title: Preliminary outcomes of a paediatric highly active antiretroviral therapy cohort from KwaZulu-Natal, South Africa.
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.
  
  
  CONCLUSIONS
  This report suggests that paediatric HAART can be effective despite the challenges of a resource-limited setting.
authors: Sinikithemba HIV/AIDS Clinic, McCord Hospital, Durban, South Africa. areddi@fulbrightweb.org
authors: Anand
authors: A
authors: Reddi
authors: Sarah C
authors: SC
authors: Leeper
authors: Anneke C
authors: AC
authors: Grobler
authors: Rosemary
authors: R
authors: Geddes
authors: K Holly
authors: KH
authors: France
authors: Gillian L
authors: GL
authors: Dorse
authors: Willem J
authors: WJ
authors: Vlok
authors: Mbali
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authors: Mntambo
authors: Monty
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authors: Thomas
authors: Kristy
authors: K
authors: Nixon
authors: Helga L
authors: HL
authors: Holst
authors: Quarraisha Abdool
authors: QA
authors: Karim
authors: Nigel C
authors: NC
authors: Rollins
authors: Hoosen M
authors: HM
authors: Coovadia
authors: Janet
authors: J
authors: Giddy
mesh_terms: D000293:Adolescent; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D017028:Caregivers; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D015331:Cohort Studies; D005260:Female; D005759:Gastroenteritis / Q000401:mortality; D015658:HIV Infections / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D010349:Patient Compliance; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D013019:South Africa / Q000453:epidemiology; D016896:Treatment Outcome; D019562:Viral Load