Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

Summary

The purpose of this study is to compare the efficacy of maribavir to investigator-assigned anti-Cytomegalovirus (CMV) therapy in CMV viremia clearance in transplant recipients who are refractory or resistant to prior anti-CMV treatment.

Timeline

Start

2016-12-22

Primary completion

2020-08-17

Completion

2020-08-17

Outcome

Met primary endpoint

paper Significantly more patients in the maribavir versus IAT group achieved the primary endpoint PMID 34864943 ↗

registry analysis (superiority test); Investigator-assigned Anti-CMV Treatment (IAT) vs Maribavir 400 mg; p <0.001; Difference in percentage of responders 32.8 (95% CI 22.80 to 42.74) NCT02931539 ↗

release “TAK-620-303 (SOLSTICE) trial, for the investigational drug TAK-620 (maribavir) which met its primary endpoint of superiority compared to conventional antiviral therapies” takeda.com ↗

release “SOLSTICE trial, which compared LIVTENCITY to conventional antiviral treatments for transplant patients with refractory/resistant cytomegalovirus infections, met its primary endpoint of statistical superiority” takeda.com ↗

release “In the SOLSTICE trial, LIVTENCITY was superior to conventional therapies at Week 8 for the primary endpoint of confirmed CMV viremia clearance” takeda.com ↗

Publications

• Kamar N, Avery RK, Bo T, Gu J, Kumar D, Witzke O. Association Between Cytomegalovirus Viremia Clearance and Post-Solid Organ Transplant Mortality in Patients With Refractory Cytomegalovirus Infection: SOLSTICE Post Hoc Analysis. Transpl Int. 2025 Nov 26;38:15331. doi: 10.3389/ti.2025.15331. eCollection 2025.
• Rajagopalan K, Bullano M, Gelone D, Bo T, Taduka V, Syed SS. Real-world effectiveness and tolerability of post solid organ transplant patients with CMV switching from valganciclovir treatment to maribavir: analysis using lab-linked claims data in the United States. Expert Rev Anti Infect Ther. 2025 Aug;23(8):653-662. doi: 10.1080/14787210.2025.2517344. Epub 2025 Jun 27.
• Blumberg EA, Witzke O, Harber M, Ison MG, Saliba F, Kamar N, Sundberg AK, Gu J, Kumar D, La Hoz RM. Maribavir for refractory cytomegalovirus infection (with or without resistance) in solid organ transplant recipients: Subgroup analysis of the phase 3 randomized SOLSTICE study. J Heart Lung Transplant. 2025 Jun;44(6):986-994. doi: 10.1016/j.healun.2024.11.026. Epub 2024 Nov 28.
• Sun K, Fournier M, Sundberg AK, Song IH. Maribavir: Mechanism of action, clinical, and translational science. Clin Transl Sci. 2024 Jan;17(1):e13696. doi: 10.1111/cts.13696.
• Chou S, Alain S, Cervera C, Chemaly RF, Kotton CN, Lundgren J, Papanicolaou GA, Pereira MR, Wu JJ, Murray RA, Buss NE, Fournier M. Drug Resistance Assessed in a Phase 3 Clinical Trial of Maribavir Therapy for Refractory or Resistant Cytomegalovirus Infection in Transplant Recipients. J Infect Dis. 2024 Feb 14;229(2):413-421. doi: 10.1093/infdis/jiad293.
• Avery RK, Alain S, Alexander BD, Blumberg EA, Chemaly RF, Cordonnier C, Duarte RF, Florescu DF, Kamar N, Kumar D, Maertens J, Marty FM, Papanicolaou GA, Silveira FP, Witzke O, Wu J, Sundberg AK, Fournier M; SOLSTICE Trial Investigators. Maribavir for Refractory Cytomegalovirus Infections With or Without Resistance Post-Transplant: Results From a Phase 3 Randomized Clinical Trial. Clin Infect Dis. 2022 Sep 10;75(4):690-701. doi: 10.1093/cid/ciab988.
• Del Pozo Martin Y. 47th Annual Meeting of the EBMT. Lancet Haematol. 2021 May;8(5):e317-e318. doi: 10.1016/S2352-3026(21)00104-6. Epub 2021 Mar 31. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	CIDOFOVIR ANHYDROUS	Small molecule	—	—
Comparator	Foscarnet	Small molecule	—	—
Comparator	Ganciclovir	Small molecule	—	—
Subject	Maribavir	Small molecule	400 mg	Oral
Comparator	Valganciclovir	Small molecule	—	—

Indications