1. Maribavir for Refractory Cytomegalovirus Infections With or Without Resistance Post-Transplant: Results From a Phase 3 Randomized Clinical Trial
- Author
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Avery, Robin K, Alain, Sophie, Alexander, Barbara D, Blumberg, Emily A, Chemaly, Roy F, Cordonnier, Catherine, Duarte, Rafael F, Florescu, Diana F, Kamar, Nassim, Kumar, Deepali, Maertens, Johan, Marty, Francisco M, Papanicolaou, Genovefa A, Silveira, Fernanda P, Witzke, Oliver, Wu, Jingyang, Sundberg, Aimee K, and Fournier, Martha
- Subjects
Microbiology (medical) ,drug resistance ,maribavir ,transplant recipients ,Medizin ,virus diseases ,Cytomegalovirus ,Antiviral Agents ,Infectious Diseases ,antiviral agents ,Cytomegalovirus Infections ,Drug Resistance, Viral ,Humans ,Valganciclovir ,Viremia ,cytomegalovirus ,Ganciclovir ,Dichlororibofuranosylbenzimidazole ,Foscarnet - Abstract
Background Therapies for refractory cytomegalovirus infections (with or without resistance [R/R]) in transplant recipients are limited by toxicities. Maribavir has multimodal anti-cytomegalovirus activity through the inhibition of UL97 protein kinase. Methods In this phase 3, open-label study, hematopoietic-cell and solid-organ transplant recipients with R/R cytomegalovirus were randomized 2:1 to maribavir 400 mg twice daily or investigator-assigned therapy (IAT; valganciclovir/ganciclovir, foscarnet, or cidofovir) for 8 weeks, with 12 weeks of follow-up. The primary endpoint was confirmed cytomegalovirus clearance at end of week 8. The key secondary endpoint was achievement of cytomegalovirus clearance and symptom control at end of week 8, maintained through week 16. Results 352 patients were randomized (235 maribavir; 117 IAT). Significantly more patients in the maribavir versus IAT group achieved the primary endpoint (55.7% vs 23.9%; adjusted difference [95% confidence interval (CI)]: 32.8% [22.80–42.74]; P Conclusions Maribavir was superior to IAT for cytomegalovirus viremia clearance and viremia clearance plus symptom control maintained post-therapy in transplant recipients with R/R cytomegalovirus. Maribavir had fewer treatment discontinuations due to TEAEs than IAT. Clinical Trials Registration. NCT02931539 (SOLSTICE).
- Published
- 2021