title: Entecavir maleate versus entecavir in Chinese chronic hepatitis B predominantly genotype B or C: Results at week 144.
abstract: Reports 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 0.5 mg/day entecavir (group A) or 0.5 mg/day entecavir maleate (group B), and then all patients received treatment with 0.5 mg/day entecavir maleate from week 49. Two hundred and seventy-five patients with CHB (HBeAg-positive: 218) were analysed, 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 log10IU/mL vs B: by 6.31 log10IU/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>.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 log10IU/mL vs B: by 5.65 log10IU/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.
authors.affiliation: Department of Infectious Diseases, Center for Liver Diseases, Peking University First Hospital, Beijing, China.
authors.forename: J-H
authors.initials: JH
authors.lastname: Xu
authors.affiliation: Department of Infectious Diseases, Center for Liver Diseases, Peking University First Hospital, Beijing, China.
authors.forename: S
authors.initials: S
authors.lastname: Wang
authors.affiliation: Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd, Nanjing, China.
authors.forename: Z-N
authors.initials: ZN
authors.lastname: Xu
authors.affiliation: Department of Infectious Diseases, Center for Liver Diseases, Peking University First Hospital, Beijing, China.
authors.forename: Y-Y
authors.initials: YY
authors.lastname: Yu
authors.affiliation: Department of Infectious Diseases, Center for Liver Diseases, Peking University First Hospital, Beijing, China.
authors.forename: C-W
authors.initials: CW
authors.lastname: Si
authors.affiliation: Department of Infectious Diseases, Center for Liver Diseases, Peking University First Hospital, Beijing, China.
authors.forename: Z
authors.initials: Z
authors.lastname: Zeng
authors.affiliation: Department of Infectious Diseases, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.
authors.forename: J
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Infectious Diseases, Southwest China Hospital, Chongqing, China.
authors.forename: Q
authors.initials: Q
authors.lastname: Mao
authors.affiliation: Department of Infectious Diseases, The Second Affiliated Hospital with Chongqing Medical University, Chongqing, China.
authors.forename: D-Z
authors.initials: DZ
authors.lastname: Zhang
authors.affiliation: Department of Infectious Diseases, West China Hospital, Chengdu, China.
authors.forename: H
authors.initials: H
authors.lastname: Tang
authors.affiliation: Department of Infectious Diseases, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.
authors.forename: J-F
authors.initials: JF
authors.lastname: Sheng
authors.affiliation: Department of International Medicine, Beijing Youan Hospital, Capital Medical University, Beijing, China.
authors.forename: X-Y
authors.initials: XY
authors.lastname: Chen
authors.affiliation: Department and Institute of Infectious Diseases, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Q
authors.initials: Q
authors.lastname: Ning
authors.affiliation: Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: G-F
authors.initials: GF
authors.lastname: Shi
authors.affiliation: Department of Infectious Diseases, Ruijin Hospital, Jiaotong University School of Medicine, Shanghai, China.
authors.forename: Q
authors.initials: Q
authors.lastname: Xie
authors.affiliation: Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd, Nanjing, China.
authors.forename: X-Q
authors.initials: XQ
authors.lastname: Zhang
authors.affiliation: Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd, Nanjing, China.
authors.forename: J
authors.initials: J
authors.lastname: Dai
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D015415:Biomarkers; D004279:DNA, Viral; D004339:Drug Compounding; D024882:Drug Resistance, Viral; D005260:Female; D005838:Genotype; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000737:chemistry / Q000627:therapeutic use; D006515:Hepatitis B virus / Q000235:genetics*; D019694:Hepatitis B, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D008297:Male; D008298:Maleates / Q000737:chemistry; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D004279:DNA, Viral; D008298:Maleates; C413685:entecavir; D006147:Guanine; C030272:maleic acid
keywords: chronic hepatitis B; entecavir maleate; randomized controlled trial; treatment outcome