title: Sofosbuvir/Ledipasvir Without Ribavirin Achieved High Sustained Virologic Response for Hepatitis C Recurrence After Liver Transplantation: Two-Center Experience.
abstract: Current recommended regimens to treat patients with hepatitis C virus (HCV) infection after liver transplantation include the use of ribavirin (RBV). Limited data are available on the efficacy of RBV-free regimens posttransplant, particularly the use of sofosbuvir (SOF)/ledipasvir (LDV) without RBV in this patient population. We aimed to assess the efficacy and safety of SOF/LDV fixed-dose combination without RBV in patients with HCV recurrence posttransplant.
  
  
  
  This is a retrospective study of 46 patients with HCV recurrence posttransplant. SOF/LDV without RBV was used for 12 weeks in patients with early-stage fibrosis (F0-F2) or for 24 weeks in those with advanced fibrosis (F3-F4) and/or cholestatic hepatitis. The primary endpoint was sustained virologic response at 12 weeks after the end of treatment. Secondary outcomes included relapse after treatment and adverse events.
  
  
  
  Forty-six patients, with a mean age of 62 ± 8 years, a median duration since time of transplant of 904 days (range, 78-3525 days), an HCV genotype 1, and a mean baseline viral load of 7.79 million IU/mL, were treated. Of these, 32 patients were treated for 12 weeks, and 14 patients were treated for 24 weeks. Twenty-five patients (54%) were treatment experienced (21 with interferon and 4 with SOF). All 46 patients (100%) achieved sustained virological response (SVR) 12. Neither virologic relapses nor serious adverse events were noted.
  
  
  
  The combination of SOF/LDV without RBV for 12 or 24 weeks produced 100% SVR 12 in patients with HCV recurrence after liver transplantation. The use of RBV may not be necessary to achieve SVR in this patient population.
authors.affiliation: 1 Gastroenterology and Hepatology, Digestive Disease Institute, Cleveland Clinic, Cleveland, OH. 2 Department of Tropical Medicine and Hepatology, Mansoura University, Faculty of Medicine, Mansoura, Egypt. 3 Hepato-Pancreato-Biliary and Transplant Surgery, Digestive Disease Institute, Cleveland Clinic, Cleveland, OH. 4 Department of Gastroenterology and Hepatology, Cleveland Clinic Florida, Weston, FL.
authors.forename: Mohamed A
authors.initials: MA
authors.lastname: Elfeki
authors.forename: Rachel
authors.initials: R
authors.lastname: Abou Mrad
authors.forename: Jamak
authors.initials: J
authors.lastname: Modaresi Esfeh
authors.forename: Nizar N
authors.initials: NN
authors.lastname: Zein
authors.forename: Bijan
authors.initials: B
authors.lastname: Eghtesad
authors.forename: Xaralambos
authors.initials: X
authors.lastname: Zervos
authors.forename: Ibrahim A
authors.initials: IA
authors.lastname: Hanouneh
authors.forename: Robert
authors.initials: R
authors.lastname: O'Shea
authors.forename: William D
authors.initials: WD
authors.lastname: Carey
authors.forename: Naim
authors.initials: N
authors.lastname: Alkhouri
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005449:Fluorenes / Q000627:therapeutic use*; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008103:Liver Cirrhosis / Q000601:surgery* / Q000821:virology; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012189:Retrospective Studies; D012254:Ribavirin / Q000627:therapeutic use*; D000069474:Sofosbuvir; D000072230:Sustained Virologic Response; D016896:Treatment Outcome; D014542:Uridine Monophosphate / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C000595958:ledipasvir, sofosbuvir drug combination; D012254:Ribavirin; D014542:Uridine Monophosphate; D000069474:Sofosbuvir