Z Gastroenterol 2015; 53 - P58
DOI: 10.1055/s-0035-1551746

Efficacy of interferon-free all-oral regimens in the treatment of chronic Hepatitis C outside from clinical trials – a “real life experience”

A Karpi 1, S Moser 1, E Gutic 1, M Schleicher 1, B Hellmich 1, M Gschwantler 1
  • 1Wilhelminenspital, Department of Internal Medicine IV, Vienna, Austria

Background: Phase-III studies with interferon-free all-oral regimens have yielded SVR12-rates exceeding 90%. The aim of this study was to assess, whether these excellent results can be reproduced outside from clinical trials in difficult-to-treat patients with advanced liver disease in a “real-life-setting”.

Patients and Methods: A total of 97 patients, who started treatment with an all-oral regimen outside from clinical trials at our outpatient clinic between 20.6.2014 and 10.3.2015, were included. The study population comprised 62 males and 35 females (mean age: 55 ± 22 years). The frequency of genotypes (GT) was: GT1a: 32, GT1b: 31, GT2: 3, GT3: 24, GT4: 7. Fibrosis stage was F3 in 14 patients. 71 patients had cirrhosis (Child-Pugh class A: 63, class B: 6, class C: 2). In 5 patients with low-grade fibrosis, treatment was reimbursed by insurances on account of severe extrahepatic manifestations, whereas one patient with fibrosis stage F2 decided to pay for treatment herself. An additional 6 patients with low-grade fibrosis could be treated in the course of an early access program. Treatment regimens comprised sofosbuvir (SOF) plus daclatasvir (DCV)(n = 39), simeprevir (SIM) plus SOF (n = 36), SOF plus ribavirin (R)(n = 3), SOF plus ledipasvir (n = 11), paritaprevir/ritonavir plus ombitasvir plus dasabuvir plus/minus R (n = 6) and paritaprevir/ritonavir plus ombitasvir (n = 2).

Results: So far 26 patients (including 16 patients with SOF+DCV and 10 patients with SIM+SOF) have completed treatment and at least 4 weeks of follow-up. SVR4 was achieved in 24/26 (92%). The two relapses were observed in GT-1 patients with Child-Pugh class A cirrhosis after 24 weeks of SOF+DCV and 12 weeks of SIM+SOF, respectively. On-treatment and post-treatment response will be presented at the meeting.

Conclusions: Our preliminary data indicate, that the excellent results of phase-III trials can be reproduced in difficult-to-treat patients in a “real-life-setting”.