Su Pei-Yuan, Su Wei-Wen, Hsu Yu-Chun, Huang Siou-Ping, Yen Hsu-Heng
Department of Gastroenterology, Changhua Christian Hospital, Changhua, Taiwan.
Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan.
PeerJ. 2021 Nov 19;9:e12527. doi: 10.7717/peerj.12527. eCollection 2021.
Tenofovir alafenamide (TAF) has good viral suppression efficacy and less adverse effect than tenofovir disoproxil fumarate (TDF). Real-world studies on the antiviral efficacy and safety of switching from TDF to TAF in patients with chronic hepatitis B (CHB) are limited.
This retrospective study included 167 nucleos(t)ide analogue (NA)-naive patients with CHB. All the patients received TDF at least 12 months before switching and TAF at least 12 months after switching at a single medical center. The Friedman test with Dunn-Bonferroni tests and repeated-measures analysis of variance was used to analyze the effect of complete viral suppression, alanine aminotransferase (ALT) level normalization, renal function changes, body weight, and body mass index in the periods before and after switching.
The mean age and TDF treatment duration were 52 ± 11 years and 2.8 years (interquartile range, 1.51-5.15 years), respectively. The complete viral suppression rate was similar between the time of switching and 48 weeks after switching to TAF (77.8% 76%, = 1.000). The percentage of alanine aminotransferase (ALT) normalization increased from 26.3% at TDF start to 81.4% ( < 0.001) at time of switching and 89.2% at 48 weeks after switching to TAF ( = 0.428). The median estimated glomerular filtration rate decreased from 100.09 mL/min/1.73 m² at TDF start to 91.97 mL/min/1.73 m² ( < 0.001) at the time of switching and stabilized at 48 weeks after switching to TAF (93.47 mL/min/1.73m², = 1.000). The body weight decreased from 69.2 ± 12.2 kg at TDF start to 67.4 ± 12.1 kg ( < 0.001) at the time of switching to TAF and returned to 68.7 ± 12.7 kg ( < 0.001) 48 weeks thereafter. The body mass index (BMI) decreased from 25 ± 3.3 kg/m² at TDF start to 24.5 ± 3.3 kg/m² ( = 0.002) at the time of switching to TAF and returned to 25.1 ± 3.6 kg/m² ( < 0.001) 48 weeks thereafter.
Our study showed that switching to TAF from TDF had good antiviral effectiveness and stabilized renal function. The body weight and BMI decreased during TDF therapy and regained after switching to TAF.
与富马酸替诺福韦二吡呋酯（TDF）相比，替诺福韦艾拉酚胺（TAF）具有良好的病毒抑制效果且不良反应较少。关于慢性乙型肝炎（CHB）患者从TDF转换为TAF后的抗病毒疗效和安全性的真实世界研究有限。
这项回顾性研究纳入了167例初治核苷（酸）类似物（NA）的CHB患者。所有患者在转换前至少接受12个月的TDF治疗，在转换后至少接受12个月的TAF治疗，均来自单一医疗中心。采用Friedman检验、Dunn-Bonferroni检验和重复测量方差分析来分析转换前后完全病毒抑制、丙氨酸氨基转移酶（ALT）水平正常化、肾功能变化、体重和体重指数的影响。
平均年龄和TDF治疗时长分别为52±11岁和2.8年（四分位间距为1.51 - 5.15年）。转换时与转换为TAF后48周的完全病毒抑制率相似（77.8%对76%，P = 1.000）。ALT正常化百分比从开始使用TDF时的26.3%增加到转换时的81.4%（P < 0.001），转换为TAF后48周时为89.2%（P = 0.428）。估计肾小球滤过率中位数从开始使用TDF时的100.09 mL/min/1.73m²降至转换时的91.97 mL/min/1.73m²（P < 0.001），转换为TAF后48周稳定在93.47 mL/min/1.73m²（P = 1.000）。体重从开始使用TDF时的69.2±12.2 kg降至转换为TAF时的67.4±12.1 kg（P < 0.001），此后48周恢复至68.7±12.7 kg（P < 0.001）。体重指数（BMI）从开始使用TDF时的25±3.3 kg/m²降至转换为TAF时的24.5±3.3 kg/m²（P = 0.002），此后48周恢复至25.1±3.6 kg/m²（P < 0.001）。
我们的研究表明，从TDF转换为TAF具有良好的抗病毒效果且肾功能稳定。在TDF治疗期间体重和BMI下降，转换为TAF后恢复。
