Telbivudine in the treatment of chronic hepatitis B

Advances in Therapy

Volumn 26, Issue 2, 2009, Pages 155-169

  Nash, Kathryn ^a  

^a SOUTHAMPTON GENERAL HOSPITAL   (United Kingdom)

Author keywords

Hepatitis B; Resistance; Telbivudine; Treatment

Indexed keywords

ADEFOVIR; ALPHA INTERFERON; ANTIVIRUS AGENT; CLEVUDINE; EMTRICITABINE; ENTECAVIR; INTERFERON; LAMIVUDINE; NUCLEOSIDE; PEGINTERFERON ALPHA2A; PLACEBO; STAVUDINE; TELBIVUDINE; TENOFOVIR; ZIDOVUDINE;

ABDOMINAL PAIN; ABSENCE OF SIDE EFFECTS; AMYLASE BLOOD LEVEL; ANTIBIOTIC RESISTANCE; ANTIVIRAL ACTIVITY; ARTHRALGIA; CLINICAL TRIAL; COST EFFECTIVENESS ANALYSIS; COUGHING; CREATINE KINASE BLOOD LEVEL; DIARRHEA; DIZZINESS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CONTRAINDICATION; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG ERUPTION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG METABOLISM; DRUG POTENCY; DRUG SAFETY; DRUG STRUCTURE; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; ERADICATION THERAPY; FATIGUE; HEPATITIS B; HEPATITIS B VIRUS; HUMAN; MALAISE; MYOPATHY; NAUSEA; NONHUMAN; PERIPHERAL NEUROPATHY; REVIEW; SEROCONVERSION; SIDE EFFECT; SINGLE DRUG DOSE; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT; VIRUS LOAD; VIRUS RESISTANCE; VIRUS STRAIN;

ALANINE TRANSAMINASE; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DNA, VIRAL; DRUG EVALUATION, PRECLINICAL; DRUG INTERACTIONS; DRUG RESISTANCE, VIRAL; HEPATITIS B VIRUS; HEPATITIS B, CHRONIC; HUMANS; NUCLEOSIDES; PYRIMIDINONES; SAFETY; TREATMENT OUTCOME; VIRUS REPLICATION;

EID: 73449106092     PISSN: 0741238X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s12325-009-0004-y     Document Type: Review

References (58)

1. J.E. Maynard 1984 World-wide control of hepatitis B Int J Epidemiol. 13 406 407 6240473 10.1093/ije/13.4.406 1:STN:280:BiqC3cvgtVc%3D
2. D. Lavanchy 2004 Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures J Viral Hepat. 11 97 107 14996343 10.1046/j.1365-2893.2003.00487.x 1:STN:280: DC%2BD2c7gs1Whug%3D%3D (Pubitemid 38365759)
3. C. Lai V. Ratziu M.-F. Yuen T. Poynard 2003 Viral hepatitis B Lancet 362 2089 2094 14697813 10.1016/S0140-6736(03)15108-2 1:CAS:528:DC%2BD3sXpvFylsb4%3D (Pubitemid 38032767)
4. D.K. Wong A.M. Cheung K. O'Rourke C.D. Naylor A.S. Detsky J. Heathcote 1993 Effect of alpha-interferon treatment in patients with hepatitis e-antigenpositive chronic hepatitis B. A meta analysis Ann Intern Med. 119 312 323 8328741 1:STN:280:ByyA3MbhvFc%3D
5. G.K. Lau T. Piratvisuth K.X. Luo 2005 Peginterferon alfa-2a, lamivudine, and the combination for HBeAg positive chronic hepatitis B N Engl J Med. 352 2682 2695 15987917 10.1056/NEJMoa043470 1:CAS:528:DC%2BD2MXls1SktL8%3D (Pubitemid 41007823)
6. P. Marcellin G.K. Lau F. Bonino 2004 Peginterferon alfa-2a alone, lamivudine alone and the two in combination in patients with HBeAg-negative chronic hepatitis B N Engl J Med. 351 1206 1217 15371578 10.1056/NEJMoa040431 1:CAS:528:DC%2BD2cXns12rsr0%3D (Pubitemid 39296307)
7. W.M. Lee 1997 Hepatitis B virus infection N Engl J Med. 337 1733 1745 9392700 10.1056/NEJM199712113372406 1:STN:280:DyaK1c%2FktFyjtA%3D%3D (Pubitemid 27527771)
8. A.S. Lok 1992 Natural history and control of perinatally acquired hepatitis B virus infection Dig Dis. 10 46 52 1551246 10.1159/000171343 1:STN:280:By2B3c%2Fmslw%3D
9. Hadziyannis SJ, Bramou T, Alexopoulou A, Makris A. Immunopathogenesis and natural course of anti-HBe positive chronic hepatitis with replicating B virus. In: Hollinger FB, Lemon SM, Margolis HS, eds. Viral Hepatitis and Liver Disease. Baltimore: Williams & Wilkins; 1991:673-676.
10. C.M. Hunt J.M. McGill M.I. Allen L.D. Condreay 2000 Clinical relevance of hepatitis B viral mutations Hepatology 31 1037 1044 10796877 10.1053/he.2000.6709 1:CAS:528:DC%2BD3cXjtlyltb0%3D
11. D.A. Shafritz D. Shouval H.I. Sherman S.J. Hadziyannis M.C. Kew 1981 Integration of hepatitis B virus DNA into the genome of liver cells in chronic liver disease and hepatocellular carcinoma. Studies in percutaneous liver biopsies and post-mortem specimens N Engl J Med. 305 1067 1076 6268980 1:STN:280:DyaL38%2FhtlGgtw%3D%3D
12. J.E. Newbold H. Xin Tencza 1995 The covalently closed duplex form of the hepadnavirus genome exists in situ as a heterogeneous population of viral minichromosomes J Virol. 69 3350 3357 7745682 1:CAS:528:DyaK2MXls1yitrw%3D
13. J.S. Tuttleman C. Porcel J. Summers 1986 Formation of the pool of covalently closed circular viral DNA in hepadnavirus-infected cells Cell 47 451 460 3768961 10.1016/0092-8674(86)90602-1 1:CAS:528:DyaL2sXhtlynug%3D%3D
14. J. Tan A.S. Lok 2007 Update on viral hepatitis: 2006 Curr Opin Gastroenterol 23 263 267 17414841 10.1097/MOG.0b013e328049ddc1 1:CAS:528:DC%2BD2sXjvVOgtrk%3D (Pubitemid 46573141)
15. C.L. Lai J. Dienstag E. Schiff 2003 Prevalence and clinical correlates of YMDD variants during lamivudine therapy for patients with chronic hepatitis B Clin Infect Dis. 36 687 696 12627352 10.1086/368083 1:CAS:528: DC%2BD3sXjtVKqtbk%3D (Pubitemid 36337972)
16. S.J. Hadziyannis N.C. Tassopoulos E.J. Heathcote 2006 Long-term therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis B for up to 5 years Gastorenterology 131 1743 1751 10.1053/j.gastro.2006.09.020 1:CAS:528:DC%2BD2sXhtFyltLs%3D (Pubitemid 44958517)
17. Colonno RJ, Rose RE, Pokornowski, et al. Four year assessment of entecavir resistance in nucleosidenaïve and lamivudine refractory patients. Presented at: 42nd Annual Meeting of the European Association for the Study of the Liver; April 11-15, 2007; Barcelona, Spain.
18. P. Marcellin E.J. Heathcote M. Buti 2008 Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B N Engl J Med. 359 2442 2455 19052126 10.1056/NEJMoa0802878 1:CAS:528:DC%2BD1cXhsVCrurjL
19. D.N. Standring E.G. Bridges L. Placidi 2001 Antiviral beta-L-nucleosides specific for hepatitis B virus infection Antivir Chem Chemother. 12 suppl.1 119 129 11594678 1:CAS:528:DC%2BD3MXnvFSju7s%3D
20. B. Hernandez-Santiago L. Placidi E. Cretton-Scott 2002 Pharmacology of beta-L-thymidine and beta-l-2′-deoxycytidine in HepG2 cells and primary human hepatocytes: relevance to chemotherapeutic efficacy against hepatitis b virus Antimicrob Agents Chemother 46 1728 1733 12019082 10.1128/AAC.46.6.1728- 1733.2002 1:CAS:528:DC%2BD38XktFCmsrk%3D (Pubitemid 34535189)
21. M. Seifer A. Patty D. Dukhan 2005 Telbivudine (LdT) preferentially inhibits second (+) strand HBV DNA synthesis J Hepatol. 42 suppl.2 151
22. M.L. Bryant E.G. Bridges L. Placidi 2001 Antiviral Lnucleosides specific for hepatitis B virus infection Antimicrob Agents Chemother. 45 229 235 11120971 10.1128/AAC.45.1.229-235.2001 1:CAS:528:DC%2BD3MXhsFGhsw%3D%3D (Pubitemid 32039120)
23. E. Cretton-Scott X.J. Zhou E.G. Bridges 1999 Pharmacokinetics of β-L-thymidine and β-L-2′-deoxycytidine in woodchucks and monkeys Antivir Ther. 4 A124
24. P. Hu J. Jiang H. Wang 2006 Single-dose and multiple-dose pharmacokinetics and safety of telbivudine after oral administration J Clin Pharmacol. 46 999 1007 16920894 10.1177/0091270006290623 1:CAS:528: DC%2BD28XpvFOmsL4%3D (Pubitemid 44215064)
25. X.J. Zhou T.C. Marbury H.W. Alcorn 2006 Pharmacokinetics of telbivudine in subjects with various degrees of hepatic impairment Antimicrob Agents Chemother. 50 1721 1726 16641441 10.1128/AAC.50.5.1721-1726.2006 1:CAS:528:DC%2BD28XksVKkt7g%3D
26. X.J. Zhou D.M. Lloyd G.C. Chao N.A. Brown 2006 Absence of food effect on the pharmacokinetics of telbivudine following oral administration in healthy subjects J Clin Pharmacol. 46 275 281 16490803 10.1177/0091270005284849 1:CAS:528:DC%2BD28Xitl2qsb0%3D (Pubitemid 43260314)
27. C.L. Lai S.G. Lim N.A. Brown 2004 A dose-finding study of once-daily oral telbivudine in HBeAgpositive patients with chronic hepatitis B virus infection Hepatology. 40 719 726 15349912 10.1002/hep.20374 1:CAS:528:DC%2BD2cXot1Ortb0%3D (Pubitemid 39265595)
28. X.J. Zhou S.G. Lim D.M. Lloyd G.C. Chao N.A. Brown C.L. Lai 2006 Pharmacokinetics of telbivudine following oral administration of escalating single and multiple doses in patients with chronic hepatitis B infection: pharmacodynamic implications Antimicrob Agents Chemother. 50 874 879 16495245 10.1128/AAC.50.3.874-879.2006 1:CAS:528:DC%2BD28XisFamtrc%3D (Pubitemid 43327789)
29. X.J. Zhou S. Swan W.B. Smith 2007 Pharmacokinetics of telbivudine in subjects with various degrees of renal impairment Antimicrob Agents Chemother. 51 4231 4235 17875994 10.1128/AAC.00557-07 1:CAS:528:DC%2BD2sXhsVWisLbK (Pubitemid 350209870)
30. C.L. Lai N. Leung E.K. Teo 2005 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 16083710 1:CAS:528: DC%2BD2MXpvVWmsLs%3D (Pubitemid 41096641)
31. C.L. Lai N. Leung E.K. Teo 2005 Phase IIb extended-treatment trial of telbivudine (LdT) vs. lamivudine vs. combination treatment in hepatitis B patients: two-year results Gastroenterology. 128 suppl.2 A 692
32. C.L. Lai E. Gane Y.-F. Liaw 2007 Telbivudine versus lamivudine in patients with chronic hepatitis B N Engl J Med. 357 2576 2588 18094378 10.1056/NEJMoa066422 1:CAS:528:DC%2BD2sXhsVKht7nF (Pubitemid 350294224)
33. C.L. Lai E. Gane C.W. Hsu 2006 Two-year results from the GLOBE trial in patients with hepatitis B: greater clinical and antiviral efficacy for telbivudine (LdT) vs lamivudine Hepatology. 44 suppl.1 222A
34. Y.F. Liaw E. Gane N. Leung 2009 2-year GLOBE trial results: telbivudine is superior to lamivudine in patients with chronic hepatitis B Gastroenterology 136 486 495 19027013 10.1053/j.gastro.2008.10.026 1:CAS:528:DC%2BD1MXislOhtLs%3D
35. J. Hou Y.K. Yin D. Xu 2008 Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: results at 1 year of a randomized double-blind trial Hepatology. 47 447 454 18080339 10.1002/hep.22075 1:CAS:528:DC%2BD1cXitF2ltbc%3D (Pubitemid 351280712)
36. J.D. Jia J.L. Hou Y.K. Yin 2007 Two year results of a phase III comparative trial of telbivudine vs lamivudine in Chinese patients J Hepatol. 46 suppl.1 S190
37. E.J. Heathcote H.L. Chan M. Cho 2006 A randomized trial of telbivudine (LdT) vs adefovir for HBeAg-positive chronic hepatitis B: results of the primary 24 week analysis Gastroenterology. 130 suppl.2 A765
38. H.L. Chan E.J. Heathcote P. Marcellin 2007 Treatment of hepatitis B e antigen-positive chronic hepatitis with telbivudine or adefovir Ann Intern Med. 147 745 754 17909201 (Pubitemid 351664439)
39. K.Q. Shi D.Z. Zhang S.H. Guo 2008 Short-term results of telbivudine versus entecavir treatments in HBeAg-positive chronic hepatitis B patients in China Zhonghua Gan Zang Bing Za Zhi. 16 641 645 18822200
40. E.G. Bridges J.R. Selden S. Luo 2008 Nonclinical safety profile of telbivudine, a novel potent antiviral agent for treatment of hepatitis B Antimicrob Agents Chemother. 52 2521 2528 18474576 10.1128/AAC.00029-08 1:CAS:528:DC%2BD1cXot1Ohs7o%3D (Pubitemid 351915684)
41. D. Mutimer D. Pillay P. Cook 2000 Selection of multiresistant hepatitis B virus during sequential nucleoside analogue therapy J Infect Dis. 181 713 716 10669360 10.1086/315238 1:STN:280:DC%2BD3c7jsVKjsA%3D%3D (Pubitemid 30131844)
42. M.N. Brunelle A.C. Jacquard C. Pichoud 2005 Susceptibility to antivirals of a human HBV strain with mutations conferring resistance to lamivudine and adefovir Hepatology. 41 1391 1398 15915463 10.1002/hep.20723 1:CAS:528:DC%2BD2MXlvVSmsrg%3D (Pubitemid 40770292)
43. D.J. Tenney S.M. Levine R.E. Rose 2004 Clinical emergence of entecavir-resistant hepatitis B virus requires additional substitutions in virus already resistant to lamivudine Antimicrob Agents Chemother. 48 3498 3507 15328117 10.1128/AAC.48.9.3498-3507.2004 1:CAS:528:DC%2BD2cXnsVehsL0%3D (Pubitemid 39129351)
44. S. Villet C. Pichoud A. Ollivet J. Villeneuvre C. Trepo F. Zoulim 2005 Sequential antiviral therapy leads to the emergence of multiple drug resistant hepatitis B virus Hepatology. 42suppl. 581A
45. R.G. Gisg A.S. Lok T.T. Chang 2007 Entecavir therapy for up to 96 weeks in patients with HBeAgpositive chronic hepatitis B Gastroenterology. 133 1437 1444 10.1053/j.gastro.2007.08.025 (Pubitemid 350029745)
46. A. Bartholomeusz L. Yuen S. Locarnini 2007 Understanding HBV resistance to telbivudine: molecular modelling and database mining J Hepatol. 46 suppl.1 S185 10.1016/S0168-8278(07)62084-4
47. M. Seifer A. Patty I. Serra B. Li D.N. Standring 2009 Telbivudine, a nucleoside analog inhibitor of HBV polymerase, has a different in vitro crossresistance profile than the nucleotide analog inhibitors adefovir and tenofovir Antiviral Res. 81 147 155 19028525 10.1016/j.antiviral.2008.10.008 1:CAS:528:DC%2BD1MXotVGisA%3D%3D
48. D.N. Standring M. Seifer A. Patty 2006 HBV resistance determination from the telbivudine GLOBE registration trial J Hepatol. 44 suppl.2 S191 10.1016/S0168-8278(06)80514-3
49. P. Lampertico M. Vigano E. Manenti M. Iavarone E. Sablon M. Colombo 2007 Low resistance to adefovir combined with lamivudine: a 3-year study of 145 lamivudine-resistant hepatitis B patients Gastroenterology. 133 1445 1451 17983801 10.1053/j.gastro.2007.08.079 1:CAS:528:DC%2BD2sXhsVGqtr%2FL (Pubitemid 350047463)
50. W.E. Delaney H. Yang M.D. Miller C.S. Gibbs S. Xiong 2004 Combinations of adefovir with nucleoside analogs produce additive antiviral effects against hepatitis B virus in vitro Antimicrob Agents Chemother. 48 3702 3710 15388423 10.1128/AAC.48.10.3702-3710.2004 1:CAS:528:DC%2BD2cXosVygsrg%3D (Pubitemid 39310516)
51. X.J. Zhou B.A. Fielman D.M. Lloyd 2006 Pharmacokinetics of telbivudine in healthy subjects and absence of drug interaction with lamivudine or adefovir dipivoxil Antimicrob Agents Chemother. 50 2309 2315 16801406 10.1128/AAC.01313-05 1:CAS:528:DC%2BD28XmvVWrs7c%3D (Pubitemid 43993167)
52. X. Zhou K. Pietropaolo M. Becker 2007 Absence of pharmacokinetic drug-drug interaction between telbivudine and tenofovir Gastroenterology. 132 suppl.2 A 766
53. X.J. Zhou B. Fielman G. Dubuc-Patrick G. Chao N. Brown 2006 Absence of pharmacokinetic drug-drug interaction between telbivudine and peginterferon alpha-2a or cyclosporine in healthy subjects J Hepatol. 44 suppl.2 S194 10.1016/S0168-8278(06)80522-2
54. J.B. Wong S.G. Pauker 2007 Cost effectiveness of telbivudine versus lamivudine for chronic hepatitis B J Hepatol. 46 suppl.1 S199 10.1016/S0168-8278(07)62120-5
55. D.E. Spackman D.L. Veenstra 2008 A cost-effectiveness analysis of currently approved treatments for HBeAg-positive chronic hepatitis B Pharmacoeconomics. 26 937 949 18850763 10.2165/00019053-200826110-00006
56. National Institute for Health and Clinical Excellence. Hepatitis B - telbivudine. Telbivudine for the treatment of chronic hepatitis B. Technology appraisal TA154. August 2008. Available at: www. nice.org.uk/TA154. Accessed December 1, 208.
57. E.B. Keeffe D.T. Dieterich S.H. Han 2008 A treatment algorithm for the management of chronic hepatitis B infection in the United States: 2008 update Clin Gastroenterol Hepatol. 6 1315 1341 18845489 10.1016/j.cgh.2008.08.021 1:CAS:528:DC%2BD1MXhtFSlurk%3D
58. EASL Clinical practice guideline: management of chronic hepatitis B. J Hepatol. In press.