Safety and Effectiveness of Combination Antiretroviral Therapy during the First Year of Treatment in HIV-1 Infected Rwandan Children: A Prospective Study

BACKGROUND: With increased availability of paediatric combination antiretroviral therapy (cART) in resource limited settings cART outcomes and factors associated with outcomes should be assessed. METHODS: HIV-infected children -2 immunological success as CD4 cells >/=500/mm3 and >/=25% for respectively children over 5 years and under 5 years and virological success as a plasma HIV-1 RNA concentration /=5 years of age were 20% (13 28) and 337 (236 484) cells/mm3 respectively and increased to 36% (28 41) and 620 (375 880) cells/mm3. After 12 months of cART 24% of children had a detectable viral load including 16% with virological failure (HIV-RNA>1000 c/mL). Older age at cART initiation poor adherence and exposure to antiretrovirals around birth were associated with virological failure. A third (33%) of children had side effects (by self-report or clinical assessment) but only 9% experienced a severe side effect requiring a cART regimen change. CONCLUSIONS: cART in Rwandan HIV-infected children was successful but success might be improved further by initiating cART as early as possible optimizing adherence and optimizing management of side effects.