含替诺福韦的治疗方案对中国初治HIV/AIDS病人肾功能的影响

The impact on renal function of tenofovir-containing first-line anti-retroviral regimen among Chinese HIV-infected antiretroviral therapy-naive patients during 48 weeks

目的比较含和不含替诺福韦（TDF）的一线抗病毒治疗方案,在48周随访过程中,对中国初治艾滋病病毒（HIV）感染者/艾滋病（AIDS）病人肾功能的影响。方法将722例病人按照抗病毒治疗方案的不同分为TDF组（364例）和对照组（358例）,所有病人的临床资料和实验室数据均在病历中记录。定期随访两组人群在基线和治疗4、8、12、24、36、48周的肾功能,各个随访点的肌酐清除率通过CKD-EPI公式估算获得,肾小球滤过率（eGFR）下降超过基线的25%为肾脏损伤,计算两组人群的肾脏损伤的发病率,分析两组病人48周内血清肌酐值和肌酐清除率的动态变化。结果 TDF组HIV-1初治病人,接受含＂拉米夫定（3TC）＋TDF＋依非韦伦（EFV）＂的抗病毒治疗方案;对照组HIV-1初治病人,接受含＂3TC＋齐多夫定（AZT）/司坦夫定（D4T）＋奈韦拉平（NVP）/EFV＂的抗病毒治疗方案。治疗48周后,TDF组和对照组的肌酐清除率分别为68.2[四分位数间距（IQR）：60.0~79.0]mL/min和68.7（IQR：60.1~78.4）mL/min（P〈0.001）;eGFR〈基线的25%的发生率在TDF和对照组分别4.5/100人年和6.6/100人年（P=0.12）。肌酐值和肌酐清除率在48周的高效抗反转录病毒治疗（HAART）过程中的动态变化没有明显的统计学差异（P〉0.05）。结论含TDF的一线抗病毒治疗方案对肾功能正常的中国初治HIV-1病人的肾功能影响小,但由于随访时间有限,仍需要长时间随访以进一步评估TDF的肾毒性。

Objective The aim of the study was to compare the effects on renal function of Tenofovir Disoproxil Fumarate （TDF）-containing first-line highly active anti-retroviral therapy （HAART） with a non-TDF-containing HAART over 48 weeks in Chinese HIV-1 infected treatment-naive patients. Methods This was an observational study. Clinical and laboratory data of 722 HIV-1 infected adults on first-line HAART for 48 weeks were reviewed. Serum creatinine were monitored at baseline, 4, 8,12, 24 and 48 weeks in both two groups. Creatinine clearance （CLcr） was estimated by the CKD Epidemiology Collaboration （CKD-EPI） equation. The incidence of renal dys- function, defined as more than 25 % fall in estimated glomerular filtration rate （eGFR） from the baseline, was deter- mined in each group. Changes in serum creatinine and CLcr from the baseline to week 48 for patients were compared between the TDF-containing regimens and the non-TDF-containing regimens. Results 364 patients whose nucleo- side reverse transcriptase inhibitor （NRTI） backbone included TDF （TDF group：lamivudine（3TC）＋ TDF＋ efavir- dine（EFV）） were compared to 358 patients on other NRTI backbones （Control group： 3TC ＋ zidovudine （AZT） / stavudine （D4T） ＋ nevirapine（NVP）/EFV）. CLcr were 68. 2（IQR： 60. 0-79.0）mL/min vs. 68. 7（IQR： 60. 1-78. 4）mL/ min in the TDF-treated and non-TDF-containing arms, respectively （P〈0. 001）. After 48 weeks of therapy, the incidence of renal dysfunction in the tenofovir and the control arm was 4. 5 per 100 and 6. 6 per 100 person-years, respectively （P=0. 12）. No significant difference was found in the change of serum ereatinine and CLcr from the baseline to week 48 between the TDF- containing regimens and the non-TDF-containing regimens （P〉 0. 05）. Conclusion Compared with a non-TDF-eontaining HAART, the renal toxicity of TDF-containing HAART was minimal in Chinese HIV-1 infected treatment-naive patients withnormal renal function for 48 weeks. However, ART treatment is lifelong, it would be important to see CLCr trend over longer periods in further studies.