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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 Avila15Article first published online: 16 MAR 2011
DOI: 10.1111/j.1478-3231.2011.02490.x
© 2011 John Wiley & Sons A/S
Issue
Liver International
Early View (Articles online in advance of print)
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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