Dataset Information

High Incidence of Tuberculosis Infection in HIV-exposed Children Exiting an Isoniazid Preventive Therapy Trial.

ABSTRACT: Young HIV-exposed children are at high risk for TB infection. We performed QuantiFERON-TB Gold among HIV-exposed children in South Africa at enrolment and 1-year follow-up. The incidence of TB infection was high for HIV+ (11 cases per 100 child-years) and HIV-exposed uninfected children (15 cases per 100 child-years). QuantiFERON-TB Gold may identify HIV-exposed children at risk for TB disease progression.

SUBMITTER: Cranmer LM

PROVIDER: S-EPMC6095832 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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High Incidence of Tuberculosis Infection in HIV-exposed Children Exiting an Isoniazid Preventive Therapy Trial.

Cranmer Lisa M LM Draper Heather R HR Mandalakas Anna M AM Kim Soyeon S McSherry George G Krezinski Emma E Coetzee Joan J Mitchell Charles C Nachman Sharon S van der Linde Mercia M Cotton Mark F MF Hesseling Anneke C AC

The Pediatric infectious disease journal 20181001 10

Young HIV-exposed children are at high risk for TB infection. We performed QuantiFERON-TB Gold among HIV-exposed children in South Africa at enrolment and 1-year follow-up. The incidence of TB infection was high for HIV+ (11 cases per 100 child-years) and HIV-exposed uninfected children (15 cases per 100 child-years). QuantiFERON-TB Gold may identify HIV-exposed children at risk for TB disease progression. ...[more]

PMID: 29462104

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Project description:The dual epidemic of human immunodeficiency virus (HIV) and tuberculosis is a major cause of sickness and death in sub-Saharan Africa. We conducted a double-blind, randomized, placebo-controlled trial of preexposure isoniazid prophylaxis against tuberculosis in HIV-infected children and uninfected children exposed to HIV during the perinatal period.We randomly assigned 548 HIV-infected and 804 HIV-uninfected infants (91 to 120 days of age) to isoniazid (10 to 20 mg per kilogram of body weight per day) or matching placebo for 96 weeks. All patients received bacille Calmette-Guérin (BCG) vaccination against tuberculosis within 30 days after birth. HIV-infected children had access to antiretroviral therapy. The primary outcome measures were tuberculosis disease and death in HIV-infected children and latent tuberculosis infection, tuberculosis disease, and death in HIV-uninfected children within 96 to 108 weeks after randomization.Antiretroviral therapy was initiated in 98.9% of HIV-infected children during the study. Among HIV-infected children, protocol-defined tuberculosis or death occurred in 52 children (19.0%) in the isoniazid group and 53 (19.3%) in the placebo group (P=0.93). Among HIV-uninfected children, there was no significant difference in the combined incidence of tuberculosis infection, tuberculosis disease, or death between the isoniazid group (39 children, 10%) and the placebo group (45 children, 11%; P=0.44). The rate of tuberculosis was 121 cases per 1000 child-years (95% confidence interval [CI], 95 to 153) among HIV-infected children as compared with 41 per 1000 child-years (95% CI, 31 to 52) among HIV-uninfected children. There were no significant differences in clinical or severe laboratory toxic effects between treatment groups.Primary isoniazid prophylaxis did not improve tuberculosis-disease-free survival among HIV-infected children or tuberculosis-infection-free survival among HIV-uninfected children immunized with BCG vaccine. Despite access to antiretroviral therapy, the burden of tuberculosis remained high among HIV-infected children. (Funded by the National Institutes of Health and Secure the Future; ClinicalTrials.gov number, NCT00080119.).

Project description:BackgroundIPT with or without concomitant administration of ART is a proven intervention to prevent tuberculosis among PLHIV. However, there are few data on the routine implementation of this intervention and its effectiveness in settings with limited resources.ObjectivesTo measure the level of uptake and effectiveness of IPT in reducing tuberculosis incidence in a cohort of PLHIV enrolled into HIV care between 2007 and 2010 in five hospitals in southern Ethiopia.MethodsA retrospective cohort analysis of electronic patient database was done. The independent effects of no intervention, "IPT-only," "IPT-before-ART," "IPT-and-ART started simultaneously," "ART-only," and "IPT-after-ART" on TB incidence were measured. Cox-proportional hazards regression was used to assess association of treatment categories with TB incidence.ResultsOf 7,097 patients, 867 were excluded because they were transferred-in; a further 823 (12%) were excluded from the study because they were either identified to have TB through screening (292 patients) or were on TB treatment (531). Among the remaining 5,407 patients observed, IPT had been initiated for 39% of eligible patients. Children, male sex, advanced disease, and those in Pre-ART were less likely to be initiated on IPT. The overall TB incidence was 2.6 per 100 person-years. As compared to those with no intervention, use of "IPT-only" (aHR = 0.36, 95% CI = 0.19-0.66) and "ART-only" (aHR = 0.32, 95% CI = 0.24-0.43) were associated with significant reduction in TB incidence rate. Combining ART and IPT had a more profound effect. Starting IPT-before-ART (aHR = 0.18, 95% CI = 0.08-0.42) or simultaneously with ART (aHR = 0.20, 95% CI = 0.10-0.42) provided further reduction of TB at ? 80%.ConclusionsIPT was found to be effective in reducing TB incidence, independently and with concomitant ART, under programme conditions in resource-limited settings. The level of IPT provision and effectiveness in reducing TB was encouraging in the study setting. Scaling up and strengthening IPT service in addition to ART can have beneficial effect in reducing TB burden among PLHIV in settings with high TB/HIV burden.

Project description:BACKGROUND:Tuberculosis (TB) and HIV makeup a deadly synergy of infectious disease, and the combined effect is apparent in resource limited countries like Ethiopia. Previous studies have demonstrated inconsistent results about the protective effect of isoniazid preventive therapy (IPT) on active TB incidence among HIV positive patients receiving ART. Therefore, the aim of this meta-analysis was, first, to determine the protective effect of IPT on active tuberculosis incidence, and second, to assess the pooled incidence of active TB among HIV positive patients taking ART with and without IPT intervention in Ethiopia. METHODS:PubMed, Google scholar and Cochran library databases were searched from April 1 to 30, 2018. Two independent authors explored and assessed studies for eligibility, and extracted data based on predefined criteria. Studies that reported TB incidence among HIV positive patients taking ART in Ethiopia with and without IPT concomitant intervention, and with a clear stratified data on the incidence of TB based on the duration of IPT intervention were selected. A random effects model was used to estimate risk ratios and the pooled incident TB with the respective 95% confidence intervals. RESULTS:We identified 7 suitable studies in this analysis. Accordingly, IPT reduced the risk of TB incidence by 74%, risk ratio (RR) 0.26 (95% CI; 0.16-0.43%), compared to no IPT group. Moreover, IPT for 12?months reduced incident TB by 91% (RR: 0.09, 95% CI: 0.04 to 0.21), whereas 6?months IPT averted TB incidence by 63% (RR: 0.37, 95% CI: 0.26 to 0.52). The overall pooled incident TB among HIV infected patients receiving ART was 10.30% (95% CI; 7.57-13.02%). Specifically, incident TB among study cohorts with and without IPT was 3.79% (95% CI; 2.03-5.55%) and 16.32% (95% CI; 11.57-21.06%) respectively. CONCLUSION:IPT reduced the risk of incident TB among HIV positive patients receiving ART in Ethiopian settings. Moreover, the duration of IPT intervention has effect on its protective role. Thus, scaling up the isoniazid preventive therapy program and its strict compliance is necessary to avert HIV fueled tuberculosis. STUDY PROTOCOL REGISTRATION:CRD42018090804.

Dataset Information

High Incidence of Tuberculosis Infection in HIV-exposed Children Exiting an Isoniazid Preventive Therapy Trial.

Publications

High Incidence of Tuberculosis Infection in HIV-exposed Children Exiting an Isoniazid Preventive Therapy Trial.

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