Skip to main content

Telbivudine versus lamivudine and entecavir for treatment-naïve decompensated hepatitis B virus-related cirrhosis

Abstract

The long-term effects of telbivudine (TBV) on decompensated hepatitis B virus (HBV)-related cirrhosis were still not established. This study aimed to investigate the efficacy and safety of TBV in such cohort of patients as compared to lamivudine (LAM) and entecavir (ETV). We retrospectively evaluated 130 treatment-naïve patients with HBV-related decompensated cirrhosis who started treatment with TBV (n = 31), LAM (n = 45) or ETV (n = 54). After 24 months of treatment, cumulative virological response (VR) rates (HBV DNA <500 copies/mL) were 83.7, 65.3 and 89.1 % in TBV, LAM and ETV groups, respectively (p = 0.009). Reduction in HBV DNA levels in TBV was −3.66 ± 0.56, significantly higher than LAM (−3.34 ± 0.59; p < 0.05) and lower than ETV group (−3.98 ± 0.52; p < 0.05). The rates of HBeAg loss or seroconversion and normalization of alanine aminotransferase (ALT) were similar among the groups. Child-Turcotte-Pugh (CTP) score and model for end-stage liver disease score in TBV were significantly improved compared to at baseline without difference among the groups. TBV resulted in similar cumulative rates of survival and incidence of hepatocellular carcinoma (HCC) to LAM and ETV. Frequencies of complications from cirrhosis, including variceal bleeding, hepatic encephalopathy and spontaneous bacterial peritonitis, were comparable among the groups. Four patients (16.7 %) in TBV displayed virological breakthrough, lower than LAM and higher than ETV (p = 0.004). Cox regression analysis showed that baseline HBV DNA (hazard ratio 0.743; 95 % confidence interval 0.582–949, p = 0.017) was an independent predictor for VR at 24 months. Long-term therapy with TBV was effective and safe in HBV-related decompensated cirrhosis.

This is a preview of subscription content, access via your institution.

Fig. 1
Fig. 2
Fig. 3
Fig. 4

References

  1. Lee WM. Hepatitis B infection. N Engl J Med. 1997;337:1733–45.

    CAS  Article  PubMed  Google Scholar 

  2. Sun Z, Ming L, Zhu X, Lu J. Prevention and control of hepatitis B in China. J Med Virol. 2002;67:447–50.

    Article  PubMed  Google Scholar 

  3. Bosch FX, Ribes J, Cleries R, Diaz M. Epidemiology of hepatocellular carcinoma. Clin Liver Dis. 2005;9:191–211.

    Article  PubMed  Google Scholar 

  4. McMahon BJ. The natural history of chronic hepatitis B virus infection. Semin Liver Dis. 2004;24:17–21.

    Article  PubMed  Google Scholar 

  5. Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology. 2007;45:507–39.

    CAS  Article  PubMed  Google Scholar 

  6. European Association for the Study of the Liver. EASL clinical practice guidelines: management of chronic hepatitis B virus infection. J Hepatol. 2012;57(1):167–85.

    Article  Google Scholar 

  7. de Jongh FE, Janssen HL, de Man RA, et al. Survival and prognostic indicators in hepatitis B surface antigen-positive cirrhosis of the liver. Gastroenterology. 1992;103:1630–5.

    Article  PubMed  Google Scholar 

  8. Kapoor D, Guptan RC, Wakil SM, et al. Beneficial effects of lamivudine in hepatitis B virus-related decompensated cirrhosis. J Hepatol. 2000;33:308–12.

    CAS  Article  PubMed  Google Scholar 

  9. Yao FY, Terrault NA, Freise C, Maslow L, Bass NM. 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.

    CAS  Article  PubMed  Google Scholar 

  10. 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.

    CAS  Article  PubMed  Google Scholar 

  11. Liaw YF, Raptopoulou-Gigi M, Cheinquer H, et al. Efficacy and safety of entecavir versus adefovir in chronic hepatitis B patients with hepatic decompensation: a randomized, open-label study. Hepatology. 2011;54(1):91–100.

    CAS  Article  PubMed  Google Scholar 

  12. Liaw YF, Gane E, Leung N, et al. 2-Year GLOBE trial results: telbivudine is superior to lamivudine in patients with chronic hepatitis B. Gastroenterology. 2009;136:486–95.

    CAS  Article  PubMed  Google Scholar 

  13. Child CG, Turcotte JG, Kuwahara R. Surgery and porta hypertension. Major Probl Clin Surg. 1964;1:1–85.

    CAS  PubMed  Google Scholar 

  14. Pugh RN, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Br J Surg. 1973;60:646–9.

    CAS  Article  PubMed  Google Scholar 

  15. Cholongitas E, Papatheodoridis GV, Vangeli M, Terreni N, Patch D, Burroughs AK. Systematic review: the model for end-stage liver disease—Should it replace Child-Pugh’s classification for assessing prognosis in cirrhosis? Aliment Pharmacol Ther. 2005;22(11–12):1079–89.

    CAS  Article  PubMed  Google Scholar 

  16. Kamath PS, Kim WR. The model for end-stage liver disease (MELD). Hepatology. 2007;45(3):797–805.

    Article  PubMed  Google Scholar 

  17. Lai CL, Gane E, Liaw YF, et al. Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med. 2007;357(25):2576–88.

    CAS  Article  PubMed  Google Scholar 

  18. Tsai MC, Lee CM, Chiu KW, et al. A comparison of telbivudine and entecavir for chronic hepatitis B in real-world clinical practice. J Antimicrob Chemother. 2012;67(3):696–9.

    CAS  Article  PubMed  Google Scholar 

  19. Papatheodoridis G, Buti M, Cornberg M, et al. EASL clinical practice guidelines: management of chronic hepatitis B virus infection. J Hepatol. 2012;57(1):167–85.

    Article  Google Scholar 

  20. Chien RN, Lin CH, Liaw YF. The effect of lamivudine therapy in hepatic decompensation during acute exacerbation of chronic hepatitis B. J Hepatol. 2003;38:322–7.

    CAS  Article  PubMed  Google Scholar 

  21. Schiff E, Simsek H, Lee WM, et al. Efficacy and safety of entecavir in patients with chronic hepatitis B and advanced hepatic fibrosis or cirrhosis. Am J Gastroenterol. 2008;103:2776–83.

    CAS  Article  PubMed  Google Scholar 

  22. Ye XG, Su QM. Effects of entecavir and lamivudine for hepatitis B decompensated cirrhosis: meta-analysis. World J Gastroenterol. 2013;19:6665–78.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Chan HL, Chen YC, Gane EJ, et al. Randomized clinical trial: efficacy and safety of telbivudine and lamivudine in treatment-naive patients with HBV-related decompensated cirrhosis. J Viral Hepat. 2012;19:732–43.

    CAS  Article  PubMed  Google Scholar 

  24. Kim HR, Yim HJ, Kang S, et al. Efficacy of telbivudine compared with entecavir in hepatitis B virus related cirrhosis: 2 year follow-up data. Liver Int. 2015;35:860–9.

    CAS  Article  PubMed  Google Scholar 

  25. Matthews SJ. Telbivudine for the management of chronic hepatitis B virus infection. Clin Ther. 2007;29:2635–53.

    CAS  Article  PubMed  Google Scholar 

  26. Iloeje UH, Yang HI, Su J, et al. Predicting cirrhosis risk based on the level of circulating hepatitis B viral load. Gastroenterology. 2006;130:678–86.

    Article  PubMed  Google Scholar 

  27. He J, Bowen JM, Xie F, Goeree R. Cost-effectiveness analysis of antiviral treatments for HBeAg-positive chronic hepatitis B in Canada. Value Health. 2012;15:894–906.

    Article  PubMed  Google Scholar 

  28. Kim SS, Hwang JC, Lim SG, Ahn SJ, Cheong JY, Cho SW. Effect of virological response to entecavir on the development of hepatocellular carcinoma in hepatitis B viral cirrhotic patients: comparison between compensated and decompensated cirrhosis. Am J Gastroenterol. 2014;109(8):1223–33.

    CAS  Article  PubMed  Google Scholar 

  29. Lange CM, Bojunga J, Hofmann WP, et al. Severe lactic acidosis during treatment of chronic hepatitis B with entecavir in patients with impaired liver function. Hepatology. 2009;50:2001–6.

    CAS  Article  PubMed  Google Scholar 

Download references

Authors’ contribution

Li-Hong Yang and Jin-Hui Yang were involved in study concept and design; Wan Yue-Meng and Yu-Hua Li were involved in acquisition of data, analyzed and interpreted the data, drafted the manuscript, and critically revised the manuscript for important intellectual content; Hua-Mei Wu was involved in acquisition of data and statistical analysis; Li-Hong Yang, Jin-Hui Yang, Jing Yang and Ying Xu were involved in administrative, technical or material support, and supervised the study.

Author information

Affiliations

Authors

Corresponding authors

Correspondence to Wan Yue-Meng, Li-Hong Yang or Jin-Hui Yang.

Ethics declarations

Conflict of interest

The authors declare that they have no conflicts of interest.

Ethical standard

All procedures followed were in accordance with the ethical standards of the ethics committee of the Second Affiliated Hospital of Kunming Medical University on human experimentation and with the Declaration of Helsinki 1975, as revised in 2008.

Additional information

Wan Yue-Meng and Yu-Hua Li share the first authorship.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Yue-Meng, W., Li, YH., Wu, HM. et al. Telbivudine versus lamivudine and entecavir for treatment-naïve decompensated hepatitis B virus-related cirrhosis. Clin Exp Med 17, 233–241 (2017). https://doi.org/10.1007/s10238-016-0420-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10238-016-0420-7

Keywords

  • Lamivudine (LAM)
  • Telbivudine (TBV)
  • Entecavir (ETV)
  • Chronic hepatitis B (CHB)
  • Cirrhosis