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Telbivudine in the treatment of chronic hepatitis B virus infection

INTRODUCTION

Telbivudine (L-deoxythymidine [LdT or Tyzeka]) is the unmodified beta-L enantiomer of thymidine. It is approved for the treatment of chronic HBV in adults with evidence of viral replication and either persistent elevation in serum aminotransferases or histologically active disease.

The treatment of chronic hepatitis B with telbivudine will be reviewed here. A general approach to patients with hepatitis B (including other treatment options) is presented separately. (See "Overview of the management of chronic hepatitis B and case examples".)

HBeAg POSITIVE HBV

The available data suggest that telbivudine is slightly more effective than lamivudine in suppressing HBV DNA in patients who are HBeAg positive but the benefit does not appear to translate into a clinically important advantage for HBeAg seroconversion or histologic improvement.

The largest trial (the 007 GLOBE trial) included 1367 patients who were HBsAg positive, HBeAg positive (n=797) or negative (n=417), had an ALT level >1.3 times the upper limit of normal, had not previously received nucleoside analogues, and had a liver biopsy compatible with chronic viral hepatitis [1]. The mean baseline HBV DNA level was 9.5 log10 copies/mL in those who were HBeAg positive and 7.7 log10 copies/mL in those who were HBeAg negative.

The patients were randomly assigned to telbivudine (600 mg once daily) or lamivudine (100 mg once daily) for up to 104 weeks. The following observations were made in the HBeAg positive group at week 52:
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References Top
  1. Lai, CL, Gane, E, Liaw, YF, et al. Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med 2007; 357:2576.
  2. 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.
  3. DiBisceglie, A, Lai, CL, Gane, E, et al. Telbivudine GLOBE trial: maximal early HBV suppression is predictive of optimal two-year efficacy in nucleoside-treated heaptitis B patients (abstract). Hepatology 2006; 44 (Suppl 1):230A.
  4. Poynard, T, Chutaputti, A, Hwang, SG, et al. Sustained off-treatment HBeAg response in telbivudine and lamivudine treated HBeAg-positive patients from the GLOBE study (abstract). J Hepatol 2007; 46 (Suppl 1):S27.
  5. 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.
  6. Jia, JD, Hou, YL, Yink, YK, et al. Two-year results of a phase III comparative trial of telbivudine vs lamivudine in Chinese patients (abstract). J Hepatol 2007; 46 (Supppl 1): S189.
  7. Zeuzem, S, Gane, E, Liaw, YF, et al. 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.
  8. 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.
  9. Marcellin, P, Chan, HLY, Lai, CL, et al. 76 weeks follow-up of HBeAg-positive chronic hepatitis B patients treated with telbivudine, adefovir or switched from adefovir to telbivudine (abstract). J Hepatol 2007; 46 (Suppl 1):S55.
  10. Gane, E, Lai, CL, Min, A, et al. Adefovir salvage therapy for virologic breakthrough in telbivudine-treated patients from the GLOBE study (abstract). J Hepatol 2007; 46 (Suppl 1):S187.
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