Evidence map›Paper›PMID 31179485›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020

A Mortality Analysis of Letermovir Prophylaxis for Cytomegalovirus (CMV) in CMV-seropositive Recipients of Allogeneic Hematopoietic Cell Transplantation.

Per Ljungman, Michael Schmitt, Francisco M Marty, Johan Maertens, Roy F Chemaly, Nicholas A Kartsonis, Joan R Butterton, Hong Wan, Valerie L Teal, Kendra Sarratt and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02137772 (A Phase III Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-8228), which is not on this map. Cited by 68 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 1 pooled it
–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.

NCT02137772 phase3completednot on this map

A Phase III Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-8228 (Letermovir) for the Prevention of Clinically Significant Human Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2014 to 2016Enrolled570ConditionsPrevention of CMV Infection or DiseaseArmsLetermovir, Placebo
3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Allogeneic Transplant for CMML.Current hematologic malignancy reports · 2025
    Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. Mortality in recipients of allogeneic haematopoietic cell transplantation in the era of cytomegalovirus primary prophylaxis: a single-centre retrospective experience.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2024
    Article
  17. Review
  18. Cytomegalovirus (CMV) Reactivation and CMV-Specific Cell-Mediated Immunity After Chimeric Antigen Receptor T-Cell Therapy.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Article
  19. Article
  20. Article

8 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Per LjungmanDepartment of Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.
Michael SchmittUniversity of Heidelberg, Germany.
Francisco M MartyDana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, Massachusetts.
Johan MaertensUniversitaire Ziekenhuizen Leuven, Belgium.
Roy F ChemalyUniversity of Texas, MD Anderson Cancer Center, Houston.
Nicholas A KartsonisMerck & Co., Inc., Kenilworth, New Jersey.
Joan R ButtertonMerck & Co., Inc., Kenilworth, New Jersey.
Hong WanMerck & Co., Inc., Kenilworth, New Jersey.
Valerie L TealMerck & Co., Inc., Kenilworth, New Jersey.
Kendra SarrattMerck & Co., Inc., Kenilworth, New Jersey.
Yoshihiko MurataMerck & Co., Inc., Kenilworth, New Jersey.
Randi Y LeavittMerck & Co., Inc., Kenilworth, New Jersey.
Cyrus BadshahMerck & Co., Inc., Kenilworth, New Jersey.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn a phase 3 trial, letermovir reduced clinically significant cytomegalovirus infections (CS-CMVi) and all-cause mortality at week 24 versus placebo in CMV-seropositive allogeneic hematopoietic cell transplantation (HCT) recipients. This post hoc analysis of phase 3 data further investigated the effects of letermovir on all-cause mortality.

methodsKaplan-Meier survival curves were generated by treatment group for all-cause mortality. Observations were censored at trial discontinuation for reasons other than death or at trial completion. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox modeling, adjusting for risk factors associated with mortality.

resultsOf 495 patients with no detectable CMV DNA at randomization, 437 had vital-status data available through week 48 post-HCT at trial completion (101 deaths, 20.4%). Following letermovir prophylaxis, the HR for all-cause mortality was 0.58 (95% CI, 0.35-0.98; P = .04) at week 24 and 0.74 (95% CI, 0.49-1.11; P = .14) at week 48 post-HCT versus placebo. Incidence of all-cause mortality through week 48 post-HCT in the letermovir group was similar in patients with or without CS-CMVi (15.8 vs 19.4%; P = .71). However, in the placebo group, all-cause mortality at week 48 post-HCT was higher in patients with versus those without CS-CMVi (31.0% vs 18.2%; P = .02). The HR for all-cause mortality in patients with CS-CMVi was 0.45 (95% CI, 0.21-1.00; P = .05) at week 48 for letermovir versus placebo.

conclusionsLetermovir may reduce mortality by preventing or delaying CS-CMVi in HCT recipients. CLINICAL TRIALS REGISTRATION: clinicaltrials.gov, NCT02137772.

Indexed as

Antiviral AgentsCytomegalovirus InfectionsHematopoietic Stem Cell TransplantationAcetatesCytomegalovirusHumansQuinazolinesAcetatesAntiviral AgentsletermovirQuinazolinescytomegalovirushematopoietic cell transplantationletermovirmortality

Identifiers

PMID31179485
PMCPMC7146004

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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.