title: Two-year outcomes of children on non-nucleoside reverse transcriptase inhibitor and protease inhibitor regimens in a South African pediatric antiretroviral program.
abstract: BACKGROUND
  Few data exist on the efficacy of the limited regimens for children with HIV, which are available in sub-Saharan Africa.
  
  
  METHODS
  Retrospective cohort study to evaluate the clinical and laboratory outcomes of 391 children who received protease inhibitor (PI) or non-nucleoside reverse transcription inhibitor (nNRTI)-containing highly active antiretroviral regimens (HAART) from a Cape Town clinic. Endpoints included CD4% and count, viral loads, weight-for-age Z score (WAZ), survival, drug changes, and loss to follow-up over 24 months. A generalized estimating equation population-averaged model was used to identify associations with virological suppression, and a log-rank test explored associations with survival.
  
  
  RESULTS
  Overall, this cohort achieved a sustained doubling of median CD4% from baseline, steady increase of median WAZ, and survival of 91%, despite only 49% virologic suppression at 24 months. However, when analyzed according to regimen, PI-containing regimens had better virologic suppression at all time points. There were no differences in immunologic and growth endpoints between regimens or in survival. In a multivariate model predicting virologic suppression at any duration up to 24 months and adjusting for baseline CD4%, regimen, age, baseline WAZ, duration of HAART, and year of HAART initiation, nNRTI-based regimens (odds ratio [OR]: 0.38; 95% confidence interval [CI]: 0.19-0.77) and length of time on HAART were inversely associated with virologic suppression. Age (OR: 1.23 per year; 95% CI: 1.09-1.39) was positively associated with virologic suppression.
  
  
  CONCLUSIONS
  The benefits of HAART are substantial in this setting, although PI regimens achieved greater virologic suppression than nNRTIs. Further exploration of regimens and dosing of antiretrovirals for children in these settings is needed.
authors.affiliation: School of Child and Adolescent Health, University of Cape Town, South Africa. hbjaspan@hotmail.com
authors.forename: Heather B
authors.initials: HB
authors.lastname: Jaspan
authors.forename: Alison E
authors.initials: AE
authors.lastname: Berrisford
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Boulle
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D016049:Didanosine / Q000627:therapeutic use; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D017320:HIV Protease Inhibitors / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D019259:Lamivudine / Q000627:therapeutic use; D061466:Lopinavir; D008297:Male; D015999:Multivariate Analysis; D011744:Pyrimidinones / Q000627:therapeutic use; D012189:Retrospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D019438:Ritonavir / Q000627:therapeutic use; D013019:South Africa; D018119:Stavudine / Q000627:therapeutic use; D016896:Treatment Outcome; D015215:Zidovudine / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D011744:Pyrimidinones; D018894:Reverse Transcriptase Inhibitors; D061466:Lopinavir; D019259:Lamivudine; D015215:Zidovudine; D018119:Stavudine; D016049:Didanosine; D019438:Ritonavir