Interferon-free Sofosbuvir containing treatment regimens in a real-life cohort of chronic Hepatitis C patients with cirrhosis

K Kozbial; C Freissmuth; R Al-Zoairy; S Moser; H Laferl; S Hametner; R Stauber; M Strasser; T Bamberger; S Beinhardt; A Stättermayer; R Stern; M Eder; M Mandorfer; H Zoller; W Vogel; I Graziadei; R Strassl; A Maieron; M Gschwantler; A Ferlitsch; M Peck-Radosavljevic; M Trauner; P Ferenci; H Hofer

doi:10.1055/s-0035-1551787

Zeitschrift für Gastroenterologie, Inhaltsverzeichnis

Interferon-free Sofosbuvir containing treatment regimens in a real-life cohort of chronic Hepatitis C patients with cirrhosis

K Kozbial ¹, C Freissmuth ¹, R Al-Zoairy ², S Moser ³, H Laferl ⁴, S Hametner ⁵, R Stauber ⁶, M Strasser ⁷, T Bamberger ⁸, S Beinhardt ¹, A Stättermayer ¹, R Stern ¹, M Eder ¹, M Mandorfer ¹, H Zoller ², W Vogel ², I Graziadei ⁹, R Strassl ¹⁰, A Maieron ¹¹, M Gschwantler ¹², A Ferlitsch ¹, M Peck-Radosavljevic ¹, M Trauner ¹, P Ferenci ¹, H Hofer ¹

¹Medizinische Universität Wien, Gastroenterologie und Hepatologie, Vienna, Austria
²Medizinische Universität Innsbruck, Gastroenterologie und Hepatologie, Innsbruck, Austria
³Wilhelminenspital/Gastroenterologie, Vienna, Austria
⁴Kaiser-Franz-Josef-Spital, Vienna, Austria
⁵Elisabethinen Linz/Gastroenterologie, Linz, Austria
⁶Medizinische Universität Graz, Gastroenterologie und Hepatologie, Graz, Austria
⁷Paracelsus Medizinische Universität Salzburg/Gastroenterologie und Hepatologie, Salzburg, Austria
⁸Allgemeines Krankenhaus Linz, Linz, Austria
⁹Landeskrankenhaus Hall, Hall, Austria
¹⁰Medizinische Universität Wien, Department für Virologie, Vienna, Austria
¹¹Elisabethinen Linz, Linz, Austria
¹²Wilhelminenspital Wien/Gastroenterologie, Vienna, Austria

Abstract

Background: Sofosbuvir (SOF), Simeprevir (SMV) and Daclatasvir (DCV) are reimbursed for chronic hepatitis C patients with advanced liver disease (F3, F4) and posttransplant patients in Austria.

Real-life data in these patients are scarce and the optimal duration of treatment is still under debate. The aim of this study was to evaluate the efficacy of SOF based treatment regimens in an Austrian-wide multicenter real world setting of chronic hepatitis C patients with cirrhosis.

Methods: 250 HCV monoinfected patients with cirrhosis (mean age: 56.5 ± 10.6 years, m/f: 167/83, treatment experienced: 161 [64%], prior failure to protease inhibitors: 35 [14%], median platelet count: 98 G/l) who were treated with Sofosbuvir 400 mg/day combined with 60 mg/day Daclatasvir (GT 1, 3, 4; n = 117) or with Simeprevir 150 mg/d (GT 1 and 4; n = 82) or weight based ribavirin (RBV; GT 1 – 4; n = 51) were included. Duration of treatment was at the discretion of the investigator. Viral load was measured after 48 hours, at weeks 1, 2, 3, 4 and then every 4 weeks until the end of treatment by Abbott RealTime HCV quantitative assay (lower limit of quantification [LLOQ]: 12IU/ml) or by Roche COBAS AmpliPrep/COBAS TaqManHCV quantitative assay, Version 2 (LLOQ: 15IU/ml).

Results: HCV-RNA dropped by a mean log of 2.91 and 3.54 after 48 hours and 7 days, respectively. At weeks 4, 8, 12, and 16 of treatment, 22%, 61%, 80%, and 90% of patients had undetectable HCV RNA (target not detected), respectively. Of the 155 patients who have reached end of treatment (treatment duration: 12 weeks: n = 50, 16 weeks: n = 15, 20 weeks: n = 3, 24 weeks: n = 87) 107 reached follow-up week 4 (97 SVR4 [90.6%]), 10 patients relapsed: 6 after SOF/RBV, 2 after SOF/SMV, 1 after SOF/DCV. 2 patients discontinued therapy due to psychiatric adverse events and 2 died during treatment (decompensation and sepsis).

Conclusions: IFN-free treatment regimens containing SOF are highly effective and well tolerated in patients with cirrhosis. Determination of on-treatment response may help to optimize treatment duration in patients with advanced liver disease.