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<http://onlinelibrary.wiley.com/doi/10.1111/j.1478-3231.2011.02490.x/abstract>
Efficacy and safety of prolonged 3-year telbivudine treatment in patients
with chronic hepatitis B
Edward J. Gane1, Yuming Wang2, Yun-Fan Liaw3, JinLin Hou4, Satawat
Thongsawat5, MoBin Wan6, Young M. Moon7, JiDong Jia8, You C. Chao9, Junqi
Niu10, Nancy Leung11, Didier Samuel12, Chao Wei Hsu13, Weibin Bao14,
Patricia Lopez15, Claudio Avila15
Article first published online: 16 MAR 2011
DOI: 10.1111/j.1478-3231.2011.02490.x
© 2011 John Wiley & Sons A/S
Issue
Liver International
Volume 31, Issue 5, pages 676–684, May 2011
Abstract
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. |
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