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dc.contributor.authorRegis Kreitchmannen_US
dc.contributor.authorBrookie M. Besten_US
dc.contributor.authorJiajia Wangen_US
dc.contributor.authorAlice Steken_US
dc.contributor.authorEdmund Caparellien_US
dc.contributor.authorD. Heather Wattsen_US
dc.contributor.authorElizabeth Smithen_US
dc.contributor.authorDavid E. Shapiroen_US
dc.contributor.authorSteve Rossien_US
dc.contributor.authorSandra K. Burchetten_US
dc.contributor.authorElizabeth Hawkinsen_US
dc.contributor.authorMark Byroadsen_US
dc.contributor.authorTim R. Cresseyen_US
dc.contributor.authorMark Mirochnicken_US
dc.description.abstractBACKGROUND: Reduced atazanavir exposure has been demonstrated during pregnancy with standard atazanavir/ritonavir dosing. We studied an increased dose during the third trimester of pregnancy. METHODS: International Maternal Pediatric Adolescent AIDS Clinical Trials Group 1026s is a prospective, nonblinded, pharmacokinetic study of HIV-infected pregnant women taking antiretrovirals for clinical indications, including 2 cohorts (with or without tenofovir) receiving atazanavir/ritonavir 300/100 mg once daily during the second trimester, 400/100 mg during the third trimester, and 300/100 mg postpartum (PP). Intensive steady-state 24-hour pharmacokinetic profiles were performed. Atazanavir concentrations were measured by high-performance liquid chromatography. Pharmacokinetic targets were the 10th percentile atazanavir area under the concentration versus time curve (AUC) (29.4 μg·hr· mL·) in nonpregnant adults on standard dose and 0.15 μg/mL, minimum trough concentration. RESULTS: Atazanavir pharmacokinetic data were available for 37 women without tenofovir, 35 with tenofovir; median (range) pharmacokinetic parameters are presented for second trimester, third trimester, and PP and number who met target/total. ATAZANAVIR WITHOUT TENOFOVIR: AUC 30.5 (9.19-93.8), 45.7 (11-88.3), and 48.8 (9.9-112.2) μg·hr·mL, and 8/14, 29/37, and 27/34 met target. C24 h was 0.49 (0.09-4.09), 0.71 (0.14-2.09), and 0.90 (0.05-2.73) μg/mL; 13/14, 36/37, and 29/34 met target. ATAZANAVIR WITH TENOFOVIR: AUC 26.2 (6.8-60.9) (P < 0.05 compared with PP), 37.7 (0.72-88.2) (P < 0.05 compared with PP), and 58.6 (6-149) μg·hr·mL, and 7/17, 23/32, and 27/29 met target. C24 h was 0.44 (0.12-1.06) (P < 0.05 compared with PP), 0.57 (0.02-2.06) (P < 0.05 compared with PP), and 1.26 (0.09-5.43) μg/mL; 7/17, 23/32, and 27/29 met target. Atazanavir/ritonavir was well tolerated with no unanticipated adverse events. CONCLUSIONS: Atazanavir/ritonavir increased to 400/100 mg provides adequate atazanavir exposure during the third trimester and should be considered during the second trimester. Copyright © 2013 by Lippincott Williams & Wilkins.en_US
dc.titlePharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancyen_US
article.title.sourcetitleJournal of Acquired Immune Deficiency Syndromesen_US
article.volume63en_US Research Departmenten_US of California, San Diegoen_US for Biostatistics in AIDS Researchen_US School of Medicine of USCen_US Institute of Child Health and Human Developmenten_US Institute of Allergy and Infectious Diseasesen_US's Hospital Bostonen_US &amp; Scientific Systems, Inc.en_US Science &amp; Technology Research Foundation, Inc.en_US Mai Universityen_US School of Public Healthen_US Institut de Recherche pour le Developpementen_US University School of Medicineen_US
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