A Systematic Review of Side Effects of Nucleoside and Nucleotide Drugs Used for Treatment of Chronic Hepatitis B
Tóm tắt
Từ khóa
Tài liệu tham khảo
Kao JH, Chen DS: The natural history of hepatitis B virus infection. In Hepatitis B Virus. Edited by Lai CL, Locarnini S. London: International Medical Press; 2002:161–172.
•• Lok ASF, McMahon BJ: Chronic hepatitis B: update 2009. Hepatology 2009, 50 (3): 1–36. This article presents the most up-to-date American guidelines for the treatment of chronic hepatitis B; these are the national standard of care.
•• European Association for the Study of the Liver: EASL Clinical Practice Guidelines: management of chronic hepatitis B. J Hepatol 2009, 50:227–242. This article presents the most up-to-date European guidelines for the treatment of chronic hepatitis B, which help to put the American Association for the Study of Liver Diseases guidelines into perspective.
•• Fontana RJ: Side effects of long-term oral antiviral therapy for hepatitis B. Hepatology 2009; 49: S185–S195. This article presents the most complete narrative review on the side effects of oral antiviral therapy for hepatitis B.
Birkus G, Hitchcock MJ, Cihlar T: Assessment of mitochondrial toxicity in human cells treated with tenofovir: comparison with other nucleoside reverse transcriptase inhibitors. Antimicrob Agents Chemo 2002;46:716–723.
McKenzie R, Fried MW, Sallie R, et al.: Hepatic failure and lactic acidosis due to fialuridine (FIAU), an investigational nucleoside analog for chronic hepatitis B. N Engl J Med 1995, 333:1099–1105.
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.
Lamivudine [package insert]. Research Triangle Park, NC: Glaxo SmithKline; 2008.
Adefovir [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2008.
Entecavir [package insert]. Princeton, NJ: Bristol-Meyers Squibb; 2009.
Telbivudine [package insert]. Cambridge, MA: Idenix Pharmaceuticals; 2008.
Tenofovir [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2008.
Lai CL, Chien RN, Leung NW, et al.: A one-year trial of lamivudine for chronic hepatitis B. N Engl J Med 1998, 339:61–68.
Benhamou Y, Thibault V, Vig P, et al.: Safety and efficacy of adefovir dipivoxil in patients infected with lamivudine-resistant hepatitis B and HIV-1. J Hepatol 2006, 44:62–67.
Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, et al.: Long-term therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis B for up to 5 years. Gastroenterology 2006, 131:1743–1751.
Schiff E, Ching-Lung L, Hadziyannis S, et al.: Adefovir dipivoxil for wait-listed and post-liver transplantation patients with lamivudine-resistant hepatitis B: final long-term results. Liver Transpl 2007, 13:349–360.
Ha NB, Ha NB, Garcia RT, et al.: Renal dysfunction in chronic hepatitis B patients treated with adefovir dipivoxil. Hepatology 2009, 50: 727–734.
Izzedine H, Hulot JS, Launay-Vacher V, 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.
Lee YS, Dong JS, Young-Suk L, 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.
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.
Zeng M, Mao Y, Yao G, et al.: A double-blind randomized trial of adefovir dipivoxil in chinese subjects with HBeAg-positive chronic hepatitis B. Hepatology 2006, 44: 108–116.
Gish RG, Lok AS, Chang TT, et al.: Entecavir therapy for up to 96 weeks in patients with HBeAg-positive chronic hepatitis B. Gastroenterology 2007, 133: 1437–1444.
Han SB, Chang TT, Chao YC, et al.: Five years of continuous entecavir for nucleoside-naïve HBeAg+ chronic hepatitis B: results from study ETV-901. Hepatology 2008, 48: 705A.
Tenney DJ, Rose RE, Baldick CJ, et al.: Long-term monitoring shows hepatitis B virus resistance to entecavir in nucleoside-naïve patients is rare through 5 years of therapy. Hepatology 2009, 49: 1503–1514.
Tenney DJ, Pokorowski KA, Rose RE, et al.: Entecavir maintains a high genetic barrier to HBV resistance through 6 years in naïve patients. Presented at Digestive Disease Week. Chicago, IL; May 30–June 4, 2009.
Schiff E, Simsek H, Lee WM, et al.: Efficacy and safety of entecavir in patients with chronic hepatitis B and advanced hepatic fibrosis or cirrhosis. Am J Gastroenterol 2008, 103: 2776–2783.
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.
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.
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, 136:486–495.
Zhang XS, Jin R, Zhang SB, et al.: Clinical features of adverse reactions associated with telbivudine. World J Gastroenterol 2008, 14: 3549–3553.
US Food and Drug Administration: Potential signals of serious risks/new safety information identified from the adverse event reporting system (AERS) between January–March 2008. Available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082196.htm . Accessed November 2009.
Leemans WF, Janssen HLA, Niesters HGM, et al.: Switching patients with lamivudine resistant chronic hepatitis B virus from tenofovir to adefovir results in less potent HBV-DNA suppression. J Viral Hepat 2008, 15:108–114.
Marcellin P, Heathcoate EJ, Buti M, et al.: Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med 2008, 359:2442–2455.
Tan LKK, Gilleece Y, Mandalia S: Reduced glomerular filtration rate but sustained virologic response in HIV/hepatitis B co-infected individuals on long-term tenofovir. Journal of Viral Hepatitis 2009, 16: 471–478.
Sung JJY, Lai JK, Zeuzem S, et al.: Lamivudine compared with lamivudine and adefovir dipivoxil for the treatment of HBeAg-positive chronic hepatitis B. J Hepatol 2008: 728–735.
Hannon H, Bagnis CI, Benhamou Y, et al.: The renal tolerance of low-dose adefovir dipivoxil by lamivudine-resistant individuals co-infected with hepatitis B and HIV. Nephrol Dial Transplant, 19: 386–390.
Pellicelli AM, Barbaro G, Francavilla R, et al.: Adefovir and lamivudine in combination compared with adefovir monotherapy in HBeAg-negative adults with chronic hepatitis B virus infection and clinical or virologic resistance to lamivudine: a retrospective, multicenter, nonrandomized, open-label study. Clin Ther 2008, 30:317–323.
Jonas MM, Kelly D, Pollack K, et al.: Safety, efficacy, and pharmacokinetics of adefovir dipivoxil in children and adolescents (age 2 to <18 years) with chronic hepatitis B. Hepatology 2008, 47: 1863–1871.
Chang TT, Gish RG, Hadziyannis SJ, et al.: A dose-ranging study of the efficacy and tolerability of entecavir in lamivudine-refractory chronic hepatitis B patients. Gastroenterology 2005, 129: 1198–1209.
Sherman M, Yurdaydin C, Simsek H, et al.: Entecavir therapy for lamivudine-refractory chronic hepatitis B: improved virologic, biochemical, and serology outcomes through 96 weeks. Hepatology 2008, 48: 99–108.
Suzuki F, Toyoda J, Katano Y, et al.: Efficacy and safety of entecavir in lamivudine-refractory patients with chronic hepatitis B: randomized controlled trial in Japanese patients. J Gastroenterol Hepatol 2008, 23: 1320–1326.
Kobashi H, Takaguchi K, Ikeda H, et al.: Efficacy and safety of entecavir in nucleoside-naïve, chronic hepatitis b patients: phase II clinical study in Japan. J Gastroenterol Hepatol 2009, 24: 255–261.
Leung N, Peng CY, Hann HW, et al.: Early hepatitis B virus DNA reduction in hepatitis B e antigen-positive patients with chronic hepatitis B: a randomized international study of entecavir versus adefovir. Hepatology 2009, 49: 72–79.
Pessoa MG, Gazzard B, Huang AK, et al.: Efficacy and safety of entecavir for chronic HBV in HIV/HBV coinfected patients receiving lamivudine as part of antiretroviral therapy. AIDS 2008, 22: 1779–1787.
Sherman M, Yurdaydin C, Sollano J, et al.: Entecavir for treatment of lamivudine-refractory, HBeAg-positive chronic hepatitis B. Gastroenterology 2006, 130:2039–2049.
Chang TT, Gish RG, Hadziyannis SJ, et al.: A dose-ranging study of the efficacy and tolerability of entecavir in lamivudine-refractory chronic hepatitis B patients. Gastroenterology 2005, 129:1198–1209.
Chang TT, Gish RG, de Man R, et al.: A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006, 354:1001–1010.
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.
Chan HLY, Heathcote J, Marcellin P, et al.: Treatment of hepatitis B e antigen-positive chronic hepatitis with telbivudine or adefovir. Ann Intern Med. 2007, 147: 745–754.
Peters MG, Andersen J, Lynch P, et al.: Randomized controlled study of tenofovir and adefovir in chronic hepatitis B virus and HIV infection: ACTG A5127. Hepatology 2006, 44: 1110–1116.
Bommel FV, Zollner B, Sarrazin C, 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.
