New areas in therapy for chronic hepatitis B


DOI: https://dx.doi.org/10.18565/epidem.2019.9.3.84-91

Omarova Kh.G., Makashova V.V.

Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia
The literature review provides data on promising drugs being at different stages of testing for the treatment of patients with chronic hepatitis B.
Keywords: preclinical and clinical trials, chronic HBV infection, treatment
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Literature

  1. Абдурахманов Д.Т. Хронический гепатит В и D. М.: ГЭОТАР-Медиа, 2010. 286 с.Abdurakhmanov D.T. [Chronic hepatitis B and D]. Moscow: GEOTAR-Media, 2010, 286 p. (In Russ.).
  2. Ющук Н.Д., Климова Е.А., Знойко О.О. Вирусные гепатиты. Клиника, диагностика, лечение. 2-е изд., перераб. и доп. М.: ГЭОТАР-Медиа, 2015. 302 с.Yushchuk N.D., Klimova E.A., Znoyko О.О. [Viral hepatitis. Clinic, diagnostics, treatment]. 2nd ed. Moscow: GEOTAR-Media, 2015. 302 p. (In Russ.).
  3. Luo Z., Xie Y., Deng M., Zhou X., Ruan B. Prevalence of hepatitis B in the southeast of China: a population-based study with a large sample size. Eur. J. Gastroenterol. Hepatol 2011; 23(8): 695–700.
  4. Hahne S.J., Veldhuijzen I.K., Wiessing L., Lim T.A., Salminen M., Laar M. Infection with hepatitis B and C virus in Europe: a systematic review of prevalence and cost-effectiveness of screening. BMC Infect. Dis. 2013; 13: 181.
  5. Davison S.A., Strasser S.I. Ordering and interpreting hepatitis B serology. BMJ (Clinical research ed.) 2014; 348: 2522.
  6. Hoofnagle J.H., Doo E., Liang T.J., Fleischer R., Lok A.S.F. Management of hepatitis B: Summary of a clinical research workshop. Hepatology 2007; 45(4): 1056–75.
  7. McMahon B.J. Chronic hepatitis B virus infection. Med. Clin. North Am. 2014; 98(1): 39–54.
  8. Ganem D., Prince A.M. Hepatitis B virus infection – natural history and clinical consequences. New Engl. J. Med. 2004; 350(11): 1118–29.
  9. Thiele M., Gluud L.L., Fialla A.D., Dahl E.K., Krag A. Large variations in risk of hepatocellular carcinoma and mortality in treatment naive hepatitis B patients: systematic review with meta-analyses. PLoS One 2014; 9(9): e107177.
  10. Yang Y.F., Zhao W., Zhong Y.D., Xia H.M., Shen L., Zhang N. Interferon therapy in chronic hepatitis B reduces progression to cirrhosis and hepatocellular carcinoma: a meta-analysis. J. Viral. Hepat. 2009; 16(4): 265–71.
  11. D’Amico G., Garcia-Tsao G., Pagliaro L. Natural history and prognostic indicators of survival in cirrhosis: a systematic review of 118 studies. J. Hepatol. 2006; 44(1): 217–31.
  12. Chu C.M., Liaw Y.F. Hepatitis B virus-related cirrhosis: natural history and treatment. Seminars in Liver Disease 2006; 26(2): 142–52.
  13. Yang L.S., Shan L.L., Saxena A., Morris D.L. Liver transplantation: a systematic review of long-term quality of life. Liver Int. 2014; 34(9): 1298–313.
  14. Duffy J.P., Kao K., Ko C.Y., Farmer D.G., McDiarmid S.V., Hong J.C. et al. Long-term patient outcome and quality of life after liver transplantation: analysis of 20-year survivors. Annals of Surgery 2010; 252(4): 652–61.
  15. Scientific Registry of Transplant Recipients. OPTN/SRTR 2012 annual data report: liver, 2012. http://srtr.transplant.hrsa.gov/annual_reports/2012/pdf/ 03_liver_13.pdf
  16. Schoening W.N., Buescher N., Rademacher S., Andreou A., Kuehn S., Neuhaus R. et al. Twenty-year longitudinal follow-up after orthotopic liver transplantation: a single-center experience of 313 consecutive cases. Am. J. Transplant. 2013; 13 (9): 2384–94.
  17. Исаков В.А. Стратегия лечения хронического гепатита В. Клиническая гастроэнтерология и гепатология. Русское издание 2013; (3): 112–4.Isakov V.A. [Strategy for the treatment of chronic hepatitis B]. Klinicheskaya gastroenterologiya i gepatologiya. Russkoe izdanie 2013; (3): 112–4. (In Russ.).
  18. European Association for the Study of the Liver (EASL) Clinical Practice Guidelines: Management of chronic hepatitis В virus infection. J. Hepatol. 2012; 57: 167–85.
  19. McMahon B.J. AASLD practice guidelines. Chronic hepatitis B: update 2009. https://www.aasld.org/sites/default/files/guideline_documents/Chronic HepatitisB2009.pdf
  20. Dienstag J.L. Hepatitis B virus infection. New Engl. J. Med. 2008; 359(14): 1486–500.
  21. NCBI. Interferons, 2014. https://www.ncbi.nlm.nih.gov/mesh/68007372
  22. Feld J.J., Hoofnagle J.H. Mechanism of action of interferon and ribavirin in treatment of hepatitis C. Nature 2005; 436(7053): 967–72.
  23. Anonymous. Interferon production by genetic engineering. Brit. Med. J. (Clinical research ed.) 1981; 282(6265): 674–5.
  24. Bailon P., Palleroni A., Schaffer C.A., Spence C.L., Fung W.J., Porter J.E. et al. Rational design of a potent, long-lasting form of interferon: a 40 kDa branched polyethylene glycol-conjugated interferon alpha-2a for the treatment of hepatitis C. Bioconjugate Chemistry 2001; 12(2): 195–202.
  25. Sweetman S., ed. Martindale: the complete drug reference (online version), 37th edition, 2011. http://www.pharmpress.com/product/MC_MART/martindale-the-complete-drug-reference
  26. NCBI. Thymosins, 2014. www.ncbi.nlm.nih.gov/mesh/68013947
  27. Li J., Liu C.H., Wang F.S. Thymosin alpha 1: biological activities, applications and genetic engineering production. Peptides 2010; 31(11): 2151–8.
  28. Чуланов В.П.. Проблемы лекарственной резистентности при противовирусной терапии хронического гепатита В. Клиническая гастроэнтерология и гепатология. Русское издание. 2011; 4(3): 167–72.Chulanov V.P. [Problems of drug resistance during antiviral therapy of chronic hepatitis B]. Klinicheskaya gastroenterologiya i gepatologiya. Russkoe izdanie. 2011; 4(3): 167–72. (In Russ.).
  29. Chang T.T., Liaw Y.F., Wu S.S., Schiff E., Han K.H., Lai C.L. 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.
  30. Schiff E.R., Lee S.S., Chao Y.C., Kew Yoon S., Bessone F., Wu S.S. et al. Long-term treatment with entecavir induces reversal of advanced fibrosis or cirrhosis in patients with chronic hepatitis B. Clin. Gastroenterol. Hepatol. 2011; (9): 274–6.
  31. Marcellin R., Gane E., Buti M., Afdhal N., Sievert W., Jacobson I.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.
  32. Mellerup M.T., Krogsgaard K., Mathurin P., Gluud C., Poynard T. Sequential combination of glucocorticosteroids and alfa interferon versus alfa interferon alone for HBeAg-positive chronic hepatitis B. Cochrane Database of Systematic Reviews 2005, Issue 3. DOI:10.1002/ 14651858.CD000345.pub2.
  33. Wu T., Xie L., Liu G.J., Hao B., Harrison R.A. Bicyclol for chronic hepatitis B.Cochrane Database of Systematic Reviews 2006, Issue 4. DOI:10.1002/ 14651858.CD004480.pub2
  34. Xia Y., Luo H., Liu J.P., Gluud C. Phyllanthus species for chronic hepatitis B virus infection. Cochrane Database of Systematic Reviews 2011, Issue 4. DOI:10.1002/14651858.CD008960.pub2
  35. Xia Y., Luo H., Liu J.P., Gluud C. Phyllanthus species versus antiviral drugs for chronic hepatitis B virus infection. Cochrane Database of Systematic Reviews 2013, Issue 4. DOI:10.1002/14651858.CD009004.pub2
  36. Volz T., Giersch K., Allweiss L., Bhadra O.D., Petersen J., Lohse A.W. et al. Myrcludex-B inhibits establishment of HDV super-infection in HBV infected mice and reduces HDV viremia in stably HBV/HDV coinfected mice. J. Hepatol. 2015; 62(Abstr): S514.
  37. Bogomolov P., Alexandrov A., Voronkova N., Macievich M., Kokina K., Petrachenkova M. et al. Treatment of chronic hepatitis D with the entry inhibitor myrcludex B: First results of a phase Ib/IIa study. J. Hepatol. 2016; 65(3): 490–8. DOI: 10.1016/j.jhep.2016.04.016.
  38. Yurdaydin C. et al. Optimizing the prenylation inhibitor lonafarnib 
using ritonavir boosting in patients with chronic delta hepatitis. EASL 50th International Liver Congress, Vienna, 2015. Abstract O118.
  39. http://tetralogicpharma.com/birinapant-publications-presentations/
  40. Ebert G., Preston S., Allison C., Cooney J., Toe J.G., Stutz M.D. et al. Cellular inhibitor of apoptosis proteins prevent clearance of hepatitis B virus. Proc. Natl. Acad. Sci. USA 2015; 112: 5797–802. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4426461/
  41. Yang P.L., Althage A., Chung J., Maier H., Wieland S., Isogawa M., Chisari F.V. Immune effectors required for hepatitis B virus clearance. Proc. Natl. Acad. Sci. USA 2010; 107(2): 798–802. http://www.ncbi. nlm.nih.gov/pmc/articles/PMC2818933/
  42. Lee Y.H., Bae S.C., Song G.G. Hepatitis B virus (HBV) reactivation in rheumatic patients with hepatitis core antigen (HBV occult carriers) undergoing anti-tumor necrosis factor therapy. Clin. Exp. Rheumatol. 2013; 31(1): 118–121. http://www.ncbi.nlm.nih.gov/pubmed/23111095
  43. Lan J.L., Chen Y.M., Hsieh T.Y., Chen Y.H., Hsieh C.W., Chen D.Y., Yang S.S. Kinetics of viral loads and risk of hepatitis B virus reactivation in hepatitis B core antibody-positive rheumatoid arthritis patients undergoing anti-tumour necrosis factor alpha therapy. Ann. Rheum. Dis. 2011; 70(10): 1719–25. http://www.ncbi.nlm.nih.gov/pubmed/ 21719446
  44. Silke J. The regulation of TNF signalling: What a tangled web we weave. Curr. Opin. Immunol. 2011; 23(5): 620–6. http://www.ncbi.nlm.nih. gov/pubmed/21920725
  45. Allensworth J.L., Sauer S.J., Lyerly H.K., Morse M.A., Devi G.R. Smac mimetic Birinapant induces apoptosis and enhances TRAIL potency in inflammatory breast cancer cells in an IAP-dependent and TNF-α-independent mechanism. Breast. Cancer Res. Treat. 2013; 137(2): 359–71. http://www.ncbi.nlm.nih.gov/pubmed/23225169
  46. Carter B.Z., Mak P.Y., Mak D.H., Shi Y., Qiu Y., Bogenberger J.M. et al. Synergistic targeting of AML stem/progenitor cells with IAP antagonist birinapant and demethylating agents. J. Natl. Cancer Inst. 2014; 106(2): djt440. http://www.ncbi.nlm.nih.gov/ubmed/24526787
  47. Condon S.M., Mitsuuchi Y., Deng Y., La Porte M.G., Rippin S.R., Haimowitz T. et al. Birinapant, a smac-mimetic with improved tolerability for the treatment of solid tumors and hematological malignancies. J. Med. Chem. 2014; 57(9): 3666–77. http://www.ncbi.nlm.nih.gov/pubmed/24684347
  48. Krepler C., Chunduru S.K., Halloran M.B., He X., Xiao M., Vultur A. et al. The novel SMAC mimetic birinapant exhibits potent activity against human melanoma cells. Clin. Cancer Res. 2013; 19(7): 1784–94. http://www.ncbi.nlm.nih.gov/pubmed/23403634
  49. Benetatos C.A., Mitsuuchi Y., Burns J.M., Neiman E.M., Condon S.M., Yu G. Birinapant (TL32711), a bivalent SMAC mimetic, targets TRAF2-associated cIAPs, abrogates TNF-induced NF-κB activation, and is active in patient-derived xenograft models. Mol. Cancer Ther. 2014; 13(4): 867–79. http://www.ncbi.nlm.nih.gov/pubmed/24563541
  50. Ebert G., Allison C., Preston S., Cooney J., Toe J.G., Stutz M.D. et al. Immunology and Inflammation, Eliminating hepatitis B by antagonizing cellular inhibitors of apoptosis. Proc. Natl. Acad. Sci. USA 2015; 112(18): 5803–8. DOI: 10.1073/pnas.1502400112, PMCID: PMC4426438. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4426461/
  51. Lin Y. J., Huang L. R., Yang H. C., Tzeng H. T., Hsu P. N., Wu H. L., et al. Hepatitis B virus core antigen determines viral persistence in a C57BL/6 mouse model. Proc. Natl. Acad. Sci. USA 2010; 107(20): 9340–5. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2889105/
  52. Huang L.R., Wu H.L., Chen P.J., Chen D.S. An immunocompetent mouse model for the tolerance of human chronic hepatitis B virus infection. Proc. Natl. Acad. Sci. USA 2006; 103(47): 17862–7. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1635544/
  53. Ahmed M., Wang F., Levin A., Le C., Eltayebi Y., Houghton M., Tyrrell L., Barakat K. Targeting the Achilles heel of the hepatitis B virus: a review of current treatments against covalently closed circular DNA. http://dx.doi.org/10.1016/j.drudis.2015.01.008
  54. Sanford J. The Treatment of viral hepatitis. Moscow: Granate, 2016; 27.
  55. Bazinet M., Pantea V., Cebotarescu V. et al. Significant reduction of HBsAg and HDV-RNA by the nucleic acid polymer rep 2139 in Caucasian patients with chronic HBV/HDV co-infection. J. Hepatol. 2015; 62 (Abstr.): S257. http://www.aasld.org/sites/default/files/2015SupplementFULLTEXT.pdf.
  56. Lam A., Ren S., Vogel R., Espiritu Ch., Kelly M., Lau V. et al. Inhibition of hepatitis B virus replication by the HBV core inhibitor NVR 3-778. In: 66th annual meeting of the American-Association-for-the-Study-of-Liver-Diseases (AASLD), San Francisco, CA; Hepatology 2015; 62(Suppl. 1): 223A.
  57. Li L., Niu C., Daffis S., Ramos H., Salas E., Voitenleitner Ch., Delaney W.E., Fletcher S.P. HBV Does Not Modulate the Transcriptional Response to TLR7-Induced Cytokines in Highly Infected Primary Human Hepatocytes.; Gilead Sciences, Foster City, CA. 224A AASLD Abstracts Hepatology, October, 2015.
  58. Wang J., Lu F. Dual-gRNAs and gRNA-microRNA (miRNA)-gRNA ternary cassette combined CRISPR/Cas9 system and RNAi approach promotes the clearance of HBV cccDNA. Peking University Health Science Center, Beijing, China. Hepatology 2015; 62(Suppl. 1): 223A
  59. Sepp-Lorenzino L., Sprague A.G., Mayo T.. GalNAc-siRNA conjugate ALN-HBV targets a highly conserved, pan-genotypic X-orf viral site and mediates profound and durable HBsAg silencing in vitro and in vivo. 224A AASLD Abstracts Hepatology, October, 2015.


About the Autors

Khadizhat G. Omarova, Researcher, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; е-mail: omarova71@inbox.ru; ORCID: https://orcid.org/0000-0002-9682-2230
Prof. Vera V. Makashova MD, Leading Researcher, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; е-mail: veramakashova@yandex.ru; ORCID: https://orcid.org 0000-0002-0982-3527


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