PMID- 16988517 OWN - NLM STAT- MEDLINE DCOM- 20071024 LR - 20220408 IS - 0269-9370 (Print) IS - 0269-9370 (Linking) VI - 20 IP - 15 DP - 2006 Oct 3 TI - In resource-limited settings good early outcomes can be achieved in children using adult fixed-dose combination antiretroviral therapy. PG - 1955-60 AB - OBJECTIVES: To (a) determine early treatment outcomes and (b) assess safety in children treated with adult fixed-dose combination (FDC) antiretroviral tablets. SETTING: Sixteen Medecins Sans Frontieres (MSF) HIV programs in eight countries in resource-limited settings (RLS). METHODS: Analysis of routine program data gathered June 2001 to March 2005. RESULTS: A total of 1184 children [median age, 7 years; inter-quartile range (IQR), 4.6-9.3] were treated with antiretroviral therapy (ART) of whom 616(52%) were male. At ART initiation, Centres for Disease Control stages N, A, B and C were 9, 14, 38 and 39%, respectively. Children were followed up for a median period of 6 months (IQR, 2-12 months). At 12 months the median CD4 percentage gain in children aged 18-59 months was 15% (IQR, 6-18%), and the percentage with CD4 gain < 15% was reduced from 85% at baseline to 11%. In those aged 60-156 months, median CD4 cell count gain was 275 cells/microl (IQR, 84-518 cells/microl), and the percentage with CD4 < 200 cells/mul reduced from 51% at baseline to 11%. Treatment outcomes included; 1012 (85%) alive and on ART, 36 (3%) deaths, 15 (1%) stopped ART, 89 (8%) lost to follow-up, and 31 (3%) with unknown outcomes. Overall probability of survival at 12 months was 0.87 (0.84-0.89). Side effects caused a change to alternative antiretroviral drugs in 26 (2%) but no deaths. CONCLUSIONS: Very satisfactory early outcomes can be achieved in children in RLS using generic adult FDC antiretroviral tablets. These findings strongly favour their use as an "interim solution" for scaling-up ART in children; however, more appropriate pediatric antiretroviral drugs remain urgently needed. FAU - O'Brien, Daniel P AU - O'Brien DP AD - AIDS Working Group, Medecins Sans Frontieres, Plantage Middenlaan 14, 1001 EA Amsterdam, The Netherlands. daniel.obrien@amsterdam.msf.org FAU - Sauvageot, Delphine AU - Sauvageot D FAU - Zachariah, Rony AU - Zachariah R FAU - Humblet, Pierre AU - Humblet P CN - Medecins Sans Frontieres LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PL - England TA - AIDS JT - AIDS (London, England) JID - 8710219 RN - 0 (Anti-Retroviral Agents) SB - IM MH - Africa MH - Anti-Retroviral Agents/*administration & dosage/economics/therapeutic use MH - Asia, Southeastern MH - CD4 Lymphocyte Count MH - Child MH - Child, Preschool MH - *Developing Countries MH - Drug Administration Schedule MH - Drug Costs MH - Female MH - HIV Infections/*drug therapy/immunology/mortality MH - Humans MH - Male MH - Safety MH - Survival Rate MH - Treatment Outcome EDAT- 2006/09/22 09:00 MHDA- 2007/10/25 09:00 CRDT- 2006/09/22 09:00 PHST- 2006/09/22 09:00 [pubmed] PHST- 2007/10/25 09:00 [medline] PHST- 2006/09/22 09:00 [entrez] AID - 00002030-200610030-00008 [pii] AID - 10.1097/01.aids.0000247117.66585.ce [doi] PST - ppublish SO - AIDS. 2006 Oct 3;20(15):1955-60. doi: 10.1097/01.aids.0000247117.66585.ce.