含艾博韦泰方案在住院晚期初治HIV/AIDS患者中的疗效和安全性

The Effectiveness and Safety of the Albuvirtide-Containing Regimen in Hospitalized ART-Naïve Patients with Advanced HIV Disease

目的探索含艾博韦泰(albuvirtide,ABT)方案在住院晚期初治HIV/AIDS患者中的疗效和安全性。方法回顾性收集2019年7月—2020年12月在成都市公共卫生临床医疗中心住院并且使用含ABT方案进行初治的晚期HIV/AIDS患者的相关资料,使用SAS软件(version 9.4)、重复测量的混合效应模型(MMRM)方法分析HIV-1 RNA、CD4的变化及其影响因素。结果共纳入120例患者,均合并严重机会性感染及使用多种合并用药。107例患者抗病毒治疗(antiretroviral the-rapy,ART)方案为ABT+整合酶抑制剂(integrase strand transfer inhibitors,INSTIs),13例患者为ABT+两种核苷类反转录酶抑制剂(two nucleoside reverse transcriptase inhibitors,2NRTIs)。120例患者基线HIV-1 RNA(5.43±0.06)lg10 copies/mL,基线CD428.00(12.00,70.00)cells/μL;ART 2周、4周,HIV-1 RNA较基线分别下降(2.58±0.09)lg10copies/mL(P<0.001)和(2.85±0.14)lg10copies/mL(P<0.001),CD4较基线分别上升19.50(6.50,87.75)cells/μL(P<0.001)、51.00(1.00,137.00)cells/μL(P<0.001)。ART方案、合并机会性感染数、合并用药数是影响ART疗效的重要因素。ART 2周,ABT+INSTIs较ABT+2NRTIs更能快速降低HIV-1 RNA(P<0.001),但在改善免疫功能方面,差异无统计学意义(P=0.50)。合并机会性感染数或合并用药数≥2种的患者免疫功能更差(P<0.001)。120例患者使用ABT期间,无患者发生5级不良反应及注射位点反应,无患者发生ART药物直接相关的严重不良事件,无患者因药物不良反应及药物间相互作用而停用或更换ART方案。结论住院晚期初治HIV/AIDS患者,使用含ABT方案能快速降低HIV-1 RNA,改善免疫功能,安全性良好;ABT+INSTIs方案较ABT+2NRTIs方案更能快速降低HIV-1 RNA。

Objective To explore the efficacy and safety of the albuvirtide(ABT)-containing regimen in hospitalized advanced HIV-infected ART-naïve patients.Methods This retrospective study included treatment naïve HIV/AIDS patients who were hospitalized and started ART treatment containing ABT in clinical section 1,department of Infectious Diseases,public health clinical center of Chengdu from July 2019 to December 2020.The changes of HIV-1 RNA,CD4+T counts and their influencing factors were analyzed using SAS software(version 9.4)and mixed model for repeated measures(MMRM)method.Results A total of 120 patients were included.All patients were complicated with severe opportunistic infections and co-administered with multiple drugs.The ART regimen of 107 patients was ABT+integrase inhibitors(INSTIs),and 13 patients were treated with ABT+two nucleoside transcriptase inhibitors(2NRTIs).In 120 patients,baseline HIV-1 RNA was(5.43±0.06)lg10copies/mL and baseline CD4 was 28.00(12.00,70.00)cells/μL.After 2 and 4 weeks of treatment,HIV-1 RNA decreased by(2.58±0.09)lg10copies/mL(P<0.001)and(2.85±0.14)lg10copies/mL(P<0.001),respectively.Meanwhile,CD4 increased from baseline by 19.50(6.50,87.75)cells/μL(P<0.001),51.00(1.00,137.00)cells/μL(P<0.001)after 2 and 4 weeks of treatment,respectively.ART regimen,opportunistic infection amounts and drug combination amounts were important factors affecting the efficacy of ART.After 2 weeks of ART,ABT+INSTI could reduce HIV-1 RNA more rapidly than ABT+2NRTIs(P<0.0001),but there was no significant difference in the improvement of immune function between the two groups(P=0.50).Patients whose combined opportunistic infections/medication≥2 had worse immune function(P<0.001).During the use of ABT,none of the patients had grade 5 adverse reactions,none of them had injection site reactions,and serious adverse events directly related to ART drugs.None of the patients discontinued or changed the ART regimen due to adverse drug reactions and drug interactions.Conclusion ABT-containing regimen can reduce HIV-1 RNA rapidly and improve immune function in hospitalized severe HIV/AIDS patients with good safety profile.The ABT+INSTIs regimen can reduced HIV-1 RNA more rapidly than the ABT+2NRTIs regimen.