Evidence map›Paper›PMID 17892516›Full record

ArticleBritish journal of clinical pharmacology2007

Pharmacokinetic modelling of the placental transfer of nelfinavir and its M8 metabolite: a population study using 75 maternal-cord plasma samples.

Déborah Hirt, Saïk Urien, Vincent Jullien, Ghislaine Firtion, Hélène Chappuy, Elisabeth Rey, Gérard Pons, Laurent Mandelbrot, Jean-Marc Treluyer

Open access · bronzeAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 29% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Basic obstetric pharmacology.Seminars in perinatology · 2014
    Review
  6. Article
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  8. Review
  9. 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

9 authors at 5 institutions in 1 country.

Déborah HirtPharmacologie Clinique, Assistance publique- Hôpitaux de Paris, groupe hospitalier Cochin-Saint-Vincent-de-Paul, Faculté de médecine René Descartes, Université Paris 5, Paris, France. deborah.hirt@univ-paris5.fr
Saïk Urien
Vincent Jullien
Ghislaine Firtion
Hélène Chappuy
Elisabeth Rey
Gérard Pons
Laurent Mandelbrot
Jean-Marc Treluyer
Inserm · FRGroupe Hospitalier Cochin - Port-Royal, Hôtel-Dieu, Broca - La Collégiale · FRHôpital Louis-Mourier · FRHôpital Necker-Enfants Malades · FRHôpital René Huguenin · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsA population pharmacokinetic model was developed to characterize the transfer of nelfinavir and its active metabolite M8 from maternal to cord plasma and amniotic fluid.

methodsConcentration data were obtained from 75 women on the day of delivery and for whom maternal, umbilical plasma and amniotic fluid samples were collected. Data from 53 pregnant, 61 nonpregnant and seven consecutively pregnant and non pregnant women were then added to the database, the contents of which were analyzed using NONMEM.

resultsNelfinavir and M8 concentrations in maternal plasma, umbilical plasma and amniotic fluid were described by six connected compartments. Mean (% intersubject variability) population estimates were: absorption rate 00.67 h(-1), lag time 00.87 h, oral clearance and volume of distribution: 39.5 l h(-1) (53%), and 557 l for non pregnant and pregnant women, respectively, and 115 l h(-1) (132%) and 1626 l, respectively, on the day of delivery, M8 formation clearance 0.77 l h(-1) and M8 elimination rate constant 03.41 h(-1) (74%). For nelfinavir and M8, respectively, the mother-to-cord parameters were 0.058 l h(-1) (34%), and 00.35 h(-1) (76%), the cord-to-amniotic fluid rate constants were 0.23 and 00.59 h(-1), and the elimination rate constants from amniotic fluid were 0.36 and 00.49 h(-1). The nelfinavir fetus : maternal concentration ratio was 25% for maternal concentrations between 0.1 and 2.5 mg l(-1), between the 31 and 41st week of gestation.

conclusionsThe low transfer of nelfinavir from the placenta is unlikely to protect the fetus from vertical HIV-1 transmission.

Indexed as

Amniotic FluidDose-Response Relationship, DrugFemaleFetal BloodHIV InfectionsHIV Protease InhibitorsHumansNelfinavirPlacentaPregnancyPregnancy Complications, InfectiousTreatment OutcomeHIV Protease InhibitorsNelfinavir

Identifiers

PMID17892516
PMCPMC2203265
OpenAlexW2039884039

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.