Simplification of therapeutic drug monitoring for twice-daily regimens of lopinavir/ritonavir for HIV infection.

作者: Christopher S. Alexander , Julio S. G. Montaner , J??r??me J. Asselin , Lillian Ting , Kelly McNabb

DOI: 10.1097/00007691-200410000-00009

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摘要: Cost and inconvenience limit the application of full 12-hour pharmacokinetic (PK) analysis for routine therapeutic drug monitoring anti retroviral medications. We explore whether lopinavir (LPV) ritonavir (RTV) exposures can be estimated with limited sampling patients taking twice-daily LPV/RTV. One hundred one PK profiles from 81 patients, most receiving salvage therapies including LPV/RTV, were obtained analysis. After a minimum 2 weeks on stable regimen, blood was drawn immediately before at 1, 2, 4, 6, 8, 10, 12 hours after timed medication dose. Plasma concentrations determined by validated HPLC-MS-MS assay. Peak concentrations, evening troughs, AUC 0 - 1 h entered into linear log -log regression models to determine best correlation LPV RTV plasma using maximum time points. The accuracy precision parameter estimates resultant tested data collected an additional 25 patients. Twelve various combinations afforded accurate (maximum % bias = -6.45) precise (relative standard deviation < 15%) peak concentration or . Four sets provided simultaneous both parameters, derived 6 postdose. Evening trough estimators daily nadir; however, no adequate substitute collecting postdose emerged this

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