title: Hepatic decompensation/serious adverse events in post-liver transplantation recipients on sofosbuvir for recurrent hepatitis C virus.
abstract: OBJECTIVE
  To determine the safety profile of new hepatitis C virus (HCV) treatments in liver transplant (LT) recipients with recurrent HCV infection.
  
  
  METHODS
  Forty-two patients were identified with recurrent HCV infection that underwent LT at least 12 mo prior to initiating treatment with a Sofosbuvir-based regimen during December 2013-June 2014. Cases were patients who experienced hepatic decompensation and/or serious adverse events (SAE) during or within one month of completing treatment. Controls had no evidence of hepatic decompensation and/or SAE. HIV-infected patients were excluded. Cumulative incidence of decompensation/SAE was calculated using the Kaplan Meier method. Exact logistic regression analysis was used to identify factors associated with the composite outcome.
  
  
  RESULTS
  Median age of the 42 patients was 60 years [Interquartile Range (IQR): 56-65 years], 33% (14/42) were female, 21% (9/42) were Hispanic, and 9% (4/42) were Black. The median time from transplant to treatment initiation was 5.4 years (IQR: 2.1-8.8 years). Thirteen patients experienced one or more episodes of hepatic decompensation and/or SAE. Anemia requiring transfusion, the most common event, occurred in 62% (8/13) patients, while 54% (7/13) decompensated. The cumulative incidence of hepatic decompensation/SAE was 31% (95%CI: 16%-41%). Risk factors for decompensation/SAE included lower pre-treatment hemoglobin (OR = 0.61 per g/dL, 95%CI: 0.40-0.88, P < 0.01), estimated glomerular filtration rate (OR = 0.95 per mL/min per 1.73 m(2), 95%CI: 0.90-0.99, P = 0.01), and higher baseline serum total bilirubin (OR = 2.43 per mg/dL, 95%CI: 1.17-8.65, P < 0.01). The sustained virological response rate for the cohort of 42 patients was 45%, while it was 31% for cases.
  
  
  CONCLUSIONS
  Sofosbuvir/ribavirin will continue to be used in the post-transplant population, including those with HCV genotypes 2 and 3. Management of anemia remains an important clinical challenge.
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Neal
authors.initials: N
authors.lastname: Patel
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Kian
authors.initials: K
authors.lastname: Bichoupan
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Ku
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Rachana
authors.initials: R
authors.lastname: Yalamanchili
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Alyson
authors.initials: A
authors.lastname: Harty
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Donald
authors.initials: D
authors.lastname: Gardenier
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Michel
authors.initials: M
authors.lastname: Ng
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: David
authors.initials: D
authors.lastname: Motamed
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Viktoriya
authors.initials: V
authors.lastname: Khaitova
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Nancy
authors.initials: N
authors.lastname: Bach
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Charissa
authors.initials: C
authors.lastname: Chang
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Priya
authors.initials: P
authors.lastname: Grewal
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Meena
authors.initials: M
authors.lastname: Bansal
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Ritu
authors.initials: R
authors.lastname: Agarwal
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Liu
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Gene
authors.initials: G
authors.lastname: Im
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Leong
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Leona
authors.initials: L
authors.lastname: Kim-Schluger
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Joseph
authors.initials: J
authors.lastname: Odin
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Jawad
authors.initials: J
authors.lastname: Ahmad
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Scott
authors.initials: S
authors.lastname: Friedman
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Douglas
authors.initials: D
authors.lastname: Dieterich
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Thomas
authors.initials: T
authors.lastname: Schiano
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Ponni
authors.initials: P
authors.lastname: Perumalswami
authors.affiliation: Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Scott Friedman, Douglas Dieterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
authors.forename: Andrea
authors.initials: A
authors.lastname: Branch
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000998:Antiviral Agents / Q000009:adverse effects*; D004359:Drug Therapy, Combination; D058625:End Stage Liver Disease / Q000175:diagnosis / Q000601:surgery* / Q000821:virology; D005260:Female; D016174:Hepacivirus / Q000187:drug effects* / Q000472:pathogenicity; D006526:Hepatitis C / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D053208:Kaplan-Meier Estimate; D017093:Liver Failure / Q000139:chemically induced* / Q000175:diagnosis; D016031:Liver Transplantation / Q000009:adverse effects*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D012008:Recurrence; D012254:Ribavirin / Q000009:adverse effects; D012307:Risk Factors; D000069474:Sofosbuvir / Q000009:adverse effects*; D013997:Time Factors; D016896:Treatment Outcome; D014775:Virus Activation / Q000187:drug effects
chemical_list: D000998:Antiviral Agents; D012254:Ribavirin; D000069474:Sofosbuvir
keywords: Anemia; Hepatic decompensation; Hepatitis C virus; Liver transplant; Ribavirin; Serious adverse event; Sofosbuvir