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Efficacy and Renal Safety of Long-Term
Tenofovir Disoproxil Fumarate Therapy in
Chronic Hepatitis B Patients with Normal
or Mild Renal Dysfunction (eGFR ≥60 mL/
min/1.73m2)
In Hee KIM, Chang Hun Lee, Seong Hun Kim, Sang Wook
Kim, Seung Ok Lee and Soo Teik Lee, Internal Medicine,
Chonbuk National University Medical School, Research
Institute of Clinical Medicine of Chonbuk National University-
Biomedical Research Institute of Chonbuk National University
Hospital
Background: We aimed to compare efficacy and renal safety
of long-term tenofovir disoproxil fumarate (TDF) therapy in
chronic hepatitis B patients with normal versus mild renal
dysfunction. Methods: We reviewed both treatment-naïve
or –experienced CHB patients who had treated with TDFbased
therapy between August 2012 and December 2017
at Chonbuk National University Hospital. Study patients
had divided into group I, normal renal function, defined
as estimated glomerular filtration rate (eGFR) ≥90 mL/
min/1.73m2 or group II, mild renal dysfunction, defined as
eGFR 60-90 mL/min/1.73m2. Renal impairment was defined
as elevation of serum creatinine 0.3 mg/dL above the baseline
level or a decrease of eGFR < 60 mL/min/1.73m2. Results: A
total of 426 patients (371 patients in group I and 55 patients
in group II) were included for analysis. The mean eGFR were
107.5 ± 11.2 mL/min/1.73m2 and 80.5 ± 8.6 mL/min/1.73m2 in
group I and group II, respectively. In a comparison of baseline
characteristics, group II patients were older. The treatment
outcomes showed favorable results for both group I and
group II without significant difference between the two groups.
Regarding renal safety, the incidence of renal impairment
during TDF therapy was low both in group I and group II, and
overall renal impairment was 2.9%, 1.8%, and 1.7% at 1-year,
2-year, and 3-year follow-ups, respectively. Although the
cumulative rates of virologic response were similar between
group I and group II, the cumulative rates of renal impairment
were significantly high in group II (P = 0.003). In a multivariate
analysis, the presence of diabetes mellitus and initial mild
renal dysfunction (eGFR 60-90 mL/min/1.73m2) were
associated with increased risk of renal toxicity. Conclusion:
TDF therapy is an effective treatment option among CHB
patients with conserved renal function at baseline. However,
underlying diabetes mellitus and initial mild renal dysfunction
(eGFR 60-90 mL/min/1.73m2) may increase the risk of renal
toxicity.作者: StephenW 时间: 2018-10-17 18:57
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长期疗效和肾脏安全性
替诺福韦地索普西富马酸盐治疗
慢性乙型肝炎患者正常
或轻度肾功能不全（eGFR≥60mL/
分钟/1.73平方米）
在Hee KIM，Chang Hun Lee，Seong Hun Kim，Sang Wook
Kim，Seung Ok Lee和Soo Teik Lee，内科，
全北大学医学院，研究
全北国立大学临床医学研究所 -
全北大学生物医学研究所
医院
背景：我们的目的是比较疗效和肾脏安全性
长期替诺福韦地索普西富马酸盐（TDF）治疗
慢性乙型肝炎患者，肾功能正常与轻度
功能障碍。方法：我们回顾了两种治疗方法
或经验丰富的CHB患者接受TDF治疗
2012年8月至2017年12月期间的治疗
在全北国立大学医院。研究患者
分为Ⅰ组，肾功能正常，定义明确
估计肾小球滤过率（eGFR）≥90mL/
min / 1.73m2或II组，轻度肾功能不全，定义为
eGFR 60-90 mL / min / 1.73m2。确定了肾功能损害
血清肌酐升高至基线以上0.3 mg / dL
eGFR水平或降低<60 mL / min / 1.73m2。结果：A
总共426名患者（第一组371名患者和55名患者）
在第II组中包括用于分析。平均eGFR是
107.5±11.2 mL / min / 1.73m2和80.5±8.6 mL / min / 1.73m2 in
第一组和第二组。在比较基线
特征，II组患者年龄较大。治疗
结果显示I组和I组均有良好的结果
第二组两组间无显着差异。
关于肾脏安全性，肾功能损害的发生率
在第一组和第二组中，TDF治疗期间均较低，并且
1年时整体肾功能损害为2.9％，1.8％和1.7％，
分别为2年和3年的随访。虽然
病毒学应答的累积率相似
第一组和第二组，肾功能损害的累积率
II组显着高（P = 0.003）。在多变量
分析，糖尿病和初始轻度的存在
肾功能不全（eGFR 60-90 mL / min / 1.73m2）
与肾毒性风险增加有关。结论：
TDF疗法是CHB中有效的治疗选择
基线时保守肾功能的患者。然而，
潜在的糖尿病和初期轻度肾功能不全
（eGFR 60-90 mL / min / 1.73m2）可能增加肾脏的风险
毒性。