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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.
- Source :
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Clinical Infectious Diseases . 3/15/2024, Vol. 78 Issue 3, p562-572. 11p. - Publication Year :
- 2024
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Abstract
- Background Neutropenia 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. Methods In 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. Results Among 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%). Conclusions Although 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]. [ABSTRACT FROM AUTHOR]
- Subjects :
- *HEMATOPOIETIC stem cell transplantation
*PROTEIN kinase inhibitors
*DRUG toxicity
*PATIENT safety
*DRUG side effects
*RESEARCH funding
*CYTOMEGALOVIRUS diseases
*STATISTICAL sampling
*BLIND experiment
*TERMINATION of treatment
*RANDOMIZED controlled trials
*DESCRIPTIVE statistics
*SURGICAL complications
*VALGANCICLOVIR
*DRUG efficacy
*RESEARCH
*VIREMIA
*CONFIDENCE intervals
*PATIENT aftercare
*NEUTROPENIA
Subjects
Details
- Language :
- English
- ISSN :
- 10584838
- Volume :
- 78
- Issue :
- 3
- Database :
- Academic Search Index
- Journal :
- Clinical Infectious Diseases
- Publication Type :
- Academic Journal
- Accession number :
- 176151689
- Full Text :
- https://doi.org/10.1093/cid/ciad709