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Novel approach to therapeutic drug monitoring of nevirapine in pediatric HIV infected patients
Author(s) -
Rakhmani. Y.,
Soldin S. J.,
Spiegel H. M.,
Sever J.,
Anker J. N.
Publication year - 2005
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2005.01.001
Subject(s) - nevirapine , therapeutic drug monitoring , saliva , medicine , human immunodeficiency virus (hiv) , antiretroviral therapy , drug , pharmacokinetics , gastroenterology , pharmacology , viral load , immunology
Background Therapeutic drug monitoring (TDM) of nevirapine (NVP) in children is important due to the use of NVP in HIV preventive and treatment regimens. Adequate trough levels of NVP predict successful therapy whereas low levels are correlated with higher viral loads. Our previous studies did suggest that saliva might be useful for non‐invasive TDM of several antiretroviral drugs. The aim of this study was to determine total and free levels of NVP in plasma of HIV‐infected children and compare them with saliva levels. Methods 20 pediatric patients (median age 8.2 yrs) on therapy with NVP were studied. Unbound NVP was separated by ultrafiltration and NVP levels were determined by a tandem‐mass spectrometry using the Applied Biosystems/Sciex API‐2000. Within‐run precision was below 7% and between‐day precision was below 10%. Accuracy ranged 95%‐105%. Linear regression analysis was used through PRISM program. Results The correlation of saliva to total and free plasma levels of NVP was significant with r values of 0.971(NVPSal= 0.587× NVP total Pl +444.5, p<0.001) and 0.969(NVPSal= 1.23× NVP free Pl+584.0, p<0.001. Total and free plasma levels of NVP showed a significant correlation with a r value of 0.949(NVP free PL=0.419× NVP total PL+144.2, p<0.001. Conclusions This study shows a significant linear correlation between total saliva and both bound and unbound (free) plasma NVP levels. The levels of NVP in saliva correlate significantly with plasma values and may be useful for non‐invasive TDM of NVP. Clinical Pharmacology & Therapeutics (2005) 77 , P97–P97; doi: 10.1016/j.clpt.2005.01.001