Lee Seung Bum, Jeong Joonho, Park Jae Ho, Jung Seok Won, Jeong In Du, Bang Sung-Jo, Shin Jung Woo, Park Bo Ryung, Park Eun Ji, Park Neung Hwa
Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
Biomedical Research Center, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
Clin Mol Hepatol. 2020 Jul;26(3):364-375. doi: 10.3350/cmh.2020.0012. Epub 2020 May 29.
BACKGROUND/AIMS: Low-level viremia (LLV) after nucleos(t)ide analog treatment was presented as a possible cause of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B (CHB). However, detailed information on patients' adherence in the real world was lacking. This study aimed to evaluate the effects of LLV on HCC development, mortality, and cirrhotic complications among patients according to their adherence to entecavir (ETV) treatment.
We performed a retrospective observational analysis of data from 894 consecutive adult patients with treatment-naïve CHB undergoing ETV treatment. LLV was defined according to either persistent or intermittent episodes of <2,000 IU/mL detectable hepatitis B virus DNA during the follow-up period. Good adherence to medication was defined as a cumulative adherence ≥90% per study period.
Without considering adherence in the entire cohort (n=894), multivariate analysis of the HCC incidence showed that LLV was an independent prognostic factor in addition to other traditional risk factors in the entire cohort (P=0.031). Good adherence group comprised 617 patients (69.0%). No significant difference was found between maintained virologic response and LLV groups in terms of the incidence of liver-related death or transplantation, HCC, and hepatic decompensation in good adherence group, according to multivariate analyses.
In patients with treatment-naïve CHB and good adherence to ETV treatment in the real world, LLV during treatment is not a predictive factor for HCC and cirrhotic complications. It may be unnecessary to adjust their antiviral agent for patients with good adherence who experience LLV during ETV treatment.
背景/目的：核苷（酸）类似物治疗后出现的低水平病毒血症（LLV）被认为是慢性乙型肝炎（CHB）患者肝细胞癌（HCC）的一个可能病因。然而，缺乏关于现实世界中患者依从性的详细信息。本研究旨在根据患者对恩替卡韦（ETV）治疗的依从性，评估LLV对HCC发生、死亡率和肝硬化并发症的影响。
我们对894例初治成年CHB患者接受ETV治疗的数据进行了回顾性观察分析。LLV根据随访期间持续或间歇性出现的可检测到的乙肝病毒DNA<2000 IU/mL来定义。良好的药物依从性定义为每个研究期间累积依从性≥90%。
在不考虑整个队列（n = 894）依从性的情况下，对HCC发病率的多因素分析显示，除了其他传统危险因素外，LLV是整个队列中的一个独立预后因素（P = 0.031）。良好依从性组包括617例患者（69.0%）。根据多因素分析，在良好依从性组中，维持病毒学应答组和LLV组在肝相关死亡或移植、HCC和肝失代偿的发生率方面没有显著差异。
在现实世界中，对于初治CHB且对ETV治疗依从性良好的患者，治疗期间的LLV不是HCC和肝硬化并发症的预测因素。对于在ETV治疗期间出现LLV但依从性良好的患者，可能没有必要调整其抗病毒药物。
