Abstract #367  -  The introduction of Tenofovir-containing HAART at the Botswana-Baylor childrens clinical centre of excellence: an overview of the patients and adverse events to date
Authors:   Presenting Author:   David Thuso -
Additional Authors:  Mr Paul Mullan, Mr Ryan Phelps, Ms Floriza Gennari,
Aim: Tenofovir disoproxil fumarate (TDF) usage is sometimes associated with nephrotoxicity and bone mineral density defects. As a result of limited safety and efficacy data, TDF has not been licensed for use in the under 18 year old population. However, as part of Botswana�s first-line HAART in the adult population, TDF is readily available and has been used in adolescents in other settings as part of second line or salvage regimens. Here, we describe our experience using TDF-containing HAART in a cohort of HIV-infected adolescents in Botswana.
Method / Issue: Any adolescent taking TDF at the Botswana COE in the year 2009 was included in the analysis of creatinine clearance, dosing calculations, adverse events, virologic response, immunologic response, and sexual maturational rating (SMR). Data were abstracted from our electronic medical records and a national lab database.
Results / Comments: 23 of 1600 children in our clinic are currently on a TDF based HAART regimen for an average duration of 5.9 months. In this cohort, the average creatinine clearance at baseline was __170 mol/L_(n=9) and increased to an average of _203�mol/L(n=4)_ at 3 month follow-up. The average dosing of TDF was __7.30 mg/kg at initiation (range: 5.60-10.60 mg/kg ). No adverse events were seen, including no hospitalizations and no recorded bone fractures The average CD4 count rise per month was 21cells/m3, and 6 out 6 ( 100 %) of the 6 children with a suppressed viral load at baseline had a follow-up suppressed viral load. The median SMR was 4(2-5).
Discussion: A few small case reports and case series document adverse effects of TDF in children. Our current Botswana data suggest that TDF is a safe and effective drug. Increased patient number and more experience with TDF is needed before we can draw stronger conclusions about its long-term safety and efficacy.
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