Alice J Hsu1, Asha Neptune, Constants Adams, Nancy Hutton, Allison L Agwu. 1. From the *Division of Pediatric Pharmacy, Department of Pharmacy, The Johns Hopkins Hospital, Baltimore, Maryland; †Howard University College of Medicine, Washington, DC; ‡Medical University of South Carolina, Charleston, South Carolina; §Division of General Pediatrics & Adolescent Medicine, and ¶Division of Infectious Diseases, Department of Pediatrics, The Johns Hopkins University School of Medicine, Baltimore, Maryland.
Abstract
BACKGROUND: Antiretroviral (ARV) management in pediatrics is a challenging process in which multiple barriers to optimal therapy can lead to poor clinical outcomes. In a pediatric HIV clinic, we implemented a systematic ARV stewardship program to evaluate ARV regimens and make recommendations for optimization when indicated. METHODS: A comprehensive assessment tool was used to screen for issues related to genotypic resistance, virologic/immunologic response, drug-drug interactions, side effects and potential for regimen simplification. The ARV stewardship team (AST) made recommendations to the HIV clinic provider, and followed patients prospectively to assess clinical outcomes at 6 and 12 months. RESULTS: The most common interventions made by the AST included regimen optimization in patients on suboptimal regimens based on resistance mutations (35.4%), switching to safer ARVs (33.3%) and averting significant drug-drug interactions (10.4%). In patients anticipated to have a change in viral load (VL) as a result of the AST recommendations, we identified a significant benefit in virologic outcomes at 6 and 12 months when recommendations were implemented within 6 months of ARV review. Patients who had recommendations implemented within 6 months had a 7-fold higher probability of achieving a 0.7 log10 reduction in VL by 6 months, and this benefit remained significant after controlling for adherence [adjusted odds ratio: 6.8 (95% confidence interval: 1.03-44.9; P <0.05)]. CONCLUSIONS: A systematic ARV stewardship program implemented at a pediatric HIV clinic significantly improved clinical outcomes. ARV stewardship programs can be considered a core strategy for continuous quality improvement in the management of HIV-infected children and adolescents.
BACKGROUND: Antiretroviral (ARV) management in pediatrics is a challenging process in which multiple barriers to optimal therapy can lead to poor clinical outcomes. In a pediatric HIV clinic, we implemented a systematic ARV stewardship program to evaluate ARV regimens and make recommendations for optimization when indicated. METHODS: A comprehensive assessment tool was used to screen for issues related to genotypic resistance, virologic/immunologic response, drug-drug interactions, side effects and potential for regimen simplification. The ARV stewardship team (AST) made recommendations to the HIV clinic provider, and followed patients prospectively to assess clinical outcomes at 6 and 12 months. RESULTS: The most common interventions made by the AST included regimen optimization in patients on suboptimal regimens based on resistance mutations (35.4%), switching to safer ARVs (33.3%) and averting significant drug-drug interactions (10.4%). In patients anticipated to have a change in viral load (VL) as a result of the AST recommendations, we identified a significant benefit in virologic outcomes at 6 and 12 months when recommendations were implemented within 6 months of ARV review. Patients who had recommendations implemented within 6 months had a 7-fold higher probability of achieving a 0.7 log10 reduction in VL by 6 months, and this benefit remained significant after controlling for adherence [adjusted odds ratio: 6.8 (95% confidence interval: 1.03-44.9; P <0.05)]. CONCLUSIONS: A systematic ARV stewardship program implemented at a pediatric HIV clinic significantly improved clinical outcomes. ARV stewardship programs can be considered a core strategy for continuous quality improvement in the management of HIV-infectedchildren and adolescents.
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