艾博韦泰对HIV/AIDS合并肾功能损伤患者的疗效和安全性

The Effectiveness and Safety of Albuvirtide for HIV/AIDS Patients with Renal Function Impairment

目的观察艾博韦泰(ABT)联合蛋白酶抑制剂(PIs)或整合酶抑制剂(INSTIs)的抗逆转录病毒治疗(ART)方案在HIV/AIDS合并肾功能损伤患者的疗效和安全性。方法2021年3月—2023年3月期间,从郑州市第六人民医院感染科住院患者中筛选伴有肾功能损伤的HIV/AIDS初治或经治患者进入12周开放治疗。观察和比较基线及各治疗时间点HIV病毒载量(HIV RNA)、CD4^(+)T淋巴细胞(CD4^(+)T细胞)计数、肾功能等生化指标变化。结果入组30例患者,26例完成12周治疗。26例患者基线情况:男性为主(88.46%),平均年龄(51.77±14.49)岁,初治患者占50%,69.23%和46.15%患者分别合并机会性感染和慢性合并症。急性肾损伤5例,慢性肾损伤21例,平均肾小球滤过率(eGFR)为38.30(14.94,69.57)mL/(min·1.73 m^(2)),18例慢性肾损伤伴尿蛋白或尿微量白蛋白(ALB)阳性。4例HIV RNA≥105 CPs/mL,HIV RNA在最低检测线(40 CPs/mL)~10^(5)CPs/mL者12例;CD4^(+)T细胞计数<100个/μL 16例;ART治疗12周:初治、平稳转换、治疗失败患者病毒抑制率分别为76.92%(10/13)、100%(10/10)、100%(3/3)。CD4^(+)T细胞计数从基线75(28.75,203.75)个/μL升至156(90.25,359.25)个/μL,CD4^(+)/CD8^(+)比值从0.16(0.06,0.68)升至0.21(0.14,0.68),差异均有统计学意义(P<0.05)。12周eGFR、血清肌酐(Scr)、血红蛋白(Hb)较基线有好转,差异有统计学意义(P<0.05);12周后25例患者转换为口服ART方案,其中17例完成12个月随访。12个月时:15例HIV RNA低于最低检测线,平均CD4^(+)T细胞计数上升至212.00(102.50,333.00)个/μL,较12周时CD4^(+)T细胞计数130.00(95.00,229.00)个/μL相比,差异有统计学意义(P<0.05)。结论含有艾博韦泰ART方案治疗26例HIV/AIDS合并肾功能损伤患者取得良好的病毒抑制和免疫应答,同时具有良好的安全性,后续扩大样本值得进一步研究。

Objective To analyze the curative effect and safety of Albuvirtide(ABT)combined with protease inhibitors(PIs)or integrase inhibitors(INSTIs)as a novel antiretroviral therapy(ART)for HIV/AIDS patients with renal function impairment.Methods From March 2021 to March 2023,HIV/AIDS patients with impaired renal function,whether ART-na ve or ART-experienced(including virologically-suppressed and treatment-failed patients),were selected from the Infection Department of the Sixth People′s Hospital of Zhengzhou and enrolled in a 12-week open-label treatment.Changes in HIV viral load(HIV RNA),CD4^(+)T lymphocyte(CD4^(+)T)count,and renal function were compared at baseline and various time points during treatment.Results A total of 30 patients were enrolled,of which 26 completed the 12-week treatment and follow-up.The patients were mainly male(23/26,88.46%),with an average age of(51.77±14.49)years.The ART-na ve patients accounted for 50%(13/26).Of the 26 patients,69.23%experienced opportunistic infection,46.15%had chronic complications,5 had acute kidney injury and 21 had chronic kidney injury.The average glomerular filtration rate(eGFR)at baseline was 38.30(14.94,69.57)mL/(min·1.73 m^(2)),with urinary protein or micro-albumin positive in 18 of 21 chronic kidney injury patients.At baseline,4 patients had HIV RNA levels of 105 CPs/mL or more and 12 patients had HIV RNA load between 40 CPs/mL and 10^(5)CPs/mL.Sixteen patients had a CD4^(+)T count of less than 100 cells/μL.After 12 weeks of antiretroviral therapy,the virologic suppression rate was 76.92%(10/13)in treatment-na ve patients,100.00%(10/10)in virologically-suppressed patients and 100.0%(3/3)in treatment-failed patients.The average CD4^(+)T count increased significantly from 75(28.75,203.75)cells/μL at baseline to 156(90.25,359.25)cells/μL(P<0.05);the CD4^(+)/CD8^(+)ratio also increased significantly from 0.16(0.06,0.68)at baseline to 0.21(0.14,0.68)(P<0.05).At week 12,improvement was observed in eGFR,serum creatinine(Scr),and hemoglobin(Hb)compared to baseline(P<0.05).After 12 weeks,25 patients switched to oral ART regimens,and 17 patients completed a 12-month follow-up.After the end of 12 months,the virologic suppression rate was 88.24%(15/17),and the CD4^(+)T count had significantly increased to 212.00(102.50,333.00)cells/μL,compared to 130.00(95.00,229.00)cells/μL at week 12(P<0.05).Conclusion The treatment of 26 HIV/AIDS patients with renal function impairment using ABT-containing ART regimen achieved good virological suppression and immune response,and was also found to be safe.Further studies with a larger sample size are recommended.