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Erschienen in: Wiener klinische Wochenschrift 1-2/2019

14.11.2018 | original article

Burden of disease in patients with chronic hepatitis C in the Austrian REAL study

verfasst von: Prof. Dr. Michael Gschwantler, Thomas Bamberger, Ivo Graziadei, Andreas Maieron, Nives Katalinic, Rudolf Stauber

Erschienen in: Wiener klinische Wochenschrift | Ausgabe 1-2/2019

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Summary

Background

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).

Methods

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.

Results

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.

Conclusions

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.
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Metadaten
Titel
Burden of disease in patients with chronic hepatitis C in the Austrian REAL study
verfasst von
Prof. Dr. Michael Gschwantler
Thomas Bamberger
Ivo Graziadei
Andreas Maieron
Nives Katalinic
Rudolf Stauber
Publikationsdatum
14.11.2018
Verlag
Springer Vienna
Erschienen in
Wiener klinische Wochenschrift / Ausgabe 1-2/2019
Print ISSN: 0043-5325
Elektronische ISSN: 1613-7671
DOI
https://doi.org/10.1007/s00508-018-1404-2

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