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Randomized Controlled Trial
. 2011 Sep;15(9):1194-200, i.
doi: 10.5588/ijtld.10.0721.

Early antiretroviral treatment reduces risk of bacille Calmette-Guérin immune reconstitution adenitis

H Rabie  1 , A Violari, T Duong, S A Madhi, D Josipovic, S Innes, E Dobbels, E Lazarus, R Panchia, A G Babiker, D M Gibb, M F Cotton; CHER team
Affiliations
Randomized Controlled Trial

Early antiretroviral treatment reduces risk of bacille Calmette-Guérin immune reconstitution adenitis

H Rabie et al. Int J Tuberc Lung Dis. 2011 Sep.

Abstract

Setting: Two centres in Soweto and Cape Town, South Africa.

Objective: 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.

Design: 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.

Results: 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.

Conclusions: Early ART initiation before immunological and/or clinical progression substantially reduces the risk of BCG-IRIS regional adenitis.

Keywords: BCG; immune reconstitution inflammatory syndrome; paediatric HIV.

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Figures

Figure 1
Figure 1
Kaplan-Meir curves of time from starting ART to diagnosis of BCG-related regional adenitis, by ART groups.
See this image and copyright information in PMC

References

    1. Bhat GJ, Diwan VK, Chintu C, et al. HIV, BCG and TB in children: a case control study in Lusaka, Zambia. J Trop Pediatr. 1993;39:219–223. - PubMed
    1. Mansoor N, Scriba TJ, de Kock M, et al. HIV-1 infection in infants severely impairs the immune response induced by bacille Calmette-Guerin vaccine. J Infect Dis. 2009;199:982–990. - PMC - PubMed
    1. Trunz BB, Fine P, Dye C. Effect of BCG vaccination on child-hood tuberculous meningitis and miliary tuberculosis world wide: a meta-analysis and assessment of cost-effectiveness. Lancet. 2006;367:1173–1180. - PubMed
    1. Azzopardi P, Bennett CM, Graham SM, Duke T. Bacille Calmette-Guérin vaccine-related disease in HIV-infected children: a systematic review. Int J Tuberc Lung Dis. 2009;13:1331–1344. - PubMed
    1. Revised BCG vaccination guidelines for infants at risk for HIV infection. Wkly Epidemiol Rec. 2007;82:193–196. - PubMed

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