Medicine (Baltimore). 2019 Oct;98(42):e17590. doi: 10.1097/MD.0000000000017590.
Efficacy and safety of tenofovir disoproxil fumarate in Chinese patients with chronic hepatitis B virus infection: A 2-year prospective study.
Zheng S1,2, Liu L1,2, Lu J1,2, Zhang X1,2, Shen H2, Zhang H2, Xue Y1,2, Lin L2,3.
Author information
1
Department of Liver Diseases.
2
Institute for the Study of Liver Diseases.
3
Department of Pharmacy, The Third People's Hospital of Changzhou, Changzhou, Jiangsu, China.
Abstract
To date, a small number of studies concerning the effects and safety of tenofovir disoproxil fumarate (TDF) in Chinese individuals were conducted. In this study, we aimed to assess the antiviral effects and nephrotoxicity of TDF in Chinese patients with chronic hepatitis B virus (HBV) infection.Patients with chronic HBV infection were prospectively recruited and TDF treatment was given for 96 weeks. HBV serologic markers, HBV DNA, creatinine and phosphorus were collected.Fifty-seven treatment-naïve and 48 treatment-experienced patients were recruited. Irrespective of the prior treatment history, more than 95% of patients achieved virological response during 96 weeks treatment with TDF. Estimated glomerular filtration rate (eGFR) significantly declined in the first year of treatment in patients with chronic hepatitis B or younger age (<65 years old) (both P < .05), while that was not achieved in patients with liver cirrhosis or older age (≥65 years old) (both P > .05). For patients who were treatment-naïve or treated previously with adefovir dipivoxil, eGFR declined at the 48th week; however, eGFR was partially recovered at the 96th week. Furthermore, multivariable analysis showed that basal eGFR <90 mL/min/1.73 m (P = .001; odds ratio: 4.821; 95% confidence interval: 1.904-12.206) is the only independent risk factor for eGFR <90 mL/min/1.73 m at the 96th week.TDF has potent antiviral effect in both treatment-naïve and treatment-experienced patients.
迄今为止，已进行了少量有关富马酸替诺福韦酯（TDF）在中国个体中的作用和安全性的研究。在这项研究中，我们旨在评估TDF在中国慢性乙型肝炎病毒（HBV）感染患者中的抗病毒作用和肾毒性。预期招募患有慢性HBV感染的患者并给予TDF治疗96周。收集HBV血清学指标，HBV DNA，肌酐和磷水平。未接受治疗的有57名患者，有48名接受过治疗的患者。无论先前的治疗史如何，超过95％的患者在TDF治疗96周期间均达到了病毒学应答。慢性乙型肝炎或更年轻（<65岁）（均P <.05）的患者在治疗的第一年，估计的肾小球滤过率（eGFR）显着下降，而肝硬化或更高年龄的患者则未达到年龄（≥65岁）（均P> .05）。对于未接受过治疗或先前接受过阿德福韦酯治疗的患者，eGFR在第48周下降；但是，eGFR在第96周部分恢复。此外，多变量分析表明，基础eGFR <90 mL / min / 1.73 m（P = .001；优势比：4.821； 95％置信区间：1.904-12.206）是eGFR <90 mL / min /的唯一独立危险因素。在第96周时1.73m。TDF对未接受治疗和有治疗经验的患者均具有有效的抗病毒作用。