Chronic hepatitis B: Who to treat and which choice of treatment?

Expert Review of Anti-Infective Therapy

Volumn 7, Issue 3, 2009, Pages 281-291

  Di Marco, Vito ^a   Craxi, Antonio ^a  

^a UNIVERSITY OF PALERMO   (Italy)

Author keywords

Antiviral therapy; Chronic hepatitis; Cirrhosis; Hepatitis B virus; Hepatocellular carcinoma; Interferon; Nucleoside analog; Nucleotide analog

Indexed keywords

ADEFOVIR; ADEFOVIR DIPIVOXIL; ALANINE AMINOTRANSFERASE; ALBINTERFERON ALPHA2B; ANTIVIRUS AGENT; ENTECAVIR; HEPATITIS B(E) ANTIGEN; LAMIVUDINE; PEGINTERFERON; PEGINTERFERON ALPHA2A; PLACEBO; TELBIVUDINE; TENOFOVIR; VIRUS DNA; NUCLEOSIDE; NUCLEOTIDE;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIVIRAL ACTIVITY; ANTIVIRAL THERAPY; ARTICLE; CLINICAL TRIAL; DISEASE COURSE; DISEASE SEVERITY; DRUG CHOICE; DRUG COST; DRUG POTENCY; DRUG SAFETY; HEPATITIS B; HUMAN; IMMUNOLOGICAL TOLERANCE; LIVER BIOPSY; LIVER CIRRHOSIS; LIVER FIBROSIS; LONG TERM CARE; MONOTHERAPY; PREVALENCE; SEROCONVERSION; TREATMENT DURATION; TREATMENT INDICATION; TREATMENT RESPONSE; VIRUS LOAD; VIRUS REPLICATION; VIRUS RESISTANCE; ANTIVIRAL RESISTANCE; DRUG ADMINISTRATION; DRUG EFFECT; HEPATITIS B VIRUS; LIVER CELL CARCINOMA; PATHOPHYSIOLOGY; PHYSIOLOGY; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL; REVIEW; VIROLOGY;

ANTIVIRAL AGENTS; CARCINOMA, HEPATOCELLULAR; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, VIRAL; HEPATITIS B VIRUS; HEPATITIS B, CHRONIC; HUMANS; LIVER CIRRHOSIS; NUCLEOSIDES; NUCLEOTIDES; PRACTICE GUIDELINES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; VIRUS REPLICATION;

EID: 67649124578     PISSN: 14787210     EISSN: 17448336     Source Type: Journal    
DOI: 10.1586/ERI.09.4     Document Type: Article

References (71)

1. Yim HJ, Lok AS. Natural history of chronic hepatitis B virus infection: what we knew in 1981 and what we know in 2005. Hepatology 43, S173-S181 (2006).
2. Fattovich G, Bortolotti F, Donato F. Natural history of chronic hepatitis B: special emphasis on disease progression and prognostic factors. J. Hepatol. 48, 335-352 (2008).
3. Fattovich G. Natural history and prognosis of hepatitis B. Semin. Liver Dis. 23, 47-58 (2003).
4. Manno M, Cammà C, Schepis et al. Natural history of chronic HBV carriers in Northern Italy: morbidity and mortality after 30 years. Gastroenterology 127, 756-763 (2004).
5. Hadziyannis S, Papatheodoridis GV. Hepatitis B e antigen negative chronic hepatitis: natural history and treatment. Semin. Liver Dis. 26, 130-141 (2006).
6. Werle-Lapostolle B, Bowden S, Locarnini S et al. Persistence of cccDNA during the natural history of chronic hepatitis B and decline during adefovir dipivoxil therapy. Gastroenterology 126, 1750-1758 (2004).
7. Lai CL, Yuen MF. The natural history and treatment of chronic hepatitis B: a critical evaluation of standard treatment criteria and end points. Ann. Intern. Med. 147, 58-61 (2007).
8. Gluud C, Brok J, Gong Y, Koretz RL. Hepatology may have problems with putative, surrogate outcome measures. J. Hepatol. 46, 734-742 (2007).
9. Niederau C, Heintges T, Lange S et al. Long-term follow-up of HBeAg-positive patients treated with interferon alfa for chronic hepatitis B. N. Engl. J. Med. 334, 1422-1427 (1996).
10. Liaw Y-F, Sung JJY, Chow WC et al. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N. Engl. J. Med. 351, 1521-1531 (2004).
11. Zoulim F. Mechanism of viral persistence and resistance to nucleoside and nucleotide analogs in chronic hepatitis B virus infection. Antivir. Res. 64, 1-15 (2004).
12. Wong DK, Cheung AM, O'Rourke K, Naylor CD, Detsky AS, Heathcote J. Effect of α-interferon treatment in patients with hepatitis B e antigen-positive chronic hepatitis B. A meta-analysis. Ann. Intern. Med. 119, 312-323 (1993).
13. Craxì A, Di Bona D, Camma C. Interferon-α for HBeAg-positive chronic hepatitis B. J. Hepatol. 39, S99-S105 (2003).
14. Lau GK, Piratvisuth T, Luo KX et al. Peginterferon α-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. N. Engl. J. Med. 352, 2682-2695 (2005).
15. Marcellin P, Lau GK, Bonino F et al. Peginterferon α-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. N. Engl. J. Med. 351, 1206-1217 (2004).
16. Lai CL, Chien RN, Leung NW et al. A one-year trial of lamivudine for chronic hepatitis B. Asia Hepatitis Lamivudine Study Group. N. Engl. J. Med. 339, 61-68 (1998).
17. Dienstag JL, Schiff ER, Wright TL et al. Lamivudine as initial treatment for chronic hepatitis B in the United States. N. Engl. J. Med. 341, 1256-1263 (1999).
18. Di Marco V, Lampertico P, Marzano A et al. Clinical outcome of HBeAg-negative chronic hepatitis B in relation to virological response to lamivudine. Hepatology 40, 883-891 (2004).
19. Yuen MF, Seto WK, Chow DH et al. Long-term lamivudine therapy reduces the risk of long-term complications of chronic hepatitis B infection even in patients without advanced disease. Antivir. Ther. 12, 1295-1303 (2007).
20. Marcellin P, Chang TT, Lim SG et al. Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. N. Engl. J. Med. 348, 808-816 (2003).
21. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ et al. Adefovir dipivoxil for the treatment of hepatitis B e antigen-negative chronic hepatitis B. N. Engl. J. Med. 348, 800-807 (2003).
22. Lampertico P, Vigano M, Manenti E, Iavarone M, Lunghi G, Colombo M. Adefovir rapidly suppresses hepatitis B in HBeAg-negative patients developing genotypic resistance to lamivudine. Hepatology 42, 1414-1419 (2005).
23. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ et al. Long-term therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis B. N. Engl. J. Med. 352, 2673-2681 (2005).
24. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ et al. Long-term therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis B for up to 5 years. Gastroenterology 131, 1743-1751 (2006).
25. Lampertico P, Vigano M, Manenti E, Iavarone M, Sablon E, Colombo M. Low resistance to adefovir combined with lamivudine: a 3-year study of 145 lamivudine-resistant hepatitis B patients. Gastroenterology 133, 1445-1451 (2007).
26. Rapti I, Dimou E, Mitsoula P, Hadziyannis SJ. Adding-on versus switching-to adefovir therapy in lamivudine-resistant HBeAg-negative chronic hepatitis B. Hepatology 45, 307-313 (2007).
27. Qi X, Xiong S, Yang H et al. In vitro susceptibility of adefovir-associated hepatitis B virus polymerase mutations to other antiviral agents. Antivir. Ther. 12, 355-362 (2007).
28. Lai CL, Shouval D, Lok AS et al. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N. Engl. J. Med. 354, 1011-1020 (2006).
29. Chang TT, Gish RG, de Man R et al. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N. Engl. J. Med. 354, 1001-1010 (2006).
30. Sherman M, Yurdaydin C, Sollano J et al. Entecavir for treatment of lamivudine-refractory, HBeAg-positive chronic hepatitis B. Gastroenterology 130, 2039-2049 (2006).
31. 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 48, 99-108 (2008).
32. Colonno RJ, Rose R, Baldick CJ et al. Entecavir resistance is rare in nucleoside naive patients with hepatitis B. Hepatology 44, 1656-1665 (2006).
33. Tenney DJ, Pokornowsky KA, Rose RE et al. Entecavir at five years shows long-term maintenance of high genetic barrier to hepatitis B resistance Hepatolobgy (2009) (In Press).
34. Lai CL, Leung N, Teo EK et al. A 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis B. Gastroenterology 129, 528-536 (2005).
35. Chan HL, Heathcote EJ, Marcellin P et al. Treatment of hepatitis B e antigen-positive chronic hepatitis with telbivudine or adefovir: a randomized trial. Ann. Intern. Med. 147, 745-754 (2007).
36. 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 136(2), 486-495 (2009).
37. Marcellin P, Heathcote EJ, Buti M et al. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N. Engl. J. Med. 359, 2442-2455 (2008).
38. Pawlotsky JM, Dusheiko G, Hatzakis A et al. Virologic monitoring of hepatitis B virus therapy in clinical trials and practice: recommendations for a standardized approach. Gastroenterology 134, 405-415 (2008).
39. Prati D, Taioli E, Zanella A et al. Updated definitions of healthy ranges for serum alanine aminotransferase levels. Ann. Intern. Med. 137, 1-10 (2002).
40. Lai M, Hyatt BJ, Nasser I et al. The clinical significance of persistently normal ALT in chronic hepatitis B infection. J. Hepatol. 47, 760-767 (2007).
41. EASL Clinical Practice Guidelines. Management of chronic hepatitis B. J. Hepatol. 50, 227-242 (2009).
42. Carosi G, Rizzetto M. Treatment of chronic hepatitis B: recommendations from an Italian workshop. Dig. Liver Dis. 40, 603-617 (2008).
43. Keeffe EB, Dieterich DT, Han SH et al. A treatment algorithm for the management of chronic hepatitis B virus infection in the United States: 2008 update. Clin. Gastroenterol. Hepatol. 6, 1315-1341 (2008).
44. Moucari R, Mackiewicz V, Lada O et al Early serum HBsAg drop: a strong predictor of sustained virological response to pegylated interferon α-2a in HBeAg-negative patients. Hepatology (2009) (In Press).
45. Wilt TJ, Shamliyan T, Shaukat A et al. Management of chronic hepatitis B. Evidence report/technology assessment No. 174. Prepared by the Minnesota evidence-based practice center under contract no. 290-202-0009). AHRQ Publication No. 09-E002. Agency for Healthcare Research and Quality, Rockville, MD, USA (2008).
46. Janssen HL, Gerken G, Carreno V et al. Interferon alfa for chronic hepatitis B infection: increased efficacy of prolonged treatment. The European Concerted Action on Viral Hepatitis (EUROHEP). Hepatology 30, 238-243 (1999).
47. Chan HL, Wang H, Niu J et al. Two-year lamivudine treatment for hepatitis B e antigen negative chronic hepatitis B: a double-blind, placebo controlled trial. Antivir. Ther. 12, 345-353 (2007).
48. Schiff ER, Dienstag JL, Karayalcin S et al. Lamivudine and 24 weeks of lamivudine/interferon combination therapy for hepatitis B e antigen positive chronic hepatitis B in interferon nonresponders. J. Hepatol. 38, 818-826 (2003).
49. Akarca US, Ersoz G, Gunsar F et al. Interferon lamivudine combination is no better than lamivudine alone in anti-HBe-positive chronic hepatitis B. Antivir. Ther. 9, 325-334 (2004).
50. Janssen HL, van Zonneveld M, Senturk H et al. Pegylated interferon α-2b alone or in combination with lamivudine for HBeAg-positive chronic hepatitis B: a randomised trial. Lancet 365, 123-129 (2005).
51. Gish RG, Lok AS, Chang TT et al. Entecavir therapy for up to 96 weeks in patients with HBeAg positive chronic hepatitis B. Gastroenterology 133, 1437-1444 (2007).
52. Peters MG, Hann Hw H, Martin P et al. Adefovir dipivoxil alone or in combination with lamivudine in patients with lamivudine-resistant chronic hepatitis B. Gastroenterology 126, 91-101 (2004).
53. Barbaro G, Zechini F, Pellicelli AM et al. Long-term efficacy of interferon α-2b and lamivudine in combination compared with lamivudine monotherapy in patients with chronic hepatitis B. An Italian multicenter, randomized trial. J. Hepatol. 35, 406-411 (2001).
54. Economou M, Manolakopoulos S, Trikalinos TA et al. Interferon-α plus lamivudine vs lamivudine reduces breakthroughs, but does not affect sustained response in HBeAg negative chronic hepatitis B. World J. Gastroenterol. 11, 5882-5887 (2005).
55. Flink HJ, van Zonneveld M, Hansen BE et al. Treatment with peg-interferon α-2b for HBeAg positive chronic hepatitis B: HBsAg loss is associated with HBV genotype. Am. J. Gastroenterol. 101, 297-303 (2006).
56. Ke CZ, Chen Y, Gong ZJ et al. Dynamic changes of HBV DNA in serum and peripheral blood mononuclear cells of chronic hepatitis patients after lamivudine treatment. World J. Gastroenterol. 12, 4061-4063 (2006).
57. Liaw YF, Leung NW, Chang TT et al. Effects of extended lamivudine therapy in Asian patients with chronic hepatitis B. Asia Hepatitis Lamivudine Study Group. Gastroenterology 119, 172-180 (2000).
58. Perrillo R, Hann HW, Mutimer D et al. Adefovir dipivoxil added to ongoing lamivudine in chronic hepatitis B with YMDD mutant hepatitis B virus. Gastroenterology 126, 81-90 (2004).
59. Zeng M, Mao Y, Yao G et al. A double-blind randomized trial of adefovir dipivoxil in Chinese subjects with HBeAg-positive chronic hepatitis B. Hepatology 44, 108-116 (2006).
60. Perrillo R, Hann H W, Mutimer D et al. Adefovir dipivoxil added to ongoing lamivudine in chronic hepatitis B with YMDD mutant hepatitis B virus. Gastroenterology 126, 81-90 (2004).
61. Di Bisceglie AM, Fong TL, Fried MW et al. A randomized, controlled trial of recombinant α-interferon therapy for chronic hepatitis B. Am. J. Gastroenterol. 88, 1887-1892 (1993).
62. Perrillo RP, Lai CL, Liaw YF et al. Predictors of HBeAg loss after lamivudine treatment for chronic hepatitis B. Hepatology 36, 186-194 (2002).
63. Chan HL, Hui AY, Wong VW et al. Long-term follow-up of peg interferon and lamivudine combination treatment in HBeAg-positive chronic hepatitis B. Hepatology 41, 1357-1364 (2005).
64. Sarin SK, Kumar M, Kumar R et al. Higher efficacy of sequential therapy with interferon-α and lamivudine combination compared with lamivudine monotherapy in HBeAg positive chronic hepatitis B patients. Am. J. Gastroenterol. 100, 2463-2471 (2005).
65. Yuen MF, Chow DH, Tsui K et al. Liver histology of Asian patients with chronic hepatitis B on prolonged lamivudine therapy. Aliment. Pharmacol. Ther. 21, 841-849 (2005).
66. Buster EH, Hansen BE, Buti M et al. Peginterferon α-2b is safe and effective in HBeAg-positive chronic hepatitis B patients with advanced fibrosis. Hepatology 46, 388-394 (2007).
67. Fontana RJ, Hann HW, Perrillo RP et al. Determinants of early mortality in patients with decompensated chronic hepatitis B treated with antiviral therapy. Gastroenterology 123, 719-727 (2002).
68. Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology 45, 507-539 (2007).
69. Keeffe EB, Dieterich DT, Han SH et al. A treatment algorithm for the management of chronic hepatitis B virus infection in the United States: 2008 update. Clin. Gastroenterol. Hepatol. 6, 1315-1341 (2008).
70. Liaw Y-F, Leung N, Kao J-H et al. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2008 update. Hepatol. Int. 2, 263-283 (2008).
71. Fournier C, Zoulim F. Antiviral therapy of chronic hepatitis B: prevention of drug resistance. Clin. Liver Dis. 11, 869-892 (2007).