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Burden of disease in patients with chronic hepatitis C in the Austrian REAL study
Michael Gschwantler1,2, Thomas Bamberger3,4, Ivo Graziadei5
1Department of Medicine IV, Wilhelminen Hospital, Montleartstraße 37, 1160, Vienna, Austria. michael.gschwantler@wienkav.at.
Insights
The ombitasvir/paritaprevir/ritonavir regimen effectively treated chronic hepatitis C genotypes 1 and 4 in real-world Austrian patients. Patient-reported outcomes remained stable during treatment and improved significantly post-treatment, indicating no negative impact on quality of life.
Area of Science:
- Hepatology
- Virology
- Clinical Pharmacology
Background:
- Direct-acting antiviral (DAA) regimens, including ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± ribavirin (RBV), are approved for chronic hepatitis C (CHC) genotypes 1 or 4.
- These regimens are indicated for patients with CHC, including those with compensated cirrhosis.
Purpose of the Study:
- To evaluate the effectiveness of the OBV/PTV/r ± DSV ± RBV regimen in a real-world Austrian setting.
- To assess the impact of this DAA regimen on patient-reported outcomes (PROs) in CHC patients.
Main Methods:
- Prospective, multicenter, observational study design (REAL study).
- Effectiveness measured by sustained virologic response 12 weeks post-treatment (SVR12).
- PROs assessed using EuroQol 5 Dimension 5 Level (EQ-5D-5L) and Work Productivity and Activity Impairment (WPAI) questionnaires.
Main Results:
- High SVR12 rates: 95.9% in the core population with sufficient follow-up and 84.8% in the overall core population.
- PROs, including EQ-5D-5L scores and WPAI activity impairment, remained largely unchanged during treatment.
- A statistically significant improvement in PROs was observed 12 weeks after treatment completion compared to baseline.
Conclusions:
- The OBV/PTV/r ± DSV ± RBV regimen demonstrates effectiveness in real-world clinical practice for CHC genotypes 1 and 4.
- Treatment with this DAA regimen does not negatively impact patients' quality of life.
- These findings support the use of OBV/PTV/r ± DSV ± RBV in routine clinical management of CHC.
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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