Guideline on prevention and treatment of chronic hepatitis B in China (2005)

Chinese Medical Journal

Volumn 120, Issue 24, 2007, Pages 2159-2173

  Zhuang, Hui ^a  

^a PEKING UNIVERSITY HEALTH SCIENCE CENTER   (China)

Author keywords

[No Author keywords available]

Indexed keywords

ADEFOVIR DIPIVOXIL; ALANINE AMINOTRANSFERASE; ALBUMIN; ALPHA FETOPROTEIN; ALPHA INTERFERON; ANTIFIBROTIC AGENT; ANTIINFLAMMATORY AGENT; ANTIVIRUS AGENT; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CHOLINESTERASE; ENTECAVIR; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; HEPATITIS B ANTIBODY; HEPATITIS B SURFACE ANTIGEN; HEPATITIS B VACCINE; HEPATITIS B(E) ANTIGEN; HERBACEOUS AGENT; IMMUNOMODULATING AGENT; INTERFERON; LAMIVUDINE; NUCLEOSIDE ANALOG; NUCLEOTIDE DERIVATIVE; PEGINTERFERON ALPHA2A; PEGINTERFERON ALPHA2B; PLACEBO; VIRUS DNA;

ACUTE KIDNEY FAILURE; ALBUMIN BLOOD LEVEL; ARTICLE; AUTOIMMUNE DISEASE; BONE MARROW DEPRESSION; CARDIOMYOPATHY; CARDIOVASCULAR DISEASE; CHINA; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CREATININE BLOOD LEVEL; DISEASE COURSE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG MEGADOSE; DRUG POTENTIATION; DRUG RESPONSE; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FLU LIKE SYNDROME; GENE SEQUENCE; GENOTYPE; HEART ARRHYTHMIA; HEPATITIS B; HUMAN; INTERSTITIAL NEPHRITIS; INTERSTITIAL PNEUMONIA; ISCHEMIC HEART DISEASE; KIDNEY INJURY; LABORATORY TEST; LEUKOPENIA; LIVER CIRRHOSIS; MENTAL DISEASE; MONOTHERAPY; NEPHROTIC SYNDROME; NEPHROTOXICITY; NEUTROPENIA; PHOSPHATE BLOOD LEVEL; PREVALENCE; PROTHROMBIN TIME; RECOMMENDED DRUG DOSE; RETINOPATHY; SEROLOGY; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT DURATION; VIRUS CARRIER; VIRUS GENOME; VIRUS TRANSMISSION;

EID: 38349116816     PISSN: 03666999     EISSN: None     Source Type: Journal    
DOI: 10.1097/00029330-200712020-00002     Document Type: Article

References (85)

1. Strader DB, Wright T, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C. Hepatology 2004; 39: 1147-1171.
2. Seeger C, Mason W. Hepatitis B virus biology. Microbiol Mol Biol Rev 2000; 64: 51-68.
3. Scaglioni PP, Melegari M, Wands JR. Biologic properities of hepatitis B viral genomes with mutations in the precore promoter and precore open reading finame. Virology 1997; 233: 374-381.
4. Lai CL, Dienstag J, Schiff E, Leung NW, Atkins M, Hunt C, et al. Prevalence and clinical correlates of YMDD variants during lamivudine therapy for patients with chronic hepatitis B. Clin Infect Dis 2003; 36: 687-696.
5. Hu KQ. Occult hepatitis B virus infection and its clinical implications. J Viral Hepat 2002; 9: 243-257.
6. Janssen HL, van Zonneveld M, Senturk H, Zeuzem S, Akarca US, Cakaloglu Y, et al. Pegylated interferon alfa-2b alone or in combination with lamivudine for HBeAg-positive chronic hepatitis B: a randomised trial. Lancet 2005; 365: 123-129.
7. Liang XF, Chen YS, Wang XJ, He X, Chen IJ, Wang J, et al. Study on the seroepidemiology of hepatitis B in the population over 3 years old in China. Chin J Epidmiol (Chin) 2005; 26: 655-658.
8. Fan JS, Zhuang H, Li YG, Zhu XJ, Xu DZ, Ma WM, et al. Serotyping and genotyping of hepatitis B virus among HBsAg positive and negative hepatitis B patients in 8 cities of China. Chin J Microbiol Immunol (Chin) 1998; 18: 88-91.
9. World Health Organization. Hepatitis B. World Health Organization Fact Sheet 204 dex. (Accessed October 2000 at http://www.who.int/ mediacentre/factsheets/fs204/en/in html)
10. de Franchis R, Hadengue A, Lau G, Lavanchy D, Lok A, McIntyre N, et al. EASL International Consensus Conference on Hepatitis B. J Hepatol 2003; 39 (Suppl): s3-s25.
11. Lok AS, Heathcote EJ, Hoofnagle JH. Management of hepatitis B: 2000-summary of a workshop. Gastroenterology 2001; 120: 1828-1853.
12. McMahon BJ, Alward WL, Hall DB, Heyward WL, Bender TR, Francis DP, et al. Acute hepatitis B virus infection: relation of age to the clinical expression of disease and subsequent development of the carrier state. J Infect Dis 1985; 151: 599-603.
13. Bortolotti F, Cadrobbi P, Crivellaro C, Guido M, Rugge M, Jimenez FJ, et al. Long-term outcome of chronic type B hepatitis in patients who acquire hepatitis B virus infection in childhood. Gastroenterology 1990; 99: 805-810.
14. McMahon BJ, Holck P, Bulkow L, Snowball M. Serologic and clinical outcomes of 1536 Alaska Natives chronically infected with hepatitis B virus. Ann Intern Med 2001; 135: 759-768.
15. Liaw YF, Tai DI, Chu CW, Pao CC, Chen TJ. The development of cirrhosis in patients with chronic type B hepatitis: a prospective study. Hepatology 1988; 8: 493-496.
16. Hsu YS, Chien RN, Yeh CT, Sheen IS, Chiou HY, Chu CM, et al. Long-term outcome after spontaneous HBeAg, serocoversion in patients with chronic hepatitis B. Hepatology 2002; 35: 1522-1527.
17. Liaw YF, Tai DI, Chu CW, Chu CM. Natural course after the development of cirrhosis in patients with chronic type B hepatitis: a prospective study. Liver 1989; 9: 235-241.
18. Di Marco V, Lo Lacono O, Camma C, Vaccaro A, Giunta M, Martorana G, et al. The long-term course of chronic hepatitis B. Hepatology 1999; 30: 257-264.
19. Brunetto MR, Oliveri F, Rocca G, Criscuolo D, Chiaberge E, Capalbo M, et al. Natural course and response to interferon of chronic hepatitis B accompanied by antibody to hepatitis B e antigen. Hepatology 1989; 10: 198-202.
20. Fattovich G, Brollo L, Alberti A, Pontisso P, Giustina G, Realdiet G, et al. Long-term follow-up of anti-HBe-positive chronic active hepatitis B. Hepatology 1988; 8: 1651-1654.
21. Liaw YF, Sung JJ, Chow WC, Farrell G, Lee CZ, Yuen H, et al. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N EngI J Med 2004; 351: 1521-1531.
22. Yang HI, Lu SN, Liaw YF, You SI, Sun CA, Wang LY, et al. Hepatitis B e antigen and the risk of hepatocellular carcinoma. N Engl J Med 2002; 347: 168-174.
23. Lavanchy D. Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures. J Viral Hepat 2004; 11: 97-107.
24. Tai DI, Chen CH, Chang TT, Chen SC, Liao LY, Kuo CH, et al. Eight-year nationwide survival analysis in relatives of patients with hepatocellular carcinoma: role of viral infection. J Gastroenterol Hepatol 2002; 17: 682-689.
25. Zhuang H. Hepatitis B vaccination in China. 11th International Symposium on Viral Hepatitis & Liver Disease Proceedings Book; 2004: 229-233.
26. Xia GL, Gong J, Wang JJ, Meng ZD, Jia ZY, Cao HL, et al. Efficacy of recombinant hepatitis B vaccine and low dose hepatitis B immune globulin in preventing mother-infant transmission of hepatitis B virus infection. Chin J Epidmiol (Chin) 2003; 24: 362-365.
27. World Health Organization. Hepatitis B. (Accessed at http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022./ou/)
28. Xing YL, Gong XH, Zhou SL, Xu FM, Fang BF, Ni CR, et al. Study on the vaccination in preventing perinatal mother-infant transmission of hepatitis B virus infection. Chin J Exp Clin Virol (Chin) 1990; 4: 485-488.
29. World Health Organization. Hepatitis B and breastfeeding. (Accessed on October 23, 2005 at http://www.who.int/child-adolescent-health/ New_Publications/NUTRITION/updt-22.htm)
30. John T J, Cooksley G. Hepatitis B vaccine boosters: Is there a clinical need in high endemicity populations? J Gastroenterol Hepatol 2005; 20: 5-10.
31. U.S. Public Health Service. Updated U.S. public health service guidelines for the management of occupational exposures to HBV, HCV and HIV and recommendations for postexposure prophylaxis. MMWR Recomm Rep 2001; 50 (RR-11): 1-52.
32. Chinese Society of Infectious Diseases and Parasitology and Chinese Society of Hepatology of Chinese Medical Association. The programme of prevention and cure for viral hepatitis. Chin J Hepatol (Chin) 2000; 8: 324-329.
33. Roque-Afonso AM, Ferey MP, Mackiewicz V, Fki L, Dussaix E. Monitoring the emergence of hepatitis B virus polymerase gene variants during lamivudine therapy in human immunodeficiency virus coinfected patients: performance of CLIP sequencing and line probe assay. Antivir Ther 2003; 8: 627-634.
34. Whalley SA, Brown D, Teo CG, Dusheiko GM, Saunders NA. Monitoring the emergence of hepatitis B virus polymerase gene variants during lamivudine therapy using LightCycler. J Clin Microbiol 2001; 39: 1456-1459.
35. Ishak KG. Pathologic features of chronic hepatitis. A review and update. Am J Clin Pathol 2000; 113: 40-45.
36. Knodell RG, Ishak KG, Black WC, Chen TS, Craig R, Kaplowitz N, et al. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology 1981; 1: 431-435.
37. Scheuer PJ, Standish RA, Dhillon AP. Scoring of chronic hepatitis. Clin Liver Dis 2002; 6: 335-347.
38. Chevallier M, Guerret S, Chossegros P, Chossegros P, Gerard F, Grimaud JA. A histological semiquantitative scoring system for evaluation of hepatic fibrosis in needle liver biopsy specimens: comparison with morphometric studies. Hepatology 1994; 20: 349-355.
39. Wong DK, Cheung AM, O'Rourke K, Naylor CD, Detsky AS, Heathcote J. Effect of alpha-interferon treatment in patients with hepatitis B e antigen-positive chronic hepatitis B: a meta-analysis. Ann Intern Med 1993; 119: 312-323.
40. Lampertico P, Del Ninno E, Manzin A, Donato MF, Rumi M G, Lunghi G, et al. A randomized, controlled trial of a 24-month course of interferon alpha 2b in patients with chronic hepatitis B who had hepatitis B virus DNA without hepatitis e antigen in serum. Hepatology 1997; 26: 1621-1625.
41. Fattovich G, Farci P, Rugge M, Brollo L, Mandas A, Pontisso P, et al. A randomized controlled trial of lymphoblastoid interferon-alpha in patients with chronic hepatitis B lacking HBeAg. Hepatology 1992; 15: 584-589.
42. Manesis EK, Hadziyannis SJ. Interferon alpha treatment and retreatment of hepatitis B e antigen-negative chronic hepatitis B. Gastroenterology 2001; 121: 101-109.
43. Ma WM, Lu J, Jiang XL, Zhou BP, Ao FJ. The therapeutic efficacy of recombinant interferon alfa 1b for the treatment of chronic hepatitis B and its predictive factors. Chin J Infect Dis (Chin) 2001; 19: 148-151.
44. Mao QG, Luo KX, Fit QF, Feng XY, Guo YB, Zhu YF, et al. Efficacy of interferon-alpha therapy for HBeAg-negative chronic hepatitis B and its influencing factors. Chin J Hepatol (Chin) 2004; 12: 582-584.
45. Hoofnagle JH, DiBisceglie AM, Waggoner JG, Park Y. Interferon alfa for patients with clinically apparent cirrhosis due to chronic hepatitis B. Gastroenterology 1993; 104: 1116-1121.
46. Harris JM, Martin NE, Modi M. Pegylation: a novel process for modifying pharmacokinetics. Clin Pharmacokinet 2001; 40: 539-551.
47. Lau GK, Piratvisuth T, Luo KX, Marcellin P, Thongsawat S, Cooksley G, et al. Peginterferon Alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. N Engl J Med 2005; 352: 2682-2695.
48. Marcellin P, Lau GKK, Bonino F, Farci P, Hadziyannis S, Jin F, et al. Peginterferon Alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2004; 351: 1206-1217.
49. Cooksley WG, Piratvisuth T, Lee SD, Mahachai V, Chao YC, Tanwandee T, et al. Peginterferon alpha 2a (40 kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat 2003; 10: 298-305.
50. Carreno V, Marcellin P, Hadziyannis S, Salmerón J, Diago M, Kitis GE, et al. Retreatment of chronic hepatitis B e antigen-positive patients with recombinant interferon alfa-2a. The European Concerted Action on Viral Hepatitis (EUROHEP). Hepatology 1999; 30: 277-282.
51. Janssen HL, Gerken G, Carreno V, Marcellin P, Naoumov NV, Craxi A, et al. Interferon alfa for chronic hepatitis B infection: increased efficacy of prolonged treatment. The European Concerted-Action on Viral Hepatitis (EUROHEP). Hepatology 1999; 30: 238-243.
52. Sokal E. Drug treatment of peadiatric chronic hepatitis B. Peadiatr Drugs 2002; 4: 361-369.
53. Hoofnagle JH, Dibisceglie AM. The treatment of chronic viral hepatitis. N Engl J Med 1997; 5336: 347-356.
54. Brook MG, Karayiannis P, Thomas HC. Which patients with chronic hepatitis B virus infection will respond to alpha-interferon therapy? Hepatology 1989; 10: 761-763.
55. Lok AS, Lai CL, Leung N, Yao GB, Cui ZY, Schiff ER, et al. Long-term safety of lamivudine treatment in patients with chronic hepatitis B. Gastroenterology 2003; 125: 1714-1722.
56. Lai CL, Chien RN, Leung NW, Chang TT, Guan R, Tai DI, et al. A one-year trial of lamivudine for chronic hepatitis B. Asia Hepatitis Lamivudine Study Group. N Engl J Med 1998; 339: 61-68.
57. Liaw YF, Leung NW, Chang TT, Guan R, Tai DI, Ng KY, et al. Effects of extended lamivudine therapy in Asian patients with chronic hepatitis B. Asia Hepatitis Lamivudine Study Group. Gastroenterology 2000; 119: 172-180.
58. Dienstag JL, Schiff ER, Wright TL, Perrillo RP, Hann HW, Goodman Z, et al. Lamivudine as initial treatment for chronic hepatitis B in the United States. N Engl J Med 1999; 341: 1256-1263.
59. Chien RN, Liaw YF, Atkins M. Pretherapy alanine transaminase level as a determinant for hepatitis B e antigen seroconversion during lamivudine therapy in patients with chronic hepatitis B. Asian Hepatitis Lamivudine Trial Group. Hepatology 1999; 30: 770-774.
60. Dienstag JL, Goldin RD, Heathcote EJ, Hann HWL, Stephenson SL, Gardner S, et al. Histological outcome during long-term lamivudine therapy. Gastroenterology 2003; 124: 105-117.
61. Villeneuve JP, Condreay LD, Willems B, Pomier-Layrargues G, Fenyves D, Bilodeau M, et al. Lamivudine treatment for decompensated cirrhosis resulting from chronic hepatitis B. Hepatology 2000; 31: 207-210.
62. Perrillo RP, Wright T, Rakela J, Levy G, Schiff E, Gish R, et al. A multicenter United States-Canadian trial to assess lamivudine monotherapy before and after liver transplantation for chronic hepatitis B. Hepatology 2001; 33: 424-432.
63. Hann HW, Fontana RJ, Wright T, Everson G, Baker A, Schiff ER, et al. A United States compassionate use study of lamivudine treatment in nontransplantation candidates with decompensated hepatitis B virus-related cirrhosis. Liver Transpl 2003; 9: 49-56.
64. Jonas MM, Kelly DA, Mizerski J, Badia IB, Areias JA, Schwarz KB, et al. Clinical trial of lamivudine in children with chronic hepatitis B. N Engl J Med 2002; 346: 1706-1713.
65. Figlerowicz M, Kowala-Piaskowska A, Filipowicz M, Bujnowska A, Mozer-Lisewska I, Shuzewski W. Efficacy of lamivudine in the treatment of children with chronic hepatitis B. Hepatol Res 2005; 31: 217-222.
66. Yao GB, Wang BE, Cui ZY, Yao JL, Zeng MD. The long-term efficacy of lamivudine in chronic hepatitis B: interim analysis of 3 year's clinical course. Chin J Intern Med (Chin) 2003; 42: 382-387.
67. Yao GB, Cui ZY, Yao JL, Zhang DF, Ji NX, Huang Y. Chronic hepatitis B treated with domestic manufactured lamivudine in 2200 patients: a phase IV study. Chin J Hepatol (Chin) 2003; 11: 103-108.
68. Liaw YF, Chien RN, Yeh CT, Tsai SL, Chu CM. Acute exacerbation and hepatitis B virus clearance after emergence of YMDD motif mutation during lamivudine therapy. Hepatology 1999; 30: 567-572.
69. Liu CJ, Huang WL, Chen PJ, Lai MY, Kan JH, Chen DS. End-of-treatment virologic response does not predict relapse after lamivudine treatment for chronic hepatitis B. World J Gastroenterol 2004; 10: 3574-3578.
70. Marcellin P, Chang TT, Lim SG, Tong MJ, Sievert W, Shiffman ML, et al. Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. N Engl J Med 2003; 348: 808-816.
71. Macellin P, Chang TT, Lim S, Sievert W, Tong M, Arterburn S, et al. Long term efficacy and safety of adefovir dipivoxil 10 mg in HBeAg + chronic hepatitis B patients: increasing serologic, virologic and biochemical response over time. Hepatology 2004; 40 (4 suppl): 655A.
72. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, Chang TT, Kitis G, Rizzetto M, et al. Adefovir dipivoxil for the treatment of hepatitis B e antigen-negative chronic hepatitis B. N Engl J Med 2003; 348: 800-807.
73. Locarnini S, Shaw T, Sozzi T, Edwards R. HBV mutants associated with clinical resistance to adefovir dipivoxil display only small decreases in antiviral sensitivity in vitro. Hepatology 2004; 40 (4 suppl): 244A.
74. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, Chang TT, Kitis G, Rizzetto M, et al. Long-term therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis B. N Engl J Med 2005; 352: 2673-2681.
75. Peters MG, Hann HW, Martin P, Heathcote EJ, Buggisch P, Rubin R, et al. Adefovir dipivoxil alone or in combination with lamivudine in patients with lamivudine-resistant chronic hepatitis B. Gastroenterology 2004; 126: 91-101.
76. Perrillo R, Hann HW, Mutimer D, Willems B, Leung N, Lee WM, et al. Adefovir dipivoxil added to ongoing lamivudine in chronic hepatitis B with YMDD mutant hepatitis B virus. Gastroenterology 2004; 126: 81-90.
77. Izzedine H, Hulot JS, Launay-Vacher V, Marcellini P, Hadziyannis SJ, Currie G, et al. Renal safety of adefovir dipivoxil in patients with chronic hepatitis B: two double-blind, randomized, placebo-controlled studies. Kidney Int 2004; 66: 1153-1158.
78. Lai CL, Rosmawati M, Lao J, Van Vlierberghe, Anderson FH, Thomas N, et al. Entecavir is superior to lamivudine in reducing hepatitis B virus DNA in patients with chronic hepatitis B infection. Gastroenterology 2002; 123: 1831-1838.
79. Yao GB, Zhang DF, Wang BE, Xu DZ, Zhou XQ, Lei BJ, et al. A study of the dosage and efficacy of entecavir for treating hepatitis B virus. Chin J Hepatol (Chin) 2005; 13: 484-487.
80. Yao GB, Ren H, Wang BE. A double blinded, randomized, placebo controlled trial of entecavir for Chinese hepatitis B patients failed with lamivudine therapy. Chin Hepatol (Chin) 2005; 10: 2-4.
81. Colonno RJ, Rose R, Levine SM, Pokornotoski K, Plym M, Yu CF, et al. Emergence of entecavir resistant hepatitis B virus after one year of therapy in phase II & III studies is only observed in lamivudine refractory patients. Hepatology 2004; 40 (4 suppl 1): 661A.
82. Lu LG, Zeng MD, Mao YM, Li JQ, Wan MS, Li CZ, et al. Capsule oxymatrine in the treatment of chronic hepatitis B: A randomized double-blind placebo controlled multicenter study (I). Chin Hepatol (Chin) 2002; 7: 218-221.
83. Yu YY, Wang QH, Zhu LM, Zhang QB, Xu DZ, Guo YB, et al. A clinical research on oxymatrine for the treatment of chronic hepatitis B. Chin J Hepatol (Chin) 2002; 10: 280-282.
84. Yu YY, Si CW, Zeng Z, Wang QH, Zhou QX, Zhang QB, et al. A clinical trial of oxymatrine in treating chronic viral hepatitis type B. Chin J Intern Med (Chin) 2001; 40: 843-846.
85. Liaw YF, Leung N, Guan R, Lau GKK, Merican I, McCaughan G, et al. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2005 update. Liver International 2005; 25: 472-489.