Preview

Transplantologiya. The Russian Journal of Transplantation

Advanced search

The use of sofosbuvir for the treatment of recurrent hepatitis C after liver transplantation

https://doi.org/10.23873/2074-0506-2017-9-1-13-22

Abstract

The article presents the experience of direct-acting antiviral (DAA) drug treatment for hepatitis C in the patients after liver transplantation. The end-stage liver disease caused by hepatitis C is the main indication for orthotopic liver transplantation (OLT). In 2013, the first agent in the class of antiviral drugs directly acting on hepatitis C virus (HCV) was introduced into clinical practice. That was sofosbuvir, a HCV polymerase inhibitor, that could be used without interferon alfa.

Materials and methods. The study enrolled 33 liver transplant recipients with recurrent hepatitis C. Thirty-five courses of antiviral therapy (AT) were conducted with sofosbuvir being one of AT components.

Results. By the time of analysis, 21 patients had completed the antiviral therapy. All the patients showed an initial response to the antiviral therapy, HCV aviremia was achieved. In 3 patients, with the evaluable sustained virologic response (SVR), a renewed HCV replication was observed in the first weeks after the AT completion.

Conclusion. The new direct-acting antiviral drugs offer an effective antiviral therapy to all liver graft recipients with recurrent HCV.

About the Authors

M. Sh. Khubutiya
N.V. Sklifosovsky Research Institute for Emergency Medicine
Russian Federation

Acad. of RAS, Professor, Director

Moscow, Russia



V. E. Syutkin
N.V. Sklifosovsky Research Institute for Emergency Medicine
Russian Federation
Moscow, Russia


S. V. Zhuravel'
N.V. Sklifosovsky Research Institute for Emergency Medicine
Russian Federation
Moscow, Russia


M. S. Novruzbekov
N.V. Sklifosovsky Research Institute for Emergency Medicine
Russian Federation
Moscow, Russia


A. B. Fedin
Burnasyan Federal Medical Biophysical Center of FMBA
Russian Federation
Moscow, Russia


A. A. Salienko
N.V. Sklifosovsky Research Institute for Emergency Medicine
Russian Federation
Moscow, Russia


References

1. Scientific Registry of Transplant Recipients 2012 annual data report. Rockville, MD: Health Resources and Services Administration. 2012. Available at: http://srtr.transplant.hrsa.gov/annual_reports/2012/pdf/03_liver_13.pdf

2. World Health Organization, Spanish National Transplant Organization. Global observatory on donation and transplantation. 2012. Available at: http://issuu.com/o-n-t/docs/2012ad

3. Crespo G., Marino Z., Navasa M., et al. Viral hepatitis in liver transplantation. Gastroenterology. 2012;142(6):1373– 1383,e1371. PMID:22537446 DOI:10.1053/j.gastro.2012.02.011

4. Berenguer M., Ferrell L., Watson J., et al. HCV-related fibrosis progression following liver transplantation: increase in recent years. J Hepatol. 2000;32(4):673–684. PMID:10782918

5. Prieto M., Berenguer M., Rayon J.M., et al. High incidence of allograft cirrhosis in hepatitis C virus genotype 1b infection following transplantation: relationship with rejection episodes. Hepatology. 1999;29(1):250–256. PMID:9862874 DOI:10.1002/hep.510290122

6. Carrion J.A., Navasa M., Garcia-Retortillo M., et al. Efficacy of antiviral therapy on hepatitis C recurrence after liver transplantation: a rando mized controlled study. Gastroenterology. 2007;132(5):1746–1756. PMID:17484872 DOI:10.1053/j.gastro.2007.03.041

7. Belli L.S., Volpes R., Graziadei I., et al. Antiviral therapy and fibrosis progression in patients with mild-moderate hepatitis C recurrence after liver transplantation. A randomized controlled study. Dig Liver Dis. 2012;44(7):603–609. PMID:22424641 DOI:10.1016/j.dld.2012.01.017

8. Berenguer M. Systematic review of the treatment of established recurrent hepatitis C with pegylated interferon in combination with ribavirin. J Hepatol. 2008;49(2):274–287. PMID:18571272 DOI:10.1016/j.jhep.2008.05.002

9. Burton J.R. Jr., O'Leary J.G., Verna E.C., et al. A US multicenter study of hepatitis C treatment of liver transplant recipients with protease-inhibitor triple therapy. J Hepatol. 2014;61(3):508– 514. PMID:24801415 DOI:10.1016/j.jhep.2014.04.037

10. Nair S.P. Protease inhibitor therapy post-liver transplantation in the treatment of hepatitis C virus infection. Gastroenterol Hepatol (NY). 2013;9(6):388– 390. PMID:23935546

11. Faisal N., Yoshida E.M., Bilodeau M., et al. Protease inhibitor-based triple therapy is highly effective for hepatitis C recurrence after liver transplant: a multicenter experience. Ann Hepatol. 2014;13(5):525–532. PMID:25152985

12. Koff R.S. Review article: the efficacy and safety of sofosbuvir, a novel, oral nucleotide NS5B polymerase inhibitor, in the treatment of chronic hepatitis C virus infection. Aliment Pharmacol Ther. 2014;39(5):478–487. PMID:24387618 DOI:10.1111/apt.12601

13. Mathias A., Cornpropst M.T., Clemons D., et al. No clinically significant pharmacokinetic drug-drug interactions between sofosbuvir (GS-7977) and the immunosuppressants, cyclosporine A or tacrolimus in healthy volunteers. Hepatology. 2012;56(Suppl S1):1063A–1064A.

14. Charlton M., Gane E., Manns M.P., et al. Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation. Gastroenterology. 2015.148(1):108– 117. PMID:25304641 DOI:10.1053/j.gastro.2014.10.001

15. Forns X., Charlton M., Denning J., et al. Sofosbuvir compassionate use program for patients with severe recurrent hepatitis C after liver transplantation. Hepatology. 2015;61(5):1485–1494. PMID:25557906 DOI:10.1002/hep.27681

16. Nguyen N.H., Yee B.E., Chang C., et al. Tolerability and effectiveness of sofosbuvir and simeprevir in the posttransplant setting: systematic review and meta- analysis. BMJ Open Gastroenterology.2016;3(1):e000066. PMID:26966549 DOI:10.1136/bmjgast-2015-000066

17. Punzalan C.S., Barry C., Zacharias I., et al. Sofosbuvir plus simeprevir treatment of recurrent genotype 1 hepatitis C after liver transplant. Clin Transplant. 2015;29(12):1105–1111. PMID:26358816 DOI:10.1111/ctr.12634

18. 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. PMID:25913321 DOI:10.1111/liv.12856

19. Nair S., Satapathy S.K., Gonzalez H. Sofosbuvir and Simeprevir for Treatment of Recurrent Hepatitis C Infection After Liver Transplant. Exp Clin Transplant. 2016. Epub ahead of print PMID:26926117 DOI:10.6002/ect.2015.0289

20. Issa D., Eghtesad B., Zein N.N., et al. Sofosbuvir and Simeprevir for the Treatment of Recurrent Hepatitis C with Fibrosing Cholestatic Hepatitis after Liver Transplantation. Int J Organ Transplant Med. 2016;7(1):38–45. PMID:26889372

21. Ouwerkerk-Mahadevan S., Snoeys J., Peeters M., et al. Drug-Drug Interactions with the NS3/4A Protease Inhibitor Simeprevir. Clin Pharmacokinetics. 2016;55(2):197–208. PMID:26353895 DOI:10.1007/s40262-015-0314-y

22. Kirby B.J., Symonds W.T., Kearney B.P., et al. Pharmacokinetic, Pharmacodynamic, and Drug-Interaction Profile of the Hepatitis C Virus NS5B Polymerase Inhibitor Sofosbuvir. Clin Pharmacokinetics. 2015;54(7):677–690. PMID:25822283 DOI:10.1007/s40262-015-0261-7

23. Bifano M., Adamczyk R., Hwang C., et al. An open-label investigation into drugdrug interactions between multiple doses of daclatasvir and single-dose cyclosporine or tacrolimus in healthy subjects. Clin Drug Investig. 2015;35(5):281– 289. PMID:25896946 DOI:10.1007/s40261-015-0279-5.

24. Poordad F., Schiff E.R., Vierling J.M., et al. Daclatasvir with sofosbuvir and ribavirin for hepatitis C virus infection with advanced cirrhosis or post-liver transplantation recurrence. Hepatology. 2016;63(5):1493–1505. PMID:26754432 DOI:10.1002/hep.28446

25. Fontana R.J., Brown R.S., Jr., Moreno-Zamora A., et al. Daclatasvir combined with sofosbuvir or simeprevir in liver transplant recipients with severe recurrent hepatitis C infection. Liver Transpl. 2016;22(4):446–458. PMID:26890629 DOI:10.1002/lt.24416

26. Charlton M., Everson G.T., Flamm S.L., et al. Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Di sease. Gastroenterol. 2015;149(3):649–659. PMID:25985734 DOI:10.1053/j.gastro.2015.05.010

27. Manns M., Samuel D., Gane E.J. et al. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial. Lancet Infect Dis. 2016;16(6):685–697. PMID:26907736 DOI:10.1016/S1473-3099(16)00052-9

28. HCV guidance: recommendations for testing, managing, and treating hepatitis C. Available at: http://www.hcvguidelines.org/full-report-view.

29. Lawitz E., Lalezari J.P., Hassanein T., et al. Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, doubleblind, phase 2 trial. Lancet Infect Dis. 2013;13(5):401–408. PMID:23499158 DOI:10.1016/S1473-3099(13)70033-1

30. Lawitz E., Mangia A., Wyles D., et al. Sofosbuvir for Previously Untre ated Chronic Hepatitis C Infection. N Engl J Med. 2013;368(20):1878–1887. PMID:23607594 DOI:10.1056/NEJMoa1214853

31. Zeuzem S., Dusheiko G.M., Salupere R., et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014;370(21):1993–2001. PMID:24795201 DOI:10.1056/NEJMoa1316145.

32. Coilly A., Fougerou-Leurent C., De Ledinghen V., et al. Multicentre experience using daclatasvir and sofosbuvir to treat hepatitis C recurrence after liver transplantation – The CO23 ANRS CUPILT study. J Hepatol. 2016;65(4):711–718. PMID:27262758 DOI:10.1016/j.jhep.2016.05.039


Review

For citations:


Khubutiya M.Sh., Syutkin V.E., Zhuravel' S.V., Novruzbekov M.S., Fedin A.B., Salienko A.A. The use of sofosbuvir for the treatment of recurrent hepatitis C after liver transplantation. Transplantologiya. The Russian Journal of Transplantation. 2017;9(1):13-22. https://doi.org/10.23873/2074-0506-2017-9-1-13-22

Views: 1537


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2074-0506 (Print)
ISSN 2542-0909 (Online)