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Gastroenterology. 2015 Jan;148(1):100-107.e1. doi: 10.1053/j.gastro.2014.09.023. Epub 2014 Sep 28.

Sofosbuvir and ribavirin prevent recurrence of HCV infection after liver transplantation: an open-label study.

Author information

  • 1Transplant Institute, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Electronic address: mcurry@bidmc.harvard.edu.
  • 2Liver Unit, Hospital Clínic, Institut d'Investigacions Biomédiques August Pi i Sunyer and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Barcelona, Spain.
  • 3GI Unit, Massachusetts General Hospital, Boston, Massachusetts.
  • 4Division of Gastroenterology, University of California San Francisco, San Francisco, California.
  • 5Center for Liver Diseases and Transplantation, Columbia University, New York, New York.
  • 6Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.
  • 7Liver Transplantation & Hepatology, Lahey Clinic, Burlington, Massachusetts.
  • 8Transplant Hepatology, Baylor University Medical Center, Dallas, Texas.
  • 9Liver Transplantation, University of California, San Diego, La Jolla, California.
  • 10Liver Diseases, Mount Sinai School of Medicine, New York, New York.
  • 11Section of Hepatology, University of Colorado, Denver, Colorado.
  • 12Center for Liver Disease, University of Miami, Miami, Florida.
  • 13Division of Gastroenterology and Hepatology, Saint Louis University, St. Louis, Missouri.
  • 14New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand.
  • 15Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California.
  • 16Gilead Sciences, Foster City, California.
  • 17Gastroenterology, Henry Ford Health System, Detroit, Michigan.
  • 18Transplant Institute, Beth Israel Deaconess Medical Center, Boston, Massachusetts.

Abstract

BACKGROUND & AIMS:

Patients with detectable hepatitis C virus (HCV) RNA at the time of liver transplantation universally experience recurrent HCV infection. Antiviral treatment before transplantation can prevent HCV recurrence, but existing interferon-based regimens are poorly tolerated and are either ineffective or contraindicated in most patients. We performed a trial to determine whether sofosbuvir and ribavirin treatment before liver transplantation could prevent HCV recurrence afterward.

METHODS:

In a phase 2, open-label study, 61 patients with HCV of any genotype and cirrhosis (Child-Turcotte-Pugh score, ≤7) who were on waitlists for liver transplantation for hepatocellular carcinoma, received up to 48 weeks of sofosbuvir (400 mg) and ribavirin before liver transplantation. The primary end point was the proportion of patients with HCV-RNA levels less than 25 IU/mL at 12 weeks after transplantation among patients with this HCV-RNA level at their last measurement before transplantation.

RESULTS:

Sixty-one patients received sofosbuvir and ribavirin, and 46 received transplanted livers. The per-protocol efficacy population consisted of 43 patients who had HCV-RNA level less than 25 IU/mL at the time of transplantation. Of these 43 patients, 30 (70%) had a post-transplantation virologic response at 12 weeks, 10 (23%) had recurrent infection, and 3 (7%) died (2 from nonfunction of the primary graft and 1 from complications of hepatic artery thrombosis). Of all 61 patients given sofosbuvir and ribavirin, 49% had a post-transplantation virologic response. Recurrence was related inversely to the number of consecutive days of undetectable HCV RNA before transplantation. The most frequently reported adverse events were fatigue (in 38% of patients), headache (23%), and anemia (21%).

CONCLUSIONS:

Administration of sofosbuvir and ribavirin before liver transplantation can prevent post-transplant HCV recurrence. ClinicalTrials.gov: NCT01559844.

Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

KEYWORDS:

Direct-Acting Antiviral Agents; HCV Recurrence; Hepatitis C Virus; Liver Transplantation

PMID:
25261839
[PubMed - indexed for MEDLINE]
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