{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T01:53:23Z","timestamp":1793066003993,"version":"4.5.0"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2021,12,2]],"date-time":"2021-12-02T00:00:00Z","timestamp":1638403200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Takeda Development Center Americas, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,9,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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\u00a0mg 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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\u201342.74]; P\u2005&amp;lt;\u2005.001) and key secondary endpoint (18.7% vs 10.3%; adjusted difference [95% CI]: 9.5% [2.02\u201316.88]; P\u2005=\u2005.01). Rates of treatment-emergent adverse events (TEAEs) were similar between groups (maribavir, 97.4%; IAT, 91.4%). Maribavir was associated with less acute kidney injury versus foscarnet (8.5% vs 21.3%) and neutropenia versus valganciclovir\/ganciclovir (9.4% vs 33.9%). Fewer patients discontinued treatment due to TEAEs with maribavir (13.2%) than IAT (31.9%). One patient per group had fatal treatment-related TEAEs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                    <jats:p>Clinical Trials Registration. NCT02931539 (SOLSTICE).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciab988","type":"journal-article","created":{"date-parts":[[2021,11,30]],"date-time":"2021-11-30T23:25:24Z","timestamp":1638314724000},"page":"690-701","source":"Crossref","is-referenced-by-count":302,"title":["Maribavir for Refractory Cytomegalovirus Infections With or Without Resistance Post-Transplant: Results From a Phase 3 Randomized Clinical Trial"],"prefix":"10.1093","volume":"75","author":[{"given":"Robin K","family":"Avery","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, Johns Hopkins University , Baltimore, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Alain","sequence":"additional","affiliation":[{"name":"Department of Virology and National Reference Center for Herpesviruses, Limoges University Hospital, UMR Inserm 1092, University of Limoges , Limoges , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara D","family":"Alexander","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases and International Health, Duke University , Durham, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily A","family":"Blumberg","sequence":"additional","affiliation":[{"name":"Department of Medicine, Perelman School of Medicine at the University of Pennsylvania , Philadelphia, Pennsylvania , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roy F","family":"Chemaly","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Infection Control, and Employee Health, University of Texas MD Anderson Cancer Center , Houston, Texas , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Cordonnier","sequence":"additional","affiliation":[{"name":"Haematology Department, Henri Mondor Hospital and University Paris-Est-Cr\u00e9teil , Cr\u00e9teil , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rafael F","family":"Duarte","sequence":"additional","affiliation":[{"name":"Department of Haematology, Hospital Universitario Puerta de Hierro Majadahonda , Madrid , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana F","family":"Florescu","sequence":"additional","affiliation":[{"name":"Infectious Diseases Division, University of Nebraska Medical Center , Omaha, Nebraska , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nassim","family":"Kamar","sequence":"additional","affiliation":[{"name":"Department of Nephrology and Organ Transplantation, Toulouse Rangueil University Hospital, INFINITY-Inserm U1291-CNRS U5051, University Paul Sabatier , Toulouse , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deepali","family":"Kumar","sequence":"additional","affiliation":[{"name":"Transplant Centre, University Health Network , Toronto, Ontario , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johan","family":"Maertens","sequence":"additional","affiliation":[{"name":"Haematology Department, University Hospitals Leuven , KU Leuven, Leuven , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francisco M","family":"Marty","sequence":"additional","affiliation":[{"name":"Department of Infectious Disease, Brigham and Women\u2019s Hospital and Dana-Farber Cancer Institute , Boston, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Genovefa A","family":"Papanicolaou","sequence":"additional","affiliation":[{"name":"Infectious Disease Service, Department of Medicine, Memorial Sloan Kettering Cancer Center , New York, New York , USA"},{"name":"Department of Medicine, Weill Cornell Medicine , New York, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernanda P","family":"Silveira","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Infectious Diseases, University of Pittsburgh and University of Pittsburgh Medical Center , Pittsburgh, Pennsylvania , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oliver","family":"Witzke","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, West German Centre of Infectious Diseases, University Medicine Essen, University Duisburg-Essen , Essen , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingyang","family":"Wu","sequence":"additional","affiliation":[{"name":"Biostatistics, Takeda Development Center Americas, Inc , Lexington, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aimee K","family":"Sundberg","sequence":"additional","affiliation":[{"name":"Clinical Sciences, Takeda Development Center Americas, Inc , Lexington, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martha","family":"Fournier","sequence":"additional","affiliation":[{"name":"Clinical Sciences, Takeda Development Center Americas, Inc , Lexington, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"SOLSTICE Trial Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,12,2]]},"reference":[{"key":"2023010807181741400_CIT0001","doi-asserted-by":"crossref","first-page":"S23","DOI":"10.1093\/infdis\/jiz454","article-title":"Cytomegalovirus infection in solid organ and hematopoietic cell transplantation: state of the evidence.","volume":"221","author":"Haidar","year":"2020","journal-title":"J Infect Dis"},{"key":"2023010807181741400_CIT0002","doi-asserted-by":"crossref","first-page":"413","DOI":"10.5935\/0101-2800.20170074","article-title":"The current burden of cytomegalovirus 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