ArticleJournal of acquired immune deficiency syndromes (1999)2015
Pharmacokinetics of Once Versus Twice Daily Darunavir in Pregnant HIV-Infected Women.
Article in Journal of acquired immune deficiency syndromes (1999), 2015. 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 21 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.
- Pregnancy-Associated Changes in Pharmacokinetics: A Systematic Review.PLoS medicine · 2016Pooled it
- Maintenance darunavir/ritonavir monotherapy to prevent perinatal HIV transmission, ANRS-MIE 168 MONOGEST study.The Journal of antimicrobial chemotherapy · 2023Trial
- Pharmacokinetics of Increased Nelfinavir Plasma Concentrations in Women During Pregnancy and Postpartum.Journal of clinical pharmacology · 2019Trial
- Elvitegravir/cobicistat pharmacokinetics in pregnant and postpartum women with HIV.AIDS (London, England) · 2018Trial
- Dolutegravir pharmacokinetics in pregnant and postpartum women living with HIV.AIDS (London, England) · 2018Trial
- Pharmacokinetics of Rilpivirine in HIV-Infected Pregnant Women.Journal of acquired immune deficiency syndromes (1999) · 2016Trial
- Dosing of ritonavir-boosted darunavir for treatment of HIV in pregnancy.AIDS (London, England) · 2026Observational
- Brief Report: Breast Milk Transfer and Infant Exposures to Dolutegravir, Tenofovir, and Tenofovir Alafenamide: Results From IMPAACT 2010/VESTED.Journal of acquired immune deficiency syndromes (1999) · 2026Article
- An Update on the Clinical Management of HIV and Tuberculosis Co-Infection in Pregnancy: TB Preventative Therapy, Long-Acting ARVs, and Bedaquiline-Based Regimens.Current HIV/AIDS reports · 2025Review
- Physiologic Changes During Pregnancy and Impact on Small-Molecule Drugs, Biologic (Monoclonal Antibody) Disposition, and Response.Journal of clinical pharmacology · 2023Review
- An update on the physiologic changes during pregnancy and their impact on drug pharmacokinetics and pharmacogenomics.Journal of basic and clinical physiology and pharmacology · 2022Review
- Successful Prediction of Human Fetal Exposure to P-Glycoprotein Substrate Drugs Using the Proteomics-Informed Relative Expression Factor Approach and PBPK Modeling and Simulation.Drug metabolism and disposition: the biological fate of chemicals · 2021Article
- Pharmacokinetic Enhancement of HIV Antiretroviral Therapy During Pregnancy.Journal of clinical pharmacology · 2020Review
- Drug-Drug Interactions with Antiretroviral Drugs in Pregnant Women Living with HIV: Are They Different from Non-Pregnant Individuals?Clinical pharmacokinetics · 2020Review
- Darunavir Pharmacokinetics With an Increased Dose During Pregnancy.Journal of acquired immune deficiency syndromes (1999) · 2020Article
- Inclusion of pregnant women in antiretroviral drug research: what is needed to move forwards?Journal of the International AIDS Society · 2019Article
- Ritonavir and cobicistat as pharmacokinetic enhancers in pregnant women.Expert opinion on drug metabolism & toxicology · 2019Article
- Evaluating darunavir/ritonavir dosing regimens for HIV-positive pregnant women using semi-mechanistic pharmacokinetic modelling.The Journal of antimicrobial chemotherapy · 2019Article
- Prediction of Fetal Darunavir Exposure by Integrating Human Ex-Vivo Placental Transfer and Physiologically Based Pharmacokinetic Modeling.Clinical pharmacokinetics · 2018Article
- Treatment With Antipsychotics in Pregnancy: Changes in Drug Disposition.Clinical pharmacology and therapeutics · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 7 institutions in 3 countries.
Funding
Abstract
objectiveTo describe darunavir (DRV) pharmacokinetics with once-and twice-daily dosing during pregnancy and postpartum in HIV-infected women.
designWomen were enrolled in International Maternal Pediatric Adolescent AIDS Clinical Trials Network Protocol P1026s, a prospective nonblinded study of antiretroviral pharmacokinetics in HIV-infected pregnant women that included separate cohorts receiving DRV/ritonavir dosed at either 800 mg/100 mg once daily or 600 mg/100 mg twice daily.
methodsIntensive steady-state 12- or 24-hour pharmacokinetic profiles were performed during the second trimester, third trimester, and postpartum. DRV was measured using high-performance liquid chromatography (detection limit: 0.09 μg/mL).
resultsPharmacokinetic data were available for 64 women (30 once daily and 34 twice daily dosing). Median DRV area under the concentration-time curve (AUC) and maximum concentration were significantly reduced during pregnancy with both dosing regimens compared with postpartum, whereas the last measurable concentration (Clast) was also reduced during pregnancy with once daily DRV. DRV AUC with once daily dosing was reduced by 38% during the second trimester and by 39% during the third trimester. With twice daily dosing, DRV AUC was reduced by 26% in both trimesters. The median (range) ratio of cord blood/maternal delivery DRV concentration in 32 paired samples was 0.18 (range: 0-0.82).
conclusionsDRV exposure is reduced by pregnancy. To achieve DRV plasma concentrations during pregnancy equivalent to those seen in nonpregnant adults, an increased twice daily dose may be necessary. This may be especially important for treatment-experienced women who may have developed antiretroviral resistance mutations.
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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.