Efficacy and safety of continuous 4‐year telbivudine treatment in patients with chronic hepatitis B |
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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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Institution: | 1. Institute of Infectious Diseases, Southwest Hospital, Third Military Medical University, , Chongqing, China;2. Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, , Chiang Mai, Thailand;3. New Zealand Liver Unit, Auckland City Hospital, , Auckland, New Zealand;4. Liver Research Unit, Chang Gung Memorial Hospital & University, , Taipei, Taiwan;5. Liver Research Center, Beijing Friendship Hospital, Capital Medical University, , Beijing, China;6. Hepatology Unit and Department of Infectious Diseases, Nanfang Hospital, , Guangzhou, China;7. Medicine and Therapeutics, Chinese University of Hong Kong, , Hong Kong, China;8. Academic Department of Medicine, Hippokration General Hospital, , Athens, Greece;9. Department of Infectious Diseases, ChangHai Hospital of the Second Military Medical University, , Shanghai, China;10. Department of Hepatology, First hospital of Jilin University, , Jilin, China;11. Novartis Pharma Corporation, , East Hanover, NJ, USA;12. Novartis Pharma AG, , Basel, Switzerland |
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Abstract: | 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. |
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Keywords: | HBeAg seroconversion long‐term treatment off‐treatment renal function safety |
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