Z Gastroenterol 2017; 55(05): e28-e56
DOI: 10.1055/s-0037-1603411
Hepatologie
Georg Thieme Verlag KG Stuttgart · New York

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

M Gschwantler
1   Wilhelminen Hospital, Department of Medicine IV, Vienna, Austria
,
P Ferenci
2   Medical University of Vienna, Department for Internal Medicine III, Vienna, Austria
,
B Bauer
3   LKH Hörgas-Enzenbach, Department of Internal Medicine, Hörgas, Austria
,
H Laferl
4   Kaiser-Franz-Josef Hospital, Department of Internal Medicine IV, Infectious Disease, Vienna, Austria
,
T Bamberger
5   Kepler University Hospital, Department of Internal Medicine II and GESPAG KH Schärding, Department of Internal Medicine, Linz and Schärding, Austria
,
R Stauber
6   Medical University of Graz, Department of Internal Medicine, Graz, Austria
,
I Graziadei
7   Academic Teaching Hospital, Department of Internal Medicine, Hall, Austria
,
A Teskey
8   AbbVie GmbH, Vienna, Austria
,
A Maieron
9   Elisabethinen Hospital Linz, Department of Internal Medicine 4, Gastroenterology & Hepatology and University Clinic St. Pölten, Department of Internal Medicine 2, Gastroenterology & Hepatology, Linz and St. Pölten, Austria
› Author Affiliations
Further Information

Publication History

Publication Date:
16 May 2017 (online)

Also available at
 

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.

Tab. 1:

Baseline Characteristics

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%)