Abstract
Background/aim
Recurrent hepatitis C virus infection is a challenging complication post-liver transplant. Current guidelines recommend the combination of ribavirin and ledipasvir/sofosbuvir for 12 weeks for the treatment of recurrent HCV genotype 1 post-liver transplant. Data are limited on the use of ledipasvir/sofosbuvir without ribavirin. The aim of this study was to evaluate the use of ledipasvir/sofosbuvir without ribavirin for the treatment of recurrent hepatitis C virus post-liver transplant.
Methods
This is a retrospective study of liver transplant patients who received ledipasvir/sofosbuvir without ribavirin for the treatment of recurrent hepatitis C virus in our liver center from 2014 to 2016.
Results
A total of 60 patients were enrolled of which 70% were male, 88% Caucasian, age 60 ± 7 years, 15% cirrhotic, and 45% treatment-experienced with recurrent hepatitis C virus infection genotype 1 post-liver transplant. Treatment duration varied from 8 to 24 weeks. There were no serious adverse events and no discontinuation of treatment. A total of 71% of patients had undetectable serum hepatitis C virus at 4 weeks. However, irrespective of treatment duration, 100% of patients had undetectable serum hepatitis C virus at the end of treatment and 100% of patients achieved sustained viral response at 12 weeks.
Conclusion
Ledipasvir/sofosbuvir without ribavirin is an effective treatment of recurrent hepatitis C virus infection post-liver transplant. The entire group achieved sustained viral response at 12 weeks irrespective of the length of treatment. The combination of ledipasvir/sofosbuvir was well tolerated without serious adverse effects or discontinuation.
Similar content being viewed by others
References
Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med 2006;144(10):705–714
Kim W. The burden of hepatitis C in the United States. Hepatology 2002;36(S1):S30–S34
Greenberg HB. Recurrent and acquired hepatitis C viral infection in liver transplant recipients. Gastroenterology. 1992;103(1):317–322
Alonso O, Loinaz C, Abradelo M, et al. Changes in the incidence and severity of recurrent hepatitis C after liver transplantation over 1990–1999. In Proceedings of the transplantation proceedings of conference 2003
Schluger LK, Sheiner PA, Thung SN, et al. Severe recurrent cholestatic hepatitis C following orthotopic liver transplantation. Hepatology 1996;23(5):971–976
Narang TK, Ahrens W, Russo MW. Post-liver transplant cholestatic hepatitis C: a systematic review of clinical and pathological findings and application of consensus criteria. Liver Transpl 2010;16(11):1228–1235
Gurusamy KS, Tsochatzis E, Xirouchakis E, Burroughs AK, Davidson BR. Antiviral therapy for recurrent liver graft infection with hepatitis C virus. The Cochrane Library 2010
Ledipasvir/sofosbuvir. American Society of Health System Pharmacists I in DynaMed Plus [database online]. EBSCO Information Services. http://web.b.ebscohost.com/dynamed/detail?vid=2&sid=63502cb0-def8-4995-9591-1ea45f69d79f%40sessionmgr102&hid=102&bdata=JnNpdGU9ZHluYW1lZC1saXZlJnNjb3BlPXNpdGU%3d#AN=907806&db=dme. Updated 18 Feb 2016. Accessed 13 July 2016
Charlton M, Everson GT, Flamm SL, et al. Ledipasvir and sofosbuvir plus ribavirin for treatment of hcv infection in patients with advanced liver disease. Gastroenterology 2015;149(3):649–659
Panel A. Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology 2015;62:932–954
Reddy KR, Everson GT, Flamm SL, Denning JM, Arterburn S, Brandt-Sarif T, et al. Ledipasvir/sofosbuvir with ribavirin for the treatment of HCV in patients with post transplant recurrence: preliminary results of a prospective, multicenter study [Abstract]. In Proceedings of the 65th annual meeting of the American Association for the Study of Liver Diseases (AASLD). November 7–11, 2014; Boston, MA. Abstract 8
Suraweera D, Sundaram V, Saab S. Treatment of hepatitis C virus infection in liver transplant recipients. Gastroenterol Hepatol (NY) 2016;12(1):23–30
Coilly A, Roche B, Dumortier J, et al. Safety and efficacy of protease inhibitors to treat hepatitis C after liver transplantation: a multicenter experience. J Hepatol 2014;60(1):78–86
Lawitz E, Gruener D, Hill J, et al. 1219 Three-day, dose-ranging study of the HCV NS5A inhibitor GS-5885. J Hepatol 2011;54:S481–S482
Gentile I, Borgia F, R Buonomo A, Castaldo G, Borgia G. A novel promising therapeutic option against hepatitis C virus: an oral nucleotide NS5B polymerase inhibitor sofosbuvir. Curr Med Chem 2013;20(30):3733–3742
Feld JJ, Hoofnagle JH. Mechanism of action of interferon and ribavirin in treatment of hepatitis C. Nature 2005;436(7053):967–972
Thomas E, Ghany MG, Liang TJ. The application and mechanism of action of ribavirin in therapy of hepatitis C. Antiviral Chem Chemother 2012;23(1):1–12
Fried MW. Side effects of therapy of hepatitis C and their management. Hepatology 2002;36(1):S237
Saab S, Greenberg A, Li E, et al. Sofosbuvir and simeprevir is effective for recurrent hepatitis C in liver transplant recipients. Liver Int 2015;35(11):2442–2447
Jothimani D, Govil S, Rela M. Management of post-liver transplantation recurrent hepatitis C infection with directly acting antiviral drugs: a review. Hepatol Int 2016;10(5):749–761
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Compliance with ethical standards
All authors are in compliance with ethical standards for this study.
Funding
This study has no funding sources, grants, or other types of financial support to disclose.
Conflict of interest
Mohamed Shoreibah was a participant on the Gilead advisory board on 5/29/2015 and Omar Massoud received research grants and education grants from Gilead. Jordan Orr, DeAnn Jones, Jie Zhang, and Krishna Venkata have no conflict of interest to disclose.
Ethical approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.
Informed consent
Informed consent was not required for this study as decided by our university’s institutional review board (IRB).
Rights and permissions
About this article
Cite this article
Shoreibah, M., Orr, J., Jones, D. et al. Ledipasvir/sofosbuvir without ribavirin is effective in the treatment of recurrent hepatitis C virus infection post-liver transplant. Hepatol Int 11, 434–439 (2017). https://doi.org/10.1007/s12072-016-9778-6
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s12072-016-9778-6