Evidence map›Paper›PMID 35980827›Full record

ArticleThe Pediatric infectious disease journal2022

Maraviroc Population Pharmacokinetics Within the First 6 Weeks of Life.

Marlon Liyanage, Mina Nikanjam, Lynn McFadyen, Manoli Vourvahis, Luise Rogg, John Moye, Ellen G Chadwick, Patrick Jean-Philippe, Mark Mirochnick, Kyle Whitson and 3 more

Open access · greenAbstract read
In one paragraph

Article in The Pediatric infectious disease journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 89% 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

1 citing paper in PubMed, 0 citations in OpenAlex.

  1. Review
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

13 authors at 10 institutions in 2 countries.

Marlon LiyanageFrom the Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, CA.ORCID 0000-0003-3801-6174
Mina NikanjamFrom the Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, CA.
Lynn McFadyenDepartment of Pharmacometrics, Pfizer Global Research and Development, Sandwich, United Kingdom.
Manoli VourvahisDepartment of Clinical Pharmacology, Pfizer Global Research and Development, New York, NY.
Luise RoggViiV Healthcare, Research Triangle, NC.
John MoyeEunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.
Ellen G ChadwickAnn & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.
Patrick Jean-PhilippeNational Institute of Allergy and Infectious Diseases, Bethesda, MD.
Mark MirochnickBoston University School of Medicine, Boston, MA.
Kyle WhitsonFrontier Science Foundation, Amherst, NY.
Sarah BradfordFHI 360, Durham, NC.
Edmund V CapparelliFrom the Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, CA.
Brookie M BestFrom the Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, CA.ORCID 0000-0001-8569-2293
University of California San Diego · USBoston University · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USFamily Health International 360 · USFrontier Science & Technology Research Foundation · USLurie Children's Hospital · USNational Institute of Allergy and Infectious Diseases · USPfizer (United Kingdom) · GBPfizer (United States) · USTriangle · US

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Sharon A Nachman · 2011 to 2026
$278.1M
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 AI068632NIAID NIH HHS UM1 AI106716NICHD NIH HHS HHSN275201800001CNICHD NIH HHS HHSN275201800001I
6 · The paper itself

Abstract

backgroundTreatment and prophylaxis options for neonatal HIV are limited. This study aimed to develop a population pharmacokinetic model to characterize the disposition of maraviroc in neonates to inform dosing regimens and expand available options.

methodsUsing maraviroc concentrations from neonates who received either a single dose or multiple doses of 8 mg/kg of maraviroc in the first 6 weeks of life, a population pharmacokinetic model was developed to determine the effects of age, sex, maternal efavirenz exposure and concomitant ARV therapy on maraviroc disposition. The final model was used in Monte Carlo simulations to generate expected exposures with recommended dosing regimens.

resultsA total of 396 maraviroc concentrations, collected in the first 4 days of life, at 1 week, at 4 weeks and at 6 weeks, from 44 neonates were included in the analysis. After allometrically scaling for weight, age less than 4 days was associated with a 44% decreased apparent clearance compared with participants 7 days to 6 weeks of life. There were no differences identified in apparent clearance or volume of distribution from ages 7 days to 6 weeks, sex, maternal efavirenz exposure or concomitant nevirapine therapy. Monte Carlo simulations with FDA-approved weight band dosing resulted in the majority of simulated patients (84.3%) achieving an average concentration of ≥75 ng/mL.

conclusionsWhile maraviroc apparent clearance is decreased in the first few days of life, the current FDA-approved maraviroc weight band dosing provides maraviroc exposures for neonates in the first 6 weeks of life, which were consistent with adult maraviroc exposure range. Maraviroc provides another antiretroviral treatment option for very young infants.

Indexed as

HIV InfectionsNevirapineAdultAlkynesBenzoxazinesCyclopropanesHumansInfantInfant, NewbornMaravirocAlkynesBenzoxazinesCyclopropanesefavirenzMaravirocNevirapine

Identifiers

PMID35980827
PMCPMC9560968
OpenAlexW4292229954

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.