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Population Pharmacokinetics of Boosted‐Elvitegravir in HIV‐Infected Patients

Elvitegravir (EVG) is an HIV strand transfer integrase inhibitor approved for the treatment of HIV infection as a part of antiretroviral regimens containing cobicistat (COBI) or ritonavir (RTV) as a booster. The population pharmacokinetics of EVG in treatment‐naive and ‐experienced HIV patients was... Full description

Journal Title: Journal of Clinical Pharmacology June 2016, Vol.56(6), pp.723-732
Main Author: Custodio, Joseph M.
Other Authors: Gordi, Toufigh , Zhong, Lijie , Ling, Kah Hiing J. , Ramanathan, Srini
Format: Electronic Article Electronic Article
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ID: ISSN: 0091-2700 ; E-ISSN: 1552-4604 ; DOI: 10.1002/jcph.657
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recordid: wj10.1002/jcph.657
title: Population Pharmacokinetics of Boosted‐Elvitegravir in HIV‐Infected Patients
format: Article
creator:
  • Custodio, Joseph M.
  • Gordi, Toufigh
  • Zhong, Lijie
  • Ling, Kah Hiing J.
  • Ramanathan, Srini
subjects:
  • Clinical Pharmacology Cph
  • Hiv/Aids
  • Pharmacokinetics And Drug
  • Metabolism
  • Population Pharmacokinetics
  • Pharmacometrics
ispartof: Journal of Clinical Pharmacology, June 2016, Vol.56(6), pp.723-732
description: Elvitegravir (EVG) is an HIV strand transfer integrase inhibitor approved for the treatment of HIV infection as a part of antiretroviral regimens containing cobicistat (COBI) or ritonavir (RTV) as a booster. The population pharmacokinetics of EVG in treatment‐naive and ‐experienced HIV patients was determined, and the effects of demographic, biometric, and formulation covariates on EVG pharmacokinetics (PK) were evaluated. Data from 31 clinical studies (25 in healthy subjects, 6 phase 1b to phase 3 in HIV‐1–infected patients) with COBI‐boosted EVG studies (as EVG/co or EVG/COBI/FTC/TDF single‐tablet regimen) or RTV‐boosted EVG studies (EVG/r) were analyzed using NONMEM. The effect of the covariates age, sex, race, health status (healthy volunteers vs HIV patients), weight, body mass index (BMI), body surface area (BSA), creatinine clearance (estimated GFR), and formulation were evaluated. EVG PK, with COBI or RTV, was described by a 2‐compartment model, with first‐order absorption and elimination and an absorption lag time. A statistically significant, but not clinically relevant, effect of BSA on EVG clearance (CL) was observed. Coadministration of atazanavir or lopinavir with EVG/r had an effect on EVG CL consistent with the known interaction with these agents. No other covariate had a meaningful effect on EVG PK. EVG PK was well described in a population PK model with HIV‐infected patients, with low PK variability and no relevant effect of demographic or biometric covariates.
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identifier: ISSN: 0091-2700 ; E-ISSN: 1552-4604 ; DOI: 10.1002/jcph.657
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  • 0091-2700
  • 00912700
  • 1552-4604
  • 15524604
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titlePopulation Pharmacokinetics of Boosted‐Elvitegravir in HIV‐Infected Patients
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descriptionElvitegravir (EVG) is an HIV strand transfer integrase inhibitor approved for the treatment of HIV infection as a part of antiretroviral regimens containing cobicistat (COBI) or ritonavir (RTV) as a booster. The population pharmacokinetics of EVG in treatment‐naive and ‐experienced HIV patients was determined, and the effects of demographic, biometric, and formulation covariates on EVG pharmacokinetics (PK) were evaluated. Data from 31 clinical studies (25 in healthy subjects, 6 phase 1b to phase 3 in HIV‐1–infected patients) with COBI‐boosted EVG studies (as EVG/co or EVG/COBI/FTC/TDF single‐tablet regimen) or RTV‐boosted EVG studies (EVG/r) were analyzed using NONMEM. The effect of the covariates age, sex, race, health status (healthy volunteers vs HIV patients), weight, body mass index (BMI), body surface area (BSA), creatinine clearance (estimated GFR), and formulation were evaluated. EVG PK, with COBI or RTV, was described by a 2‐compartment model, with first‐order absorption and elimination and an absorption lag time. A statistically significant, but not clinically relevant, effect of BSA on EVG clearance (CL) was observed. Coadministration of atazanavir or lopinavir with EVG/r had an effect on EVG CL consistent with the known interaction with these agents. No other covariate had a meaningful effect on EVG PK. EVG PK was well described in a population PK model with HIV‐infected patients, with low PK variability and no relevant effect of demographic or biometric covariates.
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abstractElvitegravir (EVG) is an HIV strand transfer integrase inhibitor approved for the treatment of HIV infection as a part of antiretroviral regimens containing cobicistat (COBI) or ritonavir (RTV) as a booster. The population pharmacokinetics of EVG in treatment‐naive and ‐experienced HIV patients was determined, and the effects of demographic, biometric, and formulation covariates on EVG pharmacokinetics (PK) were evaluated. Data from 31 clinical studies (25 in healthy subjects, 6 phase 1b to phase 3 in HIV‐1–infected patients) with COBI‐boosted EVG studies (as EVG/co or EVG/COBI/FTC/TDF single‐tablet regimen) or RTV‐boosted EVG studies (EVG/r) were analyzed using NONMEM. The effect of the covariates age, sex, race, health status (healthy volunteers vs HIV patients), weight, body mass index (BMI), body surface area (BSA), creatinine clearance (estimated GFR), and formulation were evaluated. EVG PK, with COBI or RTV, was described by a 2‐compartment model, with first‐order absorption and elimination and an absorption lag time. A statistically significant, but not clinically relevant, effect of BSA on EVG clearance (CL) was observed. Coadministration of atazanavir or lopinavir with EVG/r had an effect on EVG CL consistent with the known interaction with these agents. No other covariate had a meaningful effect on EVG PK. EVG PK was well described in a population PK model with HIV‐infected patients, with low PK variability and no relevant effect of demographic or biometric covariates.
doi10.1002/jcph.657
pages723-732
date2016-06