Evidence map›Paper›PMID 31215170›Full record

ArticleCPT: pharmacometrics & systems pharmacology2019

Maternal-Neonatal Raltegravir Population Pharmacokinetics Modeling: Implications for Initial Neonatal Dosing.

Jos Lommerse, Diana Clarke, Thomas Kerbusch, Henri Merdjan, Han Witjes, Hedy Teppler, Mark Mirochnick, Edward P Acosta, Larissa Wenning, Sharon Nachman and 1 more

Open access · goldAbstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 28% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 2 countries.

Jos LommerseCertara Strategic Consulting, Oss, The Netherlands.
Diana ClarkeBoston Medical Center, Boston, Massachusetts, USA.
Thomas KerbuschCertara Strategic Consulting, Oss, The Netherlands.
Henri MerdjanCertara Strategic Consulting, Paris, France.
Han WitjesCertara Strategic Consulting, Oss, The Netherlands.
Hedy TepplerMerck & Co., Inc., Upper Gwynedd, Pennsylvania, USA.
Mark MirochnickBoston University School of Medicine, Boston, Massachusetts, USA.
Edward P AcostaUniversity of Alabama at Birmingham, Birmingham, Alabama, USA.
Larissa WenningMerck & Co., Inc., Upper Gwynedd, Pennsylvania, USA.
Sharon NachmanState University of New York, Stony Brook, New York, USA.
Anne ChainMerck & Co., Inc., Rahway, New Jersey, USA.
ABS Consulting (United States) · USBoston Medical Center · USBoston University · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USState University of New York · USUniversity of Alabama at Birmingham · US

Funding

Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI106716NICHD NIH HHS HHSN275201800001Ithe National Institute of Mental Health NIMH UM1AI068632
6 · The paper itself

Abstract

Raltegravir readily crosses the placenta to the fetus with maternal use during pregnancy. After birth, neonatal raltegravir elimination is highly variable and often extremely prolonged, with some neonates demonstrating rising profiles after birth despite removal from the source of extrinsic raltegravir. To establish an appropriate dosing regimen, an integrated maternal-neonatal pharmacokinetics model was built to predict raltegravir plasma concentrations in neonates with in utero raltegravir exposure. Postnatal age and body weight were used as structural covariates. The model predicted rising or decreasing neonatal elimination profiles based on the time of maternal drug administration relative to time of birth and degree of in utero drug disposition into the central and peripheral compartments. Based on this model, it is recommended to delay the first oral dose of raltegravir until 1-2 days of age in those neonates born to mothers who received raltegravir during pregnancy, labor, and delivery.

Indexed as

Anti-HIV AgentsCase-Control StudiesDrug Dosage CalculationsFemaleHIV InfectionsHumansInfant, NewbornMaternal-Fetal ExchangeModels, TheoreticalPregnancyRaltegravir PotassiumAnti-HIV AgentsRaltegravir Potassium

Identifiers

PMID31215170
PMCPMC6765695
OpenAlexW2950993997

What OpenQuestion holds

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Registered trials

None linked

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.