Z Gastroenterol 2015; 53 - P62
DOI: 10.1055/s-0035-1551750

Real life experience with Interferon/Ribavirin-free antiviral treatment in renal transplant recipients and endstage renal disease-patients on dialysis infected with Hepatitis C virus

S Beinhardt 1, K Kozbial 1, A Schmidt 2, C Freissmuth 1, M Mandorfer 1, R Strassl 3, R Al-Zoairy 4
  • 1Medizinische Universität Wien; Innere Medizin III, Gastroenterologie und Hepatologie, Wien, Austria
  • 2Medizinische Universität Wien, Department of Internal Medicine III, Division of Nephrology and Dialysis, Wien, Austria
  • 3Medizinische Universität Wien,3Department of Laboratory Medicine, Division of Clinical Virology, Medical University of Vienna, Vienna, Austria; 4Division of Gastroenterology and Hepatology, Department of Medicine II, Wien, Austria
  • 4Medizinische Universität Innsbruck;4Division of Gastroenterology and Hepatology, Department of Medicine II, Innsbruck, Austria

Background & Aims: Since introduction of all-oral interferon-free treatment-regimens for hepatitis C virus infection (HCV), former "difficult to treat" patient-groups, like end-stage renal disease (ESRD)-patients or patients after renal transplant (NTx) are focused on recently, as treatment of those represented an area of unmet therapeutically need. As real-life data of sofosbuvir-based all-oral treatment-regimens is scarce, we investigated on-treatment viral response (otVR) and clinical profiles in ESRD- and NTx-patients.

Patients & Methods: Fifteen patients with chronic HCV-infection (2 GT1; 2 GT1a, 7 GT1b; 1 GT3a; 1 GT4; 1GT4a/c/d; 1 GT1b/3a; Cirrhosis: 8/53%) after NTx (11/73%) or on dialysis (5/33%) due to ESRD are being treated with sofosbuvir (SOF)/daclatasvir (DCV; N = 9), SOF/simeprevir (SIM; N = 5) or DCV/SIM (N = 1); 24h-dosage: N = 14/93%, 48h-dosage: N = 1/7% patient(s). Viral-load was measured by Abbott RealTime HCV-quantitative assay (lower limit of quantification [LLOQ]: 12IU/ml); treatment-response (defined as: TND [target not detected) evaluated at weeks: 4/8/12 (EoT)/16/24 (EoT)/SVR4/SVR12. Continuous variables were reported as mean ± SD or median (interquartile range).

Results: 15 patients (male: 11; age: 52.4 ± 13.4 [31 – 71] years mean ± SD [range] were evaluated. On-treatment response was: week4 – TND: 4/36.4%, LLOQ: 5/45.5%; week12 – TND: 5/100%; EoT – TND: 5/100%. SVR 12: 1. Treatment-duration was reduced in 1 patient to 12 weeks due to worsening of renal function (creatinine: BL: 3.01/WE12: 4.16 mg/dl; otVR: WE4: LLOQ; EoT: TND). One SOF/SIM-patient developed pancytopenia at week7; as a result treatment-regimen had to be re-evaluated and switched from 24h- to 48h-dosage with consecutive increase in HCV RNA (week 4: LLOQ – week 8: 200IU/ml). No patient required dose-adjustment of immuno-suppressive treatment or discontinuation due to further (severe) adverse events (clinical/laboratory) as far. Final SVR12-results, safety-data as well as subgroup-analyses will be presented.

Conclusion: On-treatment virological response rates with interferon-free therapy-regimens in ESRD/renal transplant-patients are promising and resulted in rapid viral on-treatment suppression. Overall SOF-based treatment-regimens were safe in patients with ESRD or after NTx; no interactions with immuno-suppressive regimens were observed.