Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Ansan Hospital, Ansan, Korea.
College of Pharmacy, Yonsei Institute of Pharmaceutical Research, Yonsei University, Seoul, Korea.
J Korean Med Sci. 2021 Apr 12;36(14):e89. doi: 10.3346/jkms.2021.36.e89.
The occurrence of hepatocellular carcinoma (HCC) is a major concern during antiviral therapy for chronic hepatitis B. There are conflicting opinions regarding the effects of entecavir (ETV) and tenofovir disoproxil fumarate (TDF) on HCC prevention. We assessed these two antiviral medications for preventing HCC in treatment-naïve patients with chronic hepatitis B.
We conducted a retrospective cohort study using nationwide claims data from the Korea Health Insurance Review and Assessment Service. We included 55,473 treatment-naïve adult cases where ETV or TDF treatment was started between 2013 and 2017 (cohort 1). The ETV and TDF groups were matched 1:2 based on age, sex, comorbidities, hospital type, and index date year. Patients were followed up until December 2018. The outcome was the development of HCC. Subgroup analyses were conducted according to sex, age, hospital type and the presence of cirrhosis. We also compared the outcomes of patients who had started antiviral therapy during the 2012-2014 period (cohort 2).
The matched participants (18,491 in the ETV and 36,982 in the TDF groups) were a part of the study for, on average, 41.2 months. The incidence of HCC did not differ significantly between the ETV (1.46 per 100 patient-years) and the TDF (1.36 per 100 patient-years) treatments (hazard ratio, 0.93; 95% confidence interval, 0.86-1.01; = 0.081). By contrast, HCC incidence was significantly higher in the ETV group than tenofovir group of cohort 2.
In patients with chronic hepatitis B, the ETV treatment did not result in a higher rate of HCC than the TDF treatment.
在慢性乙型肝炎的抗病毒治疗过程中，肝细胞癌（HCC）的发生是一个主要关注点。对于恩替卡韦（ETV）和替诺福韦酯富马酸（TDF）在预防 HCC 方面的影响，存在相互矛盾的观点。我们评估了这两种抗病毒药物在治疗初治的慢性乙型肝炎患者中预防 HCC 的效果。
我们使用韩国健康保险审查和评估服务的全国性索赔数据进行了回顾性队列研究。我们纳入了 55473 例在 2013 年至 2017 年间开始接受 ETV 或 TDF 治疗的初治成年病例（队列 1）。根据年龄、性别、合并症、医院类型和索引日期年份，将 ETV 和 TDF 组按 1:2 匹配。患者随访至 2018 年 12 月。结局为 HCC 的发生。根据性别、年龄、医院类型和肝硬化的存在情况进行亚组分析。我们还比较了在 2012-2014 年期间开始抗病毒治疗的患者（队列 2）的结局。
匹配的参与者（ETV 组 18491 例，TDF 组 36982 例）平均随访 41.2 个月。ETV（每 100 患者年 1.46 例）和 TDF（每 100 患者年 1.36 例）治疗组的 HCC 发生率无显著差异（风险比，0.93；95%置信区间，0.86-1.01；P=0.081）。相比之下，队列 2 中 ETV 组的 HCC 发生率明显高于替诺福韦组。
在慢性乙型肝炎患者中，ETV 治疗并未导致 HCC 发生率高于 TDF 治疗。
