The safety and efficacy of ledipasvir/sofosbuvir with or without ribavirin in the treatment of orthotopic liver transplant recipients with recurrent hepatitis C: real-world data

BACKGROUNDRecurrent hepatitis C (RHC) in orthotopic liver transplantation (OLT) population is associated with accelerated rates of fibrosis, low efficacy and decreased tolerability with traditional therapies. AIMThe aim of this study was to evaluate the safety and efficacy of ledipasvir/sofosbuvir (...

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Published in:	European journal of gastroenterology & hepatology Vol. 30; no. 7; pp. 761 - 765
Main Authors:	Pyrsopoulos, Nikolaos, Trilianos, Panagiotis, Lingiah, Vivek A, Fung, Phoenix, Punnoose, Merlin
Format:	Journal Article
Language:	English
Published:	England Copyright Wolters Kluwer Health, Inc. All rights reserved 01-07-2018
Subjects:	Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Benzimidazoles - adverse effects Benzimidazoles - therapeutic use Female Fluorenes - adverse effects Fluorenes - therapeutic use Hepacivirus - drug effects Hepacivirus - pathogenicity Hepatitis C - diagnosis Hepatitis C - drug therapy Hepatitis C - virology Humans Immunosuppressive Agents - therapeutic use Liver Cirrhosis - diagnosis Liver Cirrhosis - drug therapy Liver Cirrhosis - virology Liver Transplantation - adverse effects Male Middle Aged Recurrence Retrospective Studies Ribavirin - adverse effects Ribavirin - therapeutic use Sustained Virologic Response Time Factors Treatment Outcome Uridine Monophosphate - adverse effects Uridine Monophosphate - analogs & derivatives Uridine Monophosphate - therapeutic use Virus Activation - drug effects
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Summary:	BACKGROUNDRecurrent hepatitis C (RHC) in orthotopic liver transplantation (OLT) population is associated with accelerated rates of fibrosis, low efficacy and decreased tolerability with traditional therapies. AIMThe aim of this study was to evaluate the safety and efficacy of ledipasvir/sofosbuvir (LED/SOF) with or without ribavirin (RBV) in OLT patients with RHC. PATIENTS AND METHODSPatients at least 3 months post-OLT and with documented RHC were treated with LED/SOF with or without RBV for either 12 or 24 weeks. End-of-treatment and sustained virological response 12 weeks after the completion of treatment were documented. Patients were closely monitored for treatment-related adverse effects and the potential need for adjustment in their immunosuppression. RESULTSSeventy-one patients were included in the study. Median age was 62 years. Median time from OLT was 55 months. Twenty-six (36.6%) patients were treatment-naive and 45 (63.4%) had previously failed interferon-based therapies. The majority of patients (57.7%) had stage F0–F2 fibrosis. Sixty-seven (94.3%) patients completed 12 weeks of LED/SOF with RBV, three patients completed 12 or 24 weeks of LED/SOF without RBV, and one patient completed only 8 weeks of LED/SOF without RBV owing to severe allograft dysfunction. Sustained virological response was near universal in our cohort (98.5%) regardless of genotype, fibrosis stage, and regimen or treatment duration. Most commonly reported side effects were malaise and gastrointestinal upset. No patient required adjustment in immunosuppression and no episodes of rejection were documented during treatment. CONCLUSIONThe combination of LED/SOF with RBV for 12 weeks or LED/SOF for 24 weeks is very effective and safe in treating OLT recipients with RHC.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23
ISSN:	0954-691X 1473-5687
DOI:	10.1097/MEG.0000000000001101