TITLE: Entecavir Plus Tenofovir Combination Therapy in Patients with Multi-drug Resistant Chronic Hepatitis B: A multicenter, Prospective Study - Early Experience
AUTHORS (FIRST NAME, LAST NAME): Jun Yong Park1, Chang Wook Kim2, Si Hyun Bae2, Sang Hoon Ahn1
Institutional Author(s):
INSTITUTIONS (ALL): 1. Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea, Republic of.
2. Department of Internal Medicine, The Catholic University College of Medicine, Seoul, Korea, Republic of.
ABSTRACT BODY: Background: It has been one of unsolved issues and unmet needs in chronic hepatitis B (CHB) treatment to manage multi-drug resistant (MDR) hepatitis B virus. The aim of this study was to elucidate the antiviral efficacy and safety of entecavir plus tenofovir combination therapy in patients with MDR CHB.
Methods: In this prospective ongoing multicenter study, patients with MDR CHB defined as detectable HBV DNA (≥ 60 IU/mL) while on any rescue treatment regimen for at least 24 weeks and prior experience of genotypic resistance to both nucleoside analogue(s) and nucleotide analogue are treated with entecavir and tenofovir combination therapy. The primary endpoint is the proportion of patients with HBV DNA < 60 IU/ml at Week 48. We present here the first 12 week interim analysis.
Results: 61 patients were enrolled at the time interim analysis and 42 of these reached week 12. At baseline, mean age was 47.4 years, 83% were male, 86% were HBeAg(+), mean HBV DNA was 4.55 (±1.23) log 10IU/ml, and mean ALT was 41.3 IU/ml; 4 patients (9.5%) had documented resistance mutations to lamivudine (LAM) only, 3 (7.1%) to LAM and adefovir (ADF), 14 (33.3%) to ADF, 4 (9.5%) to LAM and entecavir, and 8 (19.0%) to all. By week 4, 9 (21.4%) patients achieved HBV DNA < 60 IU/ml and the mean reductions in HBV DNA was 1.39 ± 0.77 log 10IU/ml. By week 12, 24 (57.1%) patients achieved HBV DNA < 60 IU/ml and the mean reductions in HBV DNA was 2.11 ± 0.77 log 10IU/ml. On-treatment ALT flare was reported in 1 patient during the first 12 week. There was no serious adverse event.
Conclusions: In the first 12 week interim analysis in patients with MDR CHB, entecavir plus tenofovir combination therapy early suppressed HBV replication to undetectable HBV DNA levels in the majority (57.1%) of patients. 作者: StephenW 时间: 2013-10-20 19:03
方法：在这项前瞻性正在进行的多中心临床研究， MDR CHB患者检测到HBV DNA （ ≥ 60国际单位/毫升） ，而在任何的抢救治疗方案定义为至少24周和以往的经验，两个核苷类似物（次）基因型耐药核苷类似物恩替卡韦和替诺福韦联合治疗治疗。主要终点是患者HBV DNA < 60 IU / ml的48周的比例。我们在座的第12周的中期分析。