Evidence map›Paper›PMID 39302855›Full record

Trial reportThe Journal of infectious diseases2025

Comparative Emergence of Maribavir and Ganciclovir Resistance in a Randomized Phase 3 Clinical Trial for Treatment of Cytomegalovirus Infection.

Sunwen Chou, Drew J Winston, Robin K Avery, Catherine Cordonnier, Rafael F Duarte, Shariq Haider, Johan Maertens, Karl S Peggs, Carlos Solano, Jo-Anne H Young and 3 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIComparative Study
In one paragraph

Trial report in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02927067 (A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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.

NCT02927067 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients

TypeinterventionalSponsorShireRan2017 to 2022Enrolled553ConditionsCytomegalovirus (CMV)ArmsMaribavir, Valganciclovir, Placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Trial
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  4. Review
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  13. Advancements in Cytomegalovirus Management Among Solid Organ Transplant Recipients: Insights From the ESOT CMV Workshop 2023.Transplant international : official journal of the European Society for Organ Transplantation · 2025
    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

13 authors.

Sunwen ChouDivision of Infectious Diseases, Oregon Health and Science University, Portland, Oregon, USA.
Drew J WinstonLos Angeles Medical Center, University of California, Los Angeles, California, USA.
Robin K AveryDivision of Infectious Diseases, Johns Hopkins University, Baltimore, Maryland, USA.ORCID 0000-0001-7692-3619
Catherine CordonnierHaematology Department, Henri Mondor Hôpital, Assistance Publique-Hopitaux de Paris, and Université Paris-Est-Créteil, Créteil, France.
Rafael F DuarteDepartment of Haematology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
Shariq HaiderJuravinski Hospital and Cancer Center, Hamilton Health Sciences, Hamilton, Ontario, Canada.
Johan MaertensHaematology Department, University Hospitals Leuven, Katholieke Universiteit Leuven, Leuven, Belgium.
Karl S PeggsDepartment of Haematology, University College London Hospitals NHS Foundation Trust, London, United Kingdom.
Carlos SolanoHematology Department, Hospital Clínico Universitario, University of Valencia, Valencia, Spain.
Jo-Anne H YoungDivision of Infectious Disease and International Medicine, University of Minnesota, Minneapolis, Minnesota, USA.ORCID 0000-0003-4182-341X
Joan GuTakeda Development Center Americas, Inc, Cambridge, Massachusetts, USA.
Ginger PocockTakeda Development Center Americas, Inc, Cambridge, Massachusetts, USA.
Genovefa A PapanicolaouInfectious Disease Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Genetic Pathways of Human Cytomegalovirus Drug ResistanceR01AI116635 · NIAID · PORTLAND VA RESEARCH FOUNDATION, INC. · PI Sunwen Chou · 2015 to 2026
$2.8M
NCI NIH HHS P30 CA008748NIAID NIH HHS R01 AI116635NIH HHS R01-AI116635Takeda Development Center Americas, IncUSVA
6 · The paper itself

Abstract

backgroundAmong 547 patients receiving maribavir or valganciclovir for first-episode cytomegalovirus infection after hematopoietic cell transplant, the treatment response rate was 69.6% and 77.4% respectively. Development of maribavir and ganciclovir resistance was compared after receiving either drug.

methodsViral mutations conferring drug resistance were analyzed in plasma DNA extracts at baseline and posttreatment.

resultsPrior antiviral drug exposure was limited, with only 2 instances of baseline drug resistance detected. An equal number (n = 241) received valganciclovir or maribavir for at least 21 days (median, 55-56 days). Among them, drug resistance mutations were detected in 24 (10%) maribavir recipients at 35-125 days (median, 56 days) after starting therapy, including in 12 of 14 who experienced a viral load rebound while on therapy. Ganciclovir resistance mutations developed in 6 (2.5%) valganciclovir recipients at 66-110 days (median, 90 days). One maribavir recipient developed a novel UL97 gene mutation (P-loop substitution G343A) that conferred strong maribavir and ganciclovir resistance in vitro. Viral clearance was confirmed in 17 (74%) of 23 patients with emergent maribavir resistance after retreatment with an alternative CMV antiviral drug.

conclusionsAfter 3-8 weeks of therapy, maribavir resistance emerged earlier and more frequently than ganciclovir resistance but was usually treatable using alternative therapy. Clinical Trials Registration. NCT02927067 (AURORA).

Indexed as

Antiviral AgentsBenzimidazolesCytomegalovirusCytomegalovirus InfectionsDrug Resistance, ViralGanciclovirRibonucleosidesAdultAgedDichlororibofuranosylbenzimidazoleDNA, ViralFemaleHematopoietic Stem Cell TransplantationHumansMaleMiddle AgedAntiviral AgentsBenzimidazolesDichlororibofuranosylbenzimidazoleDNA, ViralGanciclovirmaribavirRibonucleosidesValganciclovirantiviral drug resistanceantiviral therapycytomegalovirusmaribavirvalganciclovir

Identifiers

PMID39302855
PMCPMC11911792

What OpenQuestion holds

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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.