Safety evaluation of telbivudine

Expert Opinion on Drug Safety

Volumn 9, Issue 5, 2010, Pages 821-829

  But, David Yiu Kuen ^a   Yuen, Man Fung ^a   Fung, James ^a   Lai, Ching Lung ^a  

^a UNIVERSITY OF HONG KONG   (Hong Kong)

Author keywords

Creatine kinase; Efficacy; Myopathy; Safety; Telbivudine

Indexed keywords

ADEFOVIR; ALANINE AMINOTRANSFERASE; CREATINE KINASE; ENTECAVIR; HEPATITIS B SURFACE ANTIGEN; HEPATITIS B(E) ANTIGEN; LAMIVUDINE; PEGINTERFERON; TELBIVUDINE; TENOFOVIR DISOPROXIL;

ACUTE KIDNEY FAILURE; ANTIVIRAL ACTIVITY; ANTIVIRAL RESISTANCE; CLINICAL TRIAL; CREATININE BLOOD LEVEL; DRUG EFFICACY; DRUG INDUCED CANCER; DRUG MECHANISM; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; FANCONI ANEMIA; HEPATITIS B; HUMAN; LACTIC ACIDOSIS; LIVER FAILURE; MUSCLE WEAKNESS; MYALGIA; MYOSITIS; NEPHROGENIC DIABETES INSIPIDUS; NEPHROTOXICITY; NONHUMAN; PERIPHERAL NEUROPATHY; REVIEW; SEROCONVERSION; SIDE EFFECT; VIRUS MUTATION;

ADULT; ANTIVIRAL AGENTS; BIOLOGICAL MARKERS; CREATINE KINASE; DOUBLE-BLIND METHOD; DRUG RESISTANCE, VIRAL; FEMALE; HEPATITIS B VIRUS; HEPATITIS B, CHRONIC; HUMANS; ISOENZYMES; MALE; MULTICENTER STUDIES AS TOPIC; MUSCULAR DISEASES; NUCLEOSIDES; PERIPHERAL NERVOUS SYSTEM DISEASES; PREDICTIVE VALUE OF TESTS; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PYRIMIDINONES; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 77955929197     PISSN: 14740338     EISSN: None     Source Type: Journal    
DOI: 10.1517/14740338.2010.507190     Document Type: Review

References (63)

1. Lee W. Hepatitis B virus infection. N Engl J Med 1997;337:1733-1745
2. Lai CL, Yuen MF. The natural history of chronic hepatitis B. J Viral Hepat 2007;14(Suppl 1):6-10
3. Ohata K, Hamasaki K, Toriyama K, et al. High viral load is a risk factor for hepatocellular carcinoma in patients with chronic hepatitis B virus infection. J Gastroenterol Hepatol 2004;19:670-675
4. Yuan HJ, Yuen MF, Ka-Ho Wong D, et al. The relationship between HBV-DNA levels and cirrhosis-related complications in Chinese with chronic hepatitis B. J Viral Hepat 2005;12:373-379
5. Liaw YF, Sung JJ, Chow WC, et al. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med 2004;351:1521-1531
6. Gane EJ. The Roadmap concept: using early on-treatment virologic responses to optimize long-term outcomes for patients with chronic hepatitis B. Hepatol Int 2008;2:304-307
7. Yuen MF, Hui CK, Cheng CC, et al. Long-term follow-up of interferon alfa treatment in Chinese patients with chronic hepatitis B infection: the effect on epatitis B e antigen seroconversion and the development of cirrhosis-related complications. Hepatology 2001;34:139-145
8. Truong BX, Seo Y, Kato M, et al. Long-term follow-up of Japanese patients with chronic hepatitis B treated with interferon-alpha. Int J Mol Med 2005;16:279-284
9. Lin SM, Yu ML, Lee CM, et al. Interferon therapy in HBeAg positive chronic hepatitis reduces progression to cirrhosis and hepatocellular carcinoma. J Hepatol 2007;46:45-52
10. Fung SK, Andreone P, Han SH, et al. Adefovir-resistant hepatitis B can be associated with viral rebound and hepatic decompensation. J Hepatol 2005;43:937-943
11. Bryant M, Bridges E, Placidi L, et al. Antiviral L-nucleosides specific for hepatitis B virus infection. Antimicrob Agents Chemother 2001;45:229-235
12. Low E, Atkins M, Nelson M. Telbivudine has activity against HIV-1. AIDS 2009;23:546-547
13. Zhou X, Lim S, Lloyd D, et al. Pharmacokinetics of telbivudine following oral administration of escalating single and multiple doses in patients with chronic hepatitis B virus infection: pharmacodynamic implications. Antimicrob Agents Chemother 2006;50:874-879
14. Zhou XJ, Swan S, Smith WB, et al. Pharmacokinetics of telbivudine in subjects with various degrees pf renal impairment. Antimicrob Agents Chemother 2007;51:4231-4235
15. Zhou XJ, Marbury TC, Alcorn HW, et al. Pharmacokinetics of telbivudine in subjects with various degrees of hepatic impairments. Antimicrob Agents Chemother 2006;50:1721-1726
16. Lai C, Lim S, Brown N, 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
17. 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 2005;129:528-536
18. Lai CL, Gane E, Liaw YF, et al. Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med 2007;357:2576-2588
19. 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 2009;136(2):486-495
20. Hou J, Yin YK, Xu D, et al. Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: results at 1 year of a randomized, double-blind trial. Hepatology 2008;47:447-454
21. Wang Y, Jia JD, Hou J, et al. A phase III comparative trial of telbivudine vs lamivudine in Chinese patients with chronic hepatitis B: two-year results [abstract]. Gastroenterology 2007;132:1768
22. Wang Y, Thongsawat S, Gane EJ, et al. Efficacy and Safety Outcomes After 4 Years of Telbivudine Treatment in Patients with Chronic Hepatitis B [abstract]. Hepatology 2009;S4:533A
23. 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 2007;147:745-754
24. Suh DJ, Um SH, Herrmann E, et al. Early viral kinetics of telbivudine and entecavir: results of a 12-week randomized exploratory study with patients with HBeAg-positive chronic hepatitis B. Antimicrob Agents Chemother 2010;54:1242-1247
25. Liang J, Han T, Xiao SX, et al. Telbivudine treatment on cirrhosis resulting from chronic hepatitis B. Chin J Hepatol 2009;17:24-27
26. Gane EJ, Chan HL, Choudhuri G, et al. Treatment of decompensated HBV-Cirrhosis: results from 2-years randomized trial with telbivudine or lamivudine [abstract] J Hepatol 2010;52:S4
27. Zoulim F, Locarnini S. Hepatitis B virus Resistance to nucleos(t)ide analogues. Gastroenterology 2009;137:1593-1608
28. Lai CL, Dienstag J, Schiff E, 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
29. Seifer M, Patty A, Serra I, et al. Telbivudine, a nucleoside analog inhibitor of HBV polymerase, has a different in vitro cross-resistance profile than the nucleotide analog inhibitors adefovir and tenofovir. Antiviral Res 2009;81(2):147-155
30. Colonno R, Rose RE, Pokornowski K, et al. Four year assessment of ETV resistance in nucleoside-naive and lamivudine refractory patients. J Hepatol 2007;46(Suppl 1):S294
31. Yuen MF, Sablon E, Hui CK, et al. Factors associated with hepatitis B virus DNA breakthrough in patients receiving prolonged lamivudine therapy. Hepatology 2001;34:785-791
32. Locarnini S, Qi S, Arterburn S, et al. Incidence and predictors of emergence of adefovir resistant HBV during four years of adefovir dipivoxil (ADV)therapy for patients with chronic hepatitis B (CHB). J Hepatol 2005;42:17
33. Farci P, Marcellin P, Lu ZM, et al. On-treatment predictors of sustained biochemical and virological response in patients with HBeAg-negative chronic hepatitis B (CHB) treated with peginterferon alpha-2a (40kDa) (PEGASYS). J Hepatol 2005;42:S175
34. Zeuzem S, Gane E, Liaw YF, et al. Baseline characteristics and early on-treatment response predict the outcomes of 2 years of telbivudine treatment of chronic hepatitis B. J Hepatol 2009;51:11-20
35. Angus P, Vaughan R, Xiong S, et al. Resistance to adefovir dipivoxil therapy associated with the selection of a novel mutation in the HBV polymerase. Gastroenterology 2003;125:292-297
36. Villet S, Pichoud C, Billioud G, et al. Impact of hepatitis B virus rtA181V/T mutants on hepatitis B treatment failure. J Hepatol 2008;48:747-755
37. Van Bommel F, de Man RA, Wedemeyer H, et al. Long-term efficacy of tenofovir monotherapy for hepatitis B virus-monoinfected patients after failure of nucleoside/nucleotide analogues. Hepatology 2010;51:73-80
38. Angus P, Vaughan R, Xiong S, et al. Resistance to adefovir dipivoxil therapy associated with the selection of a novel mutation in the HBV polymerase. Gastroenterology 2003;125:292-297
39. Avila, Goncalves. Creatine kinase elevations during 4 years of continuous telbivudine treatment are transient and not predictive of uncommonly observed muscle related symptoms [abstract]. 60th Annual Meeting of the American Association for the Study of the Liver Diseases (AASLD); October 30 - November 3 2009; Boston, USA
40. Marcellin P, Avila C, Wursthorn K, et al. Telbivudine (LDT) plus Peg-intereron (PEGIFN) in HBeAg-positive chronic hepatitis B - very potent antiviral efficacy but risk of peripheral neuropathy (PN) [abstract]. J Hepatol 2010;52(S1):S6-7
41. Goncalves J, Laeufle R, Avila C. Increased risk with combination of Telbivudine and Pegylated-Interferon Alfa-2A in Study CLDT600A2406, compared to uncommon rate with telbivudine monotherapy from the Novartis Global Database. J Hepatol 2009;50(Suppl 1):S329-30
42. Weaver M, Wolf A, Persohn E, et al. Absence of Mitochondrial toxicity of telbivudine in skeletal muscle cells, hepatocytes, and neuronal cells from rat or human. Abstract from the 19th Asian Pacific Association for the Study of the Liver (APASL); 13 - 16 February 2009; Hong Kong
43. Zhang LJ, Wang L. Blocking intrauterine infection by telbivudine in pregnant chronic hepatitis B patients. Chin J Hepatol 2009;17:561-563
44. Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology 2007;45:507-539
45. European Association for the Study of the Liver. EASL clinical practice guidelines: Management of chronic hepatitis B. J Hepatol 2009;50:227-242
46. Adani GL, Baccarani U, Risaliti A, et al. Rhabdomyolysis due to lamivudine administration in a liver transplant recipient. Am J Transplant 2005;5:634
47. Fodale V, Mazzeo A, Pratico C, et al. Fatal exacerbation of peripheral neuropathy during lamivudine therapy: evidence for iatrogenic mitochondrial damage. Anaesthesia 2005;60:806-810
48. Bayraekci US, Baskin E, Ozcay F, et al. Renal fanconi syndrome and myopathy after liver transplantation: drug related mitochondrial cytopathy? Pediatr Transplant 2008;12:109-112
49. Cupler EJ, Dalakas MC. Exacerbation of peripheral neuropathy by lamivudine. Lancet 1995;345:460-461
50. Ojetti VA, Gasharrini A, Migneco A, et al. Lamivudine induced muscle mitochondrial toxicity. Dig Liver Dis 2002;34:384-385
51. Fontana RJ. Management of patients with decompensated HBV cirrhosis. Semin Liver Dis 2003;23:89-100
52. Yeo W, Johnson PJ. Diagnosis, prevention and management of hepatitis B virus reactivation during anticancer therapy. Hepatology 2006;43:209-220
53. Marcellin P, Chang TT, Lim SGL, et al. Long-term efficacy and safety of adefovir dipivoxil for the treatment of hepatitis B e antigen positive chronic hepatitis B. Hepatology 2008;48:750-758
54. Fontana RJ. Side effects of long-term oral antiviral therapy for hepatitis B. Hepatology 2009;49:S185-95
55. Lange CM, Bojunga J, Hofmann WP, et al. Severe lactic acidosis during treatment of chronic hepatitis B with entecavir in patients with impaired liver function. Hepatology 2009;50:2001-2006
56. Nelson MR, Katlama C, Montaner JS, et al. The safety of tenofovir disoproxil fumarate for the treatment of HIV infection in adults: the first 4 years. AIDS 2007;21:1273-1281
57. Verheist D, Monge M, Meynard JL, et al. Fanconi syndrome and renal failure induced by tenofovir: a first case report. Am J Kidney Dis 2002;40:1331-1333
58. Izzedine H, Isnard-bagnis C, Hulot JS, et al. Renal safety of tenofovir in HIV treatment-experienced patients. AIDS 2004;18:1074-1076
59. Karras A, Lafaurie M, Furco A, et al. Tenofovir-related nephrotoxicity in human immunodeficiency virus-infected patients: three cases of renal failure, fanconi syndrome, and nephrogenic diabetes insipidus. Clin Infect Dis 2003;36:1070-1073
60. Lee JC, Marosok RD. Acute tubular necrosis in a patient receiving tenofovir. AIDS 2003;17:2543-2544
61. Coca S, Parzella MA. Acute renal failure associated with tenofovir: evidence of drug-induced nephrotoxicity. Am J Med Sci 2002;324:342-344
62. Gallant J, Staszewski ES, Pozniak AL, et al. Efficacy and safety of tenofovir DF vs stavudine in combination therapy in anti-retroviral naive patients: a 3-year randomized trial. JAMA 2004;292:191-201
63. Gafni RL, Hazra R, Reynolds JC, et al. Tenofovir disoproxil fumarate and anoptimized background regimen of antiretroviral agents as salvage therapy: impact on bone mineral density in HIV-infected children. Pediatrics 2006;118:e711-18