Safety evaluation of telbivudine

Bibliography

• Lee W. Hepatitis B virus infection. N Engl J Med 1997;337:1733-45
   PubMed Web of Science ®Google Scholar
• Lai CL, Yuen MF. The natural history of chronic hepatitis B. J Viral Hepat 2007;14(Suppl 1):6-10
   PubMedGoogle Scholar
• Ohata K, Hamasaki K, Toriyama K, High viral load is a risk factor for hepatocellular carcinoma in patients with chronic hepatitis B virus infection. J Gastroenterol Hepatol 2004;19:670-5
   PubMed Web of Science ®Google Scholar
• Yuan HJ, Yuen MF, Ka-Ho Wong D, The relationship between HBV-DNA levels and cirrhosis-related complications in Chinese with chronic hepatitis B. J Viral Hepat 2005;12:373-9
   PubMed Web of Science ®Google Scholar
• Liaw YF, Sung JJ, Chow WC, Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med 2004;351:1521-31
   PubMed Web of Science ®Google Scholar
• 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;2:304-7
   PubMed Web of Science ®Google Scholar
• Yuen MF, Hui CK, Cheng CC, Long-term follow-up of interferon alfa treatment in Chinese patients with chronic hepatitis B infection: the effect on hepatitis B e antigen seroconversion and the development of cirrhosis-related complications. Hepatology 2001;34:139-45
   PubMed Web of Science ®Google Scholar
• Truong BX, Seo Y, Kato M, Long-term follow-up of Japanese patients with chronic hepatitis B treated with interferon-alpha. Int J Mol Med 2005;16:279-84
   PubMed Web of Science ®Google Scholar
• Lin SM, Yu ML, Lee CM, Interferon therapy in HBeAg positive chronic hepatitis reduces progression to cirrhosis and hepatocellular carcinoma. J Hepatol 2007;46:45-52
   PubMed Web of Science ®Google Scholar
• Fung SK, Andreone P, Han SH, Adefovir-resistant hepatitis B can be associated with viral rebound and hepatic decompensation. J Hepatol 2005;43:937-43
   PubMed Web of Science ®Google Scholar
• Bryant M, Bridges E, Placidi L, Antiviral L-nucleosides specific for hepatitis B virus infection. Antimicrob Agents Chemother 2001;45:229-35
   PubMed Web of Science ®Google Scholar
• Low E, Atkins M, Nelson M. Telbivudine has activity against HIV-1. AIDS 2009;23:546-7
   PubMed Web of Science ®Google Scholar
• Zhou X, Lim S, Lloyd D, 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;50:874-9
   PubMed Web of Science ®Google Scholar
• Zhou XJ, Swan S, Smith WB, Pharmacokinetics of telbivudine in subjects with various degrees pf renal impairment. Antimicrob Agents Chemother 2007;51:4231-5
   PubMed Web of Science ®Google Scholar
• Zhou XJ, Marbury TC, Alcorn HW, Pharmacokinetics of telbivudine in subjects with various degrees of hepatic impairments. Antimicrob Agents Chemother 2006;50:1721-6
   PubMed Web of Science ®Google Scholar
• Lai C, Lim S, Brown N, A dose-finding study of once-daily oral telbivudine in HBeAg-positive patients with chronic hepatitis B virus infection. Hepatology 2004;40:719-26
   PubMed Web of Science ®Google Scholar
• Lai CL, Leung N, Teo EK, A 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis B. Gastroenterology 2005;129:528-36
   PubMed Web of Science ®Google Scholar
• Lai CL, Gane E, Liaw YF, Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med 2007;357:2576-88
   PubMed Web of Science ®Google Scholar
• Liaw YF, Gane E, Leung N, 2-Year GLOBE trial results: telbivudine Is superior to lamivudine in patients with chronic hepatitis B. Gastroenterology 2009;136(2):486-95
   PubMed Web of Science ®Google Scholar
• Hou J, Yin YK, Xu D, Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: results at 1 year of a randomized, double-blind trial. Hepatology 2008;47:447-54
   PubMed Web of Science ®Google Scholar
• Wang Y, Jia JD, Hou J, A phase III comparative trial of telbivudine vs lamivudine in Chinese patients with chronic hepatitis B: two-year results [abstract]. Gastroenterology 2007;132:1768
   Google Scholar
• Wang Y, Thongsawat S, Gane EJ, Efficacy and Safety Outcomes After 4 Years of Telbivudine Treatment in Patients with Chronic Hepatitis B [abstract]. Hepatology 2009;S4:533A
   Google Scholar
• Chan HL, Heathcote EJ, Marcellin P, Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial. Ann Intern Med 2007;147:745-54
   PubMed Web of Science ®Google Scholar
• Suh DJ, Um SH, Herrmann E, 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;54:1242-7
   PubMed Web of Science ®Google Scholar
• Liang J, Han T, Xiao SX, Telbivudine treatment on cirrhosis resulting from chronic hepatitis B. Chin J Hepatol 2009;17:24-7
   PubMedGoogle Scholar
• Gane EJ, Chan HL, Choudhuri G, Treatment of decompensated HBV-Cirrhosis: results from 2-years randomized trial with telbivudine or lamivudine [abstract] J Hepatol 2010;52:S4
   Web of Science ®Google Scholar
• Zoulim F, Locarnini S. Hepatitis B virus Resistance to nucleos(t)ide analogues. Gastroenterology 2009;137:1593-608
   PubMed Web of Science ®Google Scholar
• Lai CL, Dienstag J, Schiff E, Prevalence and clinical correlates of YMDD variants during lamivudine therapy for patients with chronic hepatitis B. Clin Infect Dis 2003;36:687-96
   PubMed Web of Science ®Google Scholar
• Seifer M, Patty A, Serra I, 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):147-55
   PubMed Web of Science ®Google Scholar
• Colonno R, Rose RE, Pokornowski K, Four year assessment of ETV resistance in nucleoside-naive and lamivudine refractory patients. J Hepatol 2007;46(Suppl 1):S294
   Google Scholar
• Yuen MF, Sablon E, Hui CK, Factors associated with hepatitis B virus DNA breakthrough in patients receiving prolonged lamivudine therapy. Hepatology 2001;34:785-91
   PubMed Web of Science ®Google Scholar
• Locarnini S, Qi S, Arterburn S, 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
   Web of Science ®Google Scholar
• Farci P, Marcellin P, Lu ZM, 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
   Web of Science ®Google Scholar
• Zeuzem S, Gane E, Liaw YF, 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
   PubMed Web of Science ®Google Scholar
• Angus P, Vaughan R, Xiong S, Resistance to adefovir dipivoxil therapy associated with the selection of a novel mutation in the HBV polymerase. Gastroenterology 2003;125:292-7
   PubMed Web of Science ®Google Scholar
• Villet S, Pichoud C, Billioud G, Impact of hepatitis B virus rtA181V/T mutants on hepatitis B treatment failure. J Hepatol 2008;48:747-55
   PubMed Web of Science ®Google Scholar
• Van Bommel F, de Man RA, Wedemeyer H, Long-term efficacy of tenofovir monotherapy for hepatitis B virus-monoinfected patients after failure of nucleoside/nucleotide analogues. Hepatology 2010;51:73-80
   PubMed Web of Science ®Google Scholar
• Angus P, Vaughan R, Xiong S, Resistance to adefovir dipivoxil therapy associated with the selection of a novel mutation in the HBV polymerase. Gastroenterology 2003;125:292-7
   PubMed Web of Science ®Google Scholar
• 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
   Google Scholar
• Marcellin P, Avila C, Wursthorn K, 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
   Google Scholar
• 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
   Google Scholar
• Weaver M, Wolf A, Persohn E, 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
   Google Scholar
• Zhang LJ, Wang L. Blocking intrauterine infection by telbivudine in pregnant chronic hepatitis B patients. Chin J Hepatol 2009;17:561-3
   PubMedGoogle Scholar
• Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology 2007;45:507-39
   PubMed Web of Science ®Google Scholar
• European Association for the Study of the Liver. EASL clinical practice guidelines: Management of chronic hepatitis B. J Hepatol 2009;50:227-42
   PubMed Web of Science ®Google Scholar
• Adani GL, Baccarani U, Risaliti A, Rhabdomyolysis due to lamivudine administration in a liver transplant recipient. Am J Transplant 2005;5:634
   PubMed Web of Science ®Google Scholar
• Fodale V, Mazzeo A, Pratico C, Fatal exacerbation of peripheral neuropathy during lamivudine therapy: evidence for iatrogenic mitochondrial damage. Anaesthesia 2005;60:806-10
   PubMed Web of Science ®Google Scholar
• Bayraekci US, Baskin E, Ozcay F, Renal fanconi syndrome and myopathy after liver transplantation: drug related mitochondrial cytopathy? Pediatr Transplant 2008;12:109-12
   PubMed Web of Science ®Google Scholar
• Cupler EJ, Dalakas MC. Exacerbation of peripheral neuropathy by lamivudine. Lancet 1995;345:460-1
   PubMed Web of Science ®Google Scholar
• Ojetti VA, Gasharrini A, Migneco A, Lamivudine induced muscle mitochondrial toxicity. Dig Liver Dis 2002;34:384-5
   PubMedGoogle Scholar
• Fontana RJ. Management of patients with decompensated HBV cirrhosis. Semin Liver Dis 2003;23:89-100
   PubMed Web of Science ®Google Scholar
• Yeo W, Johnson PJ. Diagnosis, prevention and management of hepatitis B virus reactivation during anticancer therapy. Hepatology 2006;43:209-20
   PubMed Web of Science ®Google Scholar
• Marcellin P, Chang TT, Lim SGL, Long-term efficacy and safety of adefovir dipivoxil for the treatment of hepatitis B e antigen positive chronic hepatitis B. Hepatology 2008;48:750-8
   PubMed Web of Science ®Google Scholar
• Fontana RJ. Side effects of long-term oral antiviral therapy for hepatitis B. Hepatology 2009;49:S185-95
   Web of Science ®Google Scholar
• Lange CM, Bojunga J, Hofmann WP, Severe lactic acidosis during treatment of chronic hepatitis B with entecavir in patients with impaired liver function. Hepatology 2009;50:2001-6
   PubMed Web of Science ®Google Scholar
• Nelson MR, Katlama C, Montaner JS, The safety of tenofovir disoproxil fumarate for the treatment of HIV infection in adults: the first 4 years. AIDS 2007;21:1273-81
   PubMed Web of Science ®Google Scholar
• Verheist D, Monge M, Meynard JL, Fanconi syndrome and renal failure induced by tenofovir: a first case report. Am J Kidney Dis 2002;40:1331-3
   PubMed Web of Science ®Google Scholar
• Izzedine H, Isnard-bagnis C, Hulot JS, Renal safety of tenofovir in HIV treatment-experienced patients. AIDS 2004;18:1074-6
   PubMed Web of Science ®Google Scholar
• Karras A, Lafaurie M, Furco A, Tenofovir-related nephrotoxicity in human immunodeficiency virus-infected patients: three cases of renal failure, fanconi syndrome, and nephrogenic diabetes insipidus. Clin Infect Dis 2003;36:1070-3
   PubMed Web of Science ®Google Scholar
• Lee JC, Marosok RD. Acute tubular necrosis in a patient receiving tenofovir. AIDS 2003;17:2543-4
   PubMed Web of Science ®Google Scholar
• Coca S, Parzella MA. Acute renal failure associated with tenofovir: evidence of drug-induced nephrotoxicity. Am J Med Sci 2002;324:342-4
   PubMed Web of Science ®Google Scholar
• Gallant J, Staszewski ES, Pozniak 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
   PubMed Web of Science ®Google Scholar
• Gafni RL, Hazra R, Reynolds JC, Tenofovir disoproxil fumarate and an optimized background regimen of antiretroviral agents as salvage therapy: impact on bone mineral density in HIV-infected children. Pediatrics 2006;118:e711-18
   PubMed Web of Science ®Google Scholar