Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024
Treatment for First Cytomegalovirus Infection Post-Hematopoietic Cell Transplant in the AURORA Trial: A Multicenter, Double-Blind, Randomized, Phase 3 Trial Comparing Maribavir With Valganciclovir.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. 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 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 24 papers.
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.
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.
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
Who cites it
24 citing papers in PubMed, 46 citations in OpenAlex.
- Efficacy and safety of maribavir in Japanese patients with post-transplant cytomegalovirus infections: a phase III study.International journal of hematology · 2026Trial
- CMV-specific T-cell receptor-engineered T-cell therapy as first-line treatment for CMV reactivation after haploidentical hematopoietic stem cell transplantation: a phase 2 trial.Frontiers in immunology · 2026Trial
- [Phase Ⅲ, multicenter, randomized, double-blinded, positive-controlled trial on the efficacy and safety of maribavir compared with valganciclovir in the treatment of post-transplant cytomegalovirus infection: Subgroup analysis of AURORA Trial in the Chinese population].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025Trial
- Population Pharmacokinetics and Exposure-Response Relationships of Maribavir in Transplant Recipients With First Episode or Refractory Cytomegalovirus.CPT: pharmacometrics & systems pharmacology · 2025Trial
- Comparative Emergence of Maribavir and Ganciclovir Resistance in a Randomized Phase 3 Clinical Trial for Treatment of Cytomegalovirus Infection.The Journal of infectious diseases · 2025Trial
- Population pharmacokinetics and exposure-response relationships of maribavir in transplant recipients with cytomegalovirus infection.Journal of pharmacokinetics and pharmacodynamics · 2024Trial
- Multi-Criteria Decision Analysis using Physician Preferences from a Global Discrete Choice Experiment to Investigate the Selection of Preemptive Antiviral Treatments for Post-Hematopoietic Cell Transplant Cytomegalovirus Infection.Open forum infectious diseases · 2026Article
- Article
- Maribavir for Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients: A Case Series.IJU case reports · 2026Article
- Human Cytomegalovirus Infection in Haematopoietic Stem Cell Transplant Recipients and CAR-T Cell Recipients-PART 2: Antiviral Therapy and Virus-Specific T Cell Therapy for HCMV in Allo-HSCT.Reviews in medical virology · 2026Review
- Advances in immunotherapy for cytomegalovirus infection following allogeneic hematopoietic stem cell transplantation.Immunotherapy · 2026Review
- Successful Use of Maribavir for Secondary CMV Prophylaxis in a Pediatric HSCT Patient.Pediatric blood & cancer · 2025Article
- New evidence in the management of CMV infection: impact on prophylaxis and treatment.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2025Review
- Current and Future Strategies for the Prevention and Treatment of Cytomegalovirus Infections in Transplantation.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Review
- [Chinese expert consensus on the diagnosis and treatment strategies for refractory/resistant cytomegalovirus infection in immunocompromised populations (2025)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025Article
- PTCy-based graft-versus-host disease prophylaxis for matched sibling donor allogeneic hematopoietic cell transplantation.Blood advances · 2025Article
- Revisiting cytomegalovirus in pediatric allogeneic hematopoietic stem cell transplant recipients: current strategies for prevention and management in the letermovir era.Frontiers in pediatrics · 2025Review
- Adverse event profile differences between maribavir and valganciclovir: findings from the FDA adverse event reporting system.Frontiers in pharmacology · 2025Article
- Impact of viral load kinetics and recurrent cytomegalovirus infection in kidney transplantation.Frontiers in immunology · 2025Article
- AURORA: A New Dawn.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Article
Corrections and comments
- Erratum issued
Authors and funding
14 authors at 12 institutions in 6 countries.
Funding
Abstract
backgroundNeutropenia may limit the use of valganciclovir treatment for cytomegalovirus (CMV) infection following hematopoietic cell transplant (HCT). A phase 2 study indicated efficacy of maribavir with fewer treatment-limiting toxicities than valganciclovir.
methodsIn this multicenter, double-blind, phase 3 study, patients with first asymptomatic CMV infection post-HCT were stratified and randomized 1:1 to maribavir 400 mg twice daily or valganciclovir (dose-adjusted for renal clearance) for 8 weeks with 12 weeks of follow-up. The primary endpoint was confirmed CMV viremia clearance at week 8 (primary hypothesis of noninferiority margin of 7.0%). The key secondary endpoint was a composite of the primary endpoint with no findings of CMV tissue-invasive disease at week 8 through week 16. Treatment-emergent adverse events (TEAEs) were assessed.
resultsAmong patients treated (273 maribavir; 274 valganciclovir), the primary endpoint of noninferiority of maribavir was not met (maribavir, 69.6%; valganciclovir, 77.4%; adjusted difference: -7.7%; 95% confidence interval [CI]: -14.98, -.36; lower limit of 95% CI of treatment difference exceeded -7.0%). At week 16, 52.7% and 48.5% of patients treated (maribavir and valganciclovir, respectively) maintained CMV viremia clearance without tissue-invasive disease (adjusted difference: 4.4%; 95% CI: -3.91, 12.76). With maribavir (vs valganciclovir), fewer patients experienced neutropenia (16.1% and 52.9%) or discontinued due to TEAEs (27.8% and 41.2%). Discontinuations were mostly due to neutropenia (maribavir, 4.0%; valganciclovir, 17.5%).
conclusionsAlthough noninferiority of maribavir to valganciclovir for the primary endpoint was not achieved based on the prespecified noninferiority margin, maribavir demonstrated comparable CMV viremia clearance during post-treatment follow-up, with fewer discontinuations due to neutropenia. Clinical Trials Registration. NCT02927067 [AURORA].
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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.