Efficacy and safety of IFN-free antiviral therapy in patients with HCV recurrence after liver transplantation: real-life experience from Austria

S Beinhardt; C Freissmuth; R Al-Zoairy; K Kozbial; S Hamethner; S Hametner; R Sern

doi:10.1055/s-0035-1551752

Zeitschrift für Gastroenterologie, Table of Contents

Efficacy and safety of IFN-free antiviral therapy in patients with HCV recurrence after liver transplantation: real-life experience from Austria

S Beinhardt ¹, C Freissmuth ¹, R Al-Zoairy ², K Kozbial ¹, S Hamethner ³, S Hametner ⁴, R Sern ¹

¹Medizinische Universität Wien; Innere Medizin III, Gastroenterologie und Hepatologie, Wien, Austria
²Department of Internal Medicine II, Division of Gastroenterololgy and Hepatology, Medical University of Innsbruck, Innsbruck, Austria, Innsbruck, Austria
³Medizinisch Innere Medizin III, Gastroenterologie und Hepatologie, Wien, Austria
⁴Hospital Elisabethinen, Linz, Austria;, Linz, Austria

Abstract

Background & Aims: Patients with hepatitis C virus (HCV) recurrence after orthotopic liver transplantation (OLT) have a high need of antiviral therapy due to accelerated progression of the disease. IFN-free regimens revealed promising efficacy and safety data in clinical studies. We evaluated real-life experience of efficacy and safety of all-oral regimens in patients with HCV-recurrence after OLT.

Patients & Methods: 77 OLT-patients and 5 with liver/kidney-transplantation started an all-oral anti-HCV treatment. 68 beyond treatment-week 4 were analyzed (male: 54/79%, age: 59 ± 9 [33 – 78] years, GT-1: 51 [1a: 13; 1b: 35; 1 g: 1, no subtype: 2 ]; GT-3a: 10; GT-4: 6 [h: 1]; missing: 1). Time from OLT to treatment was 77 ± 67 months. 7 patients had fibrosing cholestatic hepatitis (FCH), 37 cirrhosis (CPS-A: 31; CPS-B/C: 6), 47/69% were treatment-experienced. 53/78% patients received immunosuppression with calcineurin-, the others with mTor-inhibitors.

Treatment regimens were: Sofosbuvir (SOF) with ribavirin (RBV): 18 (27%), SOF/Daclatasvir (DCV): 39, SOF/Simeprevir (SIM): 7, SOF/Ledipasvir (LDV): 3; one patient received SIM/DCV. HCV-RNA-quantification was performed with Abbott RealTime HCV ([ART], lower limit of quantification [LLOQ]: 12IU/ml) or Roche COBAS AmpliPrep/COBAS TaqMan assay (LLOQ: 15IU/ml).

Results: At present 51 patients reached end-of-treatment and 33 end of follow up. Overall SVR12 rate was 29/33 (88%; see table). 2 FCH-patients died at weeks 8 and 20, respectively. Two patients interrupted treatment before week 12; one was transplanted at week10, the other was hospitalized for hepatic encephalopathy; treatment was stopped at week8, but the patient reached SVR12. No episode of graft rejection was observed. Compared to baseline (BL) in SVR12-patients transaminases (BL/SVR12: ALT: 139 ± 94.3 vs. 44 ± 43.2; AST: 133 ± 105 vs. 44 ± 48, p < 0.001) decreased, platelets (133 ± 72.3 vs. 177 ± 77.9 G/L [p = 0.037]), and serum-albumin (34.5 ± 12.3 vs. 12: 40.6 ± 5.6 g/L [p = 0.048]) increased.

Conclusion: Real life-data of IFN-free DAA-based regimens in OLT-patients with HCV-recurrence show high on-treatment and SVR-rates with favorable safety-profile. Additionally