Efficacy and safety of prolonged 3-year telbivudine treatment in patients with chronic hepatitis B
Article first published online: 16 MAR 2011
© 2011 John Wiley & Sons A/S
Volume 31, Issue 5, pages 676–684, May 2011
How to Cite
Gane, E. J., Wang, Y., Liaw, Y.-F., Hou, J., Thongsawat, S., Wan, M., Moon, Y. M., Jia, J., Chao, Y. C., Niu, J., Leung, N., Samuel, D., Hsu, C. W., Bao, W., Lopez, P. and Avila, C. (2011), Efficacy and safety of prolonged 3-year telbivudine treatment in patients with chronic hepatitis B. Liver International, 31: 676–684. doi: 10.1111/j.1478-3231.2011.02490.x
- Issue published online: 3 APR 2011
- Article first published online: 16 MAR 2011
- Received 17 May 2010, Accepted 3 February 2011
- ALT normalization;
- GLOBE trial;
- HBeAg seroconversion;
- HBV DNA;
- viral suppression
Background: In the GLOBE trial, telbivudine demonstrated superior efficacy to lamivudine at 2 years in patients with chronic hepatitis B (CHB).
Aims: To investigate the long-term efficacy and safety of telbivudine in the telbivudine-treated cohort from the GLOBE trial.
Methods: Virological and biochemical responses were assessed in 213 HBeAg-positive and 186 HBeAg-negative CHB patients who continued telbivudine treatment for 3 years.
Results: Undetectable hepatitis B virus DNA and HBeAg seroconversions were achieved by 77 and 37% of HBeAg-positive patients respectively. Cumulative HBeAg seroconversion rate was 46%. HBeAg seroconversion was sustained at 52 weeks off therapy in 84% of the patients enrolled in the off-treatment follow-up arm of the study. Undetectable viraemia and normal alanine aminotransferase (ALT) levels at 3 years were achieved by 85 and 83% of HBeAg-negative patients respectively. Genotypic resistance rates for the study population who continued therapy during the third year were 11.3 in HBeAg-positive and 6.5% in HBeAg-negative patients. Patients with undetectable viraemia at treatment week 24 had optimal outcomes at 3 years. In the HBeAg-positive population, cumulative HBeAg seroconversion occurred in 58%. Resistance rates for HBeAg-positive and HBeAg-negative patients were 3.6 and 6.2% respectively. The telbivudine safety profile during prolonged therapy was similar to that in the GLOBE trial.
Conclusions: Three years of telbivudine treatment yielded high rates of viral suppression and ALT normalization with a favourable safety profile. High rates of HBeAg seroconversion were achieved with prolonged telbivudine therapy and were sustained in the majority of patients over 52 weeks off therapy.