SOLSTICE: Maribavir for refractory CMV infection in SOT recipients

The phase III, global, randomized, open-label, multicenter SOLSTICE study (NCT02931539), evaluated maribavir vs investigator-assigned therapy (IAT) for the treatment of refractory cytomegalovirus (CMV) infection following either hematopoietic stem cell transplantation (HSCT) or solid organ transplantation. Results from a subgroup analysis of solid organ transplant (SOT) recipients were published by Blumberg et al. in the Journal of Heart and Lung Transplantation. The analysis included 211 SOT recipients (maribavir, n = 142; IAT, n = 69). The primary endpoint was CMV viremia clearance at Week 8.

Key data: At Week 8, higher rates of CMV viremia clearance were observed in patients who received maribavir vs those who received IAT (55.6% vs 26.1%; adjusted difference, 30.5; 95% confidence interval [CI], 17.3–43.6; p < 0.001). The CMV viremia clearance benefit with maribavir vs IAT was observed across SOT types, including kidney (59.5% vs 34.4%), lung (47.5% vs 13.6%), and heart (42.9% vs 11.1%). Rates of CMV viremia clearance with symptom control maintained from Week 8 to 16 were comparable between cohorts (maribavir, 13.4% vs IAT, 11.6%; adjusted difference, 2.4%; 95% CI, −7.05 to 11.83; p = 0.620). Treatment-emergent adverse events (TEAEs) were reported in 96.5% and 88.4% of patients receiving maribavir and IAT, respectively. Treatment discontinuations due to TEAEs were lower with maribavir vs IAT (3.5% vs 23.2%).

Key learning: Maribavir demonstrated superior CMV viremia clearance vs IAT in patients with refractory CMV infection following SOT, regardless of transplanted organ, supporting its feasibility as a treatment option in this clinical setting.