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DOI: 10.1055/s-0037-1603411
Burden of disease in patients with chronic hepatitis C in the Austrian REAL Study
Publikationsverlauf
Publikationsdatum:
16. Mai 2017 (online)
Background:
The direct-acting antiviral regimen of ombitasvir (OBV), paritaprevir co-dosed with ritonavir [PTV/r])± dasabuvir (DSV)± ribavirin (RBV) was approved in 2015 in Europe for treatment of patients with chronic hepatitis C genotype 1 (GT1) or 4 (GT4) infection. To this date, real-world data as well as data on patient-reported outcomes (PROs) on this regimen in Austria are limited.
Goals:
In this analysis, we investigated PROs as well as effectiveness in real-world for the treatment regimen of OBV/PTV/r ± DSV ± RBV.
Methods:
GT1 and GT4-infected patients, participating in the multi-center, non-interventional cohort study REAL (NCT02582658) in Austria receiving OBV/PTV/r ± DSV ± RBV, were included in this analysis. Efficacy was assessed by SVR12. Health-related quality of life (HRQoL) and work productivity were assessed by standardized questionnaires (EQ-5D-5L; WPAI Hep C V2.0; PAM-13).
Results:
A total of 165 patients received the regimen of OBV/PTV/r ± DSV ± RBV. Baseline characteristics are shown in the table. Assessment of HRQoL by EQ-5D-5L in patients with data available at baseline (BL) and end of treatment (EoT) revealed no major mean change in index score [0.011 (SD: 0.140); n = 120]. Analysis of total activity impairment scores by WPAI revealed no significant differences between BL (mean 23.0; SD: 26.4; n = 135) and EoT (mean 21.3; SD: 25.6; n = 110). SVR12 was reached by 138 of 144 (95.8%) patients who completed the study and reasons for not achieving SVR12 were virological failures.
Conclusions:
This study demonstrated for the first time that the treatment with OBV/PTV/r ± DSV ± RBV did not negatively impact HRQoL and total activity of patients in a real-world setting in Austria. SVR12 rate was similar to those seen in previous clinical trials.
OBV/PTV/r ± DSV ± RBV (N = 165) |
|
Male, n (%) |
115 (69.7%) |
Age > 65 Years, n (%) |
26 (15.8%) |
HCV Genotype, n (%) |
|
GT1a |
70 (42.4%) |
GT1b |
87 (52.7%) |
GT4 |
8 (4.9%) |
Liver Cirrhosis, n (%) |
23 (13.9%) |
Prior HCV-Treatment, n (%) |
62 (37.6%) |
HCV Treatment |
|
OBV/PTV/r + RBV (12 Weeks) |
7 (4.2%) |
OBV/PTV/r + DSV (12 Weeks) |
105 (63.6%) |
OBV/PTV/r + DSV + RBV (12 Weeks) |
53 (32.1%) |
Suspected Transmission |
|
Drug Use (i.v.) |
52 (31.5%) |
Occupational |
2 (1.2%) |
Blood Transfusion or Transplantation |
25 (15.2%) |
Perinatal |
1 (0.6%) |
Contaminated medical device (other than i.v. drug use) |
4 (2.4%) |
Other |
4 (2.4%) |
Unknown |
77 (46.7%) |