Use of entecavir for the treatment of complex forms of Hepatitis B

European Review for Medical and Pharmacological Sciences

Volumn 18, Issue 9, 2014, Pages 1333-1343

  Sacco, R ^a  

^a UNIVERSITY HOSPITAL OF PISA   (Italy)

Author keywords

Complex forms; Entecavir; HBV; Hepatitis B

Indexed keywords

ADEFOVIR; ALANINE AMINOTRANSFERASE; ENTECAVIR; HEPATITIS B SURFACE ANTIGEN; HEPATITIS B(E) ANTIGEN; LAMIVUDINE; TELBIVUDINE; ANTIVIRUS AGENT; GUANINE;

ARTICLE; DECOMPENSATED LIVER CIRRHOSIS; DISEASE EXACERBATION; DRUG EFFICACY; DRUG SAFETY; EMBASE; FULMINANT HEPATIC FAILURE; HEPATITIS B; HUMAN; IMMUNOCOMPROMISED PATIENT; KIDNEY FAILURE; LACTIC ACIDOSIS; LIVER TRANSPLANTATION; MEDLINE; MONOTHERAPY; PHASE 2 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); SURVIVAL RATE; SURVIVAL TIME; SYSTEMATIC REVIEW; VIRAL CLEARANCE; VIRUS REPLICATION; ANALOGS AND DERIVATIVES; ANTIVIRAL RESISTANCE; COMPLICATION; COST BENEFIT ANALYSIS; DRUG COST; DRUG EFFECTS; ECONOMICS; GENETICS; GENOTYPE; HEPATITIS B VIRUS; RISK FACTOR; TREATMENT OUTCOME;

ANTIVIRAL AGENTS; COST-BENEFIT ANALYSIS; DRUG COSTS; DRUG RESISTANCE, VIRAL; GENOTYPE; GUANINE; HEPATITIS B; HEPATITIS B VIRUS; HUMANS; RISK FACTORS; TREATMENT OUTCOME;

EID: 84902175937     PISSN: 11283602     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (63)

1. LAVANCHY D. Worldwide epidemiology of HBV infection, disease burden, and vaccine prevention. J Clin Virol 2005; 34: S1-3. (Pubitemid 43197742)
2. NEGRO F. Management of chronic hepatitis B: An update. Swiss Med Wkly 2011; 141: w13264.
3. WIERSMA S. The global burden of disease and viral hepatitis. Viral Hepat 2011; 19: 9-10.
4. EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL. Hepatitis B and C in the EU neighbourhood: Prevalence, burden of disease and screening policies. Technical report. Stockholm: European centre for disease prevention and control; 2010. Available from: http://www.ecdc.europa.eu/en/publications/Publications/ TER-100914-Hep-B-C%20-EU-neighbourhood.pdf (accessed January, 2014).
5. NARDONE A, ANASTASSOPOULOU CG, THEETEN H, KRIZ B, DAVIDKIN I, THIERFELDER W, O'FLANAGAN D, BRUZZONE B, MOSSONG J, BOOT HJ, BUTUR D, SLACIKOVÁ M, PANAIT ML, HELLENBRAND W, DE MELKER H, SOBOTOVÁ Z, ICARDI G, ANDREWS N, PEBODY RG, VAN DAMME P, KAFATOS G, MILLER E, HATZAKIS A. A comparison of hepatitis B seroepidemiology in ten European countries. Epidemiol Infect 2009; 137: 961-969.
6. EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVEr. EASL Clinical Practice Guidelines: management of chronic hepatitis B. J Hepatol 2012; 57: 167-185.
7. LOK AS, MCMAHON BJ Chronic hepatitis B: update 2009. Hepatology 2009; 50: 661-662.
8. HATZAKIS A, WAIT S, BRUIX J, BUTI M, CARBALLO M, CAVALERI M, COLOMBO M, DELAROCQUE-ASTAGNEAU E, DUSHEIKO G, ESMAT G, ESTEBAN R, GOLDBERG D, GORE C, LOK AS, MANNS M, MARCELLIN P, PAPATHEODORIDIS G, PETERLE A, PRATI D, PIORKOWSKY N, RIZZETTO M, ROUDOT-THORAVAL F, SORIANO V, THOMAS HC, THURSZ M, VALLA D, VAN DAMME P, VELDHUIJZEN IK, WEDEMEYER H, WIESSING L, ZANETTI AR, JANSSEN HL. The state of hepatitis B and C in Europe: report from the hepatitis B and C summit conference. J Viral Hepat 2011; 18: 1-16.
9. CHEN EQ, TANG H. The current status of combination therapy of chronic hepatitis B. Eur Rev Med Pharmacol Sci 2013; 17: 2023-2031.
10. WANG JC1, HE LL, CHEN Q. Comparison of re-treatment outcomes of lamivudine plus adefovir or entecavir in chronic hepatitis B patients with viral relapse after cessation of adefovir. Eur Rev Med Pharmacol Sci 2013; 17: 1162-1166.
11. GONZALEZ SA, KEEFFE EB Entecavir for the longterm treatment of chronic hepatitis B. Expert Rev Anti Infect Ther 2009; 7: 1053-1062.
12. ZOULIM F. Hepatitis B virus resistance to antiviral drugs: where are we going? Liver Int 2011; 31: 111-116.
13. CEYLAN B, YARDIMCI C, FINCANCI M, EREN G, TOZALGAN U, MUDERRISOGLU C, AKKOYUNLU Y. Comparison of tenofovir and entecavir in patients with chronic HBV infection. Eur Rev Med Pharmacol Sci 2013; 17: 2467-2473.
14. BUTI M, OYAGÜEZ I, LOZANO V, CASADO MA Cost effectiveness of first-line oral antiviral therapies for chronic hepatitis B: A systematic review. Pharmacoeconomics 2013; 31: 63-75.
15. DIENSTAG JL. Hepatitis B virus infection. N Engl J Med 2008; 359: 1486-1500.
16. LANGLEY DR, WALSH AW, BALDICK CJ, EGGERS BJ, ROSE RE, LEVINE SM, KAPUR AJ, COLONNO RJ, TENNEY DJ. Inhibition of hepatitis B virus polymerase by entecavir. J Virol 2007; 81: 3992-4001. (Pubitemid 46586894)
17. YAMANAKA G, WILSON T, INNAIMO S, BISACCHI GS, EGLI P, RINEHART JK, ZAHLER R, COLONNO RJ Metabolic studies on BMS-200475, a new antiviral compound active against hepatitis B virus. Antimicrob Agents Chemother 1999; 43: 190-193. (Pubitemid 29069227)
18. ONO SK, KATO N, SHIRATORI Y, KATO J, GOTO T, SCHINAZI R F, CARRILHO FJ, OMATA M. The polymerase L528M mutation cooperates with nucleotide binding-site mutations, increasing hepatitis B virus replication and drug resistance. J Clin Invest 2001; 107: 449-455. (Pubitemid 32167991)
19. LEVINE S, HERNANDEZ D, YAMANAKA G, ZHANG S, ROSE R, WEINHEIMER S, COLONNO RJ. Efficacies of entecavir against lamivudine resistant hepatitis B virus replication and recombinant polymerases in vitro. Antimicrob Agents Chemother 2002; 46: 2525-2532. (Pubitemid 34793459)
20. DI MARCO V, MARZANO A, LAMPERTICO P, ANDREONE P, SANTANTONIO T, ALMASIO PL, RIZZETTO M, CRAXÌ A; ITALIAN ASSOCIATION FOR THE STUDY OF THE LIVER (AISF) LAMIVUDINE STUDY GROUP, ITALY. Clinical outcome of HBeAg negative chronic hepatitis B in relation to virological response to lamivudine. Hepatology 2004; 40: 883-891. (Pubitemid 39288121)
21. BANG SJ, KIM BG, SHIN JW, JU HU, PARK BR, KIM MH, KIM CJ, PARK JH, JEONG ID, JUNG SW, PARK NH. Clinical course of patients with insufficient viral suppression during entecavir therapy in genotype C chronic hepatitis B. Dig Liver Dis 2013; 45: 600-605.
22. QI X, XIONG S, YANG H, MILLER M, DELANEY WE 4TH. In vitro susceptibility of adefovir-associated hepatitis virus B polymerase mutations to other antiviral agents. Antivir Ther 2007; 12: 355-362. (Pubitemid 46787980)
23. GISH R, JIA J, LOCARNINI S and ZOULIM F. Selection of chronic hepatitis B therapy with high barrier to resistance. Lancet 2012; 12: 341-353.
24. LEE GH, INOUE M, TOH JK, CHONG RH, AUNG MO, KOAY ES, LIM SG Two step evolution of the hepatitis B drug-resistant mutations in a patient who developed primary entecavir resistance. Liver Int 2013; 33: 642-646.
25. CHANG TT, GISH RG, DE MAN R, GADANO A, SOLLANO J, CHAO YC, LOK AS, HAN KH, GOODMAN Z, ZHU J, CROSS A, DEHERTOGH D, WILBER R, COLONNO R, APELIAN D; BEHOLD AI463022 STUDY GROUP. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006; 354: 1001-1010. (Pubitemid 43357804)
26. LAI CL, SHOUVAL D, LOK AS, CHANG TT, CHEINQUER H, GOODMAN Z, DEHERTOGH D, WILBER R, ZINK RC, CROSS A, COLONNO R, FERNANDES L; BEHOLD AI463027 STUDY GROUP. Entecavir versus Lamivudine for HBeAg-negative chronic hepatitis B. N Engl J Med 2006; 354: 1011-1020. (Pubitemid 43357805)
27. BUTI M, MORILLAS RM, PRIETO M, DIAGO M, PÉREZ J, SOLÀ R, BONET L, PALAU A, TESTILLANO M, GARCÍA-SAMANIEGO J, RODRÍGUEZ M; ORIENTE STUDY GROUp. Efficacy and safety of entecavir in clinical practice in treatment-naïve Caucasian chronic hepatitis B patients. Eur J Gastroenterol Hepatol 2012; 24: 535-542.
28. MANNS MP. Long-term safety and tolerability of entecavir in patients with chronic hepatitis B in the rollover study ETV-901. Expert Opin Drug Saf 2012; 11: 361-368.
29. ZOUTENDIJK R, REIJNDERS J, ZOULIM F, BROWN A, MUTIMER DJ, DETERDING K, HOFMANN W P, PETERSEN J, FASANO M, BUTI M, BERG T, HANSEN BE, SONNEVELD MJ, WEDEMEYER H, JANSSEN HL; VIRGIL SURVEILLANCE STUDY GROUP. Virological response to entecavir is associated with a better clinical outcome in chronic hepatitis B patients with cirrhosis. Gut 2013; 62: 760-765.
30. PAN CQ, HU KQ and TSAI N. Long term therapy with nucleoside/nucleotide analogues for chronic hepatitis B in Asian patients. Antivir Ther 2013; 18: 841-852.
31. WOLTERS LM, HANSEN BE, NIESTERS HG, DEHERTOGH D, DE MAN RA. Viral dynamics during and after entecavir therapy in patients with chronic hepatitis B. J Hepatol 2002; 37: 137-144. (Pubitemid 34713065)
32. LEUNG N, PENG C Y, HANN HW, SOLLANO J, LAO-TAN J, HSU CW, LESMANA L, YUEN M F, JEFFERS L, SHERMAN M, MIN A, MENCARINI K, DIVA U, CROSS A, WILBER R, LOPEZ-TALAVERA J. 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 2009; 49: 72-79.
33. D'ETTORRE G, BARBARINI G, CORTI F, GOBBER M, PASTECCHIA C, RICCI GL, SICILIANO M, ANNICCHIARICO BE, VULLO V. Seroconversion of HBsAg in HBeAg positive and HBeAg negative patients with chronic HBV treated with entecavir: A case series. Eur Rev Med Pharmacol Sci 2010; 14: 551-554.
34. ONO A, SUZUKI F, KAWAMURA Y, SEZAKI H, HOSAKA T, AKUTA N, KOBAYASHI M, SUZUKI Y, SAITOU S, ARASE Y, IKEDA K, KOBAYASHI M, WATAHIKI S, MINETA R, KUMADA H. Long-term continuous entecavir therapy in nucleos(t)ide-naïve chronic hepatitis B patients. J Hepatol 2012; 57: 508-514.
35. LIAW YF, KAO JH, PIRATVISUTH T, CHAN HLY, CHIEN RN, LIU CJ, LOCARNINI S, LIM SG, HAN KH, AMARAPURKAR D, COOKSLEY G, JAFIRI W, MOHAMED R, HOU JL, CHUANG WL, LESMANA LA, SOLLANO JD, SUH DJ, OMATA M. Asian-Pacific consensus statement on the management of chronic hepatitis B: A 2012 update. Hepatol Int 2012; 6: 531-561.
36. LIAW YF, SUNG JJ, CHOW WC, FARRELL G, LEE CZ, YUEN H, TANWANDEE T, TAO QM, SHUE K, KEENE ON, DIXON JS, GRAY D F, SABBAT J; CIRRHOSIS ASIAN LAMIVUDINE MULTICENTRE STUDY GROUp. Cirrhosis Asian Lamivudine Multicentre Study Group. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med 2004; 351: 1521-1531.
37. LOK AS, LAI CL, LEUNG N, YAO GB, CUI ZY, SCHIFF ER, DIENSTAG JL, HEATHCOTE EJ, LITTLE NR, GRIFFITHS DA, GARDNER SD, CASTIGLIA M. Long-term safety of lamivudine treatment in patients with chronic hepatitis B. Gastroenterology 2003; 125: 1714-1722. (Pubitemid 37500436)
38. HA NB, HA NB, GARCIA RT, TRINH HN, VU AA, NGUYEN HA, NGUYEN KK, LEVITT BS, NGUYEN MH. Renal dysfunction in chronic hepatitis B patients treated with adefovir dipivoxil. Hepatology 2009; 50: 727-734.
39. HADZIYANNIS SJ, TASSOPOULOS NC, HEATHCOTE EJ, CHANG TT, KITIS G, RIZZETTO M, MARCELLIN P, LIM SG, GOODMAN Z, MA J, BROSGART CL, BORROTO-ESODA K, ARTERBURN S, CHUCK SL; ADEFOVIR DIPIVOXIL 438 STUDY GROUP. Adefovir Dipivoxil 438 Study Group. Long-term therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis B for up to 5 years. Gastroenterology 2006; 131: 1743-1751. (Pubitemid 44958517)
40. LIAW YF, RAPTOPOULOU-GIGI M, CHEINQUER H, SARIN SK, TANWANDEE T, LEUNG N, PENG C Y, MYERS R P, BROWN RS JR, JEFFERS L, TSAI N, BIALKOWSKA J, TANG S, BEEBE S, COONEY E. Efficacy and safety of entecavir versus adefovir in chronic hepatitis B patients with hepatic decompensation: A randomized, open label study. Hepatology 2011; 54: 91-100.
41. LIAW YF, SHEEN IS, LEE CM, AKARCA US, PAPATHEODORIDIS G V, SUET-HING WONG F, CHANG TT, HORBAN A, WANG C, KWAN P, BUTI M, PRIETO M, BERG T, KITRINOS K, PESCHELL K, MONDOU E, FREDERICK D, ROUSSEAU F, SCHIFF ER. Tenofovir disoproxil fumarate (TDF), emtricitabine/TDF, and entecavir in patients with decompensated chronic hepatitis B liver disease. Hepatology 2011; 53: 62-72.
42. SINGAL AK, FONTANA RJ Meta-analysis: Oral anti-viral agents in adults with decompensated hepatitis B virus cirrhosis. Aliment Pharmacol Ther 2012; 35: 674-689.
43. PERRILLO RP. Acute flares in chronic hepatitis B: the natural and unnatural history of an immunologically mediated liver disease. Gastroenterology 2001; 120: 1009-1022. (Pubitemid 32193199)
44. MATSUMOTO K, MI YAKE Y, MI YATAKE H, TAKAHARA M, IMADA T, YAGI S, TOYOKAWA T, NAKATSU M, ANDO M, HIROHATA M. A combination treatment of entecavir and early-phase corticosteroid in severe exacerbation of chronic hepatitis B. World J Gastroenterol 2009; 15: 1650-1652.
45. SEEFF LB, KOFF RS Evolving concepts of the clinical and serologic consequences of hepatitis B virus infection. Semin Liver Dis 1986; 6: 11-22. (Pubitemid 16087703)
46. WONG VW, WONG GL, YIU KK, CHIM AM, CHU SH, CHAN H Y, SUNG JJ, CHAN HL Entecavir treatment in patients with severe acute exacerbation of chronic hepatitis B. J Hepatol 2011; 54: 236-242.
47. YAMAMOTO T, KONDO S, SUGAWARA A, YONECHI M, NISHIOKA K, MEGURO T, ABE M, MURAKAMI K, INOUE J, UENO Y, SHIMOSEGAWA T. Case of fulminant hepatic failure in an elderly asymptomatic HBV carrier without proximate cause. Nihon Shokakibyo Gakkai Zasshi 2008; 105: 1781-1786.
48. WANG YM, TANG YZ Antiviral therapy for hepatitis B virus associated hepatic failure. Hepatobiliary Pancreat Dis Int 2009; 8: 17-24.
49. XI ZF, XIA Q, ZHANG JJ, CHEN XS, HAN LZ, WANG X, SHEN CH, LUO Y, XIN TY, WANG SY, QIU DE K. The role of entecavir in preventing hepatitis B recurrence after liver transplantation. J Dig Dis 2009; 10: 321-327.
50. TUJIOS S, LEE W. New advances in chronic hepatitis B. Liver 2012; 28: 193-197.
51. KIM WR, POTERUCHA JJ, KREMERS WK, ISHITANI MB, DICKSON ER Outcome of liver transplantation for hepatitis B in the United States. Liver Transpl 2004; 10: 968-974. (Pubitemid 39232749)
52. OLIVERA-MARTÍNEZ MA, GALLEGOS-OROZCO J F. Recurrent viral liver disease (hepatitis B and C) after liver transplantation. Arch Med Res 2007; 38: 691-701. (Pubitemid 47001565)
53. th 2012, Barcelona, Spain. Poster 535 available at http://www.natap.org/2012/EASL/EASL- 88.htm
54. CHOLONGITA SE, PAPATHEODORIDIS GV High genetic barrier nucleos(t)ide analogue(s) for prophylaxis from hepatitis B virus recurrence after liver transplantation: A systematic review. Am J Transplant 2013; 13: 353-362.
55. FUNG J, CHEUNG C, CHAN SC, YUEN M F, CHOK KS, SHARR W, DAI WC, CHAN AC, CHEUNG TT, TSANG S, LAM B, LAI CL, LO CM. Entecavir Monotherapy Is Effective in Suppressing Hepatitis B Virus After Liver Transplantation. Gastroenterology 2011; 141: 1212-1219.
56. CAI CJ, LU MQ, CHEN YH, ZHAO H, LI MR, CHEN GH Clinical study on prevention of HBV re-infection by entecavir after liver transplantation. Clin Transplant 2012; 26: 208-215.
57. SACCO R, BERTINI M, BRESCI G, ROMANO A, ALTOMARE E, CAPRIA A. Entecavir for hepatitis B virus flare treatment in patients with Crohn's disease. Hepatogastroenterology 2010; 57: 242-245.
58. BROST S, SCHNITZLER P, STREMMEL W, EISENBACH C. Entecavir as treatment for reactivation of hepatitis B in immunosuppressed patients. World J Gastroenterol 2010; 16: 5447-5451.
59. KOBASHI H, MIYAKE Y, IKEDA F, YASUNAKA T, NISHINO K, MORIYA A, KUBOTA J, NAKAMURA S, TAKAKI A, NOUSO K, YAMADA G, YAMAMOTO K. Long-term outcome and hepatocellular carcinoma development in chronic hepatitis B or cirrhosis patients after nucleoside analog treatment with entecavir or lamivudine. Hepatol Res 2011; 41: 405-416.
60. JIN YJ, SHIM JH, LEE HC, YOO DJ, KIM KM, LIM YS, SUH DJ Suppressive effects of entecavir on hepatitis B virus and hepatocellular carcinoma. J Gastroenterol Hepatol 2011; 26: 1380-1388.
61. HOSAKA T, SUZUKI F, KOBAYASHI M, SEKO Y, KAWAMURA Y, SEZAKI H, AKUTA N, SUZUKI Y, SAITOH S, ARASE Y, IKEDA K, KOBAYASHI M, KUMADA H. Long-term entecavir treatment reduces hepatocellualr carcinoma incidence in patients with hepatitis B virus infection. Hepatology 2013; 58: 98-107.
62. D'ANGELO S, SECONDULFO M, DE CRISTOFANO R, SORRENTINO P. Selection and management of hepatocellular carcinoma patients with sorafenib: recommendations and opinions from an Italian liver unit. Future Oncology 2013; 9: 485-491.
63. MARZANO A, MARENGO A, MARIETTI M, RIZZETTO M. Lactic acidosis during Entecavir treatment in decompensated hepatitis B virus-related cirrhosis. Dig Liver Dis 2011; 43: 1027-1028.