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Purpose: Optimizing therapy through TDM may assist in achieving VS in HIV infected pediatric patients; however, current guidelines do not recommend its routine use.
Methods: A retrospective chart review was conducted in perinatally infected HIV patients from birth to 18 years of age between 1/2002 and 9/2010. The primary objective was to determine if ART serum drug concentrations could predict the probability of VS, as defined by an undetectable viral load (VL) at 6 months from a clinical intervention. The secondary objective was to assess change in virologic status (detectable VL to VS) from baseline to 6 months following a clinical intervention.
Results: Of the 53 clinic patients screened, 29 were included in the analysis: 17 LPV/RTV, 3 ATV, 2 EFV, and 7 NFV. The sample was stratified by age: less than 1 year (17%), 1 to 5 years (17%), 6 to 12 years (35%), and 13 to 18 years (31%). Baseline demographics were similar amongst groups. The median (IQR) CD4% and VL were 24% (17.8 – 32.5) and 2637 copies/mL (884 – 20,729), respectively. Primary analysis was performed only on the LPV/RTV group who had at least 2 data time points (n=12). Logistic regression showed no statistically significant difference in virologic outcome based on serum LPV/RTV trough concentrations (p = 0.8811). Of the 29 patients included, 20 (69%) had detectable VL at baseline; of which 13 (65%) achieved VS at 6 months after a clinical intervention. There was a significant shift change in virologic status after a clinical intervention (p=0.0009). Most common interventions included dosage adjustment and adherence counseling.
Conclusion: Serum LPV/RTV trough concentrations did not appear to have a significant effect on VS. However, there was a significant change in virologic status after a clinical intervention. Further studies are required to assess the utility of TDM in pediatric patients.