title: Treatment of HCV infection in liver transplant recipients with ledipasvir and sofosbuvir without ribavirin.
abstract: Ledipasvir and sofosbuvir is a well-tolerated regimen with high sustained virological response (SVR) rates in pre-liver transplant patients infected with chronic hepatitis C virus (HCV), but data in liver transplant recipients outside of clinical trials is limited.
  
  
  
  To address this knowledge gap and assess SVR rates without the use of ribavirin in liver transplant recipients METHODS: This is a retrospective study examining the treatment of 75 post-liver transplant recipients with ledipasvir and sofosbuvir without ribavirin. Differences between SVR cohorts and predictors of SVR were analysed in an intention-to-treat (ITT) fashion.
  
  
  
  A total of 408 genotype 1, HCV patients were treated with ledipasvir/sofosbuvir from October 2014 to August 2015 at our centre. Seventy-three patients were post-liver transplant and were treated with a median of 2.9 years from transplant. Ledipasvir/sofosbuvir achieved an SVR12 of 95.9%. African Americans made up 28.8% of the cohort. Sixty-three per cent of patients were treated previously, including 13.7% of patients previously treated with direct-acting antivirals. Only 2.7% had recurrent allograft cirrhosis, and the majority (90.4%) was on calcineurin inhibitor based immunosuppressive therapy. Approximately 82% of patients had chronic kidney disease (CKD) stage 2 or 3. In univariate logistic regression, only detectable week 8 viral load was predictive of failure to achieve SVR.
  
  
  
  Our data confirm excellent SVR outcomes and favourable safety and tolerability profiles with ledipasvir/sofosbuvir without ribavirin in post-liver transplant recipients infected with HCV, despite treatment guidelines to use ribavirin.
authors.affiliation: University of chicago, Chicago, IL, USA.
authors.forename: A A
authors.initials: AA
authors.lastname: Pillai
authors.affiliation: Emory University, Atlanta, GA, USA.
authors.forename: R
authors.initials: R
authors.lastname: Maheshwari
authors.affiliation: Emory University, Atlanta, GA, USA.
authors.forename: R
authors.initials: R
authors.lastname: Vora
authors.affiliation: Emory University, Atlanta, GA, USA.
authors.forename: J P
authors.initials: JP
authors.lastname: Norvell
authors.affiliation: Emory University, Atlanta, GA, USA.
authors.forename: R
authors.initials: R
authors.lastname: Ford
authors.affiliation: Emory University, Atlanta, GA, USA.
authors.forename: S
authors.initials: S
authors.lastname: Parekh
authors.affiliation: Emory University, Atlanta, GA, USA.
authors.forename: N
authors.initials: N
authors.lastname: Cheng
authors.affiliation: Emory University, Atlanta, GA, USA.
authors.forename: A
authors.initials: A
authors.lastname: Patel
authors.affiliation: Emory University, Atlanta, GA, USA.
authors.forename: N
authors.initials: N
authors.lastname: Young
authors.affiliation: Emory University, Atlanta, GA, USA.
authors.forename: J R
authors.initials: JR
authors.lastname: Spivey
authors.affiliation: Emory University, Atlanta, GA, USA.
authors.forename: O
authors.initials: O
authors.lastname: Mgbemena
authors.affiliation: Emory University, Atlanta, GA, USA.
authors.forename: J P
authors.identifier: 0000-0001-9768-3909
authors.initials: JP
authors.lastname: Wedd
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001562:Benzimidazoles / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage*; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy; D016031:Liver Transplantation; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D000069474:Sofosbuvir / Q000008:administration & dosage*; D000072230:Sustained Virologic Response; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C586541:ledipasvir; D000069474:Sofosbuvir