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Fontana, RJ; Brown, RS; Moreno-Zamora, A; Prieto, M; Joshi, S; Londoño, MC; Herzer, K; Chacko, KR; Stauber, RE; Knop, V; Jafri, SM; Castells, L; Ferenci, P; Torti, C; Durand, CM; Loiacono, L; Lionetti, R; Bahirwani, R; Weiland, O; Mubarak, A; ElSharkawy, AM; Stadler, B; Montalbano, M; Berg, C; Pellicelli, AM; Stenmark, S; Vekeman, F; Ionescu-Ittu, R; Emond, B; Reddy, KR.
Daclatasvir combined with sofosbuvir or simeprevir in liver transplant recipients with severe recurrent hepatitis C infection.
Liver Transpl. 2016; 22(4):446-458 Doi: 10.1002/lt.24416 [OPEN ACCESS]
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Co-authors Med Uni Graz: Stauber Rudolf
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Abstract:: Daclatasvir (DCV) is a potent, pangenotypic nonstructural protein 5A inhibitor with demonstrated antiviral efficacy when combined with sofosbuvir (SOF) or simeprevir (SMV) with or without ribavirin (RBV) in patients with chronic hepatitis C virus (HCV) infection. Herein, we report efficacy and safety data for DCV-based all-oral antiviral therapy in liver transplantation (LT) recipients with severe recurrent HCV. DCV at 60 mg/day was administered for up to 24 weeks as part of a compassionate use protocol. The study included 97 LT recipients with a mean age of 59.3 ± 8.2 years; 93% had genotype 1 HCV and 31% had biopsy-proven cirrhosis between the time of LT and the initiation of DCV. The mean Model for End-Stage Liver Disease (MELD) score was 13.0 ± 6.0, and the proportion with Child-Turcotte-Pugh (CTP) A/B/C was 51%/31%/12%, respectively. Mean HCV RNA at DCV initiation was 14.3 × 6 log10 IU/mL, and 37% had severe cholestatic HCV infection. Antiviral regimens were selected by the local investigator and included DCV+SOF (n = 77), DCV+SMV (n = 18), and DCV+SMV+SOF (n = 2); 35% overall received RBV. At the end of treatment (EOT) and 12 weeks after EOT, 88 (91%) and 84 (87%) patients, respectively, were HCV RNA negative or had levels <43 IU/mL. CTP and MELD scores significantly improved between DCV-based treatment initiation and last contact. Three virological breakthroughs and 2 relapses occurred in patients treated with DCV+SMV with or without RBV. None of the 8 patient deaths (6 during and 2 after therapy) were attributed to therapy. In conclusion, DCV-based all-oral antiviral therapy was well tolerated and resulted in a high sustained virological response in LT recipients with severe recurrent HCV infection. Most treated patients experienced stabilization or improvement in their clinical status. © 2016 American Association for the Study of Liver Diseases.
Find related publications in this database (using NLM MeSH Indexing): Aged -; Antiviral Agents - administration & dosage; Antiviral Agents - adverse effects; Antiviral Agents - therapeutic use; Compassionate Use Trials -; Drug Therapy, Combination - methods; Female -; Genotype -; Hepacivirus - genetics; Hepacivirus - isolation & purification; Hepatitis C, Chronic - complications; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - virology; Humans -; Imidazoles - administration & dosage; Imidazoles - adverse effects; Imidazoles - therapeutic use; Liver Cirrhosis - etiology; Liver Cirrhosis - pathology; Liver Diseases - surgery; Liver Transplantation - adverse effects; Male -; Middle Aged -; Recurrence -; Retrospective Studies -; Ribavirin - administration & dosage; Ribavirin - adverse effects; Ribavirin - therapeutic use; Simeprevir - administration & dosage; Simeprevir - adverse effects; Simeprevir - therapeutic use; Sofosbuvir - administration & dosage; Sofosbuvir - adverse effects; Sofosbuvir - therapeutic use; Treatment Outcome -