Ji-Dong Jia1, Jin-Lin Hou2, You-Kuan Yin3, De-Ming Tan4, Daozhen Xu5, Jun-Qi Niu6, Xia-Qiu Zhou7, Yu-Ming Wang8, Li-Min Zhu9, Cheng-Wei Chen10, Yong-Wen He11, Hong Ren12, Mo-Bin Wan13, Shan-Ming Wu14, Qin-Huan Wang15, Lai Wei16, Weibin Bao17, Yuhong Dong18, Aldo Trylesinski19. 1. Beijing Friendship Hospital, Capital Medical University, 95 Yong-An Road, Xicheng District, Beijing, 100050, China. jia_jd@ccmu.edu.cn. 2. Nanfang Hospital, Southern Medical University, Guangzhou, China. jlhousmu@yahoo.com.cn. 3. Shanghai Hua Shan Hospital, Shanghai, China. hshyyk@yahoo.com.cn. 4. Xiang Ya Hospital, Changsha, China. dmt2008@yahoo.com.cn. 5. Beijing Ditan Hospital, Beijing, China. xudaozhen@126.com. 6. First Hospital, University of Jilin, Changchun, China. junqiniu@yahoo.com.cn. 7. Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. rjzhouxiaqiu@hotmail.com. 8. Southwest Hospital, Third Military Medical University, Chongqing, China. wym417@mail.tmmu.com.cn. 9. Tianjin Infectious Diseases Hospital, Tianjin, China. zhuliminidh@yahoo.com.cn. 10. Shanghai Liver Research Centre, Nanjing Military Command, Shanghai, China. ccw2@163.com. 11. Xie He Hospital, Wuhan, China. hyw581441@yahoo.com.cn. 12. The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China. renhong0531@vip.sina.com.cn. 13. Shanghai Changhai Hospital, Shanghai, China. mobinwan@yahoo.com.cn. 14. Shanghai Public Health Center, Shanghai, China. wusm96@yahoo.com.cn. 15. First Hospital of Peking University, Beijing, China. wangqh2008@163.com. 16. Peking University People's Hospital, Beijing, China. weelai@163.com. 17. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. weibin.bao@novartis.com. 18. Novartis Pharma AG, Basel, Switzerland. yuhong.dong@novartis.com. 19. Novartis Pharma AG, Basel, Switzerland. aldo.trylesinski@novartis.com.
Abstract
PURPOSE: The burden of chronic hepatitis B infection is high in China, where prevalence exceeds 7 %. This was a randomized, double-blinded, phase III study of the efficacy and safety of telbivudine and lamivudine treatment at 104 weeks in Chinese patients with chronic hepatitis B. METHODS:Hepatitis B e antigen-positive (n = 290) and -negative (n = 42) adults with nucleoside analog-naïve compensated chronic hepatitis B were randomized to receive telbivudine 600 mg/day or lamivudine 100 mg/day for 104 weeks. The primary endpoint was reduction from baseline in serum hepatitis B virus (HBV) DNA at week 52. Week 104 analyses included HBV DNA reductions, undetectable HBV DNA (<300 copies/mL), ALT normalization, and e-antigen loss/seroconversion. Efficacy at week 104 was also assessed as a function of week 24 HBV DNA. RESULTS: In the intention-to-treat population (n = 332) at week 104, telbivudine was superior to lamivudine for reduction of HBV DNA [-5.48 vs. -4.00 log10 copies/mL; difference -1.49 log10 (95 % confidence interval -2.2, -0.8); p < 0.0001], for the proportion with undetectable HBV DNA (61.9 vs. 38.5 %; p < 0.0001), for ALT normalization (75.8 vs. 61.3 %; p = 0.0049), and for e-antigen loss (39.9 vs. 28.2 %; p = 0.0373). The cumulative probability of genotypic drug resistance was 15.4 % on telbivudine versus 23.6 % on lamivudine through week 104. Early virologic response at week 24 was associated with improved outcomes at week 104. Adverse events were similar to those seen in the GLOBE study. CONCLUSIONS:Telbivudine is superior to lamivudine over 2 years of chronic hepatitis B treatment in Chinese patients.
RCT Entities:
PURPOSE: The burden of chronic hepatitis B infection is high in China, where prevalence exceeds 7 %. This was a randomized, double-blinded, phase III study of the efficacy and safety of telbivudine and lamivudine treatment at 104 weeks in Chinese patients with chronic hepatitis B. METHODS:Hepatitis B e antigen-positive (n = 290) and -negative (n = 42) adults with nucleoside analog-naïve compensated chronic hepatitis B were randomized to receive telbivudine 600 mg/day or lamivudine 100 mg/day for 104 weeks. The primary endpoint was reduction from baseline in serum hepatitis B virus (HBV) DNA at week 52. Week 104 analyses included HBV DNA reductions, undetectable HBV DNA (<300 copies/mL), ALT normalization, and e-antigen loss/seroconversion. Efficacy at week 104 was also assessed as a function of week 24 HBV DNA. RESULTS: In the intention-to-treat population (n = 332) at week 104, telbivudine was superior to lamivudine for reduction of HBV DNA [-5.48 vs. -4.00 log10 copies/mL; difference -1.49 log10 (95 % confidence interval -2.2, -0.8); p < 0.0001], for the proportion with undetectable HBV DNA (61.9 vs. 38.5 %; p < 0.0001), for ALT normalization (75.8 vs. 61.3 %; p = 0.0049), and for e-antigen loss (39.9 vs. 28.2 %; p = 0.0373). The cumulative probability of genotypic drug resistance was 15.4 % on telbivudine versus 23.6 % on lamivudine through week 104. Early virologic response at week 24 was associated with improved outcomes at week 104. Adverse events were similar to those seen in the GLOBE study. CONCLUSIONS:Telbivudine is superior to lamivudine over 2 years of chronic hepatitis B treatment in Chinese patients.
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Authors: William W L Wong; Petros Pechivanoglou; Josephine Wong; Joanna M Bielecki; Alex Haines; Aysegul Erman; Yasmin Saeed; Arcturus Phoon; Mina Tadrous; Mona Younis; Noha Z Rayad; Valeria Rac; Harry L A Janssen; Murray D Krahn Journal: Syst Rev Date: 2019-08-19