摘要目的 分析人类免疫缺陷病毒(HIV)初治患者联合艾博韦泰(ABT)抗逆转录病毒治疗(ART)的效果及安全性。方法 回顾性分析2021-03至2022-03天津市第二人民医院启动ART的163例患者,分为复方单片整合酶抑制剂(INSTIs)治疗组(单药治疗组)及ABT联合复方单片INSTIs治疗组(联合治疗组),分别采用INSTIs治疗及ABT联合复方单片INSTIs治疗,评估联合ABT治疗的病毒学抑制率、免疫恢复程度及安全性。结果 共纳入57例ABT+复方单片INSTIs联合治疗及106例复方单片INSTIs治疗患者。联合治疗组在第4周、12周病毒学抑制率高于单药治疗组,但无统计学差异(4周61.1% vs. 53.1%,P=0.618; 12周87.8% vs. 81.5%,P=0.801),此后至随访48周,两组病毒学抑制率相当。联合治疗组的CD4计数在治疗第4周(中位数358 vs. 194, P=0.042)、12周(中位数331 vs. 249, P=0.044)均高于单药治疗组,CD4/CD8比率联合治疗组在治疗第4周(中位数0.28 vs. 0.17, P=0.036)、12周(中位数0.33 vs. 0.19, P=0.049)也高于单药治疗组,此后至随访48周,两组CD4计数,CD4/CD8比率在各随访点无显著统计学差异。联合ABT治疗12周期间,仅1例患者出现轻度过敏性皮炎,无其他不良事件发生。结论 ABT联合复方单片INSTIs对HIV初治患者的安全性、耐受性良好,治疗12周内可快速升高CD4,降低病毒载量。
Abstract：Objective To evaluate the efficacy and safety of albuvirtide therapy (ABT) combined with antiretroviral therapy (ART)in newly treated HIV patients. Methods A total of 163 patients with ART initiated in Tianjin Second People's Hospital from March 2021 to March 2022 were retrospectively analyzed and divided into compound monolithic integrase inhibitors (INSTIs) treatment group and the group of INSTIs combined with ABT. Virological inhibition, immune recovery, and safety were evaluated in the two groups of newly treated HIV patients treated with baseline age, sex, and CD4 count-matched combined monolithic integrase inhibitors (INSTIs) and ABT combined with combined INSTIs. Results A total of 57 patients with ABT plus INSTIs and 106 patients with INSTIs were included. The rate of virological inhibition in the combined treatment group was higher than that in the monotherapy group at week 4 and 12, but there was no significant difference (61.1% vs. 53.1% at week 4, P=0.618; 87.8% vs. 81.5% at 12 weeks, P=0.801), and virological inhibition rates were comparable between the two groups through 48 weeks of follow-up. CD4 count in the combination treatment group was higher than that in the monotherapy group at week 4 (median 358 vs. 194, P=0.042) and week 12 (median 331 vs. 249, P=0.044). CD4/CD8 ratios were also higher in the combined treatment group at week 4 (median 0.28 vs. 0.17, P=0.036) and week 12 (median 0.33 vs. 0.19, P=0.049) than in the monotherapy group, and CD4 counts were higher in both groups until 48 weeks of follow-up. There was no significant difference in CD4/CD8 ratio at each follow-up point. During 12 weeks of ABT treatment, only 1 patient developed mild atopic dermatitis, and no other adverse events occurred. Conclusions ABT combined with INSTIs is safe and well tolerated in patients with initial treatment of HIV, which can rapidly increase CD4 and decrease viral load within 12 weeks of treatment.
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