AUTHOR=Kamar Nassim , Avery Robin K. , Bo Tien , Gu Joan , Kumar Deepali , Witzke Oliver 

TITLE=Association Between Cytomegalovirus Viremia Clearance and Post-Solid Organ Transplant Mortality in Patients With Refractory Cytomegalovirus Infection: SOLSTICE Post Hoc Analysis

JOURNAL=Transplant International

VOLUME=Volume 38 - 2025

YEAR=2025

URL=https://www.frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2025.15331

DOI=10.3389/ti.2025.15331

ISSN=1432-2277

ABSTRACT=Cytomegalovirus (CMV) infection following solid organ transplant (SOT) is associated with increased mortality risk. In the phase 3 SOLSTICE study (NCT02931539), more transplant recipients achieved CMV clearance after 8 weeks with maribavir than investigator-assigned therapy (IAT). In SOLSTICE, SOT recipients with refractory CMV infection were randomized 2:1 to receive maribavir or IAT for 8 weeks. This post hoc analysis assessed the impact of CMV clearance at Week 8 on mortality at Week 20. Patients who achieved CMV clearance at Week 8 were categorized as responders, and patients without CMV clearance, or who received maribavir rescue or alternative treatment, were categorized as nonresponders. All-cause mortality was assessed at Week 20 for responders and nonresponders using the Kaplan-Meier method with log-rank test. The analysis included 211 SOT recipients: 97 responders and 114 nonresponders. Week 20 all-cause mortality was significantly higher in nonresponders than responders (p = 0.0024). No deaths were reported in the responder group, and 10 deaths were reported in the nonresponder group (3 receiving IAT, 7 receiving maribavir). Median (range) time from treatment start to death was 30.5 (3–123) days. This analysis is consistent with other studies showing an increased risk of mortality with post-SOT CMV infection.