Department of Internal Medicine, Research Institute of Clinical Medicine, Chonbuk National University Medical School and Hospital, Jeonju, South Korea.
Intervirology. 2014;57(1):8-16. doi: 10.1159/000353851. Epub 2013 Aug 24.
We investigated the long-term efficacy of entecavir (ETV) + adefovir (ADV) combination therapy versus ETV monotherapy in lamivudine (LAM)-resistant chronic hepatitis B (CHB) patients who failed to respond to ADV rescue therapy.
A total of 91 ADV refractory patients with prior LAM resistance received ETV (1.0 mg/day) + ADV (10 mg/day) combination therapy (group A, n = 45) or ETV (1.0 mg/day) monotherapy (group B, n = 46) for more than 48 weeks.
The rates of undetectable serum hepatitis B virus DNA levels (≤20 IU/ml) at weeks 48 and 96 were not significantly different between group A and group B (31.1 vs. 23.9% at week 48, p = 0.442, and 44.7 vs. 34.5% at week 96, p = 0.457). However, the incidence of virological breakthrough in group A was significantly lower than that in group B (0 vs. 17.4% at week 48, p = 0.006, and 2.6 vs. 44.8% at week 96, p < 0.001). ETV monotherapy was the only independent factor significantly associated with virologic breakthrough (p = 0.015).
ETV + ADV combination therapy is a better therapeutic option than ETV monotherapy for ADV refractory CHB patients with prior LAM resistance.
我们研究了拉米夫定（LAM）耐药慢性乙型肝炎（CHB）患者在阿德福韦（ADV）挽救治疗失败后，恩替卡韦（ETV）+阿德福韦（ADV）联合治疗与 ETV 单药治疗的长期疗效。
共 91 例 ADV 耐药、既往 LAM 耐药的患者接受 ETV（1.0mg/天）+ADV（10mg/天）联合治疗（A 组，n=45）或 ETV（1.0mg/天）单药治疗（B 组，n=46）超过 48 周。
A 组和 B 组在第 48 周和第 96 周时血清乙型肝炎病毒 DNA 水平（≤20IU/ml）不可检测率无显著差异（第 48 周时分别为 31.1%和 23.9%，p=0.442，第 96 周时分别为 44.7%和 34.5%，p=0.457）。然而，A 组的病毒学突破发生率明显低于 B 组（第 48 周时分别为 0%和 17.4%，p=0.006，第 96 周时分别为 2.6%和 44.8%，p<0.001）。ETV 单药治疗是与病毒学突破显著相关的唯一独立因素（p=0.015）。
对于 ADV 耐药、既往 LAM 耐药的 CHB 患者，ETV+ADV 联合治疗是优于 ETV 单药治疗的选择。
