Evidence map›Paper›PMID 26282407›Full record

Trial reportAntimicrobial agents and chemotherapy2015

Emtricitabine seminal plasma and blood plasma population pharmacokinetics in HIV-infected men in the EVARIST ANRS-EP 49 study.

Elodie Valade, Jean-Marc Tréluyer, Silvia M Illamola, Naïm Bouazza, Frantz Foissac, Maïlys De Sousa Mendes, Gabrielle Lui, Camille Chenevier-Gobeaux, Marie Suzan-Monti, Christine Rouzioux and 6 more

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.0field-weighted citation impact, top 26% 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

13 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Modeling HIV Pre-Exposure Prophylaxis.Frontiers in pharmacology · 2019
    Review
  11. Review
  12. Article
  13. Observational
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

16 authors at 6 institutions in 1 country.

Elodie ValadeUniversité Paris Descartes, EA 08, Sorbonne Paris-Cité, Paris, France Unité de Recherche Clinique Paris Descartes Necker Cochin, AP-HP, Paris, France elodie.valade@free.fr.
Jean-Marc TréluyerUniversité Paris Descartes, EA 08, Sorbonne Paris-Cité, Paris, France Unité de Recherche Clinique Paris Descartes Necker Cochin, AP-HP, Paris, France CIC-1419 INSERM, Cochin-Necker, Paris, France Service de Pharmacologie Clinique, Hôpital Cochin, AP-HP, Groupe Hospitalier Paris Centre, Paris, France.
Silvia M IllamolaUniversité Paris Descartes, EA 08, Sorbonne Paris-Cité, Paris, France Unité de Recherche Clinique Paris Descartes Necker Cochin, AP-HP, Paris, France CIC-1419 INSERM, Cochin-Necker, Paris, France Service de Pharmacologie Clinique, Hôpital Cochin, AP-HP, Groupe Hospitalier Paris Centre, Paris, France.
Naïm BouazzaUniversité Paris Descartes, EA 08, Sorbonne Paris-Cité, Paris, France Unité de Recherche Clinique Paris Descartes Necker Cochin, AP-HP, Paris, France CIC-1419 INSERM, Cochin-Necker, Paris, France.
Frantz FoissacUniversité Paris Descartes, EA 08, Sorbonne Paris-Cité, Paris, France Unité de Recherche Clinique Paris Descartes Necker Cochin, AP-HP, Paris, France CIC-1419 INSERM, Cochin-Necker, Paris, France.
Maïlys De Sousa MendesUniversité Paris Descartes, EA 08, Sorbonne Paris-Cité, Paris, France Unité de Recherche Clinique Paris Descartes Necker Cochin, AP-HP, Paris, France.
Gabrielle LuiUniversité Paris Descartes, EA 08, Sorbonne Paris-Cité, Paris, France Service de Pharmacologie Clinique, Hôpital Cochin, AP-HP, Groupe Hospitalier Paris Centre, Paris, France.
Camille Chenevier-GobeauxService de Diagnostic Biologique Automatisé, Hôpital Cochin, Hôpitaux Universitaires Paris Centre (HUPC), Assistance Publique des Hôpitaux de Paris (AP-HP), Paris, France.
Marie Suzan-MontiINSERM, UMR912 (SESSTIM), Marseille, France UMR_S912, IRD, Aix Marseille Université, Marseille, France ORS PACA, Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur, Marseille, France.
Christine RouziouxUniversité Paris Descartes, EA 7327, Sorbonne Paris-Cité, Paris, France Laboratoire de Virologie, Centre Hospitalier Universitaire Necker Enfants Malades, AP-HP, Paris, France.
Lambert AssoumouINSERM, UMR-S 943, Université Pierre et Marie Curie, Paris, France.
Jean-Paul ViardUniversité Paris Descartes, EA 7327, Sorbonne Paris-Cité, Paris, France Unité Fonctionnelle de Thérapeutique en Immuno-Infectiologie, Centre Hospitalier Universitaire Hôtel-Dieu, AP-HP, Paris, France.
Déborah HirtUniversité Paris Descartes, EA 08, Sorbonne Paris-Cité, Paris, France Unité de Recherche Clinique Paris Descartes Necker Cochin, AP-HP, Paris, France CIC-1419 INSERM, Cochin-Necker, Paris, France Service de Pharmacologie Clinique, Hôpital Cochin, AP-HP, Groupe Hospitalier Paris Centre, Paris, France.
Saïk UrienUniversité Paris Descartes, EA 08, Sorbonne Paris-Cité, Paris, France Unité de Recherche Clinique Paris Descartes Necker Cochin, AP-HP, Paris, France CIC-1419 INSERM, Cochin-Necker, Paris, France.
Jade GhosnUniversité Paris Descartes, EA 7327, Sorbonne Paris-Cité, Paris, France Unité Fonctionnelle de Thérapeutique en Immuno-Infectiologie, Centre Hospitalier Universitaire Hôtel-Dieu, AP-HP, Paris, France.
Evarist ANRS-EP 49 Study Group
Assistance Publique – Hôpitaux de Paris · FRInserm · FRDélégation Paris 5 · FRHôpital Cochin · FRSorbonne Paris Cité · FREconomic & Social Sciences, Health Systems & Medical Informatics · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We aimed to describe blood plasma (BP) and seminal plasma (SP) pharmacokinetics of emtricitabine (FTC) in HIV-1-infected men, assess its penetration in the male genital tract, and evaluate its impact on seminal plasma HIV load (spVL) detection. Men from the EVARIST ANRS EP49 study receiving combined antiretroviral therapy with FTC and with suppressed BP viral load were included in the study. A total of 236 and 209 FTC BP and SP concentrations, respectively, were available. A population pharmacokinetic model was developed with Monolix 4.1.4. The impact of FTC seminal exposure on spVL detection was explored by receiver operating characteristic (ROC) curves and mixed-effects logistic regressions. FTC BP pharmacokinetics was described by a two-compartment model. The addition of an effect compartment with different input and output constants best described FTC SP pharmacokinetics. No covariates were found to explain the variability in SP. FTC exposures (area under the concentration-time curve from 0 to 24 h [AUC0-24]) were higher in SP than in BP (median AUC0-24, 38.04 and 12.95 mg · liter(-1) · h, respectively). The median (range) SP-to-BP AUC0-24 ratio was 2.91 (0.84 to 10.08). Less than 1% of FTC AUC0-24 ratios were lower than 1. The impact of FTC SP AUC0-24 or FTC SP-to-BP AUC0-24 ratio on spVL detection was not significant (P = 0.943 or 0.893, respectively). This is the first population model describing FTC pharmacokinetics simultaneously in both BP and SP. FTC distributes well in the male genital tract with higher FTC concentrations in SP than in BP. FTC seminal plasma exposures were considered efficient in the majority of men.

Indexed as

AdultAnti-HIV AgentsEmtricitabineHIV InfectionsHumansMaleMiddle AgedPlasmaSemenAnti-HIV AgentsEmtricitabine

Identifiers

PMID26282407
PMCPMC4604421
OpenAlexW1921422247

What OpenQuestion holds

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Registered trials

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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.