Timing of antiretroviral therapy for HIV-1 infection and tuberculosis.
Timing of antiretroviral therapy for HIV-1 infection and tuberculosis.
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DOI：
10.1056/nejmoa1013607
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发表时间：
2011-10-20
期刊：
影响因子：
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通讯作者：
AIDS Clinical Trials Group Study A5221
中科院分区：
文献类型：
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作者：
Havlir DV;Kendall MA;Ive P;Kumwenda J;Swindells S;Qasba SS;Luetkemeyer AF;Hogg E;Rooney JF;Wu X;Hosseinipour MC;Lalloo U;Veloso VG;Some FF;Kumarasamy N;Padayatchi N;Santos BR;Reid S;Hakim J;Mohapi L;Mugyenyi P;Sanchez J;Lama JR;Pape JW;Sanchez A;Asmelash A;Moko E;Sawe F;Andersen J;Sanne I;AIDS Clinical Trials Group Study A5221
抗逆转录病毒治疗（ART）适用于感染HIV-1的患者的结核病（TB）治疗，但对于不同程度免疫受损的患者在结核病诊断时开始抗逆转录病毒治疗的紧迫性尚不清楚。我们进行了一项开放标签随机研究，比较CD4+淋巴细胞< 250/mm3并疑似结核病的HIV-1感染患者立即（开始治疗2周内）和早期（8-12周）抗逆转录病毒治疗。主要研究终点是在48周内没有艾滋病定义疾病的患者的比例。809例患者的中位基线CD4+淋巴细胞为77细胞/mm3， HIV-1 RNA为5.43 log10拷贝/mL。在立即治疗组中，12.9%的患者在48周内出现艾滋病定义疾病或死亡，而早期治疗组为16.1% （p=0.45； 95%可信区间（CI）差异：−1.8%,8.1%）。在筛查CD4+淋巴细胞<50 cells/mm3的患者中，直接治疗组15.5%的患者与早期抗逆转录病毒治疗组26.6%的患者经历了艾滋病定义的疾病或死亡（p=0.02；差异CI: 1.5%, 20.5%）。结核病免疫重建炎症综合征（IRIS）在立即ART治疗中更为常见（11% vs. 5%: p=0.002）。48周时病毒抑制率为74%，两组间无差异（p=0.38）。总的来说，与早期抗逆转录病毒治疗相比，立即抗逆转录病毒治疗并没有减少艾滋病定义疾病和死亡。对于CD4+淋巴细胞< 50个细胞/mm3的人，与早期抗逆转录病毒治疗相比，立即接受抗逆转录病毒治疗的艾滋病定义疾病和死亡减少42%。（ClinicalTrial.gov号码NCT00108862。）
Antiretroviral therapy (ART) is indicated during tuberculosis (TB) treatment of patients infected with HIV-1, but the urgency to start ART at TB diagnosis for patients of varying levels of immune compromise is not known. We conducted an open label, randomized study comparing immediate (within 2 weeks of TB treatment initiation) to early (8–12 weeks) ART among HIV-1 infected patients with CD4+ lymphocytes < 250/mm3 and suspected TB. The primary study endpoint was proportion of patients who survived without an AIDS-defining illness at 48 weeks. 809 patients with median baseline CD4+ lymphocytes of 77 cells/mm3 and HIV-1 RNA of 5.43 log10 copies/mL were enrolled. In the immediate arm, 12.9% of patients experienced an AIDS-defining illness or death by 48 weeks compared to 16.1% in the early arm (p=0.45; 95% confidence interval (CI) for difference: −1.8%, 8.1%). In patients with screening CD4+ lymphocytes <50 cells/mm3, 15.5% of patients on the immediate arm vs. 26.6% on early ART experienced an AIDS defining illness or death (p=0.02; difference CI: 1.5%, 20.5%). TB immune reconstitution inflammatory syndrome (IRIS) was more common with immediate ART (11% vs. 5%: p=0.002). Viral suppression at 48 weeks was 74% and did not differ between arms (p=0.38). Overall, immediate ART did not reduce AIDS-defining illnesses and death compared to early ART. For persons with CD4+ lymphocytes < 50 cells/mm3, immediate ART had 42% less AIDS defining illnesses and death compared to early ART. (ClinicalTrial.gov number NCT00108862.)