Telbivudine in the treatment of chronic hepatitis B virus infection
- Anna SF Lok, MD
Anna SF Lok, MD
- Professor of Medicine
- University of Michigan Medical School
Telbivudine (L-deoxythymidine [LdT or Tyzeka]) is the unmodified beta-L enantiomer of thymidine. It is approved for the treatment of chronic hepatitis B virus (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 "Hepatitis B virus: Overview of management".)
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 alanine aminotransferase (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 . 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:
- Lai CL, Gane E, Liaw YF, et al. Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med 2007; 357:2576.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Chan HL, Chen YC, Gane EJ, et al. Randomized clinical trial: efficacy and safety of telbivudine and lamivudine in treatment-naïve patients with HBV-related decompensated cirrhosis. J Viral Hepat 2012; 19:732.
- 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.
- 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.
- 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.