Reduced exposure to darunavir and cobicistat in HIV-1-infected pregnant women receiving a darunavir/cobicistat-based regimen.
Adult
Cobicistat
/ administration & dosage
Darunavir
/ administration & dosage
Drug Therapy, Combination
Female
Gestational Age
HIV Infections
/ drug therapy
Humans
Infant, Newborn
Infectious Disease Transmission, Vertical
/ statistics & numerical data
Maternal Age
Postpartum Period
/ blood
Pregnancy
Pregnancy Complications, Infectious
/ drug therapy
Pregnancy Trimester, Second
/ blood
Treatment Outcome
HIV
cobicistat
darunavir
pharmacokinetics
pregnancy
Journal
HIV medicine
ISSN: 1468-1293
Titre abrégé: HIV Med
Pays: England
ID NLM: 100897392
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
accepted:
08
01
2019
pubmed:
16
3
2019
medline:
23
5
2020
entrez:
16
3
2019
Statut:
ppublish
Résumé
The aim of the study was to evaluate darunavir and cobicistat pharmacokinetics in pregnant women with HIV-1 infection. This phase 3b, open-label study enrolled HIV-1-infected pregnant women (18-26 weeks of gestation) receiving combination antiretroviral therapy with once-daily darunavir/cobicistat 800/150 mg. The plasma pharmacokinetics of darunavir (total and unbound) and cobicistat were assessed over 24 h during the second and third trimesters (24-28 and 34-38 weeks of gestation, respectively) and 6-12 weeks postpartum. Pharmacokinetic parameters [area under the plasma concentration-time curve over 24 h (AUC Seven women were enrolled in the study; six completed it. Total darunavir exposure was lower during pregnancy than postpartum (AUC In view of markedly reduced darunavir and cobicistat exposures during pregnancy, this combination is not recommended in HIV-1-infected pregnant women.
Substances chimiques
Cobicistat
LW2E03M5PG
Darunavir
YO603Y8113
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
337-343Subventions
Organisme : Janssen Scientific Affairs, LLC
Pays : International
Informations de copyright
© 2019 British HIV Association.