메뉴 건너뛰기




Volumn 32, Issue 4, 2010, Pages 649-658

A 24-week, parallel-group, open-label, randomized clinical trial comparing the early antiviral efficacy of telbivudine and entecavir in the treatment of hepatitis B e antigen-positive chronic hepatitis B virus infection in adult Chinese patients

Author keywords

Entecavir; HBeAg; HBV; Hepatitis B; Seroconversion; Telbivudine

Indexed keywords

ALANINE AMINOTRANSFERASE; CREATINE KINASE; ENTECAVIR; HEPATITIS B(E) ANTIGEN; TELBIVUDINE; VIRUS DNA;

EID: 77952484856     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2010.04.001     Document Type: Article
Times cited : (28)

References (32)
  • 1
    • 33847701354 scopus 로고    scopus 로고
    • Chronic hepatitis B
    • Lok AS, McMahon BJ Chronic hepatitis B. Hepatology 2007, 45:507-539.
    • (2007) Hepatology , vol.45 , pp. 507-539
    • Lok, A.S.1    McMahon, B.J.2
  • 2
    • 4644354309 scopus 로고    scopus 로고
    • Hepatitis B vaccines [in English and French]
    • Hepatitis B vaccines [in English and French]. Wkly Epidemiol Rec. 2004, 79:255-263.
    • (2004) Wkly Epidemiol Rec. , vol.79 , pp. 255-263
  • 3
    • 29944436855 scopus 로고    scopus 로고
    • Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level
    • for the REVEAL-HBV Study Group
    • 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. for the REVEAL-HBV Study Group.
    • (2006) JAMA , vol.295 , pp. 65-73
    • Chen, C.J.1    Yang, H.I.2    Su, J.3
  • 4
    • 33644858331 scopus 로고    scopus 로고
    • Predicting cirrhosis risk based on the level of circulating hepatitis B viral load
    • for the Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer-In HBV (the REVEAL-HBV) Study Group
    • Iloeje UH, Yang HI, Su J, et al. Predicting cirrhosis risk based on the level of circulating hepatitis B viral load. Gastroenterology 2006, 130:678-686. for the Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer-In HBV (the REVEAL-HBV) Study Group.
    • (2006) Gastroenterology , vol.130 , pp. 678-686
    • Iloeje, U.H.1    Yang, H.I.2    Su, J.3
  • 5
    • 19544391413 scopus 로고    scopus 로고
    • Lamivudine for patients with chronic hepatitis and advanced liver disease
    • for the Cirrhosis Asian Lamivudine Multicentre Study Group
    • Liaw YF, Sung JJ, Chow WC, et al. Lamivudine for patients with chronic hepatitis and advanced liver disease. N Engl J Med 2004, 351:1521-1531. for the Cirrhosis Asian Lamivudine Multicentre Study Group.
    • (2004) N Engl J Med , vol.351 , pp. 1521-1531
    • Liaw, Y.F.1    Sung, J.J.2    Chow, W.C.3
  • 6
    • 38049087457 scopus 로고    scopus 로고
    • Long-term lamivudine therapy reduces the risk of long-term complications of chronic hepatitis B infection even in patients without advanced disease
    • Yuen MF, Seto WK, Chow DH, et al. Long-term lamivudine therapy reduces the risk of long-term complications of chronic hepatitis B infection even in patients without advanced disease. Antivir Ther 2007, 12:1295-1303.
    • (2007) Antivir Ther , vol.12 , pp. 1295-1303
    • Yuen, M.F.1    Seto, W.K.2    Chow, D.H.3
  • 7
    • 33745793641 scopus 로고    scopus 로고
    • The clinical impact of early detection of the YMDD mutant on the outcomes of long-term lamivudine therapy in patients with chronic hepatitis B
    • Paik YH, Han KH, Hong SP, et al. The clinical impact of early detection of the YMDD mutant on the outcomes of long-term lamivudine therapy in patients with chronic hepatitis B. Antivir Ther 2006, 11:447-455.
    • (2006) Antivir Ther , vol.11 , pp. 447-455
    • Paik, Y.H.1    Han, K.H.2    Hong, S.P.3
  • 8
    • 33749170143 scopus 로고    scopus 로고
    • Resistance to adefovir dipivoxil in lamivudine resistant chronic hepatitis B patients treated with adefovir dipivoxil
    • Yeon JE, Yoo W, Hong SP, et al. Resistance to adefovir dipivoxil in lamivudine resistant chronic hepatitis B patients treated with adefovir dipivoxil. Gut 2006, 55:1488-1495.
    • (2006) Gut , vol.55 , pp. 1488-1495
    • Yeon, J.E.1    Yoo, W.2    Hong, S.P.3
  • 9
    • 33847683844 scopus 로고    scopus 로고
    • Two-year assessment of entecavir resistance in lamivudine-refractory hepatitis B virus patients reveals different clinical outcomes depending on the resistance substitutions present
    • 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, 51:902-911.
    • (2007) Antimicrob Agents Chemother , vol.51 , pp. 902-911
    • Tenney, D.J.1    Rose, R.E.2    Baldick, C.J.3
  • 10
    • 69549138465 scopus 로고    scopus 로고
    • Entecavir monotherapy for lamivudine-refractory chronic hepatitis B
    • Goulis I, Dalekos GN Entecavir monotherapy for lamivudine-refractory chronic hepatitis B. Expert Rev Anti Infect Ther 2008, 6:855-859.
    • (2008) Expert Rev Anti Infect Ther , vol.6 , pp. 855-859
    • Goulis, I.1    Dalekos, G.N.2
  • 11
    • 42649142940 scopus 로고    scopus 로고
    • Initial viral response is the most powerful predictor of the emergence of YMDD mutant virus in chronic hepatitis B patients treated with lamivudine
    • Kurashige N, Hiramatsu N, Ohkawa K, et al. Initial viral response is the most powerful predictor of the emergence of YMDD mutant virus in chronic hepatitis B patients treated with lamivudine. Hepatol Res 2008, 38:450-456.
    • (2008) Hepatol Res , vol.38 , pp. 450-456
    • Kurashige, N.1    Hiramatsu, N.2    Ohkawa, K.3
  • 12
    • 50649112802 scopus 로고    scopus 로고
    • Treatment predictors of a sustained virologic response in hepatitis B and C
    • Kau A, Vermehren J, Sarrazin C Treatment predictors of a sustained virologic response in hepatitis B and C. J Hepatol 2008, 49:634-651.
    • (2008) J Hepatol , vol.49 , pp. 634-651
    • Kau, A.1    Vermehren, J.2    Sarrazin, C.3
  • 13
    • 60349129272 scopus 로고    scopus 로고
    • Chronic hepatitis B: Early viral suppression and long-term outcomes of therapy with oral nucleos(t)ides
    • Nguyen MH, Keeffe EB Chronic hepatitis B: Early viral suppression and long-term outcomes of therapy with oral nucleos(t)ides. J Viral Hepat 2009, 16:149-155.
    • (2009) J Viral Hepat , vol.16 , pp. 149-155
    • Nguyen, M.H.1    Keeffe, E.B.2
  • 14
    • 33644818518 scopus 로고    scopus 로고
    • A comparison of entecavir and lamivudine for HBeAG-positive chronic hepatitis B
    • for the BEHoLD AI463022 Study Group
    • 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. for the BEHoLD AI463022 Study Group.
    • (2006) N Engl J Med , vol.354 , pp. 1001-1010
    • Chang, T.T.1    Gish, R.G.2    de Man, R.3
  • 15
    • 33644822860 scopus 로고    scopus 로고
    • Entecavir versus lamivudine for patients with HBeAG-negative chronic hepatitis B [published correction appears in N Engl J Med. 2006;354:1863]
    • for the BEHoLD AI463027 Study Group
    • Lai CL, Shouval D, Lok AS, et al. Entecavir versus lamivudine for patients with HBeAG-negative chronic hepatitis B [published correction appears in N Engl J Med. 2006;354:1863]. N Engl J Med 2006, 354:1011-1020. for the BEHoLD AI463027 Study Group.
    • (2006) N Engl J Med , vol.354 , pp. 1011-1020
    • Lai, C.L.1    Shouval, D.2    Lok, A.S.3
  • 16
    • 38449093445 scopus 로고    scopus 로고
    • Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: A randomized trial
    • for the 018 Study Group
    • 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. for the 018 Study Group.
    • (2007) Ann Intern Med , vol.147 , pp. 745-754
    • Chan, H.L.1    Heathcote, E.J.2    Marcellin, P.3
  • 17
    • 38049046538 scopus 로고    scopus 로고
    • Telbivudine for the management of chronic hepatitis B virus infection
    • Matthews SJ Telbivudine for the management of chronic hepatitis B virus infection. Clin Ther 2007, 29:2635-2653.
    • (2007) Clin Ther , vol.29 , pp. 2635-2653
    • Matthews, S.J.1
  • 18
    • 58749111068 scopus 로고    scopus 로고
    • Antiviral therapy for adults with chronic hepatitis B: A systematic review for a National Institutes of Health Consensus Development Conference
    • Shamliyan TA, MacDonald R, Shaukat A, et al. Antiviral therapy for adults with chronic hepatitis B: A systematic review for a National Institutes of Health Consensus Development Conference. Ann Intern Med 2009, 150:111-124.
    • (2009) Ann Intern Med , vol.150 , pp. 111-124
    • Shamliyan, T.A.1    MacDonald, R.2    Shaukat, A.3
  • 19
    • 58949087420 scopus 로고    scopus 로고
    • 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
    • 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.
    • (2009) Hepatology , vol.49 , pp. 72-79
    • Leung, N.1    Peng, C.Y.2    Hann, H.W.3
  • 20
    • 58149496652 scopus 로고    scopus 로고
    • Virodynamic predictors of response to pegylated interferon and lamivudine combination treatment of hepatitis B e antigen-positive chronic hepatitis B
    • Mihm U, Chan HL, Zeuzem S, et al. Virodynamic predictors of response to pegylated interferon and lamivudine combination treatment of hepatitis B e antigen-positive chronic hepatitis B. Antivir Ther 2008, 13:1029-1037.
    • (2008) Antivir Ther , vol.13 , pp. 1029-1037
    • Mihm, U.1    Chan, H.L.2    Zeuzem, S.3
  • 21
    • 0035857966 scopus 로고    scopus 로고
    • The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomised trials
    • Moher D, Schulz KF, Altman DG The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001, 357:1191-1194.
    • (2001) Lancet , vol.357 , pp. 1191-1194
    • Moher, D.1    Schulz, K.F.2    Altman, D.G.3
  • 22
    • 0015429924 scopus 로고
    • Standardization of clinical enzyme assays: A reference method for aspartate and alanine transaminases
    • Wilkinson JH, Baron DN, Moss DW, et al. Standardization of clinical enzyme assays: A reference method for aspartate and alanine transaminases. J Clin Pathol 1972, 25:940-944.
    • (1972) J Clin Pathol , vol.25 , pp. 940-944
    • Wilkinson, J.H.1    Baron, D.N.2    Moss, D.W.3
  • 23
    • 37349120537 scopus 로고    scopus 로고
    • Telbivudine versus lamivudine in patients with chronic hepatitis B
    • for the Globe Study Group
    • 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. for the Globe Study Group.
    • (2007) N Engl J Med , vol.357 , pp. 2576-2588
    • Lai, C.L.1    Gane, E.2    Liaw, Y.F.3
  • 24
    • 0037407912 scopus 로고    scopus 로고
    • Eng J. Sample size estimation: How many individuals should be studied?
    • Eng J. Sample size estimation: How many individuals should be studied?. Radiology 2003, 227:309-313.
    • (2003) Radiology , vol.227 , pp. 309-313
  • 25
    • 66749108101 scopus 로고    scopus 로고
    • The intention to treat principle, and the potential impact of excluding data from the analysis of clinical trial data
    • author reply 1205-1206
    • Sempos CT, Picciano MF The intention to treat principle, and the potential impact of excluding data from the analysis of clinical trial data. J Nutr. 2009, 139:1204. author reply 1205-1206.
    • (2009) J Nutr. , vol.139 , pp. 1204
    • Sempos, C.T.1    Picciano, M.F.2
  • 26
    • 34547148385 scopus 로고    scopus 로고
    • Report of an international workshop: Roadmap for management of patients receiving oral therapy for chronic hepatitis B
    • Keeffe EB, Zeuzem S, Koff RS, et al. Report of an international workshop: Roadmap for management of patients receiving oral therapy for chronic hepatitis B. Clin Gastroenterol Hepatol 2007, 5:890-897.
    • (2007) Clin Gastroenterol Hepatol , vol.5 , pp. 890-897
    • Keeffe, E.B.1    Zeuzem, S.2    Koff, R.S.3
  • 27
    • 39549113880 scopus 로고    scopus 로고
    • Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: Results at 1 year of a randomized, double-blind trial
    • 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.
    • (2008) Hepatology , vol.47 , pp. 447-454
    • Hou, J.1    Yin, Y.K.2    Xu, D.3
  • 28
    • 41649093427 scopus 로고    scopus 로고
    • Telbivudine versus lamivudine in patients with chronic hepatitis B
    • author reply 1517-1518
    • Tillmann HL, McHutchison JG Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med 2008, 358:1517. author reply 1517-1518.
    • (2008) N Engl J Med , vol.358 , pp. 1517
    • Tillmann, H.L.1    McHutchison, J.G.2
  • 29
    • 34250612285 scopus 로고    scopus 로고
    • A double-blind, double-dummy, randomized, controlled study of entecavir versus lamivudine for treatment of chronic hepatitis B [in Chinese]
    • Yao GB, Zhu M, Wang YM, et al. A double-blind, double-dummy, randomized, controlled study of entecavir versus lamivudine for treatment of chronic hepatitis B [in Chinese]. Zhonghua Nei Ke Za Zhi 2006, 45:891-895.
    • (2006) Zhonghua Nei Ke Za Zhi , vol.45 , pp. 891-895
    • Yao, G.B.1    Zhu, M.2    Wang, Y.M.3
  • 30
    • 34547841575 scopus 로고    scopus 로고
    • Entecavir is a potent anti-HBV drug superior to lamivudine: Experience from clinical trials in China
    • Yao G Entecavir is a potent anti-HBV drug superior to lamivudine: Experience from clinical trials in China. J Antimicrob Chemother 2007, 60:201-205.
    • (2007) J Antimicrob Chemother , vol.60 , pp. 201-205
    • Yao, G.1
  • 31
    • 33847667158 scopus 로고    scopus 로고
    • Telbivudine GLOBE trial: Maximal early HBV suppression is predictive of optimal two-year efficacy in nucleoside treated hepatitis B patients
    • DiBisceglie AM, Lai CL, Gane E, et al. Telbivudine GLOBE trial: Maximal early HBV suppression is predictive of optimal two-year efficacy in nucleoside treated hepatitis B patients. Hepatology 2006, 44(Suppl 1):230A.
    • (2006) Hepatology , vol.44 , Issue.SUPPL. 1
    • DiBisceglie, A.M.1    Lai, C.L.2    Gane, E.3
  • 32
    • 61849132825 scopus 로고    scopus 로고
    • On-treatment outcome prediction and adjustment during chronic hepatitis B therapy: Now and future
    • Liaw YF On-treatment outcome prediction and adjustment during chronic hepatitis B therapy: Now and future. Antivir Ther 2009, 14:13-22.
    • (2009) Antivir Ther , vol.14 , pp. 13-22
    • Liaw, Y.F.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.