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3rd International AIDS Society Conference on HIV Pathogenesis and TreatmentRio de Janeiro - July 24 - 27, 2005 |
THERAPEUTIC DRUG MONITORING OF INDINAVIR BOOSTED WITH RITONAVIR IN PEDIATRIC PATIENTS
IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. MoPe9.2C02
Curras V.1, Höcht C.1, Bramuglia G.1, Rubio M.1, Cáceres Guido P.2, Mato G.2, Mecikovsky D.3, Bologna R.3
1Cátedra de Farmacología, Facultad de Farmacia y Bioquímica (UBA), Buenos Aires, Argentina, 2Area de Farmacia, Hospital de Pediatría Juan P. Garrahan, Buenos Aires, Argentina, 3Servicio de Control Epidemiológico e Infectología, Hospital de Pediatría Juan P Garrahan, Buenos Aires, Argentina
INTRODUCTION: The aim of this work is to evaluate the results of therapeutic drug monitoring (TDM) assessed in the course of clinical routine practice in pediatric patients whose antiretroviral treatment includes indinavir boosted with ritonavir.
METHODS: 13 ambulatory patients receiving indinavir plus ritonavir (median: 38 months of treatment) were included in this work. In these patients, two plasmatic levels of indinavir were determined by HPLC: a “trough” level and a “peak” level (one hour after the corresponding dose). The average dosage of indinavir was 250 mg/m2/12hs.
RESULTS: Eight of thirteen patients yielded subtherapeutic levels with 2 patients with non detectable levels (median troughs: 0.73 µg/mL). One patient showed a peak level over the range (14.6 µg/mL). Median peak observed was 3.8 µg/mL. The therapeutic range proposed for indinavir was 0.150 and 10 µg/mL for troughs and peaks respectively, even though these levels were determined for adult patients. From the clinical viewpoint, most of the patients belong to categories B and C of the CDC pediatric classification system (A3: 1, B3: 4, C1: 1, C2: 2, C3: 5).
CONCLUSIONS: Although pediatric dosage of indinavir boosted with ritonavir is not yet defined, previous works suggested a dosage regimen of 400 mg/m2 indinavir plus 125 mg/m2 ritonavir every 12 hours. Since previous assessments of plasmatic levels of patients from our hospital had shown that this dosage regimen could lead to high levels associated with toxic reactions, the initial scheme consisted of 250 mg/m2 indinavir plus 100 mg/m2 ritonavir every 12 hours. TDM of indinavir showed that this regimen led to sub – therapeutic levels in this patients. Even though indinavir is boosted with ritonavir, the high variability observed in the plasmatic levels suggests that TDM of indinavir is advisable.
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Clinical | MoPe9.2C02 | Verónica Curras
9.2 2 9.2 Paediatric treatment strategies
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