Huang Yu-Han, Shen Chuan-Wei, Chen Chung-Yu, Bair Ming-Jong
Department of Pharmacy, Pingtung Veterans General Hospital, Pingtung, Taiwan.
Master Program in Clinical Pharmacy, School of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan.
Front Pharmacol. 2023 Dec 19;14:1301120. doi: 10.3389/fphar.2023.1301120. eCollection 2023.
Tenofovir and entecavir demonstrated substantial effectiveness in the reversion of fibrosis and reversed cirrhosis in patients with hepatitis B virus (HBV)-related cirrhosis. However, there has not been a definitive conclusion regarding the association between entecavir and tenofovir on the risk of cirrhosis-related complications. Therefore, this study aimed to investigate the comparative effectiveness between tenofovir and entecavir in HBV-related cirrhosis patients. This was a retrospective study using Taiwan's Health Insurance Research Database. We enrolled newly diagnosed HBV-related cirrhosis patients who initiated entecavir and tenofovir between 2011 and 2019. Treatment groups were determined by the initial HBV antiviral medication prescribed. The primary composite outcome was the development of hepatocellular carcinoma (HCC), death from any causes, and liver transplantation. The secondary outcomes included all the individual components of the primary outcome. The incidence rate was calculated for each outcome for both treatment groups using the Fine-Gray subdistribution hazard models. Propensity score adjustment was used to balance treatment groups. A total of 7,316 propensity score-matched treatment-naïve patients and 3,524 propensity score-matched treatment-experienced patients were included. Within treatment-naïve patients, those receiving tenofovir showed significantly lower hazards of developing the composite outcome (HR, 0.79; < 0.0001), hepatocellular carcinoma (HR, 0.86; = 0.027), mortality (HR, 0.75; < 0.0001), and liver transplantation (HR, 0.70; = 0.0189) than those receiving entecavir. As for treatment-experienced patients, tenofovir was associated with a significantly lower risk of the composite outcome (HR, 0.82; = 0.0033) and hepatocellular carcinoma (HR, 0.60; < 0.0001), but it did not show a significantly different risk of all-cause mortality (HR, 0.93; = 0.3374) or liver transplantation (HR, 1.17; = 0.5112) compared to entecavir. Tenofovir presented a significantly lower incidence of cirrhosis-related complications than entecavir in patients with hepatitis B virus-related cirrhosis. However, no statistically significant difference in death and liver transplantation was seen in treatment-experienced patients.
替诺福韦和恩替卡韦在乙肝病毒（HBV）相关肝硬化患者的纤维化逆转及肝硬化逆转方面显示出显著疗效。然而，关于恩替卡韦和替诺福韦与肝硬化相关并发症风险之间的关联，尚未得出明确结论。因此，本研究旨在调查替诺福韦和恩替卡韦在HBV相关肝硬化患者中的疗效比较。这是一项使用台湾地区健康保险研究数据库的回顾性研究。我们纳入了2011年至2019年间新诊断的开始使用恩替卡韦和替诺福韦的HBV相关肝硬化患者。治疗组根据最初开具的HBV抗病毒药物确定。主要复合结局为肝细胞癌（HCC）的发生、任何原因导致的死亡以及肝移植。次要结局包括主要结局的所有个体组成部分。使用Fine-Gray亚分布风险模型计算两个治疗组各结局的发生率。采用倾向评分调整来平衡治疗组。共纳入7316例倾向评分匹配的初治患者和3524例倾向评分匹配的经治患者。在初治患者中，接受替诺福韦治疗的患者发生复合结局（风险比[HR]，0.79；P<0.0001）、肝细胞癌（HR，0.86；P=0.027）、死亡率（HR，0.75；P<0.0001）和肝移植（HR，0.70；P=0.0189）的风险显著低于接受恩替卡韦治疗的患者。对于经治患者，替诺福韦与复合结局（HR，0.82；P=0.0033）和肝细胞癌（HR，0.60；P<0.0001）的风险显著降低相关，但与恩替卡韦相比，其全因死亡率（HR，0.93；P=0.3374）或肝移植风险（HR，1.17；P=0.5112）无显著差异。在HBV相关肝硬化患者中，替诺福韦导致的肝硬化相关并发症发生率显著低于恩替卡韦。然而，在经治患者中，死亡和肝移植方面未观察到统计学显著差异。
