Management of hepatitis B: Summary of a clinical research workshop

Hepatology

Volumn 45, Issue 4, 2007, Pages 1056-1075

  Hoofnagle, Jay H ^a,d   Doo, Edward ^a   Liang, T Jake ^a   Fleischer, Russell ^b   Lok, Anna S F ^c  

^a NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^d NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADEFOVIR DIPIVOXIL; CLEVUDINE; EMTRICITABINE; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; ENTECAVIR; HEPATITIS B ANTIBODY; HEPATITIS B VACCINE; HEPATITIS B(E) ANTIGEN; INTERFERON; LAMIVUDINE; NUCLEOSIDE ANALOG; PEGINTERFERON; PEGINTERFERON ALPHA2A; TELBIVUDINE; TENOFOVIR DISOPROXIL; TYZEKA; UNCLASSIFIED DRUG;

ADAPTIVE IMMUNITY; BONE DENSITY; CLINICAL FEATURE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; DIARRHEA; DISEASE COURSE; DOSE RESPONSE; DRUG COST; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; DRUG WITHDRAWAL; FATTY LIVER; HEADACHE; HEPATITIS B; HEPATITIS B VIRUS; HUMAN; INNATE IMMUNITY; KIDNEY DYSFUNCTION; KIDNEY FAILURE; KIDNEY TUBULE ACIDOSIS; LACTIC ACIDOSIS; LIVER CANCER; LIVER CIRRHOSIS; MONOTHERAPY; NEPHROTOXICITY; NEUROPATHY; NONHUMAN; OSTEOLYSIS; PANCREATITIS; PATHOGENESIS; PHARYNGITIS; PREGNANCY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REMISSION; REVIEW; SIDE EFFECT; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT;

ANTIVIRAL AGENTS; DRUG RESISTANCE, VIRAL; DRUG THERAPY, COMBINATION; FEMALE; HEPATITIS B VIRUS; HEPATITIS B, CHRONIC; HUMANS; PREGNANCY;

EID: 34247194561     PISSN: 02709139     EISSN: None     Source Type: Journal    
DOI: 10.1002/hep.21627     Document Type: Review

References (188)

1. Hollinger FB, Liang TJ. Hepatitis B virus. In: Knipe DM, Howley PM, Chanock RM, Monath TP, Roizman B, Straus SE, editors. Field's Virology. Fourth ed. Philadelphia: Lippincott-Raven Publishers, 2000:2971-3036.
2. Dryden KA, Wieland SF, Whitten-Bauer C, Gerin JL, Chisari FV, Yeager M. Native hepatitis B virions and capsids visualized by electron cryomicroscopy. Molecular Cell 2006;22:843-850.
3. Doo E, Liang TJ. Molecular anatomy and pathophysiologic implications of drug resistance in hepatitis B virus infection. Gastroenterology 2001; 120:1000-1008.
4. Le Mire MF, Miller DS, Foster WK, Burrell CJ, Jilbert AR. Covalently closed circular DNA is the predominant form of duck hepatitis B virus DNA that persists following transient infection. J Virol 2005;79:12242-12252.
5. Chisari FV, Ferrari C. Hepatitis B virus immunopathogenesis. Annu Rev Immunol 1995;13:29-60.
6. Summers J, Jilbert AR, Yang W, Aldrich CT, Saputelli J, Litwin S, et al. Hepatocyte turnover during resolution of a transient hepadnaviral infection. Proc Natl Acad Sci USA 2003;100:11652-11659.
7. Guidotti LG, Rochford R, Chung J, Shapiro M, Purcell R, Chisari FV. Viral clearance without destruction of infected cells during acute HBV infection. Science 1999;284:825-829.
8. Guidotti LG, Ando K, Hobbs MV, Ishikawa T, Runkel L, Schreiber RD, et al. Cytotoxic T lymphocytes inhibit hepatitis B virus gene expression by a noncytolytic mechanism in transgenic mice. Proc Natl Acad Sci U S A 1994;91:3764-3768.
9. Guidotti LG, Chisari FV. Noncytolytic control of viral infections by the innate and adaptive immune response. Annu Rev Immunol 2001;19:65-91.
10. Guidotti LG, Morris A, Mendez H, Koch R, Silverman RH, Williams BR, et al. Interferon-regulated pathways that control hepatitis B virus replication in transgenic mice. J Virol 2002;76:2617-2621.
11. Rehermann B, Ferrari C, Pasquinelli C, Chisari FV. The hepatitis B virus persists for decades after patients' recovery from acute viral hepatitis despite active maintenance of a cytotoxic T-lymphocyte response. Nat Med 1996;2:1104-1108.
12. Liang TJ, Baruch Y, Ben-Porath E, Enat R, Bassan L, Brown NV, et al. Hepatitis B virus infection in patients with idiopathic liver disease. HEPATOLOGY 1991;13:1044-1051.
13. Liang TJ, Blum HE, Wands JR. Characterization and biological properties of a hepatitis B isolated from a patient without HBV serologic markers. HEPATOLOGY 1990;12:204-212.
14. Wachs ME, Amend WJ, Ascher NL, Bretan PN, Emond J, Lake JR, et al. The risk of transmission of hepatitis B from HBsAg(-), HBcAb(+), HBIgM(-) organ donors. Transplantation 1995;59:230-234.
15. Lok AS, Liang RH, Chiu EK, Wong KL, Chan TK, Todd D. Reactivation of hepatitis B virus replication in patients receiving cytotoxic therapy. Report of a prospective study. Gastroenterology 1991;100:182-188.
16. Lau GK, Yiu HH, Fong DY, Cheng HC, Au WY, Lai LS, et al. Early is superior to deferred preemptive lamivudine therapy for hepatitis B patients undergoing chemotherapy. Gastroenterology 2003;125:1742-1749.
17. Maini MK, Boni C, Lee CK, Larrubia JR, Reignat S, Ogg GS, et al. The role of virus-specific CD8(+) cells in liver damage and viral control during persistent hepatitis B virus infection. J Exp Med 2000;191:1269-1280.
18. Tsai SL, Chen PJ, Lai MY, Yang PM, Sung JL, Huang JH, et al. Acute exacerbations of chronic type B hepatitis are accompanied by increased T cell responses to hepatitis B core and e antigens. Implications for hepatitis B e antigen seroconversion. J Clin Invest 1992;89:87-96.
19. Boni C, Penna A, Bertoletti A, Lamonaca V, Rapti I, Missale G, et al. Transient restoration of anti-viral T cell responses induced by lamivudine therapy in chronic hepatitis B. J Hepatol 2003;39:595-605.
20. Boni C, Bertoletti A, Penna A, Cavalli A, Pilli M, Urbani S, et al. Lamivudine treatment can restore T cell responsiveness in chronic hepatitis B. J Clin Invest 1998;102:968-975.
21. Lok AS, Heathcote EJ, Hoofnagle JH. Management of chronic hepatitis B: 2000 - Summary of a Workshop. Gastroenterology 2001;120:1828-1853.
22. Hoofnagle JH, Seeff LB, Bales AB, Gerety RB, Tabor E. Serological responses in HB. In: Vyas GN, Cohen S, Schmid R, editors. Viral Hepatitis: Etiology, Epidemiology, Pathogenesis and Prevention. Philadelphia. Franklin Institute Press, 1978:219-244.
23. Magnius LO, Norder H. Subtypes, genotypes and molecular epidemiology of the hepatitis B virus as reflected by sequence variability of the S-gene. Intervirology 1995;38:24-34.
24. Chu C-J, Keeffe EB, Han S-H, Perrillo RP, Min AD, Soldevila-Pico C, et al for the U.S. HBV Epidemiology Study Group. Hepatitis B virus genotypes in the United States: results of a nationwide study. Gastroenterology 2003;125:444-451.
25. Kao JH, Chen PJ, Lai MY, Chen DS. Hepatitis B genotypes correlate with clinical outcomes in patients with chronic hepatitis B. Gastroentetoloogy 2000;118:554-559.
26. Chen DS. From hepatitis to hepatoma: lessons from type B viral hepatitis. Science 1993;262:369-370.
27. Lok ASF. Chronic hepatitis B. N Engl J Med 2002;346:1682-1683.
28. Chu CM. Natural history of hepatitis B infection in adults with emphasis on the occurrence of cirrhosis and hepatocellular carcinoma. J Gastroenterol Hepatol 2000;15(Suppl):E25-E30.
29. Realdi G, Alberti A, Rugge M, Bortolotti F, Rigoli AM, Termolada F, et al. Seroconversion from hepatitis B e antigen to anti-HBe in chronic hepatitis B virus infection. Gastroenterology 1980;79:195-199.
30. Hoofnagle JH, Dusheiko GM, Seeff LB, Jones EA, Waggoner JG, Bales ZB. Seroconversion from hepatitis B e antigen to antibody in chronic type B hepatitis. Ann Intern Med 1981;94:744-748.
31. Liaw YF, Chu CM, Su IJ, Huang MJ, Lin DY, ChangChien CS. Clinical and histological events preceding hepatitis B e antigen seroconversion in chronic type B hepatitis. Gastroenterology 1983;84:216-219.
32. Hoofnagle JH, Shafritz DA, Popper H. Chronic type B hepatitis and the "healthy" HBsAg carrier state. HEPATOLOGY 1987;7:758-763.
33. De Franchis R, Meucci G, Vecchi M, Tatarella M, Colombo M, Del Ninno E, et al. The natural history of asymptomatic hepatitis B surface antigen carriers. Ann Intern Med 1993;118:191-194.
34. Manno M, Camma C, Schepis F, Bassi F, Gelmini R, Giannini G, et al. Natural history of chronic HBV carriers in Northern Italy: morbidity and mortality after 30 years. Gastroenterology 2004;127:756-763.
35. Hsu Y-S, Chien R-N, Yeh C-T, Sheen I-S, Chiou H-Y, Chu C-M, et al. Long-term outcome after spontaneous HBeAg seroconversion in patients with chronic hepatitis B. HEPATOLOGY 2002;35:1522-1527.
36. Hadziyannis SJ. Hepatitis B e antigen negative chronic hepatitis B: from clinical recognition to pathogenesis and treatment. Viral Hep Rev 1995; 1:7-36.
37. Carman WF, Jacyna MR, Hadziyannis S, Karayiannis P, McGarvey MJ, Makris A, et al. Mutation preventing formation of e antigen in patients with chronic HBV infection. Lancet 1989;2:588-591.
38. Chan HLY, Hussain M, Lok ASF. Different hepatitis B virus genotypes are associated with different mutations in the core promoter and precore regions during hepatitis B e antigen seroconversion. HEPATOLOGY 1999; 29:976-984.
39. Davis GL, Hoofnagle JH, Waggoner JG. Spontaneous reactivation of chronic type B hepatitis. Gastroenterology 1984;86:230-235.
40. Liaw FY, Tai DI, Chu CM, Chen TJ. The development of cirrhosis in patients with chronic type B hepatitis: a prospective study. HEPATOLOGY 1988;8:493-496.
41. Liaw YF, Lin DY, Chen TJ, Chu CM. Natural course after the development of cirrhosis in patients with chronic type B hepatitis: a prospective study. Liver 1989;9:235-241.
42. Chen C-J, Yang H-I, Su J, Jen C-L, You S-L, Lu S-N, et al for the REVEAL-HBV Study Group. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA 2006; 295:65-73.
43. Fattovich G. Natural history of hepatitis B. J Hepatol 2003;39(Suppl 1):S50-S58.
44. EASL Jury. EASL International Consensus Conference on Hepatitis B;13-14 September 2002. J Hepatol 2003;39(Suppl):S3-S25.
45. Prati D, Taioli E, Zanella A, Della Torre E, Butelli S, Del Vecchio E, et al. Updated definitions of healthy ranges for serum aminotransferase levels. Ann Intern Med 2002;137:1-9.
46. Desmet VJ, Gerber M, Hoofnagle JH, Manns M, Scheuer PJ. Classification of chronic hepatitis: Diagnosis, grading and staging. HEPATOLOGY 1994;19:1513-1520.
47. Bedossa P, Poynard T, French METAVIR Cooperative Study Group. An algorithm for grading activity in chronic hepatitis C. HEPATOLOGY 1996; 24:289-293.
48. Ishak K, Baptista A, Bianchi L, Callea F, De Groote J, Gudat F, et al. Histologic grading and staging of chronic hepatitis. J Hepatol 1995;22: 696-699.
49. Bedossa P, Dargere D, Paradis V. Sampling variability of liver fibrosis in chronic hepatitis C. HEPATOLOGY 2003;38:1356-1358.
50. Chevaliez S, Pawlotsky JM. Use of virologic assays in the diagnosis and management of hepatitis C virus infection. Clin Liver Dis 2005;9:371-382.
51. Lopez VA, Bourne EJ, Lutz MW, Condreay LD. Assessment of the COBAS Amplicor HBV Monitor test for quantitation of serum hepatitis B virus DNA levels. J Clin Microbiol 2002;40:1972-1976.
52. Lindh M, Hannoun C. Dynamic range and reproducibility of hepatitis B virus (HBV) DNA detection and quantification by Cobas Taqman HBV, a real-time semiautomated assay. J Clin Microbiol 2005;43:4251-4254.
53. Niederau C, Heintges T, Lange S, Goldmann G, Niederau CM, Mohr L, et al. Long-term follow-up of HBeAg-positive patients treated with interferon alfa for chronic hepatitis B. N Engl J Med 1996;334:1422-1427.
54. Lau DT, Everhart J, Kleiner DE, Park Y, Vergalla J, Schmid P, et al. Long-term follow-up of patients with chronic hepatitis B treated with interferon alfa. Gastroenterology 1997; 113:1660-1667.
55. van Zonneveld M, Honkoop P, Hansen BE, Niesters HG, Murad SD, de Man RA, et al. Long-tetm follow-up of alpha-interferon treatment of patients with chronic hepatitis B. HEPATOLOGY 2004;39:804-810.
56. Lok AS, Chung HT, Liu VW, Ma OC. Long-term follow-up of chronic hepatitis B patients treated with interferon alpha. Gastroenterology 1993; 105:1833-1838.
57. Song BC, Suh DJ, Lee HC, Chung YH, Lee YS. Hepatitis B e antigen seroconversion after lamivudine is not durable in patients with chronic hepatitis B in Korea. HEPATOLOGY 2000;32:803-806.
58. Wong DKH, 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.
59. Cooksley WGE, Piratvisuth T, Lee S-D, Mahachai V, Chao YC, Tanwandee T, et al. Peginterferon alfa-2a (40 kD): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat 2003;10:298-305.
60. Lau GKK, 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.
61. Marcellin P, Lau GKK, Bonino F, Farci P, Hadziyannis S, Jin F, et al. Peginterferon afla-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.
62. Janssen HLA, van Zannoveld 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.
63. 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.
64. Lai C-L, Chien R-N, Leung NWY, Chang T-T, Guan R, Tai D-I, et al for the Asia Hepatitis Lamivudine Study Group. A one-year trial of lamivudine for chronic hepatitis B. N Engl J Med 1998;339:61-68.
65. Lai C-L, Gane E, Hsu C-W, Thongsawat S, Wang Y, Chen Y, et al. Two-year results from the Globe trial in patients with hepatitis B: greater clinical and antiviral efficacy for telbivudine (LDT) vs. lamivudine [Abstract]. HEPATOLOGY 2006;44(Suppl 1):222A.
66. Lim SG, Ng TM, Kung N, Krastev Z, Volfova M, Husa P, et al. A double-blind placebo-controlled study of emtricitabine in chronic hepatitis B. Arch Intern Med 2006;166:49-56.
67. Marcellin P, Chang T-T, 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.
68. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, Chang T-T, 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.
69. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, Chang T-T, 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.
70. Chang T-T, Gish RG, de Man R, Gadano A, Sollano J, Chao Y-C, et al for the BEHoLD A1463022 Study Group. A randomized comparison of entecavir to lamivudine for treatment of HBeAg-positive chronic hepatitis B in nucleoside-naïve patients. N Engl J Med 2006;354:1001-1010.
71. Lai C-L, Shouval D, Lok AS, Chang T-T, Cheinquer H, Goodman Z, et al for the BEHoLD A1463027 Study Group. Entecavir for HBeAg-negative chronic hepatitis B. A randomized comparison of entecavir to lamivudine for treatment of HBeAg-negative chronic hepatitis B in nucleoside-naïve patients. N Engl J Med 2006;354:1011-1020.
72. Tipples A, Ma MM, Fischer KP, Bain VG, Kneteman NM, Tyrrell DI. Mutation in HBV RNA-dependent DNA polymerase confers resistance to lamivudine in vivo. HEPATOLOGY 1996;24:714-717
73. Ling R, Mutimer D, Ahmed M, Boxall EH, Elias F., Dusheiko GM, et al. Selection of mutations in the hepatitis B virus polymerase during therapy of transplant recipients with lamivudine. HEPATOLOGY 1996;24: 711-713.
74. Locarnini S. Molecular virology and the development of resistant mutants: implications for therapy. Seminars Liver Disease 2005;25:9-19.
75. Liaw YF. Impact of YMDD mutations during lamivudine therapy in patients with chronic hepatitis B. Antivir Chem Chemother 2001;12:67-71.
76. Liu CJ, Chen PJ, Lai MY, Kao JH, Chen DS. Hepatitis B virus variants in patients receiving lamivudine Treatment with breakthrough hepatitis evaluated by serial viral loads and full-length viral sequences. HEPATOLOGY 2001;34:583-589.
77. Lok AS, Zoulim F, Locarnini S, Bartholomeusz A, Ghany MG, Pawlotsky J-M, et al. Antiviral-resistant HBV: standardization of nomenclature and assays and recommendations for management. HEPATOLOGY 2007;45:in press.
78. Zoulim F. In vitro models for studying hepatitis B virus drug resistance. Semin Liver Dis 2006;26:142-152.
79. Ono-Nita SK, Kato N, Shiratori Y, Lan KH, Yoshida H, Carrilho FJ, et al. Susceptibility of lamivudine-resistant hepatitis B virus to other reverse transcriptase inhibitors. J Clin Invest 1999;103:1635-1640.
80. Tenney DJ, Levine SM, Rose RE, Walsh AW, Weinheimer SP, Discotto L, et al. Clinical emergence of entecavir-resistant hepatitis B virus requires additional substitutions in virus already resistant to lamivudine. Antimicrob Agents Chemother 2004;48:3498-3507.
81. Bartholomeusz A, Locarnini S, Ayres A, Thompson G, Sozzi V, Angus P, et al. Molecular modeling of hepatitis B virus polymerase and adefovir resistance identifies three clusters of mutations [Abstract]. HEPATOLOGY 2004;40 (Suppl 1):246A.
82. Fung SK, Chae HB, Fontana RJ, Conjeevaram H, Marrero J, Oberhelman K, et al. Virologic response and resistance to adefovir in patients with chronic hepatitis B. J Hepatol 2006;44:283-290.
83. Yim HJ, Hussain M, Liu Y, Wong SN, Fung SK, Lok AS. Evolution of multi-dtug resistant hepatitis B virus during sequential therapy. HEPATOLOGY 2006;44:703-712.
84. Colonno R, Rose R, Levine S, Baldick J, Pokornowski K, Plym M, et al. Entecavir two year resistance update: no resistance observed in nucleoside naïve patients and low frequency resistance emergence in lamivudine refractory patients [Abstract]. HEPATOLOGY 2005;42(Suppl 1):573A.
85. Stuyver L, Van Geyt C, De Gendt S, Van Reybroeck G, Zoulim F, Leroux-Roels G, et al. Line probe assay for monitoring drug resistance in hepatitis B virus-infected patients during antiviral therapy. J Clin Microbiol 2000;38:702-707.
86. Wai CT, Chu CJ, Hussain M, Lok AS. HBV genotype B is associated with better response to interferon therapy in HBeAg(+) chronic hepatitis than genotype C. HEPATOLOGY 2002;36:1425-1430.
87. Flink HJ, van Zonneveld M, Hansen BE, de Man RA, Schalm SW, Janssen HL. Treatment with peg-interferon alpha-2b for HBeAg-positive chronic hepatitis B: HBsAg loss is associated with HBV genotype. Am J Gastroenterol 2006;101:297-303.
88. Westland C, Delaney W 4th, Yang H, Chen SS, Marcellin P, Hadziyannis S, et al. Hepatitis B virus genotypes and virologic response in 694 patients in phase III studies of adefovir dipivoxil. Gastroenterology 2003; 125:107-116.
89. Lau DT, Khokhar MF, Doo E, Ghany MG, Herion D, Park Y, et al. Long-term therapy of chronic hepatitis B with lamivudine. HEPATOLOGY 2000;32:828-834.
90. 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.
91. Liaw YF, Chien RN, Yeh CT. No benefit to continue lamivudine therapy after emergence of YMDD mutations. Antivir Ther 2004;9:257-262.
92. Lai C-L, Lim SG, Brown NA, Zhou XJ, Lloyd DM, Lee YM, et al. A dose finding study of once-daily oral telbivudine in HBeAg-positive patients with chronic hepatitis B virus infection. HEPATOLOGY 2004;40:719-726.
93. Lai C-L, Leung N, Teo E-K, Tong M, Wong F, Hann HW, et al. A 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis B. Gastroenterology 2005; 129:528-536.
94. Schildgen O, Sirma H, Funk A, Olotu C, Wend UC, Hartmann H, et al. Variant of hepatitis B virus with primary resistance to adefovir. N Engl J Med 2006;27:354:1807-1812.
95. 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.
96. Lampertico P, Marzano A, Levrero M, Santantonio T, Andreone P, Brunetto M, et al. A multicenter Italian study of rescue adefovir dipivoxil therapy in lamivudine resistant patients: a 2-year analysis of 604 patients [Abstract]. HEPATOLOGY 2005;42(Suppl 1):591A.
97. 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.
98. Lee YS, Suh DJ, Lim YS, Jung SW, Kim KM, Lee HC, et al. Increased risk of adefovir resistance in patients with lamivudine-resistant chronic hepatitis B after 48 weeks of adefovir dipivoxil monotherapy. HEPATOLOGY 2006;43:1385-1391.
99. Brunelle MN, Jacquard AC, Pichoud C, Durantel D, Carrouee-Durantel S, Villeneuve JP, et al. Susceptibility to antivirals of a human HBV strain with mutations conferring resistance to both lamivudine and adefovir. HEPATOLOGY 2005;41:1391-1398.
100. Gallant JE, Deresinski S. Tenofovir disoproxil fumarate. Clin Infect Dis 2003;37:944-950.
101. Ristig MB, Crippin J, Aberg JA, Powderly WG, Lisker-Melman M, Kessels L, et al. Tenofovir disoproxil fumarate therapy for chronic hepatitis B in human immunodeficiency virus/hepatitis B virus-coinfected individuals for whom interferon-alpha and lamivudine therapy have failed. J Infect Dis 2002;186:1844-1847.
102. Benhamou Y, Tubiana R, Thibault V. Tenofovir disoproxil fumarate in patients with HIV and lamivudine-resistant hepatitis B virus. N Engl J Med 2003;348:177-178.
103. Peters MG, Andersen J, Lynch P, Liu T, Alston-Smith B, Brosgart CL, et al. Randomized controlled study of tenofovir and adefovir in chronic hepatitis B virus and HIV infection: ACTG A5127. HEPATOLOGY 2006; 44:1110-1116.
104. van Bömmel F, Wünsche T, Mauss S, Reinke P, Bergk A, Schürmann D, et al. Comparison of adefovir and tenofovir in the treatment of lamivudine-resistant hepatitis B virus infection. HEPATOLOGY 2004;40:1421-1425.
105. van Bömmel F, Zöllner B, Sarrazin C, Spengler U, Hüppe D, Möller B, et al. Tenofovir for patients with lamivudine-resistant hepatitis B virus (HBV) infection and high HBV DNA level during adefovir therapy. HEPATOLOGY 2006;44:318-325.
106. Sung JJY, Lai JY, Zeuzem S, Chow WC, Heathcote E, Perrillo R, et al. A randomized double-blind phase II study of lamivudine (LAM) compared to lamivudine plus adefovir dipivoxil (ADV) for treatment naïve patients with chronic hepatitis B (CHB): week 52 analysis [Abstract]. J Hepatol 2003;38(Suppl 2):25.
107. Lau G, Cooksley H, Ribeiro RM, Powers KA, Bowden S, Mommeja-Marin H, et al. Randomized, double-blind study comparing adefovir dipivoxil (ADV) plus emtricitabine (FTC) combination therapy versus ADV alone in HBeAg + chronic hepatitis B: efficacy and mechanisms of treatment response [Abstract]. HEPATOLOGY 2004;40:(Suppl 1):272A.
108. Lampertico P, Marzano A, Levrero M, Santantonio T, Di Marco V, Brunetto M, et al. Adefovir and lamivudine combination therapy is superior to adefovir monotherapy for lamivudine-resistant patients with HBeAg-negative chronic hepatitis B [Abstract]. HEPATOLOGY 2006;44 (Suppl 1):693A [abstract].
109. Rapti IN, Dimou E, Mitsoula P, Hadziyannis SJ. Combination of adefovir dipivoxil with lamivudine vs. adefovir alone in lamivudine-resistant HBeAg-negative chronic hepatitis B patients [Abstract]. HEPATOLOGY 2006;44(Suppl 1):558A.
110. Lampertico P, Viranò M, Manenti E, Iavarone M, Lunghi G, Colombo. Adefovir rapidly suppresses hepatitis B in HBeAg-negative patients developing genotypic resistance to lamivudine. HEPATOLOGY 2005;42: 1414-19.
111. Lampertico P, Marzano V, Levrero M, Santantonio T, Andreone P, Brunetto M, et al. A multicenter Italian study of rescue adefovir dipivoxil therapy in lamivudine resistant patients: a 2-year analysis of 604 patients [Abstract]. HEPATOLOGY 2005;42:591A.
112. Sokal EM, Conjeevaram HS, Roberts EA, Alvarez F, Bern EM, Goyens P, et al. Interferon alfa therapy for chronic hepatitis B in children: a multinational randomized controlled trial. Gastroenrerology 1998;114:988-995.
113. Jonas MM, Kelley 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.
114. Sokal EM, Kelly DA, Mizerski J, Badia IB, Areias JA, Schwarz KB, et al. Long-term lamivudine therapy for children with HBeAg-positive chronic hepatitis B. HEPATOLOGY 2006;43:225-232.
115. D'Antiga L, Aw M, Atkins M, Moorat A, Vergani D, Mieli-Vergani G. Combined lamivudine/ interferon-α treatment in "immunotolerant" children perinatally infected with hepatitis B: a pilot study. J Pediatr 2006;148:228-233.
116. Bortolotti F, Guido M, Bartolacci S, Cadrobbi P, Crivellaro C, Noventa F, et al. Chronic hepatitis B in children after e antigen seroclearance: final report of a 29-year longitudinal study. HEPATOLOGY 2005;43:556-562.
117. Mast EE, Margolis HS, Fiore AE, Brink EW, Goldstein ST, Wang SA, et al. A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States. Morb Mortal Wkly Rep 2005;54(RR16);1-23.
118. Tassopoulos NC, Koutelou MG, Polychronaki H, Paraloglou-Ioannides M, Hadziyannis SJ. Recombinant interferon-alpha therapy for acute hepatitis B: a randomized, double-blind, placebo-controlled trial. J Viral Hepat 1997;4:387-394.
119. Torii N, Hasegawa K, Ogawa M, Hashimo E, Hayashi N. Effectiveness and long-term outcome of lamivudine therapy for acute hepatitis B. Hepatol Res 2002;24:34-41.
120. Kondili LA, Osman H, Mutimer D. The use of lamivudine for patients with acute hepatitis B (a series of cases). J Viral Hepat 2004;11:427-431.
121. Schmilovitz-Weiss H, Ben-Ari Z, Sikuler E, Zuckerman E, Sbeit W, Ackerman Z, et al. Lamivudine treatment for acute severe hepatitis B: a pilot study. Liver International 2004;24:547-551.
122. Tillmann HL, Hadem J, Schneider A, Wedemeyer H, Manns MP. Safety and efficacy of lamivudine in patients with severe acute or fulminant hepatitis B compared to historic control at one center. J Hepatol 2005; 42(Suppl2):193.
123. Sharma P, Lok A. Viral hepatitis and liver transplantation. Semin Liver Dis 2006;26:285-297.
124. Terrault N, Roche B, Samuel D. Management of the hepatitis B virus in liver transplantation setting: a European and an American Perspective. Liver Transpl 2005;11:716-732.
125. Lok ASF, McMahon BJ. AASLD Practice Guidelines: Chronic hepatitis B. HEPATOLOGY 2007;45:507-539.
126. Hoofnagle JH, Di Bisceglie AM, Waggoner JG, Park Y. Interferon alfa for patients with clinically apparent cirrhosis due to chronic hepatitis B. Gastroenterology 1993;104:1116-1121.
127. Perrillo R, Tamburro C, Regenstein F, Balart L, Bodenheimer H, Silva M, et al. Low-dose, titratable interferon alfa in decompensated liver disease caused by chronic infection with hepatitis B virus. Gastroenterology 1995;109:908-916.
128. Perrillo RP, Wright T, Rakela J, Levy G, Schiff E, Gish R, et al for the Lamivudine North American Transplant Group. A multicenter United States-Canadian trial to assess lamivudine monotherapy before and after liver transplantation for chronic hepatitis B. HEPATOLOGY 2001;33:424-432.
129. Fontana RJ, Hann HW, Perrillo RP, Vierling JM, Wright T, Rakela J, et al. Determinants of early mortality in patients with decompensated chronic hepatitis B treated with antiviral therapy. Gastroenterology 2002; 123:719-727.
130. Yao FY, Bass NM. Lamivudine treatment in patients with severely decompensated cirrhosis due to replicating hepatitis B infection. J Hepatol 2000;33:301-307.
131. Liaw Y-F, Sung JJY, Chow WC, Ferrell G, Lee CZ, Yuen H, et al. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med 2004;351:1521-1531.
132. Markowitz JS, Martin P, Conrad AJ, Markmann JF, Seu P, Yersiz H, et al. Prophylaxis against hepatitis B recurrence following liver transplantation using combination lamivudine and hepatitis B immune globulin. HEPATOLOGY 1998;28:585-589.
133. Rosenau J, Bahr M, Tillmann HL, Trautwein C, Klempnauer J, Manns MP, et al. Lamivudine and low-dose hepatitis B immune globulin for prophylaxis of hepatitis B reinfection after liver transplantation. Possible role of mutations in the YMDD morif prior to transplantation as a risk factor for reinfection. J Hepatol 2001;34:895-902.
134. Angus PW, McCaughan GW, Gane EJ, Crawford DH, Harley H. Combination low-dose hepatitis B immune globulin and lamivudine therapy provides effective prophylaxis against post-transplantation hepatitis B. Liver Transpl 2001;6:741-748.
135. Perrillo R, Schiff E, Yoshida E, Staler A, Hirsch K, Wright T, et al. Adefovir dipivoxil for the treatment of lamivudine-resistant hepatitis B mutants. HEPATOLOGY 2000;32:129-134.
136. Angus P, Vaughan R, Xiong S, Yang H, Delaney W, Gibbs C, et al. Resistance to adefovir dipivoxil therapy associated with the selection of a novel mutation in the HBV polymerase. Gastroenterology 2003;125: 292-297.
137. Villeneuve JP, Durantel D, Durantel S, Westland C, Xiong S, Brosgart CL, et al. Selection of a hepatitis B virus strain resistant to adefovir in a liver transplantation patient. J Hepatol 2003;39:1085-1089.
138. Thio CL, Seaberg EC, Skolasky R Jr, Phair J, Visscher B, Munoz A, et al. HIV-1, hepatitis B virus, and risk of liver-related mortality in the Multicenter Cohort Study (MACS). Lancet 2002;360:1921-1926.
139. Bonacini M, Louie S, Bzowej N, Wohl A. Survival in patients with HIV infection and viral hepatitis B or C: a cohort study. AIDS 2004;18:2039-2045.
140. Bica I, McGovern B, Dhar R, Stone D, McGowan K, Scheib R, et al. Increasing mortality due to end-stage liver disease in patients with HIV infection. Clin Infect Dis 2001;32:492-497.
141. Puoti M, Spinetti A, Ghezzi A, Donato F, Zaltron S, Putzolu V, et al. Mortality for liver disease in patients with HIV infection: a cohort study. J Acquir Immune Defic Syndr 2000;24:211-217.
142. The Data Collection on Adverse Events of anti-HIV Drugs Study Group. Liver-related deaths in persons infected with the human immunodeficiency virus. The D:A:D Study. Arch Intern Med 2006;166:1632-1641.
143. Matthews GV, Bartholomeusz A, Locarnini S, Ayres A, Sasaduesz J, Seaberg E, et al. Characteristics of drug resistant HBV in an international collaborative study of HIV-HBV-infected individuals on extended lamivudine therapy. AIDS 2006;20:863-870.
144. Nelson M, Portsmouth S, Stebbing J. An open-label study of tenofovir in HIV-1 and hepatitis B virus coinfected individuals. AIDS 2003;17:F7-F10.
145. Schildgen O, Schewe C, Vogel M, Daumer M, Kaiser R, Weitner L, et al. Successful therapy of hepatitis B with tenofovir in HIV-infected patients failing previous adefovir and lamivudine treatment. AIDS 2004;18:2325-2327.
146. Dore G, Cooper D, Pozniak A, De Jesus R, Zhong L, Miller M, et al. Efficacy of tenofovir disoproxil fumarate in antiretroviral therapy-naïve and -experienced patients coinfected with HIV-1 and hepatitis B virus. J Infect Dis 2004;189:1185-1192.
147. Bani-Sadr F, Palmer P, Scieux C, Molina JM. Ninety-six week efficacy or combination therapy with lamivudine and tenofovir in patients coinfected with HIV-1 and wild type hepatitis B virus. J Infect Dis 2004;39: 1062-1064.
148. Soriano V, Puoti M, Bonacini M, Brook G, Cargnel A, Rockstroh J, et al. Care of patients with chronic hepatitis B and HIV co-infection: recommendations from an HIV-HBV International Panel. AIDS 2005;19:221-240.
149. Hammer SM, Saag MS, Schechter M, Montaner JSG, Schooley RT, Jacobsen DM, et al. Treastment for adult HIV infection: 2006 recommendations of the International AIDS Society-USA Panel. JAMA 2006; 296:827-843.
150. Martin-Carbonero L, Sanchez-Somolinos M, Garcia-Samaniego J, Nunez MJ. Reduction in liver-related hospital admissions and deaths in HIV-infected patients since the year 2002. J Viral Hepat 2006;13:851-857.
151. Galbraith RM, Eddleston AL, Williams R, Zuckermann AJ, Bagshawe KD. Fulminant hepatic failure in leukaemia and choroiocarcinoma related to withdrawal of cytotoxic drug therapy. Lancet 1975;2:528-530.
152. Hoofnagle JH, Dusheiko GM, Schafer DF, Jones EA, Micetich KC, Young RC, et al. Reactivation of chronic hepatitis B virus infection by cancer chemotherapy. Ann Intern Med 1982;96:447-449.
153. Yeo W, Chan PK, Hui P, Ho WM, Lam KC, Kwan WH, et al. Hepatitis B virus reactivation in breast cancer patients receiving cytotoxic chemotherapy: a prospective study. J Med Virol 2003;70:553-561.
154. Idilman R, Arat M, Soydan E, Toruner M, Soykan I, Akbulut H, et al. Lamivudine prophylaxis for prevention of chemotherapy-induced hepatitis B virus reactivation in hepatitis B virus carriers with malignancies. J Viral Hepat 2004;11:141-147.
155. Lim LL, Wai CT, Lee YM, Kong HL, Lim R, Koay E, et al. Prophylactic lamivudine prevents hepatitis B reactivation in chemotherapy patients. Aliment Pharmacol Ther 2002;16:1939-1944.
156. Esteve M, Saro C, Gonzalez-Huix F, Suarez F, Forne M, Viver JM. Chronic hepatitis B reactivation following infliximab therapy in Crohn's disease patients: need for primary prophylaxis. Gut 2004;53:1363-1365.
157. Niscola P, Del Principe M, Maurilio L, Venditti A, Buccisano F, Piccioni D, et al. Fulminant B hepatitis in a surface antigen-negative patient with B-cell chronic lymphocytic leukaemia after rituximab therapy. Leukemia 2005;19:1840-1841.
158. Ostuni P, Botsios C, Punzi L, Sfriso P, Todesco S. Hepatitis B reactivation in a chronic hepatitis B surface antigen carrier with rheumatoid
159. Blanpain C, Knoop C, Delforge ML, Antoine M, Peny MO, Liesnard C, et al. Reactivation of hepatitis B after transplantation in patients with pre-existing anti-hepatitis B surface antigen antibodies: report on three cases and review of the literature. Transplantation 1998;66:883-886.
160. Biggar RJ, Goedert JJ, Hoofnagle JH. Accelerated loss of antibody to hepatitis B surface antigen among immunodeficient homosexual men infected with HIV [Letter]. N Engl J Med 1987;316:630-631.
161. Lazizi Y, Grangeot-Keros L, Delfraissy J, Boue F, Dubreuil P, Badur S, et al. Reappearance of hepatitis B virus in immune patients infected with the human immunodeficiency virus type 1. J Infect Dis 1988;158:666-667.
162. Kohrt HE, Ouyang DL, Keeffe EB. Systematic review: lamivudine prophylaxis for chemotherapy-induced reactivation of chronic hepatitis B virus infection. Aliment Pharmacol Ther 2006;24:1003-1016.
163. Hui CK, Cheung WW, Zhang HY, Au WY, Yueng YH, Leung AY, et al. Kinetics and risk of de novo hepatitis B infection in HBsAg-negative patients undergoing cytotoxic chemotherapy. Gastroenterology 2006;131:59-68.
164. Dhedin N, Douvin C, Kuentz M, Saint Marc MF, Reman O, Rieux C, et al. Reverse seroconversion of hepatitis B after allogeneic bone marrow transplantation: a retrospective study of 37 patients with pretransplant anti-HBs and anti-HBc. Transplantation 1998;66:616-619.
165. Nordbo A, Skaug K, Holter E, Waage A, Brinch L. Reactivation of hepatitis B virus infection in an anti-HBc and anti-HBs positive patient after allogeneic bone marrow transplantation. Eur J Haematol 2000;65: 86-87.
166. Goyama S, Kanda Y, Nannya Y, Kawazu M, Takeshira M, Niino M, et al. Reverse seroconversion of hepatitis B virus after hematopoietic stem cell transplantation. Leuk Lymphoma 2002;43:2159-2163.
167. Moses SE, Lim ZY, Sudhanva M, Devereux S, Ho AY, Paglica A, et al. Lamivudine prophylaxis and treatment of hepatitis B virus-exposed recipients receiving reduced intensity conditioning hematopoietic stem cell transplants with alemtuzumab. J Med Virol 2006;78:1560-1563.
168. Hui CK, Cheung WW, Au WY, Lie AK, Zhang HY, Yueng YH, et al. Hepatitis B reactivation after withdrawal of pre-emptive lamivudine in patients with haematological malignancy on completion of cytotoxic chemotherapy. Gut 2005;54:1597-1603.
169. Tanji N, Tanji K, Kambham N, Markowitz GS, Bell A, D'Agati VD. Adefovir nephrotoxicity: possible role of mitochondrial DNA depletion. Hum Pathol 2001;32:734-740.
170. Coca S, Perazella MA. Rapid communication: acute renal failure associated with tenofovir: evidence of drug-induced nephrotoxicity. Am J Med Sci 2002;24:342-344.
171. Rifkin BS, Perazella MA. Tenofovir-associated nephrotoxicity: Fanconi syndrome and renal failure. Am J Med 2004;117:282-284.
172. Izzedine H, Isnard-Bagnis C, Hulot J-S, Vittecoq D, Cheng A, Jais CK, et al. Renal safety of tenofovir in HIV treatment-experienced patients.
173. 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.
174. Parsonage MJ, Wilkins EG, Snowden N, Issa BG, Savage MW. The development of hypophosphataemic osteomalacia with myopathy in two patients with HIV infection receiving tenofovir therapy. HIV Med 2005; 6:341-346.
175. Tarantal AF, Marthas ML, Shaw JP, Cundy K, Bischofberger N. Administration of 9-[2-(R)-(phosphonomethoxy)propyl] adenine (PMPA) to gravid and infant rhesus macaques (Macaca mulatto): safety and efficacy studies. J Acquir Immune Defic Syndr Human Retroviral 1999;20:323-333.
176. Fried MW. Side effects of therapy of hepatitis C and their management. HEPATOLOGY 2002;36(Suppl 1):S237-S244.
177. Su GG, Pan KH, Zhao NF, Fang SH, Yang DH, Zhou Y. Efficacy and safety of lamivudine treatment for chronic hepatitis B in pregnancy. World J Gastroenterol 2004;10:910-912.
178. van Zonneveld M, van Nunen AB, Niesters HG, de Man RA, Schalm SW, Janssen HL. Lamivudine treatment during pregnancy to prevent perinatal transmission of hepatitis B virus infection. J Viral Hepat 2003; 10:294-297.
179. Anonymous. Entecavir (Baraclude) for chronic hepatitis B. Med Lett Drugs Therapeut 2005;47:47-48.
180. Drug topics Red Book. Montvale, NJ: Thomson PDR, 2005.
181. Loomba R, Liang TJ. Novel approaches to new therapies for hepatitis B virus infection. Antivir Ther 2006;11:1-15.
182. Deres K, Schroder CH, Paessens A, Goldmann S, Hacker HJ, Weber O, et al. Inhibition of hepatitis B virus replication by drug-induced depletion of nucleocapsids. Science 2003;299:893-896.
183. King RW, Ladner SK, Miller TJ, Zaifert K, Perni RB, Conway SC, et al. Inhibition of human hepatitis B virus replication by AT-61, a phenylpropenamide derivative, alone and in combination with (-)beta-L-2′,3′-dideoxy- 3′-thiacytidine. Antimicrob Agents Chemother 1998;42:3179-3186.
184. Dyson MR, Murray K. Selection of peptide inhibitors of interactions involved in complex protein assemblies: association of the core and surface antigens of hepatitis B virus. Proc Natl Acad Sci U S A 1995;92: 2194-2198.
185. Zhang Z, Torii N, Hu Z, Jacob J, Liang TJ. X-deficient woodchuck hepatitis virus mutants behave like attenuated viruses and induce protective immunity in vivo. J Clin Invest 2001;108:1523-1531.
186. McCaffrey AP, Nakai H, Pandey K, Huang Z, Salazar FH, Xu H, et al. Inhibition of hepatitis B virus in mice by RNA interference. Nat Biotechnol 2003;21:639-644.
187. Barber DL, Wherry EJ, Masopust D, Zhu B, Allison JP, Sharpe AH, et al. Restoring function in exhausted CD8 T cells during chronic viral infection. Nature 2005;439:682-687.
188. Brooks DG, Trifilo MJ, Edelmann KH, Teyton L, McGavern DB, Oldsrone MBA. Interleukin-10 determines viral clearance or persistence in vivo. Nat Med 2006;12:1301-1309.