Access to reimbursement of interferon-free all-oral regimens for patients with chronic Hepatitis C in Austria

Background: At present, reimbursement of interferon-free all-oral regimens for chronic hepatitis C in Austria is limited to patients with advanced liver fibrosis. The aim of this study was to assess the distribution of stages of fibrosis and hence, access to interferon-free regimens in patients presenting at our outpatient clinic.

Patients and Methods: A total of 257 consecutive patients [m/f: 161/96, mean age: 51 ± 11 years, GT 1: 11 (4.3%), GT 1a: 60 (23.3%), GT 1b: 59 (23.0%), GT2: 5 (1.9%), GT 3: 42 (16.3%), GT 4: 21 (8.2%), GT not yet available: 59 (23.0%)] who presented at our outpatient clinic between 26.09.2014 and 3.3.2015 were included in this analysis. Fibroscan® was performed in all patients using the Fibroscan® 502 Touch device with the M-probe. Cut off values for liver stiffness (LS) assessment were defined as 7.1 kPa for F ≥2, 9.5 kPa for F≥3 and 12.5 kPa for F = 4. A valid LS measurement was defined as 10 successful measurements with an interquartile range < 30%.

Results: LS values varied between 2.8 and 75.0 kPa. Valid measurements were obtained in 201/257 (78.2%) patients. F0/F1, F2 and F3 were found in 89 (44.3%), 34 (16.9%) and 26 (12.9%) patients, respectively. 52 (25.9%) patients had cirrhosis [Child A: 43 (82.7%), Child B: 4 (7.7%), Child C: 1 (1.9), NA: 4 (7.7%)]. Therefore, Fibroscan® revealed evidence for either bridging fibrosis or cirrhosis in 78/257 (30.4%) patients. In addition, 29/56 (51.8%) patients in whom no valid Fibroscan® result could be obtained, were diagnosed to have liver cirrhosis based on clinical and radiological findings and laboratory results. In three patients with fibrosis stage <F3, an interferon-free, all-oral treatment was nonetheless reimbursed due to severe extrahepatic manifestations.

Conclusion: Given current reimbursement criteria in Austria, 110/257 (42.8%) of our patients were granted access to all-oral interferon-free therapy.

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