Share This Article:

Entecavir for treatment of chronic hepatitis B: A clinical update for the treatment of patients with decompensated cirrhosis

Abstract Full-Text HTML Download Download as PDF (Size:477KB) PP. 53-61
DOI: 10.4236/ojim.2012.22012    5,342 Downloads   9,568 Views   Citations

ABSTRACT

The introduction of nucleos(t)ide analogues for the treatment of chronic hepatitis B virus (HBV) infection was transformative in reducing morbidity and mortality. Entecavir, a potent selective nucleoside analogue first approved in 2005 for treatment of chronic HBV, is associated with significant antiviral, biochemical, serologic, and histologic responses. Rapid reductions in HBV DNA levels, low risk of resistance development, and a favorable adverse event profile have contributed to its clinical usefulness. Re-cent developments in the use of entecavir have increased its utility in the management of difficult-to-treat patients with chronic HBV, including those patients with decompensated liver disease. Recent studies in this population have demonstrated that entecavir 1.0 mg/d given for up to 48 weeks had superior antiviral activity when compared with adefovir and was generally safe and well tolerated. Long-term outcomes of entecavir in difficult-to-treat populations are eagerly anticipated.

Conflicts of Interest

The authors declare no conflicts of interest.

Cite this paper

Basu, P. and Brown Jr., R. (2012) Entecavir for treatment of chronic hepatitis B: A clinical update for the treatment of patients with decompensated cirrhosis. Open Journal of Internal Medicine, 2, 53-61. doi: 10.4236/ojim.2012.22012.

References

[1] Hepatitis Foundation International (2012) Hepatitis B. http://www.hepfi.org/pdfs/Hepatitis/Hepatitis_B-2012.pdf
[2] Hepatitis B Foundation (2012) Statistics. http://www.hepb.org/hepb/statistics.htm.
[3] Carey, W.D. (2009) The prevalence and natural history of hepatitis B in the 21st century. Cleveland Clinic Journal of Medicine, 76, S2-S5. doi:10.3949/ccjm.76.s3.01
[4] Liang, T.J. (2009) Hepatitis B: The virus and disease. Hepatology, 49, S13-S21. doi:10.1002/hep.22881
[5] Lok, A.S. and McMahon, B.J. (2009) Chronic hepatitis B. Hepatology, 50, 1-36. doi:10.1002/hep.23190
[6] Bosch, F.X., Ribes, J., Cléries, R. and Diaz, M. (2005) Epidemiology of hepatocellular carcinoma. Clinics in Liver Disease, 9, 191-211. doi:10.1016/j.cld.2004.12.009
[7] Shepherd, J., Gospodarevskaya, E., Frampton, G. and Cooper, K. (2009) Entecavir for the treatment of chronic hepatitis B infection. Health Technology Assessment, 13, 31-36.
[8] de Jongh, F.E., Janssen, H.L., de Man, R.A., Hop, W.C., Schalm, S.W. and van Blankenstein, M. (1992) Survival and prognostic indicators in hepatitis B surface antigen-positive cirrhosis of the liver. Gastroenterology, 103, 1630-1635.
[9] European Association for the Study of the Liver (2009) EASL Clinical Practice Guidelines: Management of chronic hepatitis B. Journal of Hepatology, 50, 227-242. doi:10.1016/j.jhep.2008.10.001
[10] Keeffe, E.B., Dieterich, D.T., Han, S.H., et al. (2008) A treatment algorithm for the management of chronic hepatitis B virus infection in the United States: 2008 update. Clinical Gastroenterology and Hepatology, 6, 1315-1341. doi:10.1016/j.cgh.2008.08.021
[11] Chang, T.T., Gish, R.G., de Man, R., et al. (2006) A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. New England Journal of Medicine, 354, 1001-1010. doi:10.1056/NEJMoa051285
[12] Chang, T.T., Gish, R.G., Hadziyannis, S.J., et al. (2005) A dose-ranging study of the efficacy and tolerability of entecavir in lamivudine-refractory chronic hepatitis B patients. Gastroenterology, 129, 1198-1209. doi:10.1053/j.gastro.2005.06.055
[13] Chang, T.T., Liaw, Y.F., Wu, S.S., et al. (2010) Long-term entecavir therapy results in the reversal of fibrosis/cirrhosis and continued histological improvement in patients with chronic hepatitis B. Hepatology, 52, 886-893. doi:10.1002/hep.23785
[14] Gonzalez, S.A. and Keeffe, E.B. (2009) Entecavir for the long-term treatment of chronic hepatitis B. Expert Review of Anti-Infective Therapy, 7, 1053-1062. doi:10.1586/eri.09.75
[15] Lai, C.L., Shouval, D., Lok, A.S., et al. (2006) Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. New England Journal of Medicine, 354, 1011-1020. doi:10.1056/NEJMoa051287
[16] Schiff, E., Simsek, H., Lee, W.M., et al. (2008) Efficacy and safety of entecavir in patients with chronic hepatitis B and advanced hepatic fibrosis or cirrhosis. American Journal of Gastroenterology, 103, 2776-2783. doi:10.1111/j.1572-0241.2008.02086.x
[17] Sherman, M., Yurdaydin, C., Sollano, J., et al. (2006) Entecavir for treatment of lamivudine-refractory, HBeAgpositive chronic hepatitis B. Gastroenterology, 130, 2039-2049. doi:10.1053/j.gastro.2006.04.007
[18] Tenney, D.J., Rose, R.E., Baldick, C.J., et al. (2009) Long-term monitoring shows hepatitis B virus resistance to entecavir in nucleoside-na?ve patients is rare through 5 years of therapy. Hepatology, 49, 1503-1514. doi:10.1002/hep.22841
[19] Yao, G., Chen, C., Lu, W., et al. (2007) Efficacy and safety of entecavir compared to lamivudine in nucleoside-na?ve patients with chronic hepatitis B: A randomized double-blind trial in China. Hepatology International, 1, 365-372. doi:10.1007/s12072-007-9009-2
[20] Pess?a, M.G., Gazzard, B., Huang, A.K., et al. (2008) Efficacy and safety of entecavir for chronic HBV in HIV/ HBV coinfected patients receiving lamivudine as part of antiretroviral therapy. AIDS, 22, 1779-1787. doi:10.1097/QAD.0b013e32830b3ab5
[21] Baraclude (package insert) (2010) Bristol-Myers Squibb Company, Princeton.
[22] Liaw, Y.F., Raptopoulou-Gigi, M., Cheinquer, H., et al. (2011) Efficacy and safety of entecavir versus adefovir in chronic hepatitis B patients with hepatic decompensation: A randomized, open-label study. Hepatology, 54, 91-100. doi:10.1002/hep.24361
[23] Lampertico, P., Del Ninno, E., Manzin, A., et al. (1997) A randomized, controlled trial of a 24-month course of interferon alfa 2b in patients with chronic hepatitis B who had hepatitis B virus DNA without hepatitis B e antigen in serum. Hepatology, 26, 1621-1625. doi:10.1002/hep.510260634
[24] INTRON A (package insert) (2011) Merck & Co. Inc., Whitehouse Station.
[25] Lee, T.A., Veenstra, D.L., Iloeje, U.H. and Sullivan, S.D. (2004) Cost of chronic hepatitis B infection in the United States. Journal of Clinical Gastroenterology, 38, S144-S147. doi:10.1097/00004836-200411003-00005
[26] Lau, G.K., Piratvisuth, T., Luo, K.X., et al. (2005) Peginterferon alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. New England Journal of Medicine, 352, 2682-2695. doi:10.1056/NEJMoa043470
[27] Lai, C.L., Chien, R.N., Leung, N.W., et al. (1998) A one-year trial of lamivudine for chronic hepatitis B. New England Journal of Medicine, 339, 61-68. doi:10.1056/NEJM199807093390201
[28] Lai, C.L., Gane, E., Liaw, Y.F., et al. (2007) Telbivudine versus lamivudine in patients with chronic hepatitis B. New England Journal of Medicine, 357, 2576-2588. doi:10.1056/NEJMoa066422
[29] Marcellin, P., Chang, T.T., Lim, S.G., et al. (2003) Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. New England Journal of Medicine, 348, 808-816. doi:10.1056/NEJMoa020681
[30] Marcellin, P., Heathcote, E.J., Buti, M., et al. (2008) Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. New England Journal of Medicine, 359, 2442-2455.
[31] Hadziyannis, S.J., Tassopoulos, N.C., Heathcote, E.J., et al. (2003) Adefovir dipivoxil for the treatment of hepatitis B e antigen-negative chronic hepatitis B. New England Journal of Medicine, 348, 800-807. doi:10.1056/NEJMoa021812
[32] Kaymakoglu, S., Oguz, D., Gur, G., et al. (2007) Pegylated interferon alfa-2b monotherapy and pegylated interferon alfa-2b plus lamivudine combination therapy for patients with hepatitis B virus e antigen-negative chronic hepatitis B. Antimicrobial Agents and Chemotherapy, 51, 3020-3022. doi:10.1128/AAC.00088-07
[33] Marcellin, P., Lau, G.K., Bonino, F., et al. (2004) Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. New England Journal of Medicine, 351, 1206-1217. doi:10.1056/NEJMoa040431
[34] Liaw, Y.F. (2001) Impact of YMDD mutations during lamivudine therapy in patients with chronic hepatitis B. Antiviral Chemistry & Chemotherapy, 12, 67-71.
[35] Mutimer, D. (2001) Hepatitis B virus infection: Resistance to antiviral agents. Journal of Clinical Virology, 21, 239-242. doi:10.1016/S1386-6532(00)00166-9
[36] Benhamou, Y., Bochet, M., Thibault, V., et al. (1999) Long-term incidence of hepatitis B virus resistance to lamivudine in human immunodeficiency virus-infected patients. Hepatology, 30, 1302-1306. doi:10.1002/hep.510300525
[37] Fontana, R.J. (2010) Entecavir in decompensated HBV cirrhosis: The future is looking brighter. Journal of Hepatology, 52, 147-149. doi:10.1016/j.jhep.2009.10.025
[38] Shim, J.H., Lee, H.C., Kim, K.M., et al. (2010) Efficacy of entecavir in treatment-na?ve patients with hepatitis B virus-related decompensated cirrhosis. Journal of Hepatology, 52, 176-182. doi:10.1016/j.jhep.2009.11.007
[39] Zoulim, F., Radenne, S. and Ducerf, C. (2008) Management of patients with decompensated hepatitis B virus associated cirrhosis. Liver Transplantation, 14, S1-S7. doi:10.1002/lt.21615
[40] Yan, J.H., Bifano, M., Olsen, S., et al. (2006) Entecavir pharmacokinetics, safety, and tolerability after multiple ascending doses in healthy subjects. Journal of Clinical Pharmacology, 46, 1250-1258. doi:10.1177/0091270006293304
[41] Liaw, Y.F., Sheen, I.S., Lee, C.M., et al. (2011) Tenofovir disoproxil fumarate (TDF), emtricitabine/TDF, and entecavir in patients with decompensated chronic hepatitis B liver disease. Hepatology, 53, 62-72. doi:10.1002/hep.23952
[42] Tsai, N., Liaw, Y.F., Raptopoulou-Gigi, M., et al. (2010) Risk and predictors of mortality or hepatocellular carcinoma among entecaviror adefovir-treated chronic hepatitis B patients with evidence of hepatic decompensation. Gastroenterology, 138, S-831. doi:10.1016/S0016-5085(10)63831-0
[43] Scott, L.J. and Keating, G.M. (2009) Entecavir: a review of its use in chronic hepatitis B. Drugs, 69, 1003-1033. doi:10.2165/00003495-200969080-00005
[44] Leung, N., Peng, C.Y., Hann, H.W., et al. (2009) Early hepatitis B virus DNA reduction in hepatitis B e antigen-positive patients with chronic hepatitis B: A randomized international study of entecavir versus adefovir. Hepatology, 49, 72-79. doi:10.1002/hep.22658
[45] Chevaliez, S. and Pawlotsky, J.M. (2008) Diagnosis and management of chronic viral hepatitis: Antigens, antibodies and viral genomes. Best Practice & Research. Clinical Gastroenterology, 22, 1031-1048. doi:10.1016/j.bpg.2008.11.004
[46] Gish, R.G., Chang, T.T., Lai, C.L., et al. (2010) Loss of HBsAg antigen during treatment with entecavir or lamivudine in nucleoside-naive HBeAg-positive patients with chronic hepatitis B. Journal of Viral Hepatitis, 17, 16-22. doi:10.1111/j.1365-2893.2009.01146.x
[47] Salmon-Ceron, D., Lewden, C., Morlat, P., et al. (2005) Liver disease as a major cause of death among HIV infected patients: Role of hepatitis C and B viruses and alcohol. Journal of Hepatology, 42, 799-805. doi:10.1016/j.jhep.2005.01.022
[48] Sorrell, M.F., Belongia, E.A., Costa, J., et al. (2009) National Institutes of Health consensus development conference statement: Management of hepatitis B. Hepatology, 49, S4-S12. doi:10.1002/hep.22946
[49] Chang, T.T., Lai, C.L., Kew Yoon, S., et al. (2010) Entecavir treatment for up to 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B. Hepatology, 51, 422-430. doi:10.1002/hep.23327
[50] Leemans, W.F., Niesters, H.G., van der Eijk, A.A., Janssen, H.L., Schalm, S.W. and de Man, R.A. (2008) Selection of an entecavir-resistant mutant despite prolonged hepatitis B virus DNA suppression, in a chronic hepatitis B patient with preexistent lamivudine resistance: Successful rescue therapy with tenofovir. European Journal of Gastroenterology & Hepatology, 20, 773-777. doi:10.1097/MEG.0b013e3282f793d6
[51] Petersen, J., Ratziu, V., Buti, M., et al. (2012) Entecavir plus tenofovir combination as rescue therapy in pretreated chronic hepatitis B patients: An international multicenter cohort study. Journal of Hepatology, 56, 520-526.
[52] Lange, C.M., Bojunga, J., Hofmann, W.P., et al. (2009) Severe lactic acidosis during treatment of chronic hepatitis B with entecavir in patients with impaired liver function. Hepatology, 50, 2001-2006. doi:10.1002/hep.23346
[53] Marzano, A., Marengo, A., Marietti, M. and Rizzetto, M. (2011) Lactic acidosis during Entecavir treatment in decompensated hepatitis B virus-related cirrhosis. Digestive and Liver Disease, 43, 1027-1028. doi:10.1016/j.dld.2011.06.013

  
comments powered by Disqus

Copyright © 2019 by authors and Scientific Research Publishing Inc.

Creative Commons License

This work and the related PDF file are licensed under a Creative Commons Attribution 4.0 International License.