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Prolonged use of tenofovir and entecavir in hepatitis B virus-related cirrhosis

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Abstract

Background and Aims

Limited data is available from India on outcome and efficacy of tenofovir and entecavir in hepatitis B virus (HBV)-related cirrhosis when used for prolonged time. We report the long-term efficacy and outcome of these antiviral drugs in patients with chronic HBV infection, with compensated or decompensated cirrhosis.

Methods

We retrospectively analyzed laboratory and clinical data of 400 HBV-related cirrhotic patients without access to liver transplantation, who were treated with tenofovir/entecavir therapy, from January 2007 to January 2014. Two hundred and ten (52.5 %) patients had at least one of the components of decompensation at baseline. Two hundred and twenty (55 %) and 180 (45 %) patients were initiated tenofovir and entecavir, respectively. Follow up period was 45 (12–68) months for tenofovir and 36 (11–60) months for entecavir.

Results

At the end of 1 year, levels of HBV DNA <20 IU/mL were achieved in 91.8 % and 88.8 % of patients, and alanine aminotransferase normalized in 54.5 % and 55.5 % of patients who received tenofovir and entecavir, respectively. At the last visit, Child-Turcotte-Pugh scores improved among 29.5 % of patients who received tenofovir, 25 % of those who received entecavir, and remained stable in 61.9 % and 65 % patients, respectively, in both groups. The 5-year cumulative rate of liver decompensation, hepatocellular carcinoma, and cirrhosis-related complications were 3.1 %, 1.9 %, and 2.1 % with an annual incidence of 0.8 %, 0.3 %, and 0.5 % per person-year, respectively.

Conclusion

Tenofovir and entecavir were effective and potent drugs for prolonged treatment of HBV cirrhosis and improved the overall clinical course.

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References

  1. Lavanchy D. Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures. J Viral Hepat. 2004;11:97–107.

    Article  CAS  PubMed  Google Scholar 

  2. Liaw YF, Chu CM. Hepatitis B virus infection. Lancet. 2009;373:582–92.

    Article  CAS  PubMed  Google Scholar 

  3. Datta S. An overview of molecular epidemiology of hepatitis B virus (HBV) in India. Virol J. 2008;5:156.

    Article  PubMed Central  PubMed  Google Scholar 

  4. McMahon BJ. The natural history of chronic hepatitis B virus infection. Hepatology. 2009;49 Suppl:S45–S55.

  5. Wu GY, Chen HS. Novel approaches towards conquering hepatitis B infection. World J Gastroenterol. 2007;13:830–6.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  6. Lok AS, Lai CL, Leung N, et al. Long-term safety of lamivudine treatment in patients with chronic hepatitis B. Gastroenterology. 2003;125:1714–22.

    Article  CAS  PubMed  Google Scholar 

  7. Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology. 2009;50:661–2.

    Article  PubMed  Google Scholar 

  8. European Association for the Study of the Liver. EASL clinical practice guidelines: management of chronic hepatitis B virus infection. J Hepatol. 2012;57:167–85.

    Article  Google Scholar 

  9. Liaw YF, Kao JH, Piratvisuth T, et al. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2012 update. Hepatol Int. 2012;6:531–61.

    Article  PubMed  Google Scholar 

  10. Chang TT, Liaw YF, Wu SS, et al. Long-term entecavir therapy results in the reversal of fibrosis/cirrhosis and continued histological improvement in patients with chronic hepatitis B. Hepatology. 2010;52:886–93.

    Article  CAS  PubMed  Google Scholar 

  11. Liaw YF, Sung JJ, Chow WC, et al. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med. 2004;351:1521–31.

    Article  CAS  PubMed  Google Scholar 

  12. Schiff ER, Lai CL, Hadziyannis S, et al. Adefovir dipivoxil therapy for lamivudine-resistant hepatitis B in pre- and post-liver transplantation patients. Hepatology. 2003;38:1419–27.

    CAS  PubMed  Google Scholar 

  13. Schiff E, Lai CL, Hadziyannis S, et al. Adefovir dipivoxil for wait-listed and post-liver transplantation patients with lamivudine-resistant hepatitis B: final long-term results. Liver Transpl. 2007;13:349–60.

    Article  PubMed  Google Scholar 

  14. Lim SG, Aung MO, Mak B, et al. Clinical outcomes of lamivudine-adefovir therapy in chronic hepatitis B cirrhosis. J Clin Gastroenterol. 2011;45:818–23.

    Article  CAS  PubMed  Google Scholar 

  15. Shim JH, Lee HC, Kim KM, et al. Efficacy of entecavir in treatment-naive patients with hepatitis B virus-related decompensated cirrhosis. J Hepatol. 2010;52:176–82.

    Article  CAS  PubMed  Google Scholar 

  16. Liaw YS, Sheen IS, Lee CM, et al. Tenofovir disoproxil fumarate (TDF), emtricitabine/TDF, and entecavir in patients with decompensated chronic hepatitis B liver disease. Hepatology. 2011;53:62–72.

    Article  CAS  PubMed  Google Scholar 

  17. Kao JTPC, Lai HC, Chuang PH, et al. Efficacy of entecavir in naive patients with chronic hepatitis B and decompensated liver cirrhosis. J Gastroenterol Hepatol. 2009;24:A202.

    Article  Google Scholar 

  18. Liaw YS, Raptopoulou-Gigi M, Cheinquer H, et al. Efficacy and safety of entecavir versus adefovir in chronic hepatitis B patients with hepatic decompensation: randomized, open label study. Hepatology. 2011;54:91–100.

    Article  CAS  PubMed  Google Scholar 

  19. Pellicelli AM, Barbarini G, Romano M, et al. Entecavir therapy for lamivudine resistant HBV cirrhotic patients waiting for OLT: viral and biochemical outcomes at one year. Hepatology. 2009;50:514A.

    Google Scholar 

  20. Koklu S, Tuna Y, Gulsen MT, et al. Long-term efficacy and safety of lamivudine, entecavir, and tenofovir for treatment of hepatitis B virus-related cirrhosis. Clin Gastroenterol Hepatol. 2013;11:88–94.

    Article  CAS  PubMed  Google Scholar 

  21. Srivastava M, Rungta S, Dixit VK, Shukla SK, Singh TB, Jain AK. Predictors of survival in hepatitis B virus related decompensated cirrhosis on tenofovir therapy: an Indian perspective. Antiviral Res. 2013;100:300–5.

    Article  CAS  PubMed  Google Scholar 

  22. Marcellin P, Gane E, Buti M, et al. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study. Lancet. 2013;381:468–75.

    Article  CAS  PubMed  Google Scholar 

  23. Scaglione SJ, Lok AS. Effectiveness of hepatitis B treatment in clinical practice. Gastroenterology. 2012;142:1360–8.

    Article  PubMed  Google Scholar 

  24. Tenney DJ, Rose RE, Baldick CJ, et al. Long-term monitoring shows hepatitis B virus resistance to entecavir in nucleoside-naive patients is rare through 5 years of therapy. Hepatology. 2009;49:1503–14.

    Article  CAS  PubMed  Google Scholar 

  25. Chang TT, Gish RG, de Man R, et al. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med. 2006;354:1001–10.

    Article  CAS  PubMed  Google Scholar 

  26. Zoulim F, Radenne S, Ducerf C. Management of patients with decompensated hepatitis B virus associated cirrhosis. Liver Transplant. 2008;14 Suppl 2:S1–7.

    Article  Google Scholar 

  27. Yao FY, Terrault NA, Freise C, et al. Lamivudine treatment is beneficial in patients with severely decompensated cirrhosis and actively replicating hepatitis B infection awaiting liver transplantation: a comparative study using a matched, untreated cohort. Hepatology. 2001;34:411–6.

    Article  CAS  PubMed  Google Scholar 

  28. Papatheodoridis GV, Lampertico P, Manolakopoulos S, Lok A. Incidence of hepatocellular carcinoma in chronic hepatitis B patients receiving nucleos(t)ide therapy: a systematic review. J Hepatol. 2010;53:348–56.

    Article  CAS  PubMed  Google Scholar 

  29. Singal AK, Fontana RJ. Meta-analysis: oral anti-viral agents in adults with decompensated hepatitis B virus cirrhosis. Aliment Pharmacol Ther. 2012;35:674–89.

    Article  CAS  PubMed  Google Scholar 

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Conflict of interest

SKG, VKD, SKS, JG, MB, MT, NG, AR, and AKJ declare that they have no competing interests.

Ethics statement

The authors declare that the study was performed in a manner that conforms to the Helsinki Declaration of 1975, as revised in 2000 and 2008 concerning Human and Animal Rights, and the authors followed the policy concerning informed consent as shown on Springer.com.

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Correspondence to Sundeep Kumar Goyal.

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Goyal, S.K., Dixit, V.K., Shukla, S.K. et al. Prolonged use of tenofovir and entecavir in hepatitis B virus-related cirrhosis. Indian J Gastroenterol 34, 286–291 (2015). https://doi.org/10.1007/s12664-015-0576-1

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  • DOI: https://doi.org/10.1007/s12664-015-0576-1

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