Entecavir in the treatment of chronic hepatitis B: multicenter randomized trials and real clinical practice


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Abstract

The goal of treatment for chronic hepatitis B (CHB) is now to improve quality of life and to prevent the poor outcomes of the disease rather than to eliminate the virus from the body. This goal may be achieved via the long-term maintenance of aviremia. According to the International and Russian clinical guidelines, entecavir is the first-line drug of choice to treat patients with CHB. For almost 10 years of world clinical practice there has been evidence that entecavir has a high efficacy and a favorable safety profile in a number of randomized clinical trials and in real medical practice worldwide, in Russia in particular. For instance, the BRAVR (Baraclude Russian Analysis of Virological Response) trial of 147 CHB patients from 10 Russian cities indicated that the rate of aviremia was 85.8% (n=147), 89.9% (n=138), 89.4% (n=97), and 93.5% (n=81) at 1, 2, 3, and 4 years, respectively. In addition to its virological, immunological, and biochemical efficacies, entecavir also proved to be effective in achieving the regression of histological changes and in preventing the decompensation of cirrhosis and the development of carcinoma. The given data permit the use of entecavir for the long-term therapy of CHB with confidence.

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Энтекавир в лечении хронического гепатита В: многоцентровые рандомизированные исследования и реальная клиническая практика. - Аннотация. В настоящее время целью лечения хронического гепатита В (ХГВ) являются улучшение качества жизни пациента и предотвращение неблагоприятных исходов заболевания, а не элиминация вируса из организма. Достижение этой цели возможно при длительном поддержании авиремии. Согласно международным и отечественным клиническим рекомендациям, энтекавир является препаратом первого ряда для лечения больных ХГВ. За почти 10 лет в мировой клинической практике доказаны высокая эффективность и благоприятный профиль безопасности энтекавира в ряде рандомизированных клинических исследований и в реальной врачебной практике в том числе в России. Так, в исследовании БРАВО (Бараклюд: Российский Анализ Вирусологического Ответа) с участием 147 больных ХГВ из 10 городов России частота авиремии составила 85,8% (n=147), 89,9% (n=138), 89,4% (n=97) и 93,5% (n=81) через 1, 2, 3 и 4 года соответственно. Помимо вирусологической, иммунологической и биохимической эффективности также доказана эффективность энтекавира в достижении обратного развития гистологических изменений, профилактике декомпенсации цирроза и развития гепатоцеллюлярной карциномы. Представленные данные позволяют уверенно использовать энтекавир для длительной терапии ХГВ.
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References

  1. World Health Organization. Fact sheet No. 204. Revised August 2008 http://www.who.int/mediacentre/factsheets/fs204/en/ (Accessed December 2011).
  2. Онищенко Г.Г., Жербун А.Б. Вирусные гепатиты в Российской Федерации. 2009. Справочник. СПб.: НИИЭМ им. Пастера, 2009.
  3. European Association for the Study of the Liver. EASL clinical practice guidelines: management of chronic hepatitis B. J Hepatol 2012; 57: 167-185.
  4. Инструкция по медицинскому применению лекарственного препарата Бараклюд; ЛСР 000035-010213.
  5. Chang T.T., Gish R.G., de Man R. et al. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006; 354: 1001-1010.
  6. Lai C.L., Shouval D., Lok A.S. et al. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2006; 354: 1011-1020.
  7. Lai C.L., Chang T.T., Chao Y.C. et al. Continued virological and biochemical Improvement through 96 weeks of Entecavir treatment in HBeAg negative chronic hepatitis B. APASL 2006.
  8. Gish R., Lok A.S., Chang T.T. et al. Entecavir therapy for up to 96 weeks in patients with HBeAg-positive chronic hepatitis B. Gastroenterology 2007; 133: 1437-1444.
  9. Chang T.T., Lai C.L., Kew Yoon S. et al. Entecavir treatment for up to 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B. Hepatology 2010; 51 (2): 422-430.
  10. Chang T.T., Liaw Y.F., Wu S.S. 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: 886-893.
  11. Mochida S., Takaguchi K., YokosukaO. et al. Long term efficacy, safety and resistance analyses of entecavir treatment in Japanese nucleoside-naive patients with chronic hepatitis B. J Hepatol 2008; 48 (suppl 2): 262.
  12. Sherman M., Yurdaydin C., Sollano J. et al. Entecavir for treatment of lamivudine-refractory, HBeAg-positive chronic hepatitis B. Gastroenterology 2006; 130 (7): 2039-2049.
  13. Sherman M., Yurdaydin C., Simsek H. et al. Entecavir therapy for lamivudine-refractory chronic hepatitis B: improved virologic, biochemical, and serology outcomes through 96 weeks. Hepatology 2008; 48 (1): 99-108.
  14. Huang Y.H., Hsiao L.T., Hong Y.C. et al. Randomized controlled trial of entecavir prophylaxis for rituximab-associated hepatitis B virus reactivation in patients with lymphoma and resolved hepatitis B. J Clin Oncol 2013; 31 (22): 2765-2772.
  15. Perillo R., Buti Ferret M., Durand F. et al. Safety and Efficacy of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B [Poster #535] http://www.natap.org/2012/EASL/EASL_88.htm
  16. European AIDS Clinical Society Guidelines http://www.eacsociety.org/Portals/0/140601_EACS%20EN7.02.pdf
  17. Summary of Product Characteristics, Baraclude (entecavir), January 2014.
  18. Tenney D.J., Pokornovski K.A., Rose R.E. et al. Entecavir maintains a high genetic barrier to HBV resistance through 6 years in naïve patients. J Hepatol 2009; 50 (suppl 1): 10.
  19. Lampertico P., Soffredini R., Vigano M. et al. Entecavir treatment for NUC naiïve, field practice patients with chronic hepatitis B: excellent viral suppression and safety profile over 5 years of treatment. Hepatology 2012; 56 (4): A366.
  20. Zoutendijk R., Reijnders J.G., Brown A. et al. Entecavir treatment for chronic hepatitis B: adaptation is not needed for the ma- jority of naïve patients with a partial virological response. Hepatology 2011; 54: 443-451.
  21. Hou J., Jia J., Wei L. et al. Randomized, observational study of long-term entecavir treatment versus other standard of care nucleos(t)ide analog therapy in nucleos(t)ide-naiïve patients with chronic hepatitis B from a "real-world" clinical practice setting in China. Hepatology 2012; 56 (4): A392.
  22. Seto W.K., Lai C.L., Fung J. et al. Outcome of 4-year treatment of entecavir for treatment of chronic hepatitis B. J Hepatol 2011; 54 Suppl 1: Abstract 748.
  23. Ono A., Suzuki F., Kawamura Y. et al. Long-term continuous entecavir therapy in nucleos(t)ide-naïve chronic hepatitis B patients. J Hepatol 2012; 57: 508-514.
  24. Luo J., Li X., Wu Y. et al. Efficacy of entecavir treatment for up to 5 years in nucleos(t)ide-naïve chronic hepatitis B patients in real life. Int J Med Sci 2013; 10: 427-433.
  25. Wang C., Tseng K.C., Peng C.Y. et al. Viral load and alanine aminotransferase correlate with serologic response in chronic hepatitis B patients treated with entecavir. J Gastroenterol Hepatol 2013; 28: 46-50.
  26. Fahrtash-Bahin F., Kariyawasam V.C., Gray T. et al. Australian tertiary care outcomes of entecavirmonotherapy in treatment naive patients with chronic hepatitis B. World J Gastroenterol 2013; 19: 721-726.
  27. Ridruejo E. Treatment of chronic hepatitis B in clinical practice with entecavir or tenofovir. World J Gastroenterol 2014; 20 (23): 7169-7180.
  28. Hosaka T., Suzuki F., Kobayashi M. et al. Long-term entecavir treatment reduces hepatocellular carcinoma incidence in patients with hepatitis B virus infection. Hepatology 2013; 58 (1): 98-107.
  29. Lampertico P. Discontinuation of nucleoside analogues in hepatitis B virus Infection. Gastroenterol Hepatol 2013; 9 (10): 656-658.

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