AURORA (maribavir)
Trial question
Is maribavir noninferior to valganciclovir in patients with first asymptomatic CMV infection after hematopoietic cell transplantation?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 547
547 patients (234 female, 313 male)
Inclusion criteria: patients with first asymptomatic CMV infection after hematopoietic cell transplant
Key exclusion criteria: tissue-invasive disease; confirmed CMV infection genotypically resistant to ganciclovir, valganciclovir, foscarnet, or cidofovir; recurrent CMV viremia
Interventions
N=273 maribavir (at an oral dose of 400 mg BID for 8 weeks with 12 weeks follow-up)
N=274 valganciclovir (at an oral dose of 900 mg BID for 8 weeks with 12 weeks follow-up)
Primary outcome
Confirmed cytomegalovirus viremia clearance at week 8
69.6
77.4
77.4 %
58.1 %
38.7 %
19.4 %
0.0 %
Maribavir
Valganciclovir
Difference exceeding
nonferiority margin ✗
Difference exceeding nonferiority margin in confirmed CMV viremia clearance at week 8 (69.6% vs. 77.4%; ARD -7.7, 95% CI -14.98 to -0.36)
Secondary outcomes
No significant difference in confirmed CMV viremia clearance without tissue-invasive disease at week 16 (52.7% vs. 48.5%; AD 4.4%, 95% CI -3.91 to 12.76)
No significant difference in confirmed CMV viremia clearance without tissue-invasive disease at week 12 (59.3% vs. 57.3%; AD 2.2%, 95% CI -6.05 to 10.37)
No significant difference in confirmed CMV viremia clearance without tissue-invasive disease at week 20 (43.2% vs. 42.3%; AD 1%, 95% CI -7.27 to 9.31)
Safety outcomes
No significant difference in treatment-emergent adverse events.
Significant difference in neutropenia (16.1% vs. 52.9%).
Conclusion
In patients with first asymptomatic CMV infection after hematopoietic cell transplant, maribavir was not noninferior to valganciclovir with respect to confirmed CMV viremia clearance at week 8.
Reference
Genovefa A Papanicolaou, Robin K Avery, Catherine Cordonnier et al. 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. Clin Infect Dis. 2023 Nov 30:ciad709.
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