Medical writing assistance was provided by Isabelle Kaufmann of ArticulateScience and was funded by Bristol-Myers Squibb. Publication assistance was provided and funded by Bristol-Myers Squibb Australia. JL HOU,1 JD JIA,2 L WEI,3 H REN,4 Q XIE,5 ZL GAO,6 W ZHAO,7 YM WANG,8 G GONG,9 W CAO,10 M YU,11 C LLAMOSO11 1Institute of Hepatology

and Key Lab for Organ Failure Research, Nanfang Hospital, Southern Medical University, No 1838 North Guangzhou Avenue, Guangzhou 510515, China, 2Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China, 3Peking University People’s Hospital, Peking University Hepatology Institute, Beijing, China, 4Second Hospital Chongqing, Chongqing Medical University, China, 5Department of Infectious Diseases, Ruijin Hospital, Jiao Tong University School of Medicine, Shanghai, China, 6Third MAPK inhibitor Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China, 7Nanjing Second Hospital Affiliated to Medical

College, Southeast University, 1-1 Zhong Fu Road, Nanjing 210003, Jiangsu Province, China, 8Institute of Infectious Diseases, Southwest Hospital, The Third Military Medical University, Chongqing 400038, China, 9Liver Diseases Center, Second Xiangya Hospital, Central South University, Changsha, China, 10Tianjin learn more Infectious Disease Hospital, Tianjin 300192, China11Research and Development, Bristol-Myers Squibb Company, Wallingford, CT, USA Introduction: Chronic hepatitis B (CHB) is a significant public health issue and an important cause of liver-related mortality in China. This study assessed the efficacy and safety of entecavir (ETV) versus other standard-of-care (oSOC) nucleos(t)ide analog (NUC) therapy in a ‘real-world’ clinical practice selleck compound setting in China. Methods: This prospective, randomized, observational cohort comprised a subgroup of NUC-naïve CHB patients with compensated liver disease and without HCV co-infection, enrolled in the REALM study at 50 sites in China. Patients treated with ETV or oSOC were assessed for virologic responses over 192 weeks. Missing values were handled using a non-completer = missing method. All treated patients

were assessed for limited safety parameters. Results: Overall, 3526 patients were treated (ETV 1766; oSOC 1760). Baseline patient characteristics were balanced across treatment groups: approximately 80% male, 100% Asian, 64% HBeAg(+); mean HBV DNA ≈7 log10 IU/mL. Median time (weeks) on original study therapy was 239.9 (1.3−276.9) for ETV, 252.3 (12.1−271.0) for lamivudine, 204.9 (147.4−218.1) for telbivudine, and 238.3 (0.3−282.0) for adefovir. At Week 192, 86% of ETV-treated patients had HBV DNA <50 IU/mL compared with 62% of patients treated with oSOC (lamivudine, telbivudine, or adefovir; non-completer = missing analysis). Serious treatment-related adverse events were infrequent (<1%) and comparable across treatment arms.