Children's Infectious Diseases Clinical Research Unit, Department of Paediatrics & Child Health, Stellenbosch University and Tygerberg Children's Hospital, Cape Town, South Africa.
Int J Tuberc Lung Dis. 2011 Sep;15(9):1194-200, i. doi: 10.5588/ijtld.10.0721.
Two centres in Soweto and Cape Town, South Africa.
To assess the effects of timing of initiation of antiretroviral treatment (ART) and other factors on the risk of bacille Calmette-Guérin (BCG) related regional adenitis due to immune reconstitution inflammatory syndrome (BCG-IRIS) in human immunodeficiency virus (HIV) infected infants.
HIV-infected infants aged 6-12 weeks with CD4 count ≥25% enrolled in the Children with HIV Early Antiretroviral Therapy (CHER) Trial received early (before 12 weeks) or deferred (after immunological or clinical progression) ART; infants with CD4 count <25% all received early ART. All received BCG vaccination after birth. Reactogenicity to BCG was assessed prospectively during routine study follow-up.
Of 369 infants, 32 (8.7%) developed BCG-IRIS within 6 months of starting ART, 28 (88%) within 2 months after ART initiation. Of the 32 cases, 30 (93.8%) had HIV-1 RNA > 750 000 copies/ml at initiation. Incidence of BCG-IRIS was 10.9 and 54.3 per 100 person-years (py) among infants with CD4 count ≥25% at enrolment receiving early (at median age 7.4 weeks) vs. deferred (23.2 weeks) ART, respectively (HR 0.24, 95%CI 0.11-0.53, P < 0.001). Infants with CD4 count <25% receiving early ART had intermediate incidence (41.7/100 py). Low CD4 counts and high HIV-1 RNA at initiation were the strongest independent risk factors for BCG-IRIS.
Early ART initiation before immunological and/or clinical progression substantially reduces the risk of BCG-IRIS regional adenitis.
南非索韦托和开普敦的两个中心。
评估抗逆转录病毒治疗（ART）开始时间和其他因素对因免疫重建炎症综合征（BCG-IRIS）而导致的人类免疫缺陷病毒（HIV）感染婴儿感染卡介苗（BCG）相关局部淋巴结炎风险的影响。
6-12 周龄、CD4 计数≥25%的 HIV 感染婴儿参加了儿童 HIV 早期抗逆转录病毒治疗（CHER）试验，他们接受了早期（12 周前）或延迟（免疫或临床进展后）ART；CD4 计数<25%的所有婴儿均接受早期 ART。所有婴儿均在出生后接种 BCG 疫苗。在常规研究随访期间，前瞻性评估 BCG 的反应性。
在 369 名婴儿中，有 32 名（8.7%）在开始 ART 后 6 个月内出现 BCG-IRIS，其中 28 名（88%）在 ART 开始后 2 个月内出现。在 32 例病例中，30 例（93.8%）在开始时 HIV-1 RNA>750000 拷贝/ml。在基线 CD4 计数≥25%的婴儿中，早期（中位年龄为 7.4 周）与延迟（23.2 周）ART 相比，BCG-IRIS 的发生率分别为 10.9 和 54.3/100 人年（py）（HR 0.24，95%CI 0.11-0.53，P<0.001）。CD4 计数<25%的婴儿接受早期 ART 的发生率居中（41.7/100 py）。起始时低 CD4 计数和高 HIV-1 RNA 是 BCG-IRIS 的最强独立危险因素。
在免疫和/或临床进展之前，早期开始 ART 可显著降低 BCG-IRIS 局部淋巴结炎的风险。
