Document Detail


Efficacy and safety of prolonged 3-year telbivudine treatment in patients with chronic hepatitis B.
MedLine Citation:
PMID:  21457439     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Edward J Gane; Yuming Wang; Yun-Fan Liaw; Jinlin Hou; Satawat Thongsawat; MoBin Wan; Young M Moon; JiDong Jia; You C Chao; Junqi Niu; Nancy Leung; Didier Samuel; Chao Wei Hsu; Weibin Bao; Patricia Lopez; Claudio Avila
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Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't     Date:  2011-03-16
Journal Detail:
Title:  Liver international : official journal of the International Association for the Study of the Liver     Volume:  31     ISSN:  1478-3231     ISO Abbreviation:  Liver Int.     Publication Date:  2011 May 
Date Detail:
Created Date:  2011-04-04     Completed Date:  2011-07-19     Revised Date:  2014-07-30    
Medline Journal Info:
Nlm Unique ID:  101160857     Medline TA:  Liver Int     Country:  England    
Other Details:
Languages:  eng     Pagination:  676-84     Citation Subset:  IM    
Copyright Information:
© 2011 John Wiley & Sons A/S.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Alanine Transaminase / blood
Antiviral Agents / administration & dosage*,  adverse effects
Biological Markers / blood
DNA, Viral / blood
Drug Administration Schedule
Drug Resistance, Viral / genetics
Female
Hepatitis B Surface Antigens / blood
Hepatitis B e Antigens / blood
Hepatitis B virus / immunology
Hepatitis B, Chronic / diagnosis,  drug therapy*
Humans
Male
Middle Aged
Nucleosides / administration & dosage*,  adverse effects
Pyrimidinones / administration & dosage*,  adverse effects
Thymidine / analogs & derivatives
Time Factors
Treatment Outcome
Viral Load
Young Adult
Chemical
Reg. No./Substance:
0/Antiviral Agents; 0/Biological Markers; 0/DNA, Viral; 0/Hepatitis B Surface Antigens; 0/Hepatitis B e Antigens; 0/Nucleosides; 0/Pyrimidinones; 2OC4HKD3SF/telbivudine; EC 2.6.1.2/Alanine Transaminase; VC2W18DGKR/Thymidine
Comments/Corrections
Comment In:
Liver Int. 2011 May;31(5):589-91   [PMID:  21457431 ]

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