL study
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The direct-acting antiviral regimen of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± ribavirin (RBV) is approved to treat patients with chronic hepatitis C (CHC) infection genotypes 1 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 12 weeks after the end of treatment (SVR12). EuroQol 5 Dimension 5 Level (EQ-5D-5L) and Work Productivity and Activity Impairment HepC v2.0 (WPAI) questionnaires were used to assess PROs.
A total 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 72 patients, respectively. All PROs remained generally unaltered during treatment with OBV/PTV/r ± DSV ± RBV but showed a statistically significant (p < 0.01) improvement 12 weeks after the end of treatment versus baseline.
These are the first data on PROs in a real-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 genotype 1 and 4 in everyday clinical practice.
KeywordsChronic hepatitis C Dasabuvir Ombitasvir/paritaprevir/ritonavir Direct-acting antivirals Patient-reported outcome measures
Statistical support was provided by Ina Burghaus, PhD, of Prometris GmbH, Mannheim, Germany, and medical writing support was provided by Ulrike Hauf-Zachariou, MD, of IST GmbH, Mannheim, Germany, both funded by AbbVie. The authors would like to express their gratitude to the study participants, investigators, and coordinators who made this study possible.
Compliance with ethical guidelines
Conflict of interest
AbbVie sponsored this study and contributed to the design, study conduct, and analysis. AbbVie participated in the interpretation of data, review, and approval of the manuscript. All authors had access to all relevant data. M. Gschwantler: advisor for AbbVie, Gilead, BMS, MSD, and Janssen; received speaker fees from AbbVie, Gilead, BMS, MSD, and Janssen; grants from AbbVie, Gilead and MSD. T. Bamberger: advisor for AbbVie, BMS, and MSD; received speaker fees from AbbVie, Gilead, and BMS. I. Graziadei: advisory board: AbbVie, Gilead, BMS, MSD, and Janssen; received speaker fees from AbbVie, Gilead, BMS, and MSD. A. Maieron: advisor for AbbVie, Gilead, BMS, MSD, and Janssen; received speaker fees from AbbVie, Gilead, BMS, MSD, and Janssen. N. Katalinic: AbbVie employee and may hold AbbVie stock or options. R. Stauber: advisor for AbbVie, BMS, Gilead, and MSD; received speaker fees from AbbVie, BMS, and Gilead; and research grant from AbbVie.
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. Informed consent was obtained from all patients included in the study.
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