Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.
Third Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
J Gastroenterol Hepatol. 2019 Nov;34(11):2004-2010. doi: 10.1111/jgh.14686. Epub 2019 May 21.
Tenofovir alafenamide (TAF) is a new prodrug of tenofovir, enabling treatment of patients with hepatitis B virus (HBV) infection at a lower dose than tenofovir disoproxil fumarate (TDF), via more efficient delivery of tenofovir to the hepatocytes. We compared the efficacy and safety of TDF and TAF and investigated switching from TDF to TAF therapy.
Consent for TDF and TAF therapy was obtained from 117 and 67 patients from August 2014 to January 2018. In total, 45 and 14 patients were administered with TDF and TAF, respectively, as naïve therapy, and 36 patients were switched from TDF to TAF. The antiviral effects and renal function safety were assessed.
At week 48, the antiviral effects on patients receiving TDF and TAF as naïve therapy were similar in terms of reduction of HBV DNA (-5.6 ± 1.8 logIU/ml vs -5.0 ± 1.7 log IU/ml; P = 0.34) and hepatitis B surface antigen (-0.29 ± 0.64 logIU/ml vs -0.15 ± 0.42 logIU/ml; P = 0.71) levels. A significant decrease in the estimated glomerular filtration rate (eGFR) was seen at 48-week TDF treatment (-5.34 ± 7.69 ml/min/1.73 m ; P < 0.001). Switching from TDF to TAF did not increase the HBV DNA or hepatitis B surface antigen at 24 weeks. Although the eGFR worsened during TDF therapy (-7.32 ± 4.87 ml/min/1.73 m ), it improved significantly at week 4 (+3.93 ± 6.18 ml/min/1.73 m ; P = 0.008) and week 24 (+2.89 ± 4.26 ml/min/1.73 m ; P = 0.020) after switching from TDF to TAF.
Tenofovir disoproxil fumarate and TAF showed adequate antiviral effects as naïve therapies. Furthermore, switching from TDF to TAF therapy contributed to the maintenance of the antiviral effect and recovery of renal dysfunction.
替诺福韦艾拉酚胺（TAF）是替诺福韦的一种新前药，与富马酸替诺福韦二吡呋酯（TDF）相比，它能以更低的剂量治疗乙型肝炎病毒（HBV）感染患者，因为它能更有效地将替诺福韦递送至肝细胞。我们比较了 TDF 和 TAF 的疗效和安全性，并研究了从 TDF 转换为 TAF 治疗的情况。
我们于 2014 年 8 月至 2018 年 1 月期间，征得 117 名和 67 名接受 TDF 和 TAF 治疗的患者同意。共有 45 名和 14 名患者分别接受 TDF 和 TAF 作为初治治疗，36 名患者从 TDF 转换为 TAF。评估了抗病毒效果和肾功能安全性。
在 48 周时，初治接受 TDF 和 TAF 治疗的患者在降低 HBV DNA（-5.6±1.8 logIU/ml 与-5.0±1.7 log IU/ml；P=0.34）和乙型肝炎表面抗原（-0.29±0.64 logIU/ml 与-0.15±0.42 logIU/ml；P=0.71）水平方面的抗病毒效果相似。TDF 治疗 48 周时肾小球滤过率（eGFR）显著下降（-5.34±7.69 ml/min/1.73 m 2 ；P<0.001）。从 TDF 转换为 TAF 不会在 24 周时增加 HBV DNA 或乙型肝炎表面抗原。尽管 TDF 治疗期间 eGFR 恶化（-7.32±4.87 ml/min/1.73 m 2 ），但在从 TDF 转换为 TAF 后第 4 周（+3.93±6.18 ml/min/1.73 m 2 ；P=0.008）和第 24 周（+2.89±4.26 ml/min/1.73 m 2 ；P=0.020）时显著改善。
TDF 和 TAF 作为初治治疗均显示出足够的抗病毒效果。此外，从 TDF 转换为 TAF 治疗有助于维持抗病毒效果和恢复肾功能障碍。
