{
    "abstract": "Neutropenia may limit the use of valganciclovir treatment for cytomegalovirus (CMV) infection following hematopoietic cell transplant (HCT). A phase 2 study indicated efficacy of maribavir with fewer treatment-limiting toxicities than valganciclovir.\nIn this multicenter, double-blind, phase 3 study, patients with first asymptomatic CMV infection post-HCT were stratified and randomized 1:1 to maribavir 400\u2005mg twice daily or valganciclovir (dose-adjusted for renal clearance) for 8 weeks with 12 weeks of follow-up. The primary endpoint was confirmed CMV viremia clearance at week 8 (primary hypothesis of noninferiority margin of 7.0%). The key secondary endpoint was a composite of the primary endpoint with no findings of CMV tissue-invasive disease at week 8 through week 16. Treatment-emergent adverse events (TEAEs) were assessed.\nAmong patients treated (273 maribavir; 274 valganciclovir), the primary endpoint of noninferiority of maribavir was not met (maribavir, 69.6%; valganciclovir, 77.4%; adjusted difference: -7.7%; 95% confidence interval [CI]: -14.98, -.36; lower limit of 95% CI of treatment difference exceeded -7.0%). At week 16, 52.7% and 48.5% of patients treated (maribavir and valganciclovir, respectively) maintained CMV viremia clearance without tissue-invasive disease (adjusted difference: 4.4%; 95% CI: -3.91, 12.76). With maribavir (vs valganciclovir), fewer patients experienced neutropenia (16.1% and 52.9%) or discontinued due to TEAEs (27.8% and 41.2%). Discontinuations were mostly due to neutropenia (maribavir, 4.0%; valganciclovir, 17.5%).\nAlthough noninferiority of maribavir to valganciclovir for the primary endpoint was not achieved based on the prespecified noninferiority margin, maribavir demonstrated comparable CMV viremia clearance during post-treatment follow-up, with fewer discontinuations due to neutropenia. Clinical Trials Registration. NCT02927067 [AURORA].",
    "authors": [
        {
            "affiliation": "Memorial Sloan Kettering Cancer Center, New York, New York, USA.",
            "firstname": "Genovefa A",
            "initials": "GA",
            "lastname": "Papanicolaou"
        },
        {
            "affiliation": "Johns Hopkins University, Baltimore, Maryland, USA.",
            "firstname": "Robin K",
            "initials": "RK",
            "lastname": "Avery"
        },
        {
            "affiliation": "Henri Mondor H\u00f4pital, Assistance Publique-Hopitaux de Paris, and Universit\u00e9 Paris-Est-Cr\u00e9teil, Cr\u00e9teil, France.",
            "firstname": "Catherine",
            "initials": "C",
            "lastname": "Cordonnier"
        },
        {
            "affiliation": "Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.",
            "firstname": "Rafael F",
            "initials": "RF",
            "lastname": "Duarte"
        },
        {
            "affiliation": "Hamilton Health Sciences Corporation, Ontario, Canada.",
            "firstname": "Shariq",
            "initials": "S",
            "lastname": "Haider"
        },
        {
            "affiliation": "University Hospitals Leuven, KU Leuven, Leuven, Belgium.",
            "firstname": "Johan",
            "initials": "J",
            "lastname": "Maertens"
        },
        {
            "affiliation": "University College London Hospitals NHS Foundation Trust, London, United Kingdom.",
            "firstname": "Karl S",
            "initials": "KS",
            "lastname": "Peggs"
        },
        {
            "affiliation": "Hospital Cl\u00ednico Universitario, University of Valencia, Valencia, Spain.",
            "firstname": "Carlos",
            "initials": "C",
            "lastname": "Solano"
        },
        {
            "affiliation": "University of Minnesota, Minneapolis, Minnesota, USA.",
            "firstname": "Jo-Anne H",
            "initials": "JH",
            "lastname": "Young"
        },
        {
            "affiliation": "Takeda Development Center Americas, Inc, Lexington, Massachusetts, USA.",
            "firstname": "Martha",
            "initials": "M",
            "lastname": "Fournier"
        },
        {
            "affiliation": "Takeda Development Center Americas, Inc, Lexington, Massachusetts, USA.",
            "firstname": "Rose Ann",
            "initials": "RA",
            "lastname": "Murray"
        },
        {
            "affiliation": "Takeda Development Center Americas, Inc, Lexington, Massachusetts, USA.",
            "firstname": "Jingyang",
            "initials": "J",
            "lastname": "Wu"
        },
        {
            "affiliation": "Los Angeles Medical Center, University of California, Los Angeles, California, USA.",
            "firstname": "Drew J",
            "initials": "DJ",
            "lastname": "Winston"
        },
        {
            "affiliation": null,
            "firstname": null,
            "initials": null,
            "lastname": null
        }
    ],
    "conclusions": null,
    "copyrights": "\u00a9 The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.",
    "doi": "10.1093/cid/ciad709",
    "journal": "Clinical infectious diseases : an official publication of the Infectious Diseases Society of America",
    "keywords": [
        "cytomegalovirus",
        "hematopoietic cell transplant",
        "maribavir",
        "valganciclovir"
    ],
    "methods": null,
    "publication_date": "2023-12-01",
    "pubmed_id": "38036487\n31153807\n26222822\n32297984\n34305463\n34060436\n34864943\n9310503\n32315708\n33220125\n35240904\n32202631\n26098499\n12502806\n19434630\n12821466\n31532960\n27682069\n25529383\n25639770\n27760756\n26947200\n30329038\n29020339\n1658652\n17640310\n31940472\n32726419\n26684607\n33549194\n35691326\n37279999\n34452721\n20353832\n36493341\n21414843\n27344206",
    "results": "Among patients treated (273 maribavir; 274 valganciclovir), the primary endpoint of noninferiority of maribavir was not met (maribavir, 69.6%; valganciclovir, 77.4%; adjusted difference: -7.7%; 95% confidence interval [CI]: -14.98, -.36; lower limit of 95% CI of treatment difference exceeded -7.0%). At week 16, 52.7% and 48.5% of patients treated (maribavir and valganciclovir, respectively) maintained CMV viremia clearance without tissue-invasive disease (adjusted difference: 4.4%; 95% CI: -3.91, 12.76). With maribavir (vs valganciclovir), fewer patients experienced neutropenia (16.1% and 52.9%) or discontinued due to TEAEs (27.8% and 41.2%). Discontinuations were mostly due to neutropenia (maribavir, 4.0%; valganciclovir, 17.5%).",
    "title": "Treatment for First Cytomegalovirus Infection Post-Hematopoietic Cell Transplant in the AURORA Trial: A Multicenter, Double-Blind, Randomized, Phase 3 Trial Comparing Maribavir With Valganciclovir.",
    "xml": "<Element 'PubmedArticle' at 0x788501d39c60>"
}