Entecavir: a step forward in combating hepatitis B disease

Bibliography

• Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology 2007;45:507-39
   PubMed Web of Science ®Google Scholar
• Lee WM. Hepatitis B virus infection. N Engl J Med 1997;337:1733-45
   PubMed Web of Science ®Google Scholar
• Ganem D, Prince AM. Hepatitis B virus infection – natural history and clinical consequences. N Engl J Med 2004;350:1118-29
   PubMed Web of Science ®Google Scholar
• Alter MJ. Epidemiology and prevention of hepatitis B. Semin Liver Dis 2003;23:39-46
   PubMed Web of Science ®Google Scholar
• Lok AS. Prevention of hepatitis B virus-related hepatocellular carcinoma. Gastroenterology 2004;127:S303-9
   PubMed Web of Science ®Google Scholar
• Alter MJ. Epidemiology and prevention of hepatitis B. Semin Liver Dis 2003;23:39-46
   PubMed Web of Science ®Google Scholar
• Banatvala J, Van Damme P, Emiroglu N. Hepatitis B immunisation in Britain: time to change? BMJ 2006;332:804-5
   PubMedGoogle Scholar
• Ni YH, Chang MH, Huang LM, et al. Hepatitis B virus infection in children and adolescants in a hyperendemic area: 15 years after mass hepatitis B vaccination. Ann Intern Med 2001;135:796-800
   PubMed Web of Science ®Google Scholar
• Chang MH, Chen CJ, Lai MS, et al. Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. Taiwan Childhood Study Group. N Engl J Med 1997;336:1855-9
   PubMed Web of Science ®Google Scholar
• de Franchis R, Meucci G, Vecchi M, et al. The natural history of asymptomatic hepatitis B surface antigen carriers. Ann Intern Med 1993;118:191-4
   PubMed Web of Science ®Google Scholar
• Manno M, Camma C, Schepis F, et al. Natural history of chronic HBV carriers in northern Italy: morbidity and mortality after 30 years. Gastroenterology 2004;127:756-63
   PubMed Web of Science ®Google Scholar
• Lok AS. Navigating the maze of hepatitis B treatments. Gastroenterology 2007;132:1586-94
   PubMed Web of Science ®Google Scholar
• Hoofnagle JH, Doo E, Liang TJ, et al. Management of hepatitis B: summary of a clinical research workshop. Hepatology 2007;45:1056-75
   PubMed Web of Science ®Google Scholar
• Iloeje UH, Yang HI, Su J, et al. Predicting liver cirrhosis risk based on the level of circulating hepatitis B viral load. Gastroenterology 2006;130:676-86
   Google Scholar
• Yu MW, Yeh SH, Chen PJ, et al. Hepatitis B virus genotype and DNA level and hepatocellular carcinoma: a prospective study in men. J Natl Cancer Inst 2005;97:265-72
   PubMed Web of Science ®Google Scholar
• Chen CJ, Yang HI, Su J, et al. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA 2006;295:65-73
   PubMed Web of Science ®Google Scholar
• Liaw YF, Sung JJY, Chow DHF, et al. 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
• 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;131:1743-51
   PubMed Web of Science ®Google Scholar
• Lau GKK, Piratvisuth T, Luo KX, et al. Peginterferon alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. NEJM 2005;352:2682-95
   PubMed Web of Science ®Google Scholar
• Marcellin P, Lau GKK, Bonino F, et al. Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. NEJM 2004;351:1206-17
   PubMed Web of Science ®Google Scholar
• Locarnini S, Hatzakis A, Heathcote J, et al. Management of antiviral resistance in patients with chronic hepatitis B. Antivir Ther 2004;9:679-93
   PubMed Web of Science ®Google Scholar
• Heathcote J, George J, Gordon S, et al. Tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B: week 72 data and week 24 adefovir dipivoxil switch data [abstract]. J Hepatol 2008;48(Suppl 2):S32
   Web of Science ®Google Scholar
• Tyzeka (package insert). Novartis Pharma Stein AG, Stein, Switzerland, November 2007. Available from: www.pharma.us.novartis.com/product/pi/pdf/tyzeka.pdf
   Google Scholar
• EMEA public statement, London, 14 February 2008 EMEA/60439/2008
   Google Scholar
• Marcellin P, Chang TT, Lim SG, et al. Long-term efficacy and safety of adefovir dipivoxil for the treatment of HBeAg-positive chronic hepatitis B patients [abstract]. Hepatology 2006;44(Suppl 1:)548A
   Google Scholar
• Szczech LA. Tenofovir nephrotoxicity: focusing research questions and putting them into clinical context. J Infect Dis 2008;197:7-9
   Google Scholar
• Slusarchyk WA, Field AK, Greytok JA, et al. 4-Hydroxy-3-(hydoxymethyl)-2-methylenecyclopentyl purines and pyrimidines, a new class of anti-herpesvirus agents. Antiviral Res 1992;17(Suppl 1):98
   Google Scholar
• Innaimo SF, Seifer M, Bisacchi GS, et al. Identification of BMS-200475 as a potent and selective inhibitor of hepatitis B virus. Antimicrob Agents Chemother 1997;41:1444-8
   PubMed Web of Science ®Google Scholar
• Bisachhi GS, Chao ST, Bachard C, et al. BMS-200475, a novel carbocyclic 2′-deoxyguanosine analog with potent and selective anti hepatitis B virus activity in vitro Bioorg Med Chem Lett 1997;7:127-32
   Web of Science ®Google Scholar
• Seeger C, Summers J, Mason WS. Viral DNA synthesis. Curr Top Microbiol Immunol 1991;168:41-59
   PubMed Web of Science ®Google Scholar
• Seifer M, Hamatake RK, Colonno RJ, Standring DN. In vitro inhibition of hepadnavirus polymerase by the triphosphates of BMS-200475 and lobucavir. Antimicrob Agents Chemother 1998;42:3200-8
   PubMed Web of Science ®Google Scholar
• Marion PL, Salazar FH, Winters MA, Colonno RJ. Potent efficacy of entecavir (BMS-200475) in a duck model of hepatitis B virus replication. Antimicrob Agents Chemother 2002;46:82-8
   PubMed Web of Science ®Google Scholar
• Yamanaka G, Wilson T, Innaimo S, et al. Metabolic studies on BMS-200475, a new antiviral compound active against hepatitis B virus. Antimicrob Agents Chemother 1999;43:190-3
   PubMed Web of Science ®Google Scholar
• Langley DR, Walsh AW, Baldick CJ, et al. Inhibition of hepatitis B virus polymerase by entecavir. J Virol 2007;81:3992-4001
   PubMed Web of Science ®Google Scholar
• Genovesi EV, Lamb L, Medina I, et al. Efficacy of the carbocyclic 2′-deoxyguanosine nucleoside BMS-200475 in the woodchuck model of hepatitis B virus infection. Antimicrob Agents Chemother 1998;42:3209-17
   PubMed Web of Science ®Google Scholar
• Colonno RJ, Genovesi EV, Medina I, et al. Long-term entecavir treatment results in sustained antiviral efficacy and prolonged life span in the woodchuck model of chronic hepatitis infection. J Infect Dis 2001;184:1236-45
   PubMed Web of Science ®Google Scholar
• Wolters LMM, Hansen B, Niesters HGM, et al. Viral dynamics during and after entecavir therapy in patients with chronic hepatitis B. J Hepatol 2002;37:137-44
   PubMed Web of Science ®Google Scholar
• Leung N, Sherman M, Peng CY, et al. Entecavir results in higher HBV DNA reductions vs. adefovir in chronically infected HBeAg(+) antiviral-naïve adults: 48 weeks results [abstract]. Gastroenterology 2007;132:A764
   Google Scholar
• Yan JH, Bifano M, Olsen S, et al. Entecavir pharmacokinetics, safety and tolerability after multiple ascending doses in healthy subjects. J Clin Pharmacol 2006;46:1250-8
   PubMed Web of Science ®Google Scholar
• Baraclude (package insert). Princeton, NJ: Bristol Myers Squibb, 2008
   Google Scholar
• Bifano M, Yan JH, Xie J, et al. Hepatic impairment does not alter single-dose pharmacokinetics and safety of entecavir [abstract]. Hepatology 2004;40(Suppl 1):663A
   Web of Science ®Google Scholar
• Tenney DJ, Levine SM, Rose RE, et al. Clinical emergence of entecavir-resistant hepatitis virus requires additional substitutions in virus already resistant to lamivudine. Antimicrob Agents Chemother 2004;48:3498-507
   PubMed Web of Science ®Google Scholar
• Tenney DJ, Rose RE, Baldick CJ, et al. Two-year assessment of entecavir resistance in lamivudine-refractory hepatitis B virus patients reveals different clinical outcomes depending on the resistance substitutions present. Antimicrob Agents Chemother 2007;51:902-11
   PubMed Web of Science ®Google Scholar
• Ono SK, Kato N, Shiratori Y, et al. The polymerase L528M mutation cooperates with nucleotide binding-site mutations, increasing hepatitis virus replication and drug resistance. J Clin Invest 2001;107:449-55
   PubMed Web of Science ®Google Scholar
• Levine S, Hernandez G, Yamanaka G, et al. Efficacies of entecavir against lamivudine-resistant hepatitis B virus replication and recombinant polymerases in vitro Antimicrob Agents Chemother 2002;46:2525-32
   PubMed Web of Science ®Google Scholar
• Baldick CJ, Eggers BJ, Fang J, et al. Hepatitis B virus quasispecies susceptibility to entecavir confirms the relationship between genotypic resistance and patient virologic response. J Hepatol 2008;48:895-902
   PubMed Web of Science ®Google Scholar
• Baldick CJ, Tenney DJ, Mazzucco CE, et al. Comprehensive evaluation of hepatitis B virus transcriptase substitutions associated with entecavir resistance. Hepatology 2008;47:1473-82
   PubMed Web of Science ®Google Scholar
• Chang TT, Gish RG, Hadziyannis SJ, et al. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006;354:1001-10
   PubMed Web of Science ®Google Scholar
• Lai CL, Shouval D, Lok AS, et al. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2006;354:1011-20
   PubMed Web of Science ®Google Scholar
• Tenney DJ, Pokorowski KA, Rose RE, et al. Entecavir at five years shows long-term maintenance of high genetic barrier to hepatitis B virus resistance [abstract]. Hepatol Int 2008;2:A88-89
   Google Scholar
• Colonno RJ, Rose R, Baldick CJ, et al. Entecavir resistance is rare in nucleoside naive patients with chronic hepatitis B. Hepatology 2006;44:1656-65
   PubMed Web of Science ®Google Scholar
• Delaney WE 4th, Yang H, Westland CE, et al. The hepatitis B virus polymerase mutation rtV173L is selected during lamivudine therapy and enhances viral replication in vitro J Virol 2003;77:11833-41
   PubMed Web of Science ®Google Scholar
• Melegari M, Bruno S, Wands JR. Properties of hepatitis B virus pre-S1 deletion mutants. Virology 1994;199:292-300
   PubMed Web of Science ®Google Scholar
• Walsh A, Langley D, Rose R, et al. Mechanistic characterization of entecavir resistance in lamivudine resistant hepatitis B virus. Antiviral Res 2006;70:A36
   Google Scholar
• Lattora D, Campbell K, Wolter A, Hurley JM. Enhanced allele-specific PCR discrimination in SNP genotyping using 3′ locked nucleic acid primers. Hum Mutat 2003;22:79-85
   PubMed Web of Science ®Google Scholar
• De Man RA, Wolters LMM, Nevens F, et al. Safety and efficacy of oral entecavir given for 28 days in patients with chronic hepatitis B virus infection. Hepatology 2001;34:578-82
   PubMed Web of Science ®Google Scholar
• Yao GB, Zhang DF, Wang BE, et al. A study of the dosage and efficacy of entecavir for treating hepatitis B virus. Zhonghua Gan Zang Bing Za Zhi 2005;13:484-7
   PubMedGoogle Scholar
• Lai C-L, Rosmawati M, Lao J, et al. Entecavir is superior to lamivudine in reducing hepatitis B virus DNA in patients with chronic hepatitis B infection. Gastroenterology 2002;123:1831-8
   PubMed Web of Science ®Google Scholar
• 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;129:1198-209
   PubMed Web of Science ®Google Scholar
• 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;354:1001-10
   PubMed Web of Science ®Google Scholar
• Yao G, Chen C, Lu W, et al. Efficacy and safety of entecavir compared to lamivudine in nucleoside-naïve Chinese patients with chronic hepatitis B: a randomized double-blind trial in China. Hepatol Int 2007;1:365-72
   PubMed Web of Science ®Google Scholar
• Lai CL, Shouval D, Lok AS, et al. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2006;354:1011-20
   PubMed Web of Science ®Google Scholar
• Sherman M, Yurdaydin C, Sollano J, et al. Entecavir for treatment of lamivudine-refractory, HbeAg-positive chronic hepatitis B. Gastroenterology 2006;130:2039-49
   PubMed Web of Science ®Google Scholar
• Knodell RG, Ishak KG, Black WC, et al. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology 1991;1:431-5
   Google Scholar
• 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;133:1437-44
   PubMed Web of Science ®Google Scholar
• Han S, Chang TT, Chao YC, et al. Four-year entecavir treatment in nucleoside-naïve HBeAg-positive patients: results from studies ETV-022 and -901 [abstract]. Hepatology 2007;46:654A
   Google Scholar
• Takehara T, Hayashi N, Takaguchi K, et al. Efficacy and safety of 3 years treatment with entecavir in Japanese nucleoside-naïve patients with chronic hepatitis B [abstract]. Hepatol Int 2008;2:A97-98
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Tenney DJ, Baldick CJ, Rose RE, et al. Only a subset of HBV substitutions at entecavir resistance residues lead to phenotypic resistance and virologic rebound [abstract]. Hepatology 2006;44:253A
   Web of Science ®Google Scholar
• Yurdaydin C, Idilman R, Çevik E, et al. Adefovir treatment of entecavir resistance in patients with lamivudine-refractory chronic hepatitis B [abstract]. J Hepatol 2008;48(Suppl 2):S255
   PubMed Web of Science ®Google Scholar
• Mazzucco CE, Hamatake RK, Colonno R, Tenney DJ. Entecavir for treatment of hepatitis B virus displays no in vitro mitochondrial toxicity or DNA polymerase gamma inhibition. Antimicrob Agents Chemother 2008;52:598-605
   PubMed Web of Science ®Google Scholar
• McMahon MA, Jilek BL, Brennan TP, et al. The HBV drug entecavir- effects on HIV-1 replication and resistance. N Engl J Med 2007;356:2614-21
   PubMed Web of Science ®Google Scholar
• Jakobsen MR, Arildsen H, Krarup HB, et al. Entecavir therapy induces de novo HIV reverse-transcriptase M184V mutation in an antiretroviral therapy-naïve patient. Clin Infect Dis 2008;46:e88-91
   Google Scholar
• Sung JJ, Lai JY, Zeuzem S, et al. Lamivudine compared with lamivudine and adefovir dipivoxil for the treatment of HBeAg-positive chronic hepatitis B. J Hepatol 2008;48:728-35
   PubMed Web of Science ®Google Scholar
• 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;129:528-36
   PubMed Web of Science ®Google Scholar
• Janssen HL, van Zonnenfeld M, Senturk H, et al. Pegylated interferon alfa 2b alone or in combination with lamivudine for HbeAg-positive chronic hepatitis B patients B: a randomized trial. Lancet 2005;365:123-9
   PubMed Web of Science ®Google Scholar
• Leung NW, Lai CL, Chang TT, et al. Extended lamivudine treatment in patients with chronic hepatitis B enhances hepatitis B e antigen seroconversion rates: results after 3 years of therapy. Hepatology 2001;33:1527-32
   PubMed Web of Science ®Google Scholar
• Marcellin P, Chang TT, Lim SG, et al. Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. N Engl J Med 2003;348:808-16
   PubMed Web of Science ®Google Scholar
• Fried MW, Piratvisuth T, Lau GKK, et al. HbeAg and hepatitis B virus DNA as outcome predictors during therapy with peginterferon alfa-2a for HbeAg-positive chronic hepatitis B. Hepatology 2008;47:428-34
   PubMed Web of Science ®Google Scholar
• Brunetto M, Moriconi F, Cavallone D, et al. Reduction in serum HBsAg level in patients with chronic hepatitis B infected with genotype D induced pegylated interferon alfa-2a alone or in combination with nucleos(t)ide analogs: a long-term single centre cohort study [abstract]. Hepatology 2007;46(Suppl 1):679A
   Google Scholar
• Yim HJ, Hussain M, Liu Y, et al. Evolution of multi-drug resistant hepatitis B virus during sequential therapy. Hepatology 2006;44:703-12
   PubMed Web of Science ®Google Scholar
• Buti M, Elefsiniotis I, Jardi R, et al. Viral genotype and baseline load predict the response to adefovir treatment in lamivudine-resistant chronic hepatitis B patients. J Hepatol 2007;47:366-72
   PubMed Web of Science ®Google Scholar