ArticleHIV medicine2012
Effect of pregnancy on emtricitabine pharmacokinetics.
Article in HIV medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00042289 (Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum
Who cites it
22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.
- Pregnancy-Associated Changes in Pharmacokinetics: A Systematic Review.PLoS medicine · 2016Pooled it
- Protecting the fetus against HIV infection: a systematic review of placental transfer of antiretrovirals.Clinical pharmacokinetics · 2014Pooled it
- Dolutegravir pharmacokinetics in pregnant and postpartum women living with HIV.AIDS (London, England) · 2018Trial
- Exploring the pharmacokinetic mechanisms that affect bictegravir exposure during pregnancy.The Journal of antimicrobial chemotherapy · 2026Article
- From Pharmacovigilance Signals to Mechanistic Phenotypes: Integrating ADMET, PK/PD, and Network Context to Interpret Antiviral Safety in Pregnancy.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Care of Pregnant Women Living with Human Immunodeficiency Virus.Clinics in perinatology · 2024Review
- Prediction of Maternal and Fetal Acyclovir, Emtricitabine, Lamivudine, and Metformin Concentrations during Pregnancy Using a Physiologically Based Pharmacokinetic Modeling Approach.Clinical pharmacokinetics · 2022Article
- Physiologically Based Pharmacokinetic Modeling Framework to Predict Neonatal Pharmacokinetics of Transplacentally Acquired Emtricitabine, Dolutegravir, and Raltegravir.Clinical pharmacokinetics · 2021Article
- Drug dosing during pregnancy-opportunities for physiologically based pharmacokinetic models.Journal of pharmacokinetics and pharmacodynamics · 2020Review
- Physiologically Based Pharmacokinetic Models to Predict Maternal Pharmacokinetics and Fetal Exposure to Emtricitabine and Acyclovir.Journal of clinical pharmacology · 2020Article
- Inclusion of pregnant women in antiretroviral drug research: what is needed to move forwards?Journal of the International AIDS Society · 2019Article
- Multiple Drug Transporters Contribute to the Placental Transfer of Emtricitabine.Antimicrobial agents and chemotherapy · 2019Article
- Toward a universal antiretroviral regimen: special considerations of pregnancy and breast feeding.Current opinion in HIV and AIDS · 2017Review
- Advancing HIV research with pregnant women: navigating challenges and opportunities.AIDS (London, England) · 2016Article
- Prediction of human fetal pharmacokinetics using ex vivo human placenta perfusion studies and physiologically based models.British journal of clinical pharmacology · 2016Article
- Physiologically-based pharmacokinetic modeling of renally excreted antiretroviral drugs in pregnant women.British journal of clinical pharmacology · 2015Article
- Alteration in cytochrome P450 3A4 activity as measured by a urine cortisol assay in HIV-1-infected pregnant women and relationship to antiretroviral pharmacokinetics.HIV medicine · 2015Article
- Modified renal function in pregnancy: impact on emtricitabine pharmacokinetics.British journal of clinical pharmacology · 2014Article
- Basic obstetric pharmacology.Seminars in perinatology · 2014Review
- Obstetric Pharmacokinetic Dosing Studies are Urgently Needed.Frontiers in pediatrics · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 11 institutions in 1 country.
Funding
Abstract
objectivesThe aim of the study was to describe emtricitabine pharmacokinetics during pregnancy and postpartum.
methodsThe International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT), formerly Pediatric AIDS Clinical Trials Group (PACTG), study P1026s is a prospective pharmacokinetic study of HIV-infected pregnant women taking antiretrovirals for clinical indications, including a cohort taking emtricitabine 200 mg once daily. Intensive steady-state 24-hour emtricitabine pharmacokinetic profiles were performed during the third trimester and 6-12 weeks postpartum, and on maternal and umbilical cord blood samples collected at delivery. Emtricitabine was measured by liquid chromatography-mass spectrometry with a quantification limit of 0.0118 mg/L. The target emtricitabine area under the concentration versus time curve, from time 0 to 24 hours post dose (AUC(0-24) ), was ≥7 mg h/L (≤30% reduction from the typical AUC of 10 mg h/L in nonpregnant historical controls). Third-trimester and postpartum pharmacokinetics were compared within subjects.
resultsTwenty-six women had pharmacokinetics assessed during the third trimester (median 35 weeks of gestation) and 22 postpartum (median 8 weeks postpartum). Mean [90% confidence interval (CI)] emtricitabine pharmacokinetic parameters during the third trimester vs. postpartum were, respectively: AUC: 8.0 (7.1-8.9) vs. 9.7 (8.6-10.9) mg h/L (P = 0.072); apparent clearance (CL/F): 25.0 (22.6-28.3) vs. 20.6 (18.4-23.2) L/h (P = 0.025); 24 hour post dose concentration (C(24) ): 0.058 (0.037-0.063) vs. 0.085 (0.070-0.010) mg/L (P = 0.006). The mean cord:maternal ratio was 1.2 (90% CI 1.0-1.5). The viral load was <400 HIV-1 RNA copies/mL in 24 of 26 women in the third trimester, in 24 of 26 at delivery, and in 15 of 19 postpartum. Within-subject comparisons demonstrated significantly higher CL/F and significantly lower C(24) during pregnancy; however, the C(24) was well above the inhibitory concentration 50%, or drug concentration that suppresses viral replication by half (IC(50) ) in all subjects.
conclusionsWhile we found higher emtricitabine CL/F and lower C(24) and AUC during pregnancy compared with postpartum, these changes were not sufficiently large to warrant dose adjustment during pregnancy. Umbilical cord blood concentrations were similar to maternal concentrations.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.