Evidence map›Paper›PMID 39333337›Full record

Trial reportJournal of pharmacokinetics and pharmacodynamics2024

Population pharmacokinetics and exposure-response relationships of maribavir in transplant recipients with cytomegalovirus infection.

Ivy H Song, Grace Chen, Siobhan Hayes, Colm Farrell, Claudia Jomphe, Nathalie H Gosselin, Kefeng Sun

Abstract readClinical Trial, Phase IIIClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Journal of pharmacokinetics and pharmacodynamics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Trial
  2. Trial
  3. 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

7 authors.

Ivy H SongQuantitative Clinical Pharmacology, Takeda Development Center Americas, Inc., 500 East Kendall Street, Cambridge, MA, 02142, USA. ivy.song@takeda.com.
Grace ChenQuantitative Clinical Pharmacology, Takeda Development Center Americas, Inc., 500 East Kendall Street, Cambridge, MA, 02142, USA.
Siobhan HayesICON plc, Reading, UK.
Colm FarrellICON plc, Reading, UK.
Claudia JompheCertara Drug Development Solutions, Princeton, NJ, USA.
Nathalie H GosselinCertara Drug Development Solutions, Princeton, NJ, USA.
Kefeng SunQuantitative Clinical Pharmacology, Takeda Development Center Americas, Inc., 500 East Kendall Street, Cambridge, MA, 02142, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Maribavir is approved for management of post-transplant cytomegalovirus (CMV) infections refractory and/or resistant to CMV therapies at a dose of 400 mg twice daily (BID). Population pharmacokinetic (PopPK) and exposure-response analyses were conducted to support the appropriateness of 400 mg BID dosing. A PopPK model was developed using non-linear mixed-effects modeling with pooled maribavir plasma concentration-time data from phase 1 and 2 studies (from 100 mg up to 1200 mg as single or repeated doses) and the phase 3 SOLSTICE study (400 mg BID). Exposure-response analyses were performed for efficacy, safety, and viral resistance based on data collected in the SOLSTICE study. Maribavir PK after oral administration was adequately described by a two-compartment model with first-order elimination, first-order absorption, and an absorption lag-time. There was no evidence that maribavir PK was affected by age, sex, race, diarrhea, vomiting, disease characteristics, or concomitant use of histamine H

Indexed as

Antiviral AgentsBenzimidazolesCytomegalovirus InfectionsRibonucleosidesAdultAgedCytomegalovirusDichlororibofuranosylbenzimidazoleDose-Response Relationship, DrugDrug Resistance, ViralFemaleHumansMaleMiddle AgedModels, BiologicalTransplant RecipientsAntiviral AgentsBenzimidazolesDichlororibofuranosylbenzimidazolemaribavirRibonucleosidesCytomegalovirusExposure responseMaribavirPopulation pharmacokineticsTransplant

Identifiers

PMID39333337
PMCPMC11579209

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.