Efficacy and safety of continuous 4-year telbivudine treatment in patients with chronic hepatitis B

In the phase-III GLOBE/015 studies, telbivudine demonstrated superior efficacy vs lamivudine during 2-year treatment in HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB). After completion, 847 patients had an option to continue telbivudine treatment for further 2 years. A total of 596 (70%...

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Main Authors: Y. Wang, S. Thongsawat, E. J. Gane, Y. F. Liaw, J. Jia, J. Hou, H. L Y Chan, G. Papatheodoridis, M. Wan, J. Niu, W. Bao, A. Trylesinski, N. V. Naoumov
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Published: 2018
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http://cmuir.cmu.ac.th/jspui/handle/6653943832/52645
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spelling th-cmuir.6653943832-526452018-09-04T09:34:06Z Efficacy and safety of continuous 4-year telbivudine treatment in patients with chronic hepatitis B Y. Wang S. Thongsawat E. J. Gane Y. F. Liaw J. Jia J. Hou H. L Y Chan G. Papatheodoridis M. Wan J. Niu W. Bao A. Trylesinski N. V. Naoumov Immunology and Microbiology Medicine In the phase-III GLOBE/015 studies, telbivudine demonstrated superior efficacy vs lamivudine during 2-year treatment in HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB). After completion, 847 patients had an option to continue telbivudine treatment for further 2 years. A total of 596 (70%) of telbivudine-treated patients, who were serum HBV DNA positive or negative and without genotypic resistance to telbivudine at the end of the GLOBE/015 trials, were enrolled into a further 2-year extension study. A group of 502 patients completed 4 years of continuous telbivudine treatment and were included in the telbivudine per-protocol population. Amongst 293 HBeAg-positive patients, 76.2% had undetectable serum HBV DNA and 86.0% had normal serum ALT at the end of 4 years. Notably, the cumulative rate of HBeAg seroconversion was 53.2%. Amongst 209 HBeAg-negative patients, 86.4% had undetectable HBV DNA and 89.6% had normal serum ALT. In patients who had discontinued telbivudine treatment due to HBeAg seroconversion, the HBeAg response was durable in 82% of patients (median 111 weeks of off-treatment follow-up). The cumulative 4-year resistance rate was 10.6% for HBeAg-positive and 10.0% for HBeAg-negative patients. Most adverse events were mild or moderate in severity and transient. Renal function measured by estimated glomerular filtration rate (eGFR) increased by 14.9 mL/min/1.73 m2 (16.6%) from baseline to 4 years (P < 0.0001). In conclusion, in HBeAg-positive and HBeAg-negative CHB patients without resistance after 2 years, two additional years of telbivudine treatment continued to provide effective viral suppression with a favourable safety profile. Moreover, telbivudine achieved 53% of HBeAg seroconversion in HBeAg-positive patients. © 2012 Blackwell Publishing Ltd. 2018-09-04T09:28:51Z 2018-09-04T09:28:51Z 2013-04-01 Journal 13652893 13520504 2-s2.0-84875229260 10.1111/jvh.12025 https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84875229260&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/52645
institution Chiang Mai University
building Chiang Mai University Library
country Thailand
collection CMU Intellectual Repository
topic Immunology and Microbiology
Medicine
spellingShingle Immunology and Microbiology
Medicine
Y. Wang
S. Thongsawat
E. J. Gane
Y. F. Liaw
J. Jia
J. Hou
H. L Y Chan
G. Papatheodoridis
M. Wan
J. Niu
W. Bao
A. Trylesinski
N. V. Naoumov
Efficacy and safety of continuous 4-year telbivudine treatment in patients with chronic hepatitis B
description In the phase-III GLOBE/015 studies, telbivudine demonstrated superior efficacy vs lamivudine during 2-year treatment in HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB). After completion, 847 patients had an option to continue telbivudine treatment for further 2 years. A total of 596 (70%) of telbivudine-treated patients, who were serum HBV DNA positive or negative and without genotypic resistance to telbivudine at the end of the GLOBE/015 trials, were enrolled into a further 2-year extension study. A group of 502 patients completed 4 years of continuous telbivudine treatment and were included in the telbivudine per-protocol population. Amongst 293 HBeAg-positive patients, 76.2% had undetectable serum HBV DNA and 86.0% had normal serum ALT at the end of 4 years. Notably, the cumulative rate of HBeAg seroconversion was 53.2%. Amongst 209 HBeAg-negative patients, 86.4% had undetectable HBV DNA and 89.6% had normal serum ALT. In patients who had discontinued telbivudine treatment due to HBeAg seroconversion, the HBeAg response was durable in 82% of patients (median 111 weeks of off-treatment follow-up). The cumulative 4-year resistance rate was 10.6% for HBeAg-positive and 10.0% for HBeAg-negative patients. Most adverse events were mild or moderate in severity and transient. Renal function measured by estimated glomerular filtration rate (eGFR) increased by 14.9 mL/min/1.73 m2 (16.6%) from baseline to 4 years (P < 0.0001). In conclusion, in HBeAg-positive and HBeAg-negative CHB patients without resistance after 2 years, two additional years of telbivudine treatment continued to provide effective viral suppression with a favourable safety profile. Moreover, telbivudine achieved 53% of HBeAg seroconversion in HBeAg-positive patients. © 2012 Blackwell Publishing Ltd.
format Journal
author Y. Wang
S. Thongsawat
E. J. Gane
Y. F. Liaw
J. Jia
J. Hou
H. L Y Chan
G. Papatheodoridis
M. Wan
J. Niu
W. Bao
A. Trylesinski
N. V. Naoumov
author_facet Y. Wang
S. Thongsawat
E. J. Gane
Y. F. Liaw
J. Jia
J. Hou
H. L Y Chan
G. Papatheodoridis
M. Wan
J. Niu
W. Bao
A. Trylesinski
N. V. Naoumov
author_sort Y. Wang
title Efficacy and safety of continuous 4-year telbivudine treatment in patients with chronic hepatitis B
title_short Efficacy and safety of continuous 4-year telbivudine treatment in patients with chronic hepatitis B
title_full Efficacy and safety of continuous 4-year telbivudine treatment in patients with chronic hepatitis B
title_fullStr Efficacy and safety of continuous 4-year telbivudine treatment in patients with chronic hepatitis B
title_full_unstemmed Efficacy and safety of continuous 4-year telbivudine treatment in patients with chronic hepatitis B
title_sort efficacy and safety of continuous 4-year telbivudine treatment in patients with chronic hepatitis b
publishDate 2018
url https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84875229260&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/52645
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