Population pharmacokinetic modelling of once-daily ritonavir-boosted darunavir in HIV-infected patients
نویسندگان
چکیده
Methods Data were pooled from 3 DRV/RTV PK studies. In total 51 HIV-infected patients (7 female) stable on DRV/RTV (800/100mg or 900/100mg once daily; n=32 and 19, respectively) were included. Median age, weight, BMI, RTV area under the curve over 24h (AUC0-24) and baseline CD4 cell count were 39yr (21-63), 74kg (57-105), 24kg/m (18-31), 4.35mg.h/L (2.27-10.99) and 500cells/ mm (227-1129), respectively; 49 patients had undetectable viral load at time of study. PK sampling was performed at steady-state and between 1-3 PK curves were available per patient. Nonlinear mixed effects modelling (NONMEM v. VI 2.0) was applied to determine DRV PK parameters, interindividual and interoccasion variability and residual error. The following covariates were evaluated: age, weight, BMI, sex, ethnicity, RTV AUC0-24 and raltegravir co-medication (400mg twice daily). The model was validated by means of simulation and visual predictive check.
منابع مشابه
Population pharmacokinetic modelling and evaluation of different dosage regimens for darunavir and ritonavir in HIV-infected individuals.
OBJECTIVES Darunavir is a protease inhibitor that is administered with low-dose ritonavir to enhance its bioavailability. It is prescribed at standard dosage regimens of 600/100 mg twice daily in treatment-experienced patients and 800/100 mg once daily in naive patients. A population pharmacokinetic approach was used to characterize the pharmacokinetics of both drugs and their interaction in a ...
متن کاملPharmacokinetics and pharmacodynamics of boosted once-daily darunavir.
The ability to dose antiretroviral agents once daily simplifies the often complex therapeutic regimens required for the successful treatment of HIV infection. Thus, once-daily dosing can lead to improved patient adherence to medication and, consequently, sustained virological suppression and reduction in the risk of emergence of drug resistance. Several trials have evaluated once-daily darunavi...
متن کاملClinical outcomes associated with once daily ritonavir-boosted darunavir in HIV infected patients harboring single or multi-class resistant virus
متن کامل
Efficacy of once daily darunavir/ritonavir 800/100 mg in PI/r-experienced HIV-1 infected patients with suppressed HIV-1 replication: the RADAR study
Background Once-daily darunavir/ritonavir 800/100 mg is licensed for first-line treatment and data are available in treatment-experienced patients with no resistance-associated mutations to darunavir. We designed an investigator study to evaluate the switch to once-daily darunavir/ ritonavir 800/100 mg in treatment-experienced patients with suppressed HIV-1 replication on a twice-daily ritonavi...
متن کاملPopulation pharmacokinetics of ritonavir-boosted atazanavir in HIV-infected patients and healthy volunteers
OBJECTIVES The aim of this study was to develop and validate a population pharmacokinetic model to: (i) describe ritonavir-boosted atazanavir concentrations (300/100 mg once daily) and identify important covariates; and (ii) evaluate the predictive performance of the model for lower, unlicensed atazanavir doses (150 and 200 mg once daily) boosted with ritonavir (100 mg once daily). METHODS No...
متن کامل