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Tytuł pozycji:

Once-daily atazanavir/cobicistat and darunavir/cobicistat exposure over 72 h post-dose in plasma, urine and saliva: contribution to drug pharmacokinetic knowledge.

Tytuł :
Once-daily atazanavir/cobicistat and darunavir/cobicistat exposure over 72 h post-dose in plasma, urine and saliva: contribution to drug pharmacokinetic knowledge.
Autorzy :
Elliot ER; St Stephen's Centre, Chelsea and Westminster Hospital, London, UK.; University of Liverpool, Liverpool, UK.
Amara A; University of Liverpool, Liverpool, UK.
Pagani N; St Stephen's Centre, Chelsea and Westminster Hospital, London, UK.
Else L; University of Liverpool, Liverpool, UK.
Moyle G; St Stephen's Centre, Chelsea and Westminster Hospital, London, UK.
Schoolmeesters A; St Stephen's Centre, Chelsea and Westminster Hospital, London, UK.
Higgs C; St Stephen's Centre, Chelsea and Westminster Hospital, London, UK.
Khoo S; University of Liverpool, Liverpool, UK.
Boffito M; St Stephen's Centre, Chelsea and Westminster Hospital, London, UK.; Imperial College, Division of Medicine, London, UK.
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Źródło :
The Journal of antimicrobial chemotherapy [J Antimicrob Chemother] 2017 Jul 01; Vol. 72 (7), pp. 2035-2041.
Typ publikacji :
Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
Język :
English
Imprint Name(s) :
Publication: 1997- : London : Oxford University Press
Original Publication: London, New York, Academic Press.
MeSH Terms :
Anti-HIV Agents/*pharmacokinetics
Atazanavir Sulfate/*pharmacokinetics
Cobicistat/*pharmacokinetics
Darunavir/*pharmacokinetics
Saliva/*chemistry
Adolescent ; Adult ; Aged ; Anti-HIV Agents/administration & dosage ; Anti-HIV Agents/blood ; Atazanavir Sulfate/administration & dosage ; Atazanavir Sulfate/blood ; Atazanavir Sulfate/urine ; Cobicistat/administration & dosage ; Cobicistat/blood ; Cobicistat/urine ; Darunavir/administration & dosage ; Darunavir/blood ; Darunavir/urine ; Female ; HIV Infections/drug therapy ; HIV Protease Inhibitors/administration & dosage ; HIV Protease Inhibitors/blood ; HIV Protease Inhibitors/pharmacokinetics ; Half-Life ; Healthy Volunteers ; Humans ; Male ; Middle Aged ; Young Adult
Substance Nomenclature :
0 (Anti-HIV Agents)
0 (HIV Protease Inhibitors)
4MT4VIE29P (Atazanavir Sulfate)
LW2E03M5PG (Cobicistat)
YO603Y8113 (Darunavir)
Entry Date(s) :
Date Created: 20170414 Date Completed: 20180427 Latest Revision: 20180625
Update Code :
20210623
DOI :
10.1093/jac/dkx108
PMID :
28407075
Czasopismo naukowe
Background: We investigated the pharmacokinetics (PK) of atazanavir/cobicistat and darunavir/cobicistat once daily over 72 h following drug intake cessation in plasma, saliva and urine.
Methods: Healthy volunteers received a fixed-dose combination of 300/150 mg of atazanavir/cobicistat once daily for 10 days, followed by a 10 day washout period and then a fixed-dose combination of 800/150 mg of darunavir/cobicistat once daily for 10 days. Full PK profiles were assessed for each phase for 72 h following day 10 and parameters determined to the last measurable concentration in plasma, saliva and urine by non-compartmental methods.
Results: Sixteen subjects completed the study. Geometric mean (GM) terminal elimination half-life values to 72 h of atazanavir and darunavir were 6.77 and 6.35 h, respectively. All subjects had atazanavir concentrations above the suggested minimum effective concentration of 150 ng/mL 24 h post-dose and 14/16 subjects had concentrations higher than this target at 30 h post-dose (GM of 759 and 407 ng/mL, respectively). Thirteen out of 16 subjects had darunavir concentrations higher than the target of 550 ng/mL at 24 h post-dose and 5/16 subjects had concentrations higher than the target at 30 h post-dose (GM of 1033 and 382 ng/mL, respectively). Cobicistat half-life to 72 h was 4.21 h with atazanavir and 3.62 h with darunavir. GM values 24 h after the observed dose ( C 24 ) for atazanavir and darunavir were 141 and 43 ng/mL, respectively, in saliva and 24857 and 11878 ng/mL, respectively, in urine. Concentration decay in saliva/urine mirrored plasma concentrations for both drugs.
Conclusions: Different concentration decay patterns were seen for atazanavir and darunavir, which may be partially explained by cobicistat half-life (longer with atazanavir than darunavir). For the first time, we also measured drug PK forgiveness in saliva and urine, which represent easier markers of adherence.
(© The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
Erratum in: J Antimicrob Chemother. 2017 Jul 1;72(7):2143. (PMID: 28482097)

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