J Viral Hepat. 2017 Mar 26. doi: 10.1111/jvh.12710. [Epub ahead of print]
Entecavir maleate versus entecavir in Chinese chronic hepatitis B predominantly genotype B or C: results at week 144.Xu JH1, Wang S1, Xu ZN2, Yu YY1, Si CW1, Zeng Z1, Li J3, Qing M4, Zhang DZ5, Tang H6, Sheng JF7, Chen XY8, Ning Q9, Shi GF10, Xie Q11, Zhang XQ2, Dai J2. Author information 1Department of Infectious Diseases, Center for Liver Diseases, Peking University First Hospital, Beijing, China.2Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd, Nanjing, China.3Department of Infectious Diseases, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.4Department of Infectious Diseases, Southwest China Hospital, Chongqing, China.5Department of Infectious Diseases, The Second Affiliated Hospital with Chongqing Medical University, Chongqing, China.6Department of Infectious Diseases, West China Hospital, Chengdu, China.7Department of Infectious Diseases, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.8Department of International Medicine, Beijing Youan Hospital, Capital Medical University, Beijing, China.9Department and Institute of Infectious Diseases, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.10Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China.11Department of Infectious Diseases, Ruijin Hospital, Jiaotong University School of Medicine, Shanghai, China.
AbstractReports on the efficacy and safety of long-term entecavir treatment in chronic hepatitis B (CHB) predominantly genotype B or C are insufficient. This study presents the efficacy and safety of entecavir maleate in Chinese CHB patients. Patients were randomly assigned to receive 48-week treatment with either 0.5mg/day entecavir (group A) or 0.5mg/day entecavir maleate (group B), then all patients received treatment with 0.5mg/day entecavir maleate from week 49. Two hundred and seventy-five patients with CHB (HBeAg-positive: 218) were analyzed, predominantly (98.5%) with genotype B or C. Baseline characteristics were balanced. For the HBeAg-positive CHB patients, the mean HBV DNA level decreased similarly (A: by 6.36 log10 IU/mL vs. B: by 6.31 log10 IU/mL) between groups at week 144. The percentages of patients who achieved undetectable HBV DNA were similar (A: 70.59% vs. B: 66.67%) between groups. Similar HBeAg loss rates (A: 43.53% vs. B: 40.23%; P>0.05), and HBeAg seroconversion rates (A: 21.52% vs. B: 21.18%) were achieved. For the HBeAg-negative CHB patients, similar reductions in HBV DNA levels from baseline (A: by 6.13 log10 IU/mL vs. B: by 5.65 log10 IU/mL), and percentages of patients who achieved undetectable HBV DNA (A: 100% vs. B: 100%) were achieved. The overall incidence of adverse events was comparable between groups. In conclusions, 48-week administration of entecavir maleate and entecavir showed similar efficacy and safety in Chinese patients with CHB. Long-term entecavir maleate treatment was effective and safe in CHB patients. ClincialTrials. gov, number NCT01926288. This article is protected by copyright. All rights reserved.
This article is protected by copyright. All rights reserved.
发表于 2017-3-28 17:00