Matsubara Takuya, Hagiwara Satoru, Nishida Naoshi, Omaru Naoya, Yoshida Akihiro, Yamamoto Tomoki, Komeda Yoriaki, Takenaka Mamoru, Kudo Masatoshi
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka- Sayama, Osaka, 589-8511, Japan.
Sci Rep. 2025 Jan 6;15(1):869. doi: 10.1038/s41598-025-85317-3.
This study evaluated the long-term efficacy and safety of the widely used drugs entecavir (ETV) and tenofovir alafenamide (TAF), as well as the incidence of HCC.A nonrandomized, prospective, observational analysis included 77 patients with chronic hepatitis B who were assigned to continue ETV or switch TAF. After 240 weeks, the mean changes in serum hepatitis B surface antigen (- 0.365 ± 0.069 log IU/mL vs. 0.301 ± 0.039 log IU/mL, p = 0.39) and hepatitis B core-related antigen (- 0.215 ± 0.092 log IU/mL vs. - 0.195 ± 0.056 log IU/mL) were not significantly different between the ETV and TAF groups. There were also no differences between the two groups in estimated glomerular filtration rate (- 5.407 ± 1.660 vs. - 2.666 ± 1.52, p = 0.240), urinary β2-microglobulin β/creatinine (ETV: 2.330 ± 0.374 at baseline and 2.335 ± 0.257 at 240 weeks; TAF: 2.720 ± 0.073 and 2.123 ± 0.310, p = 0.996 and 0.455, respectively) or urinary N-acetyl-β-D-glucosaminidase/creatinine (ETV: 0.040 ± 0.005 at baseline and 0.044 ± 0.004 at 240 weeks; TAF: 0.049 ± 0.005 and 0.053 ± 0.005, p = 0.642 and 0.684, respectively). Finally, no significant difference was found in the incidence of HCC between the ETV and TAF groups (log-rank test, p = 0.08). In conclusion, the long-term observation of this study demonstrated that ETV and TAF have comparable efficacy and safety.Clinical trial registration: UMIN000026465.
本研究评估了广泛使用的药物恩替卡韦（ETV）和替诺福韦艾拉酚胺（TAF）的长期疗效和安全性，以及肝癌的发病率。一项非随机、前瞻性观察性分析纳入了77例慢性乙型肝炎患者，他们被分配继续使用ETV或换用TAF。240周后，ETV组和TAF组血清乙肝表面抗原的平均变化（-0.365±0.069 log IU/mL对0.301±0.039 log IU/mL，p=0.39）以及乙肝核心相关抗原的平均变化（-0.215±0.092 log IU/mL对-0.195±0.056 log IU/mL）无显著差异。两组间的估计肾小球滤过率（-5.407±1.660对-2.666±1.52，p=0.240）、尿β2-微球蛋白β/肌酐（ETV组：基线时为2.330±0.374，240周时为2.335±0.257；TAF组：分别为2.720±0.073和2.123±0.310，p分别为0.996和0.455）或尿N-乙酰-β-D-氨基葡萄糖苷酶/肌酐（ETV组：基线时为0.040±0.005，240周时为0.044±0.004；TAF组：分别为0.049±0.005和0.053±0.005，p分别为0.642和0.684）也无差异。最后，ETV组和TAF组之间肝癌发病率无显著差异（对数秩检验，p=0.08）。总之，本研究的长期观察表明，ETV和TAF具有相当的疗效和安全性。临床试验注册号：UMIN000026465。
