Recent changes to World Health Organization guidelines for starting anti-AIDS drugs (antiretroviral therapy—ART) in young children are unlikely to improve death rates but may increase the numbers of children receiving ART by simplifying access to treatment, according to a study by international researchers published in this week’s PLOS Medicine.
The findings from a study, led by Michael Schomaker from the University of Cape Town in South Africa, suggest that, among southern African children aged 2-5 years at HIV diagnosis, there was no difference in three year death rates between children in whom ART was started immediately and those in whom starting ART was deferred until their CD4 count and percentage (markers of progression of HIV infection) fell below 750 cells/mm3 and 25% respectively.
The authors reached these conclusions by using information from almost 3000 2-5 year old children with HIV who enrolled for ARV treatment in HIV clinics in South Africa, Malawi, and Zimbabwe to develop a model. From this model, the authors found that if all children had started ART immediately after diagnosis irrespective of CD4 value (2013 WHO guidelines) the estimated combined death rate would be 2.1% but if ART was started at a CD4 count below 750 cells/mm3 or a CD4% below 25% (2010 WHO guidelines) the figure was 2.2%, a statistically non-significant difference. However, the authors found higher death rates when ART was started at lower CD4 counts and the study is limited by lack of clinical information on the children and loss of follow up.
The authors conclude: “Our results indicate that in children aged 2-5 y in southern Africa, there is no difference in mortality between starting ART immediately and deferring until CD4% drops below 25% or CD4 count drops below 750 cells/mm3.”
Funding: This work was supported by the National Institute of Allergy and Infectious Diseases (NIAID) and the Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD) [IeDEA Southern Africa, grant number U01 AI069924] and the World Health Organization. The opinions expressed herein are those of the authors and do not necessarily reflect the views of any of the funders. The National Institutes of Health, NIAID and NICHD, had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing Interests: LM, a WHO staff member, and MP and SE, WHO consultants, have been involved in the 2013 WHO Guidelines development process. They were involved in designing this study and writing the manuscript. MS and MAD received funding from WHO to support the data analysis. However, the opinions expressed in the manuscript are solely those of the authors and do not necessarily represent the official views or policies of WHO.
Citation: Schomaker M, Egger M, Ndirangu J, Phiri S, Moultrie H, et al. (2013) When to Start Antiretroviral Therapy in Children Aged 2-5 Years: A Collaborative Causal Modelling Analysis of Cohort Studies from Southern Africa. PLoS Med 10(11): e1001555. doi:10.1371/journal.pmed.1001555
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Categories: Lethal or Unintended Side Effects