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Pharmacology

Population Pharmacokinetics of Tenofovir in Pregnant and Postpartum Women Using Tenofovir Disoproxil Fumarate

Ahizechukwu C. Eke, Kensuke Shoji, Brookie M. Best, Jeremiah D. Momper, Alice M. Stek, Tim R. Cressey, Mark Mirochnick, Edmund V. Capparelli
Ahizechukwu C. Eke
aDivision of Maternal Fetal Medicine, Department of Gynecology & Obstetrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
bDoctoral Training Program (PhD), Graduate Training Program in Clinical Investigation (GTPCI), Johns Hopkins University School of Public Health, Baltimore, Maryland, USA
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  • ORCID record for Ahizechukwu C. Eke
Kensuke Shoji
cDivision of Infectious Diseases, Department of Medical Subspecialties, National Center for Child Health and Development, Tokyo, Japan
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Brookie M. Best
dUniversity of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, California, USA
ePediatrics Department, University of California San Diego–Rady Children’s Hospital San Diego, San Diego, California, USA
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Jeremiah D. Momper
dUniversity of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, California, USA
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Alice M. Stek
fDivision of Maternal Fetal Medicine, Department of Obstetrics & Gynecology, University of Southern California School of Medicine, Los Angeles, California, USA
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Tim R. Cressey
gPHPT/IRD UMI 174, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand
hDepartment of Molecular & Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom
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Mark Mirochnick
iDivision of Neonatology, Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts, USA
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Edmund V. Capparelli
dUniversity of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, California, USA
ePediatrics Department, University of California San Diego–Rady Children’s Hospital San Diego, San Diego, California, USA
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DOI: 10.1128/AAC.02168-20
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ABSTRACT

Pharmacokinetics of drugs can be affected by physiologic changes during pregnancy. Our aim was to assess the influence of covariates on tenofovir (TFV) pharmacokinetics in pregnant and postpartum women receiving tenofovir disoproxil fumarate (TDF). Population pharmacokinetic parameter estimates and the influence of covariates were assessed using nonlinear mixed-effects modeling (NONMEM 7.4). Forty-six women had intensive pharmacokinetic evaluations during the second and third trimesters of pregnancy, with another evaluation postpartum. A two-compartment pharmacokinetic model with allometric scaling for body weight and first-order absorption best described the tenofovir plasma concentration data. Apparent oral clearance (CL/F) and volume of distribution at steady state (Vss/F) were increased during pregnancy. Weight, serum creatinine (SCr), pregnancy, albumin, and age were associated with TFV CL/F during univariate assessment, but in the multivariate analysis, changes in CL/F and Vss/F were only associated with increased body weight and enhanced renal function. Due to greater weight and lower SCr during pregnancy, CL/F was 28% higher during pregnancy than postpartum. In the final model, CL/F (liters per hour) was described as 2.07 × (SCr/0.6)0.65 × weight0.75, with a low between-subject variability (BSV) of 24%. The probability of target attainment (proportion exceeding area under the concentration-time curve of >1.99 μg·h/ml, the 10th percentile of average TFV exposure for nonpregnant historical controls) was 68%, 80%, 87%, and 93% above the target with 300 mg, 350 mg, 400 mg, and 450 mg of TDF, respectively, during pregnancy and 88%, 92%, 96%, and 98% above the target with same doses in postpartum women. Dose adjustment of TDF during pregnancy is not generally warranted, but any modification should be based on weight and renal function. (This study has been registered at ClinicalTrials.gov under identifier NCT00042289.)

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Population Pharmacokinetics of Tenofovir in Pregnant and Postpartum Women Using Tenofovir Disoproxil Fumarate
Ahizechukwu C. Eke, Kensuke Shoji, Brookie M. Best, Jeremiah D. Momper, Alice M. Stek, Tim R. Cressey, Mark Mirochnick, Edmund V. Capparelli on behalf of the IMPAACT P1026s Protocol Team
Antimicrobial Agents and Chemotherapy Feb 2021, 65 (3) e02168-20; DOI: 10.1128/AAC.02168-20

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Population Pharmacokinetics of Tenofovir in Pregnant and Postpartum Women Using Tenofovir Disoproxil Fumarate
Ahizechukwu C. Eke, Kensuke Shoji, Brookie M. Best, Jeremiah D. Momper, Alice M. Stek, Tim R. Cressey, Mark Mirochnick, Edmund V. Capparelli on behalf of the IMPAACT P1026s Protocol Team
Antimicrobial Agents and Chemotherapy Feb 2021, 65 (3) e02168-20; DOI: 10.1128/AAC.02168-20
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KEYWORDS

HIV
AIDS
TDF
population pharmacokinetics
postpartum
pregnancy
tenofovir
tenofovir disoproxil fumarate

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