Evidence map›Paper›PMID 34864943›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022

Maribavir for Refractory Cytomegalovirus Infections With or Without Resistance Post-Transplant: Results From a Phase 3 Randomized Clinical Trial.

Robin K Avery, Sophie Alain, Barbara D Alexander, Emily A Blumberg, Roy F Chemaly, Catherine Cordonnier, Rafael F Duarte, Diana F Florescu, Nassim Kamar, Deepali Kumar and 9 more

Erratum issued Registry-linked trialOpen access · hybridAbstract 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, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02931539 (A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus), which is not on this map. Cited by 134 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
134citing papers in PubMed, 1 pooled it
28.0field-weighted citation impact, top 1% 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.

NCT02931539 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

TypeinterventionalSponsorShireRan2016 to 2020Enrolled352ConditionsCytomegalovirus (CMV)ArmsMaribavir, Ganciclovir, Valganciclovir, Foscarnet, Cidofovir
3 · Its place in the literature

Who cites it

134 citing papers in PubMed, 1 synthesis or guideline pooled it, 283 citations in OpenAlex.

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  18. Mechanisms and Determinants of CMV Reactivation in Kidney Transplantation.International journal of molecular sciences · 2026
    Review
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  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 16 institutions in 6 countries.

Robin K AveryDivision of Infectious Diseases, Johns Hopkins University, Baltimore, Maryland, USA.
Sophie AlainDepartment of Virology and National Reference Center for Herpesviruses, Limoges University Hospital, UMR Inserm 1092, University of Limoges, Limoges, France.
Barbara D AlexanderDivision of Infectious Diseases and International Health, Duke University, Durham, North Carolina, USA.
Emily A BlumbergDepartment of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Roy F ChemalyDepartment of Infectious Diseases, Infection Control, and Employee Health, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Catherine CordonnierHaematology Department, Henri Mondor Hospital and University Paris-Est-Créteil, Créteil, France.
Rafael F DuarteDepartment of Haematology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
Diana F FlorescuInfectious Diseases Division, University of Nebraska Medical Center, Omaha, Nebraska, USA.
Nassim KamarDepartment of Nephrology and Organ Transplantation, Toulouse Rangueil University Hospital, INFINITY-Inserm U1291-CNRS U5051, University Paul Sabatier, Toulouse, France.
Deepali KumarTransplant Centre, University Health Network, Toronto, Ontario, Canada.
Johan MaertensHaematology Department, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
Francisco M MartyDepartment of Infectious Disease, Brigham and Women's Hospital and Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Genovefa A PapanicolaouInfectious Disease Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Fernanda P SilveiraDepartment of Medicine, Division of Infectious Diseases, University of Pittsburgh and University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Oliver WitzkeDepartment of Infectious Diseases, West German Centre of Infectious Diseases, University Medicine Essen, University Duisburg-Essen, Essen, Germany.
Jingyang WuBiostatistics, Takeda Development Center Americas, Inc, Lexington, Massachusetts, USA.
Aimee K SundbergClinical Sciences, Takeda Development Center Americas, Inc, Lexington, Massachusetts, USA.
Martha FournierClinical Sciences, Takeda Development Center Americas, Inc, Lexington, Massachusetts, USA.
SOLSTICE Trial Investigators
Takeda (United States) · USCentre National de la Recherche Scientifique · FRCornell University · USDana-Farber Cancer Institute · USDuke University Health System · USHospital Universitario Puerta de Hierro Majadahonda · ESInserm · FRJohns Hopkins University · USKU Leuven · BEThe University of Texas MD Anderson Cancer Center · USUniversité Paris-Est Créteil · FRUniversity Health Network · CAUniversity of Duisburg-Essen · DEUniversity of Nebraska Medical Center · USUniversity of Pennsylvania · USUniversity of Pittsburgh Medical Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundTherapies for refractory cytomegalovirus infections (with or without resistance [R/R]) in transplant recipients are limited by toxicities. Maribavir has multimodal anti-cytomegalovirus activity through the inhibition of UL97 protein kinase.

methodsIn this phase 3, open-label study, hematopoietic-cell and solid-organ transplant recipients with R/R cytomegalovirus were randomized 2:1 to maribavir 400 mg twice daily or investigator-assigned therapy (IAT; valganciclovir/ganciclovir, foscarnet, or cidofovir) for 8 weeks, with 12 weeks of follow-up. The primary endpoint was confirmed cytomegalovirus clearance at end of week 8. The key secondary endpoint was achievement of cytomegalovirus clearance and symptom control at end of week 8, maintained through week 16.

results352 patients were randomized (235 maribavir; 117 IAT). Significantly more patients in the maribavir versus IAT group achieved the primary endpoint (55.7% vs 23.9%; adjusted difference [95% confidence interval (CI)]: 32.8% [22.80-42.74]; P < .001) and key secondary endpoint (18.7% vs 10.3%; adjusted difference [95% CI]: 9.5% [2.02-16.88]; P = .01). Rates of treatment-emergent adverse events (TEAEs) were similar between groups (maribavir, 97.4%; IAT, 91.4%). Maribavir was associated with less acute kidney injury versus foscarnet (8.5% vs 21.3%) and neutropenia versus valganciclovir/ganciclovir (9.4% vs 33.9%). Fewer patients discontinued treatment due to TEAEs with maribavir (13.2%) than IAT (31.9%). One patient per group had fatal treatment-related TEAEs.

conclusionsMaribavir was superior to IAT for cytomegalovirus viremia clearance and viremia clearance plus symptom control maintained post-therapy in transplant recipients with R/R cytomegalovirus. Maribavir had fewer treatment discontinuations due to TEAEs than IAT. Clinical Trials Registration. NCT02931539 (SOLSTICE).

Indexed as

Cytomegalovirus InfectionsViremiaAntiviral AgentsCytomegalovirusDichlororibofuranosylbenzimidazoleDrug Resistance, ViralFoscarnetGanciclovirHumansValganciclovirAntiviral AgentsDichlororibofuranosylbenzimidazoleFoscarnetGanciclovirmaribavirValganciclovirantiviral agentscytomegalovirusdrug resistancemaribavirtransplant recipients

Identifiers

PMID34864943
PMCPMC9464078
OpenAlexW4200419501

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.