Evidence map›Paper›PMID 29520730›Full record

ArticleClinical pharmacokinetics2018

A Mechanism-Based Population Pharmacokinetic Analysis Assessing the Feasibility of Efavirenz Dose Reduction to 400 mg in Pregnant Women.

Stein Schalkwijk, Rob Ter Heine, Angela C Colbers, Alwin D R Huitema, Paolo Denti, Kelly E Dooley, Edmund Capparelli, Brookie M Best, Tim R Cressey, Rick Greupink and 3 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Clinical pharmacokinetics, 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 32% 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.

NCT00042289 completednot on this map

Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum

TypeobservationalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2003 to 2020Enrolled1,578ConditionsHIV InfectionsArmsatazanavir/cobicistat, darunavir/ritonavir dosage #1, darunavir/ritonavir dosage #2, darunavir/ritonavir dosage #3, elvitegravir/cobicistat
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Article
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 6 institutions in 5 countries.

Stein SchalkwijkDepartment of Pharmacy, Radboud Institute for Health Sciences (RIHS), Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands. stein.j.schalkwijk@radboudumc.nl.ORCID 0000-0001-8204-5242
Rob Ter HeineDepartment of Pharmacy, Radboud Institute for Health Sciences (RIHS), Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.
Angela C ColbersDepartment of Pharmacy, Radboud Institute for Health Sciences (RIHS), Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.
Alwin D R HuitemaDepartment of Pharmacy and Pharmacology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Paolo DentiDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Kelly E DooleyJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Edmund CapparelliSkaggs School of Pharmacy and Pharmaceutical Sciences and School of Medicine, University of California San Diego, La Jolla, CA, USA.
Brookie M BestSkaggs School of Pharmacy and Pharmaceutical Sciences and School of Medicine, University of California San Diego, La Jolla, CA, USA.
Tim R CresseyFaculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.
Rick GreupinkDepartment of Pharmacology and Toxicology, Radboud Institute for Molecular Life Sciences (RIMLS), Radboud University Medical Center, Nijmegen, The Netherlands.
Frans G M RusselDepartment of Pharmacology and Toxicology, Radboud Institute for Molecular Life Sciences (RIMLS), Radboud University Medical Center, Nijmegen, The Netherlands.
Mark MirochnickBoston University, Boston, MA, USA.
David M BurgerDepartment of Pharmacy, Radboud Institute for Health Sciences (RIHS), Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.
Radboud University Nijmegen · NLUniversity of California San Diego · USHarvard University · USJohns Hopkins University · USThe Netherlands Cancer Institute · NLUniversity of Cape Town · ZA

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
Impact of TB on Outcome of HIV in Pregnant WomenR01HD064354 · NICHD · JOHNS HOPKINS UNIVERSITY · PI CHAISSON, RICHARD E. · 2010 to 2014
$3.0M
NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI106716NICHD NIH HHS R01 HD064354
6 · The paper itself

Abstract

backgroundReducing the dose of efavirenz can improve safety, reduce costs, and increase access for patients with HIV infection. According to the World Health Organization, a similar dosing strategy for all patient populations is desirable for universal roll-out; however, it remains unknown whether the 400 mg daily dose is adequate during pregnancy.

methodsWe developed a mechanistic population pharmacokinetic model using pooled data from women included in seven studies (1968 samples, 774 collected during pregnancy). Total and free efavirenz exposure (AUC

resultsUsing a 400 mg dose, the median efavirenz total AUC

conclusionsIt was predicted that reduced-dose efavirenz provides adequate exposure during pregnancy. These findings warrant prospective confirmation.

Indexed as

AlkynesAnti-HIV AgentsBenzoxazinesCase-Control StudiesCyclopropanesFeasibility StudiesFemaleHIV InfectionsHumansMeta-Analysis as TopicModels, BiologicalPregnancyAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesefavirenz

Identifiers

PMID29520730
PMCPMC6182466
OpenAlexW2792671636

What OpenQuestion holds

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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.