Observational Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Mar 7, 2016; 22(9): 2844-2854
Published online Mar 7, 2016. doi: 10.3748/wjg.v22.i9.2844
Hepatic decompensation/serious adverse events in post-liver transplantation recipients on sofosbuvir for recurrent hepatitis C virus
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
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
David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad Ahmad, Thomas Schiano, Ponni Perumalswami, Recanati Miller Transplant Institute, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States
Author contributions: Patel N, Bichoupan K, Perumalswami P and Branch A contributed to study conception and design; Patel N, Bichoupan K, Ku L, Yalamanchili R, Perumalswami P and Branch A contributed to data acquisition, data analysis and interpretation; Patel N, Bichoupan K and Branch A drafted the manuscript; Patel N, Bichoupan K, Ku L, Yalamanchili R, Harty A, Gardenier D, Ng M, Motamed D, Khaitova V, Bach N, Chang C, Grewal P, Bansal M, Agarwal R, Liu L, Im G, Leong J, Kim-Schluger L, Odin J, Ahmad J, Friedman S, Dieterich D, Schiano T, Perumalswami P and Branch A reviewed, edited, and approved the final version of the manuscript.
Supported by National Institutes of Health, No. DA031095 and No. DK090317.
Institutional review board statement: The study was reviewed and approved by the Icahn School of Medicine at Mount Sinai Institutional Review Board.
Informed consent statement: Study participants did not provide informed consent prior to study enrollment as the Icahn School of Medicine at Mount Sinai Institutional Review Board provided a waiver of authorization to release de-identified patient data for research purposes.
Conflict-of-interest statement: Kian Bichoupan is a paid consultant for Gilead Sciences and Janssen Pharmaceuticals, Inc. Dr. Andrea D. Branch is a paid consultant for Gilead Sciences and Janssen Pharmaceuticals, Inc. Dr. Douglas T. Dieterich serves as a paid lecturer, consultant and is a member on scientific advisory boards of companies which either develop or assess medicines used for the treatment of viral hepatitis. These companies include Gilead Sciences, Abbvie, Achillion, Bristol-Myers Squibb, Merck, and Janssen Pharmaceuticals, Inc. Thomas D. Schiano is a paid consultant for Salix, Merck, Gilead, BMS, Novartis, and Janssen. Alyson Harty is a paid consultant for Abbvie Pharmaceuticals, Gilead Sciences, and Janssen Pharmaceuticals, Inc. Michel Ng is a paid member of AbbVie’s Speakers bureau. Viktoriya Khaitova is a paid member of a scientific advisory board for AbbVie and Johnson & Johnson. Charissa Chang is a paid consultant for Gilead. Dr. Neal Patel, Lawrence Ku, Dr. Rachana Yalamanchili, Donald Gardenier, David Motamed, Dr. Nancy Bach, Dr. Meena Bansal, Dr. Priya Grewal, Dr. Ritu Agarwal, Dr. Lawrence Liu, Dr. Gene Im, Dr. Leona Kim-Schluger, Dr. Joseph Odin, Dr. Jawad Ahmad, Dr. Scott Friedman, and Dr. Ponni V. Perumalswmi do not have any disclosures.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at andrea.branch@mssm.edu. Consent was not obtained, but the presented data are anonymized and risk of identification is low.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Andrea Branch, PhD, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, Icahn Medical Institute, 11th floor, Room 24, 1425 Madison Avenue, New York, NY 10029, United States. andrea.branch@mssm.edu
Telephone: +1-212-6598371 Fax: +1-212-3483517
Received: August 15, 2015
Peer-review started: August 18, 2015
First decision: September 29, 2015
Revised: October 27, 2015
Accepted: November 19, 2015
Article in press: November 19, 2015
Published online: March 7, 2016
Processing time: 200 Days and 12.3 Hours
Core Tip

Core tip: Direct acting antivirals have changed the landscape of managing hepatitis C virus (HCV) infection, but there is limited data on the full safety profile of these drugs. We studied a group of liver transplant recipients with recurrent HCV who had hepatic decompensation and/or serious adverse events while on treatment with sofosbuvir-based regimens. We found that cases had lower pre-treatment hemoglobin, estimated glomerular filtration rate, and higher pre-treatment serum total bilirubin levels compared to controls. Anemia was the most common event and 62% of cases required blood transfusion. Similar to registration trials, sofosbuvir was generally well-tolerated, while ribavirin-induced anemia remains a challenge.