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Published on: March 30, 2014
Is Routine Therapeutic Drug Monitoring of Anti-Retroviral Agents Warranted in Children Living with HIV?
Jennifer Tam1,2,3, Elaine Lau2,4, Stanley Read1,2
1Division of Infectious Diseases, Department of Pediatrics (JT, SR, AB), The Hospital for Sick Children, Toronto, ON, Canada.
Insights
Routine therapeutic drug monitoring (TDM) is not recommended for well-controlled children with HIV. A targeted approach is more suitable when adherence or drug interactions are suspected.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology
- HIV/AIDS Research
Background:
- Therapeutic drug monitoring (TDM) utility in pediatric HIV is understudied.
- Antiretroviral therapy (ART) adherence and efficacy are critical for managing HIV in children.
Purpose of the Study:
- To evaluate the effectiveness of routine therapeutic drug monitoring (TDM) for antiretroviral medications in children living with HIV.
- To assess the proportion of drug concentrations within the therapeutic range and their impact on virologic control and adherence.
Main Methods:
- Prospective observational study of routine TDM for protease inhibitors (PIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and integrase strand transfer inhibitors (INSTIs).
- Included children living with HIV on ART from February to December 2014.
- Measured serum drug concentrations, viral load (VL), CD4% count, and medication adherence.
Main Results:
- 66% of measured antiretroviral (ARV) concentrations were within the therapeutic range; 12% were subtherapeutic, and 22% were supratherapeutic.
- No significant correlation found between serum ARV concentrations and patient demographics, VL, CD4%, or adherence.
- One dose adjustment was made due to a subtherapeutic raltegravir concentration, potentially due to ritonavir interaction.
Conclusions:
- Routine TDM is not supported for healthy, well-controlled children with HIV on ART.
- A targeted TDM strategy is more appropriate for situations involving questioned adherence or suspected drug interactions.
Objective:
The utility of routine therapeutic drug monitoring (TDM) in children living with HIV has not been extensively studied. The purpose of this study was to assess this strategy.
Methods:
This was a single-center, prospective observational study of routine TDM for protease inhibitors (PIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and integrase strand transfer inhibitors (INSTIs) in children living with HIV who were receiving antiretroviral therapy (ART) between February and December 2014. Outcome measures included the proportion of serum antiretroviral (ARV) medication concentrations in the therapeutic range (target values extrapolated from adult data) and the effect of serum concentrations on virologic control, medication adherence, and toxicity.
Results:
Forty-eight children with a median age of 13 years (interquartile range, 3-18) were included. Median viral load (VL) and CD4% were <40 copies/mL (range, <40-124) and 37.4% (range, 8.4-47.9), respectively. Adherence was considered excellent in 95.8% of patients. Of the 50 serum trough concentrations (PI n = 19 [38%]; NNRTI n = 27 [54%]; INSTI n = 4 [8%]), 66% (n = 33) were in the therapeutic range, 12% (n = 6) were subtherapeutic, and 22% (n = 11) were supratherapeutic. There was no statistically significant correlation between serum ARV concentrations and patient demographics, VL, CD4%, or adherence. No clinically significant adverse events were noted. One dose adjustment was made for a subtherapeutic serum raltegravir concentration, likely attributable to interaction with ritonavir.
Conclusions:
This study does not support routine TDM in healthy children living with HIV who are well controlled on antiretroviral medication regimens. A more targeted strategy, such as when adherence is questioned or when there are suspected drug interactions, may be more appropriate.
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