6/29/23, 11:44 PM SOLSTICE Pathway Feedback Search Clinical Topics Home Studies SOLSTICE SOLSTICE Disease Disease Kidney transplantation Liver transplantation Trial question Is maribavir superior to investigator-assigned therapy in patients with refractory CMV infections post-transplant? Study design Multi-center Open label RCT Population Characteristics of study participants 39.0% female N = 352 61.0% male 352 patients (139 female, 213 male) Inclusion criteria: hematopoietic-cell and solid-organ transplant recipients with refractory CMV infections Key exclusion criteria: resistant or refractory CMV infection due to inadequate adherence to prior anti-CMV treatment; CMV disease with CNS involvement or retinitis; the concomitant need for leflunomide, letermovir, or artesunate Interventions N=235 maribavir (400 mg BID for 8 weeks, with 12 weeks follow-up) N=117 investigator-assigned therapy (mono or combination therapy with valganciclovir/ganciclovir, foscarnet, or cidofovir for 8 weeks, with 12 weeks follow-up) https://web.pathway.md/studies/reclDfnUMo1nx0NN8 1/2 6/29/23, 11:44 PM SOLSTICE Pathway Primary outcome Rate of confirmed cytomegalovirus clearance at end of week 8 55.7 % 55.7 41.8 % 27.9 % 23.9 Significant increase 13.9 % NNH = 3 0.0 % Maribavir Investigator-assigned therapy Significant increase in the rate of confirmed CMV clearance at end of week 8 (55.7% vs. 23.9%; AD 32.8%, 95% CI 22.8 to 42.74) Secondary outcomes Significant increase in the rate of CMV clearance and symptom control at end of week 8, maintained through week 16 (18.7% vs. 10.3%; AD 9.5%, 95% CI 2.02 to 16.88) Significant increase in the rate of CMV clearance at end of week 12 (22.6% vs. 10.3%; AD 13.5%, 95% CI 5.84 to 21.17) Significant increase in the rate of CMV clearance at end of week 20 (18.3% vs. 9.4%; AD 9.8%, 95% CI 2.58 to 17.06) Safety outcomes No significant difference in any adverse events. Significant differences in dysgeusia (37.2% vs. 3.4%), AKI (8.5% vs. 21.3% in foscarnet), neutropenia (9.4% vs. 33.9% in valganciclovir/ganciclovir). Conclusion In hematopoietic-cell and solid-organ transplant recipients with refractory CMV infections, maribavir was superior to investigator-assigned therapy with respect to the rate of confirmed CMV clearance at end of week 8. Reference Robin K Avery, Sophie Alain, Barbara D Alexander et al. Maribavir for Refractory Cytomegalovirus Infections With or Without Resistance Post-Transplant: Results from a Phase 3 Randomized Clinical Trial. Clin Infect Dis. 2021 Dec 2;ciab988. Open reference URL https://web.pathway.md/studies/reclDfnUMo1nx0NN8 2/2