Earlier versus later start of antiretroviral therapy in HIV-infected adults with tuberculosis.
Earlier versus later start of antiretroviral therapy in HIV-infected adults with tuberculosis.
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DOI：
10.1056/nejmoa1013911
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发表时间：
2011-10-20
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影响因子：
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通讯作者：
CAMELIA (ANRS 1295–CIPRA KH001) Study Team
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文献类型：
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作者：
Blanc FX;Sok T;Laureillard D;Borand L;Rekacewicz C;Nerrienet E;Madec Y;Marcy O;Chan S;Prak N;Kim C;Lak KK;Hak C;Dim B;Sin CI;Sun S;Guillard B;Sar B;Vong S;Fernandez M;Fox L;Delfraissy JF;Goldfeld AE;CAMELIA (ANRS 1295–CIPRA KH001) Study Team
结核病仍然是人类免疫缺陷病毒（HIV）感染者死亡的一个重要原因。关于开始抗逆转录病毒治疗（ART）与开始抗结核治疗的时间，缺乏可靠的数据。我们检验了这样一个假设，即开始抗逆转录病毒治疗的时间会显著影响以前未接触过抗逆转录病毒药物、新诊断为结核病且CD4+ t细胞计数为每立方毫米200或更低的成年人的死亡率。在开始标准的6个月结核病治疗后，患者被随机分配到早期治疗（开始结核病治疗后2周）或晚期治疗（开始结核病治疗后8周），使用司他夫定、拉米夫定和依非韦伦。主要终点是生存。共有661名患者入组，随访时间中位数为25个月。中位数CD4+ t细胞计数为每立方毫米25个，中位数病毒载量为每毫升5.64 log10个拷贝。较早接受抗逆转录病毒治疗组的死亡风险显著降低，332例患者中有59例死亡（18%），而较晚接受抗逆转录病毒治疗组的329例患者中有90例死亡（27%）（风险比0.62；95%可信区间[CI]； 0.44至0.86;P = 0.006）。早期抗逆转录病毒治疗组结核病相关免疫重建炎症综合征的风险显著增加（风险比2.51;95% CI, 1.78 ~ 3.59； P<0.001）。无论研究组如何，CD4+ t细胞计数的中位数增加为每立方毫米114个，96.5%的患者在第50周无法检测到病毒载量。在结核病治疗开始2周后开始抗逆转录病毒治疗，可显著提高CD4+ t细胞计数为每立方毫米200或更低的hiv感染成人的生存率。（由法国国家艾滋病和病毒性肝炎研究机构和国立卫生研究院资助；CAMELIA ClinicalTrials.gov编号，NCT01300481。）
Tuberculosis remains an important cause of death among patients infected with the human immunodeficiency virus (HIV). Robust data are lacking with regard to the timing for the initiation of antiretroviral therapy (ART) in relation to the start of antituberculosis therapy. We tested the hypothesis that the timing of ART initiation would significantly affect mortality among adults not previously exposed to antiretroviral drugs who had newly diagnosed tuberculosis and CD4+ T-cell counts of 200 per cubic millimeter or lower. After beginning the standard, 6-month treatment for tuberculosis, patients were randomly assigned to either earlier treatment (2 weeks after beginning tuberculosis treatment) or later treatment (8 weeks after) with stavudine, lamivudine, and efavirenz. The primary end point was survival. A total of 661 patients were enrolled and were followed for a median of 25 months. The median CD4+ T-cell count was 25 per cubic millimeter, and the median viral load was 5.64 log10 copies per milliliter. The risk of death was significantly reduced in the group that received ART earlier, with 59 deaths among 332 patients (18%), as compared with 90 deaths among 329 patients (27%) in the later-ART group (hazard ratio, 0.62; 95% confidence interval [CI]; 0.44 to 0.86; P = 0.006). The risk of tuberculosis-associated immune reconstitution inflammatory syndrome was significantly increased in the earlier-ART group (hazard ratio, 2.51; 95% CI, 1.78 to 3.59; P<0.001). Irrespective of the study group, the median gain in the CD4+ T-cell count was 114 per cubic millimeter, and the viral load was undetectable at week 50 in 96.5% of the patients. Initiating ART 2 weeks after the start of tuberculosis treatment significantly improved survival among HIV-infected adults with CD4+ T-cell counts of 200 per cubic millimeter or lower. (Funded by the French National Agency for Research on AIDS and Viral Hepatitis and the National Institutes of Health; CAMELIA ClinicalTrials.gov number, NCT01300481.)