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Efficacy and safety of entecavir compared to lamivudine in nucleoside-naïve patients with chronic hepatitis B: a randomized double-blind trial in China

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An Erratum to this article was published on 12 January 2008

Abstract

Background/Aims

Chronic hepatitis B has a high prevalence (>8%) in China. We compared the safety and efficacy of entecavir with that of lamivudine for the treatment of patients with chronic hepatitis B in China.

Methods

A total of 519 nucleoside-naive Chinese patients with chronic hepatitis B were randomized (1:1) and treated with entecavir 0.5 mg/d or lamivudine 100 mg/d. The primary endpoint was serum HBV DNA <0.7 MEq/ml by bDNA assay and alanine aminotransferase <1.25 × upper limit of normal (ULN) at week 48. Patients with missing week 48 measurements were considered non-responders.

Results

About 90% (231/258) of entecavir-treated versus 67% (174/261) of lamivudine-treated patients achieved the primary endpoint (P < 0.0001). The mean reduction from baseline in HBV DNA was greater with entecavir than lamivudine (5.90 vs. 4.33 log10 copies/ml, P < 0.0001). Greater proportions of entecavir-treated patients achieved undetectable HBV DNA (<300 copies/ml) by polymerase chain reaction assay (76% vs. 43%, P < 0.0001) and alanine aminotransferase normalization (≤1 × ULN, 90% vs. 78%, P = 0.0003). Entecavir and lamivudine achieved comparable rates of HBeAg seroconversion (15% and 18%, respectively). Safety was comparable between the two treatments.

Conclusions

For nucleoside-naïve Chinese patients with chronic hepatitis B, entecavir achieves superior virological and biochemical benefit over lamivudine, with a comparable safety profile.

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Abbreviations

ALT:

alanine aminotransferase

bDNA:

branched-chain DNA

HBeAg:

hepatitis B e antigen

HBV:

hepatitis B virus

PCR:

polymerase chain reaction

ULN:

upper limit of normal

References

  1. Hepatitis B Foundation [Web site]. Available at: http://www.hepb.org/02-0360.hepb. Accessed January 19, 2005.

  2. Sun Z, Ming L, Zhu X, Lu J. Prevention and control of hepatitis B in China. J Med Virol 2002;67:447–50.

    Article  PubMed  Google Scholar 

  3. Lee WM. Hepatitis B virus infection. N Engl J Med 1997;337:1733–45.

    Article  PubMed  CAS  Google Scholar 

  4. Liaw YF, Sung JJY, Chow WC, Farrell G, Lee CZ, Yuen H, et al. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med 2004;351:1521–31.

    Article  PubMed  CAS  Google Scholar 

  5. Lai CL, Dienstag J, Schiff E, Leung NWY, Atkins M, Hunt C, et al. Prevalence and clinical correlates of YMDD variants during lamivudine therapy for patients with chronic hepatitis B. Clin Infect Dis 2003;36:687–96.

    Article  PubMed  CAS  Google Scholar 

  6. Colonno RJ, Genovesi EV, Medina I, Lamb L, Durham SK, Huang ML, 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.

    Article  PubMed  CAS  Google Scholar 

  7. Innaimo SF, Seifer M, Bisacchi GS, Standring DN, Zahler R, Colonno RJ. Identification of BMS-200475 as a potent and selective inhibitor of hepatitis B virus. Antimicrob Agents Chemother 1997;41:1444–8.

    PubMed  CAS  Google Scholar 

  8. Lai C-L, Rosmawati M, Lao J, Van Vlierberghe H, Anderson FH, Thomas N, 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.

    Article  PubMed  CAS  Google Scholar 

  9. Yao GB, Xu DZ, Wang BE, Zhou X-Q, Lei B-J, Zhang DF, et al. A phase II study in China of the safety and antiviral activity of entecavir in adults with chronic hepatitis B infection. Hepatology 2003;38(suppl 1):711A.

    Article  Google Scholar 

  10. Chang T-T, Gish RG, de Man R, Gadano A, Sollano J, Chao Y-C, et al. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006;354:1001–10.

    Article  PubMed  CAS  Google Scholar 

  11. Lai C-L, Shouval D, Lok AS, Chang T-T, Cheinquer H, Goodman Z, et al. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2006;354:1011–20.

    Article  PubMed  CAS  Google Scholar 

  12. Lok ASF, McMohan BJ. Chronic hepatitis B. Hepatology 2007;45:507–39.

    Article  PubMed  CAS  Google Scholar 

  13. Iloeje UH, Yang H-I, Su J, Jen C-L, You S-L, Chen C-J. Predicting cirrhosis risk based upon the level of circulating hepatitis B viral load. Gastroenterology 2006;130:678–86.

    Article  PubMed  Google Scholar 

  14. Chen C-J, Yang H-I, Su J, Jen C-L, You S-L, Lu S-N, et al. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA 2006;295:65–73.

    Article  PubMed  CAS  Google Scholar 

  15. Liaw YF, Leung N, Guan R, Lau GKK, Merican I, McCaughan G, et al. Asian-Pacific consensus statement on the management of chronic hepatiitis B: a 2005 update. Liver Int 2005;25:472–89.

    Article  PubMed  Google Scholar 

  16. Keeffe EB, Dieterich DT, Han S-HB, Jacobson IM, Martin P, Schiff ER, et al. A treatment algorithm for the management of chronic hepatitis B virus infection in the United States: an update. Clin Gastroenterol Hepatol 2006;8:936–62.

    Article  Google Scholar 

  17. Marcellin P, Chang T-T, Lim SG, Tong MJ, Sievert W, Shiffman ML, et al. Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. N Engl J Med 2003;348:808–16.

    Article  PubMed  CAS  Google Scholar 

  18. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, Chang T-T, Kitis G, Rizzetto M, et al. Adefovir dipivoxil for the treatment of hepatitis B e antigen-negative chronic hepatitis B. N Engl J Med 2003;348:800–7.

    Article  PubMed  CAS  Google Scholar 

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Author information

Authors and Affiliations

  1. Shanghai Jing An Qu Central Hospital, No. 259 Xikang Rd, Shanghai, 200040, China

    Guangbi Yao

  2. Shanghai Liver Disease Center of Nangjing Military Command, Shanghai, China

    Chengwei Chen

  3. No. 3 Hospital Affiliated to Sun Yat-Sen University, Guangzhou, China

    Weilun Lu

  4. No. 2 Hospital Affiliated to Chongqing Medical University, Chongqing, China

    Hong Ren

  5. Infectious Disease Department of Xiang Ya Hospital, Changsha, China

    Deming Tan

  6. Xinan Hospital, Chongqing, China

    Yuming Wang

  7. Beijing Di Tan Hospital, Beijing, China

    Daozheng Xu

  8. Shanghai Roche Pharmaceutical Company, Shanghai, China

    Zhengrong Jiang

  9. Bristol-Myers Squibb Company, Pharmaceutical Research Institution, Braine-l’Alleud, Belgium

    Jessica Liu

  10. Bristol-Myers Squibb Company, Wallingford, CT, USA

    Dong Xu & Laurie MacDonald

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  1. Guangbi Yao
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  2. Chengwei Chen
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  3. Weilun Lu
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  4. Hong Ren
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  5. Deming Tan
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  6. Yuming Wang
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  7. Daozheng Xu
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  8. Zhengrong Jiang
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  9. Jessica Liu
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  10. Dong Xu
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  11. Laurie MacDonald
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for the AI463023 Study Group

Corresponding author

Correspondence to Guangbi Yao.

Additional information

Other members of the study group

In addition to the authors, the AI463023 Study Group included the following investigators: Shuqing Cai, Weixiong Chen, Yagang Chen, Jinlin Hou, Darong Hu, Yanyan Ji, Jidong Jia, Lin Lin, Aimin Sun, Deying Tian, Mobin Wan, Qinhuan Wang, Lai Wei, Weimin Xu, Youkuan Yin, Minde Zeng, Lingxia Zhang, Shuncai Zhang, Xiaqiu Zhou, Limin Zhu.

An erratum to this article is available at http://dx.doi.org/10.1007/s12072-007-9043-0.

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Yao, G., Chen, C., Lu, W. et al. Efficacy and safety of entecavir compared to lamivudine in nucleoside-naïve patients with chronic hepatitis B: a randomized double-blind trial in China. Hepatol Int 1, 365–372 (2007). https://doi.org/10.1007/s12072-007-9009-2

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  • DOI: https://doi.org/10.1007/s12072-007-9009-2

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