Division of Gastroenterology, University of Washington, Seattle, Washington, USA
Health Services Research and Development, Veterans Affairs Puget Sound Healthcare System, Seattle, Washington, USA.
Gut. 2021 Feb;70(2):370-378. doi: 10.1136/gutjnl-2019-319867. Epub 2020 Mar 30.
Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are first-line agents for the treatment of chronic hepatitis B (CHB). Recent studies have challenged the assumption that these agents are equally effective at preventing hepatocellular carcinoma (HCC). We aimed to determine whether the risk of HCC and mortality differ in patients with CHB treated with ETV and TDF.
We performed a retrospective cohort study of Veterans Affairs patients with CHB in the USA who initiated treatment with ETV or TDF between the dates of Food and Drug Administration approval of these medications and 1 January 2017. Multivariable Cox proportional hazards regression was used to determine the association between antiviral therapy and HCC risk as well as the risk of death or liver transplantation. Propensity score adjustment and competing risks analysis were performed.
We identified 2193 ETV-treated and 1094 TDF-treated patients who were followed for a mean of 5.4 years. We found no difference in the risk of HCC in ETV-treated versus TDF-treated patients (adjusted HR (aHR) 1.00, 95% CI 0.76 to 1.32). Results were similar in propensity score adjusted and competing risks analysis, and in multiple sensitivity analyses. We also found no difference in the risk of death or liver transplantation (aHR 1.16, 95% CI 0.98 to 1.39).
We found no difference in the risk of HCC between patients with CHB treated with ETV versus TDF. Our results support current guideline recommendations that both agents are appropriate first-line options for the treatment of CHB.
恩替卡韦(ETV)和富马酸替诺福韦二吡呋酯(TDF)是治疗慢性乙型肝炎(CHB)的一线药物。最近的研究对这两种药物在预防肝细胞癌(HCC)方面同样有效的假设提出了挑战。我们旨在确定接受 ETV 和 TDF 治疗的 CHB 患者的 HCC 风险和死亡率是否存在差异。
我们对美国退伍军人事务部的 CHB 患者进行了回顾性队列研究,这些患者在这些药物获得美国食品和药物管理局批准至 2017 年 1 月 1 日期间开始接受 ETV 或 TDF 治疗。多变量 Cox 比例风险回归用于确定抗病毒治疗与 HCC 风险以及死亡或肝移植风险之间的关联。进行了倾向评分调整和竞争风险分析。
我们确定了 2193 例接受 ETV 治疗和 1094 例接受 TDF 治疗的患者,平均随访时间为 5.4 年。我们发现 ETV 治疗与 TDF 治疗患者的 HCC 风险无差异(调整后的 HR(aHR)1.00,95%CI 0.76 至 1.32)。在倾向评分调整和竞争风险分析以及多种敏感性分析中,结果相似。我们还发现死亡或肝移植的风险无差异(aHR 1.16,95%CI 0.98 至 1.39)。
我们发现接受 ETV 治疗与 TDF 治疗的 CHB 患者的 HCC 风险无差异。我们的结果支持当前指南建议,这两种药物均为治疗 CHB 的一线合适选择。