Preliminary outcomes of a paediatric highly active antiretroviral therapy cohort from KwaZulu-Natal, South Africa

Anand Reddi, Sarah C Leeper, Anneke C Grobler, Rosemary Geddes, K Holly France, Gillian L Dorse, Willem J Vlok, Mbali Mntambo, Monty Thomas, Kristy Nixon, Helga L Holst, Quarraisha Abdool Karim, Nigel C Rollins, Hoosen M Coovadia, Janet Giddy, Anand Reddi, Sarah C Leeper, Anneke C Grobler, Rosemary Geddes, K Holly France, Gillian L Dorse, Willem J Vlok, Mbali Mntambo, Monty Thomas, Kristy Nixon, Helga L Holst, Quarraisha Abdool Karim, Nigel C Rollins, Hoosen M Coovadia, Janet Giddy

Abstract

Background: Few studies address the use of paediatric highly active antiretroviral therapy (HAART) in Africa.

Methods: We performed a retrospective cohort study to investigate preliminary outcomes of all children eligible for HAART at Sinikithemba HIV/AIDS clinic in KwaZulu-Natal, South Africa. Immunologic, virologic, clinical, mortality, primary caregiver, and psychosocial variables were collected and analyzed.

Results: From August 31, 2003 until October 31, 2005, 151 children initiated HAART. The median age at HAART initiation was 5.7 years (range 0.3-15.4). Median follow-up time of the cohort after HAART initiation was 8 months (IQR 3.5-13.5). The median change in CD4% from baseline (p < 0.001) was 10.2 (IQR 5.0-13.8) at 6 months (n = 90), and 16.2 (IQR 9.6-20.3) at 12 months (n = 59). Viral loads (VLs) were available for 100 children at 6 months of which 84% had HIV-1 RNA levels < or = 50 copies/mL. At 12 months, 80.3% (n = 61) had undetectable VLs. Sixty-five out of 88 children (73.8%) reported a significant increase (p < 0.001) in weight after the first month. Eighty-nine percent of the cohort (n = 132) reported < or = 2 missed doses during any given treatment month (> 95%adherence). Seventeen patients (11.3%) had a regimen change; two (1.3%) were due to antiretroviral toxicity. The Kaplan-Meier one year survival estimate was 90.9% (95%confidence interval (CI) 84.8-94.6). Thirteen children died during follow-up (8.6%), one changed service provider, and no children were lost to follow-up. All 13 deaths occurred in children with advanced HIV disease within 5 months of treatment initiation. In multivariate analysis of baseline variables against mortality using Cox proportional-hazards model, chronic gastroenteritis was associated with death [hazard ratio (HR), 12.34; 95% CI, 1.27-119.71) and an HIV-positive primary caregiver was found to be protective against mortality [HR, 0.12; 95% CI, 0.02-0.88). Age, orphanhood, baseline CD4%, and hemoglobin were not predicators of mortality in our cohort. Fifty-two percent of the cohort had at least one HIV-positive primary caregiver, and 38.4% had at least one primary caregiver also on HAART at Sinikithemba clinic.

Conclusion: This report suggests that paediatric HAART can be effective despite the challenges of a resource-limited setting.

Figures

Figure 1
Figure 1
HIV status and HAART in the primary caregivers of the Sinikithemba paediatric cohor: The Sinikithemba cohort was cared for by 214 familial and non-familial primary caregivers. Of these 214 primary caregivers; 105 (49.1%) had tested positive for HIV of whom 68 (64.8%) were also receiving HAART at Sinikithemba, 86 (40.2%) were unaware of their status, and 23 (10.7%) had tested HIV negative. Ten children were in institutional care (orphanage), no primary caregiver identified.
Figure 2
Figure 2
CD4% and Viral Loads changes of the Sinikithemba paediatric cohort in response to HAART: A. Median increase in CD4% from baseline. The vertical bars in subfigure A indicate IQR. B. Percentage of cohort achieving undetectable viral loads. The vertical bars in subfigure B indicate 95% CI.
Figure 3
Figure 3
Kaplan-Meier mortality survival curve of the cohort.

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