Trial reportAIDS (London, England)2018
Elvitegravir/cobicistat pharmacokinetics in pregnant and postpartum women with HIV.
Trial report in AIDS (London, England), 2018. 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 28 papers.
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
28 citing papers in PubMed.
- Perinatal and early infant outcomes after first-versus second-generation integrase strand transfer inhibitor use in pregnancy.HIV medicine · 2026Article
- From Pharmacovigilance Signals to Mechanistic Phenotypes: Integrating ADMET, PK/PD, and Network Context to Interpret Antiviral Safety in Pregnancy.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Pharmacokinetic Adaptations in Pregnancy: Implications for Optimizing Antiretroviral Therapy in HIV-Positive Women.Pharmaceutics · 2025Review
- Antiretroviral Therapy in Pregnancy: A 2023 Review of the Literature.Current HIV/AIDS reports · 2024Review
- Brief Report: Dolutegravir Plasma Protein Binding and Unbound Concentrations During Pregnancy and Postpartum.Journal of acquired immune deficiency syndromes (1999) · 2023Article
- Clinical Relevance of Drug Interactions in People Living with Human Immunodeficiency Virus on Antiretroviral Therapy-Update 2022: Systematic Review.Pharmaceutics · 2023Review
- Physiologic Changes During Pregnancy and Impact on Small-Molecule Drugs, Biologic (Monoclonal Antibody) Disposition, and Response.Journal of clinical pharmacology · 2023Review
- Relationship between raltegravir trough plasma concentration and virologic response and the impact of therapeutic drug monitoring during pregnancy.International journal of STD & AIDS · 2023Article
- HIV-1 Integrase Strand Transfer Inhibitors and Neurodevelopment.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Second-Generation Human Immunodeficiency Virus Integrase Inhibitors Induce Differentiation Dysregulation and Exert Toxic Effects in Human Embryonic Stem Cell and Mouse Models.The Journal of infectious diseases · 2022Article
- Magnitude of Drug-Drug Interactions in Special Populations.Pharmaceutics · 2022Review
- A practical clinical guide to counselling on and managing contraception, pre-conception planning, and menopause for women living with HIV.Journal of the Association of Medical Microbiology and Infectious Disease Canada = Journal officiel de l'Association pour la microbiologie medicale et l'infectiologie Canada · 2021Article
- Pharmacokinetic Enhancement of HIV Antiretroviral Therapy During Pregnancy.Journal of clinical pharmacology · 2020Review
- Review
- Drug-Drug Interactions with Antiretroviral Drugs in Pregnant Women Living with HIV: Are They Different from Non-Pregnant Individuals?Clinical pharmacokinetics · 2020Review
- Innovative Approaches for Pharmacology Studies in Pregnant and Lactating Women: A Viewpoint and Lessons from HIV.Clinical pharmacokinetics · 2020Article
- Comparative Clinical Pharmacokinetics and Pharmacodynamics of HIV-1 Integrase Strand Transfer Inhibitors: An Updated Review.Clinical pharmacokinetics · 2020Review
- Cobicistat: A case of mislabelled drug-drug interaction risk?British journal of clinical pharmacology · 2020Article
- Tenofovir alafenamide use in pregnant and lactating women living with HIV.Expert opinion on drug metabolism & toxicology · 2020Review
- Physiologically Based Pharmacokinetic Models to Predict Maternal Pharmacokinetics and Fetal Exposure to Emtricitabine and Acyclovir.Journal of clinical pharmacology · 2020Article
Corrections and comments
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Authors and funding
16 authors.
Funding
Abstract
objectiveTo evaluate elvitegravir and cobicistat pharmacokinetics during pregnancy compared with postpartum and in infant washout samples after delivery.
designNonrandomized, open-label, parallel-group, multicenter phase-IV prospective study of antiretroviral pharmacokinetics in HIV-infected pregnant women and their children in the United States.
methodsIntensive steady-state 24-h pharmacokinetic profiles after 150 mg of elvitegravir and 150 mg of cobicistat given orally in fixed dose combination once-daily were performed during the second trimester, third trimester, and postpartum. Infant washout samples were collected after birth. Elvitegravir and cobicistat were measured in plasma by a validated liquid chromatography with tandem mass spectrometry assay with a lower quantitation limit of 10 ng/ml. A two-tailed Wilcoxon signed-rank test (α = 0.10) was employed for paired within-participant comparisons.
resultsThirty pregnant women taking elvitegravir and cobicistat once-daily enrolled in the study. Compared with paired postpartum data, elvitegravir AUC0-24 was 24% lower in the second trimester [n = 14, P = 0.058, geometric mean ratios (GMR) = 0.76, 90% confidence interval (CI) 0.57-1.0] and 44% lower in the third trimester (n = 24, P = 0.0001, GMR = 0.56, 90% CI 0.42-0.73), while cobicistat AUC0-24 was 44% lower in the second trimester (n = 14, P = 0.0085, GMR = 0.56, 90% CI 0.37-0.85) and 59% lower in the third trimester (n = 24, P < 0.0001, GMR = 0.41, 90% CI 0.30-0.57). Median cord blood elvitegravir concentration was 540.6 ng/ml and the median ratio of cord blood to maternal plasma elvitegravir concentrations was 0.91.
conclusionStandard elvitegravir and cobicistat dosing during pregnancy results in significantly lower exposure which may increase the risk of virologic failure and mother-to-child transmission. Additional studies are needed to optimize elvitegravir and cobicistat dosing regimens in pregnant women.
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