Fülöp Balazs, Fischer Janett, Hahn Magdalena, Böhlig Albrecht, Matz-Soja Madlen, Berg Thomas, van Bömmel Florian
Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany.
Klinik Gastroenterologie und Hepatology, Kantonsspital Baselland, 4410 Liestal, Switzerland.
Pathogens. 2024 Sep 23;13(9):820. doi: 10.3390/pathogens13090820.
Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir for the treatment of chronic hepatitis B (CHB) that has shown a favourable renal safety profile while offering suppression of HBV DNA similar to tenofovir disoproxil fumarate (TDF). We aimed to study changes in markers of HBV replication and renal function in a real-world setting in European patients. In our prospective single-arm, non-interventional observational study, HBeAg-positive and HBeAg-negative patients with chronic HBV mono-infection receiving TAF as their first or following line treatment were enrolled. HBV DNA, HBsAg, markers of bone metabolism, and renal function were determined at baseline and every consecutive 3 months. A total of 50 patients (70% male) were included. The mean duration of TAF treatment was 18 (3-36) months. In 20 patients with detectable HBV DNA at baseline, median serum levels of HBV DNA log changed from 2.33 (0.766-6.47) to 1.04 IU/mL at the end of observation and became undetectable in 11 patients. Median HBsAg log decreased from 3.37 (0.88-5.10) to 2.39 (1.52-4.19) IU/mL. During the entire observation period, the renal function parameters remained stable in patients with normal renal function and even in those with renal dysfunction. Mild adverse events were reported by 14 patients (28%). TAF was a safe and effective treatment, also in patients with decreased renal function.
替诺福韦艾拉酚胺（TAF）是一种用于治疗慢性乙型肝炎（CHB）的新型替诺福韦前体药物，已显示出良好的肾脏安全性，同时在抑制乙肝病毒（HBV）DNA方面与富马酸替诺福韦二吡呋酯（TDF）相似。我们旨在研究欧洲患者在真实世界环境中HBV复制标志物和肾功能的变化。在我们的前瞻性单臂、非干预性观察研究中，纳入了接受TAF作为一线或二线治疗的慢性HBV单一感染的HBeAg阳性和HBeAg阴性患者。在基线和随后连续每3个月测定HBV DNA、HBsAg、骨代谢标志物和肾功能。共纳入50例患者（70%为男性）。TAF治疗的平均持续时间为18（3 - 36）个月。在20例基线时可检测到HBV DNA的患者中，观察结束时血清HBV DNA log中位数水平从2.33（0.766 - 6.47）降至1.04 IU/mL，11例患者的HBV DNA变为不可检测。HBsAg log中位数从3.37（0.88 - 5.10）降至2.39（1.52 - 4.19）IU/mL。在整个观察期内，肾功能正常的患者以及肾功能不全的患者肾功能参数均保持稳定。14例患者（28%）报告了轻度不良事件。TAF是一种安全有效的治疗方法，对肾功能下降的患者也同样如此。
