Evidence map›Paper›PMID 33440077›Full record

Trial reportCPT: pharmacometrics & systems pharmacology2021

Population pharmacokinetics of letermovir following oral and intravenous administration in healthy participants and allogeneic hematopoietic cell transplantation recipients.

Marita Prohn, Anders Viberg, Da Zhang, Kevin Dykstra, Casey Davis, Sreeraj Macha, Philip Sabato, Dinesh de Alwis, Marian Iwamoto, Craig Fancourt and 1 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in CPT: pharmacometrics & systems pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.6field-weighted citation impact, top 10% 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

11 citing papers in PubMed, 25 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Observational
  6. Article
  7. Role of letermovir therapeutic drug monitoring for cytomegalovirus prophylaxis in allogeneic hematopoietic stem cell transplantation recipients: a prospective study.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2025
    Article
  8. Review
  9. Review
  10. Article
  11. 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

11 authors at 1 institution in 1 country.

Marita ProhnqPharmetra, Nijmegen, The Netherlands.
Anders VibergqPharmetra, Nijmegen, The Netherlands.
Da ZhangMerck & Co., Inc., Kenilworth, New Jersey, USA.
Kevin DykstraqPharmetra, Nijmegen, The Netherlands.
Casey DavisMerck & Co., Inc., Kenilworth, New Jersey, USA.
Sreeraj MachaMerck & Co., Inc., Kenilworth, New Jersey, USA.
Philip SabatoMerck & Co., Inc., Kenilworth, New Jersey, USA.
Dinesh de AlwisMerck & Co., Inc., Kenilworth, New Jersey, USA.
Marian IwamotoMerck & Co., Inc., Kenilworth, New Jersey, USA.
Craig FancourtMerck & Co., Inc., Kenilworth, New Jersey, USA.
Carolyn R ChoMerck & Co., Inc., Kenilworth, New Jersey, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Letermovir is indicated for prophylaxis of cytomegalovirus infection and disease in allogeneic hematopoietic stem cell transplant (HSCT) recipients. Two-stage population pharmacokinetic (PK) modeling of letermovir was conducted to support dose rationale and evaluate the impact of intrinsic/extrinsic factors. Data from healthy phase I study participants over a wide dose range were modeled to evaluate the effects of selected intrinsic factors, including pharmacogenomics; next, phase III HSCT-recipient data at steady-state following clinical doses were modeled. The model in HSCT recipients adequately described letermovir PK following both oral or i.v. administration, and was consistent with the healthy participant model at steady-state clinical doses. Intrinsic factor effects were not clinically meaningful. These staged analyses indicate that letermovir PK in HSCT recipients and healthy participants differ only with respect to bioavailability and absorption rate. The HSCT recipient model was suitable for predicting exposure for exposure-response analysis supporting final dose selection.

Indexed as

AcetatesAdministration, IntravenousAdministration, OralAdultAgedAntiviral AgentsBiological AvailabilityCase-Control StudiesCytomegalovirus InfectionsDose-Response Relationship, DrugDouble-Blind MethodFemaleHealthy VolunteersHematopoietic Stem Cell TransplantationHumansMaleAcetatesAntiviral AgentsletermovirPlacebosQuinazolines

Identifiers

PMID33440077
PMCPMC7965833
OpenAlexW3118288552

What OpenQuestion holds

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LicenceCC BY-NC
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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.