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Maribavir for Refractory Cytomegalovirus Infections With or Without Resistance Post-Transplant: Results From a Phase 3 Randomized Clinical Trial
- Source :
- Clinical Infectious Diseases. 75:690-701
- Publication Year :
- 2021
- Publisher :
- Oxford University Press (OUP), 2021.
-
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).
- 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
Subjects
Details
- ISSN :
- 15376591 and 10584838
- Volume :
- 75
- Database :
- OpenAIRE
- Journal :
- Clinical Infectious Diseases
- Accession number :
- edsair.doi.dedup.....ae3e3a1e207018b1e36ccc53313d434c