丙酚替诺福韦(tenofovir alafenamide,TAF)是得到最新版欧洲肝脏研究学会(EASL)指南[1]和美国肝病研究学会(AASLD)指南[2]推荐的初治慢性乙型肝炎(简称慢乙肝)的一线用药。TAF对比富马酸替诺福韦二吡呋酯(TDF)的2项全球III期、随机双盲、非劣效性研究(108研究[3]和110研究[4])显示,TAF与TDF的抗病毒作用相似,但肾脏和骨骼安全性更好。在第27届亚太肝病研究学会年会上,来自中国香港大学的司徒伟基(Wai Kay Seto)博士报告了这两项研究中纳入的境外华人患者的亚组分析结果[5]。
TAF在华人中的骨骼和肾脏安全性结果也与全球试验结果一致。司徒博士总结道:服用TDF治疗的患者身体不同部位骨骼的骨密度和肾功能指标都可见轻度恶化,但服用TAF治疗的患者,这些指标则比较平稳(图4、图5)。治疗96周时TAF组骨密度下降更少、eGFRCG下降≥25%的患者比例更少(6% vs. 16%)。这充分说明了TAF具有更好的骨骼和肾脏安全性。
1. European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol (2017), http://dx.doi.org/10.1016/j.jhep.2017.03.021
2. Terrault NA, Lok AS, McMahon BJ, et al. Update on Prevention, Diagnosis, and Treatment and of Chronic Hepatitis B: AASLD 2018 Hepatitis B Guidance. Hepatology. 2018, https://doi.org/10.1002/hep.29800
3. Brunetto M, Lim YS, Gane Ed, et al. A Phase 3 Study Comparing Tenofovir Alafenamide (TAF) to Tenofovir Disoproxil Fumarate (TDF) in Patients With HBeAg-Negative, Chronic Hepatitis B (CHB): Efficacy and Safety Results at Week 96. EASL2017. PS042
4. Agarwal K, Fung S, Seto WK, et al. A Phase 3 Study Comparing Tenofovir Alafenamide (TAF) to Tenofovir Disoproxil Fumarate (TDF) in Patients with HBeAg-positive, Chronic Hepatitis B (CHB): Efficacy and Safety Results at Week 96. EASL2017. FRI-153
5. Seto WK, Scott F, Hou JL, et al. Tenofovir Alafenamide (TAF) Compared with Tenofovir Disoproxil Fumarate (TDF) in Patients with Chronic HBV: Week 96 Efficacy and Safety Results in Chinese Patients enrolled in 2 Overseas Phase 3 Studies. APASL2018. O-HBV-08
6. Wong G, Kurosaki M, Zur R, et al. Increasing age and comorbidities in 43,316 adult patients with chronic hepatitis B (CHB) from 2011 to 2016 in Japan: results of a real-world analysis. APASL2018. O-HBV-36 作者: newchinabok 时间: 2018-3-24 12:17