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      Real-World Experience With Maribavir for Treatment of Cytomegalovirus Infection in High-Risk Solid Organ Transplant Recipients

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          Abstract

          We evaluated use of maribavir (MBV) for treatment of 15 episodes of refractory/resistant cytomegalovirus infection in 13 solid organ transplant recipients. Treatment failure due to treatment-emergent MBV resistance or early virological recurrence after MBV discontinuation occurred in 7 (47%) episodes. Sustained viral clearance was achieved in 6 (40%) episodes.

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          Most cited references13

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          Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials.

          Cytomegalovirus (CMV) infection and disease are important causes of morbidity and mortality in transplant recipients. For the purpose of developing consistent reporting of CMV outcomes in clinical trials, definitions of CMV infection and disease were developed and most recently published in 2002. Since then, there have been major developments in its diagnosis and management. Therefore, the CMV Drug Development Forum consisting of scientists, clinicians, regulators, and industry representatives has produced an updated version incorporating recent knowledge with the aim to support clinical research and drug development. The main changes compared to previous definitions are the introduction of a "probable disease" category and to incorporate quantitative nucleic acid testing in some end-organ disease categories. As the field evolves, the need for updates of these definitions is clear, and collaborative efforts between scientists, regulators, and industry can provide a platform for this work.
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            Cytomegalovirus in solid organ transplant recipients—Guidelines of the American Society of Transplantation Infectious Diseases Community of Practice

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              Maribavir for Refractory or Resistant Cytomegalovirus Infections in Hematopoietic-cell or Solid-organ Transplant Recipients: A Randomized, Dose-ranging, Double-blind, Phase 2 Study

              In this multicenter, dose-ranging study of maribavir for the treatment of cytomegalovirus (CMV) infections deemed refractory or resistant to current antivirals, 67% of patients achieved clearance of CMV viremia within 6 weeks, with responses maintained for up to 24 weeks.
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                Author and article information

                Contributors
                Journal
                Open Forum Infect Dis
                Open Forum Infect Dis
                ofid
                Open Forum Infectious Diseases
                Oxford University Press (US )
                2328-8957
                July 2024
                15 June 2024
                15 June 2024
                : 11
                : 7
                : ofae335
                Affiliations
                Division of Infectious Diseases, Duke University School of Medicine , Durham, North Carolina, USA
                Division of Infectious Diseases, Duke University School of Medicine , Durham, North Carolina, USA
                Division of Infectious Diseases, Duke University School of Medicine , Durham, North Carolina, USA
                Division of Infectious Diseases, Duke University School of Medicine , Durham, North Carolina, USA
                Division of Infectious Diseases, Duke University School of Medicine , Durham, North Carolina, USA
                Division of Infectious Diseases, Duke University School of Medicine , Durham, North Carolina, USA
                Division of Infectious Diseases, Duke University School of Medicine , Durham, North Carolina, USA
                Division of Infectious Diseases, Duke University School of Medicine , Durham, North Carolina, USA
                Division of Infectious Diseases, Duke University School of Medicine , Durham, North Carolina, USA
                Division of Infectious Diseases, Duke University School of Medicine , Durham, North Carolina, USA
                Author notes
                Correspondence: Bin Ni, MD, PhD, Division of Infectious Diseases, Duke University Medical Center, 315 Trent Drive, Hanes House, Durham, NC 27710 ( bin.ni@ 123456duke.edu ); Eileen K. Maziarz, MD, Division of Infectious Diseases, Duke University Medical Center, 315 Trent Drive, Hanes House, Durham, NC 27710 ( eileen.maziarz@ 123456duke.edu ).

                Potential conflicts of interest. All authors: No reported conflicts.

                Author information
                https://orcid.org/0000-0001-7148-4653
                https://orcid.org/0000-0002-3187-5905
                https://orcid.org/0000-0002-9424-1870
                https://orcid.org/0000-0001-6411-198X
                https://orcid.org/0000-0002-7684-431X
                https://orcid.org/0000-0002-0914-0291
                https://orcid.org/0000-0001-7779-9605
                Article
                ofae335
                10.1093/ofid/ofae335
                11218774
                38957689
                a573ac75-8c5c-4762-b7a4-ec908c9199b6
                © The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.

                History
                : 20 March 2024
                : 06 June 2024
                : 13 June 2024
                : 02 July 2024
                Page count
                Pages: 5
                Funding
                Funded by: National Institute of Allergy and Infectious Diseases, DOI 10.13039/100000060;
                Funded by: National Institutes of Health, DOI 10.13039/100000002;
                Award ID: K08-AI163462
                Categories
                Infectious Diseases in Special Populations
                Brief Report
                AcademicSubjects/MED00290

                cytomegalovirus,maribavir,solid organ transplantation,antiviral drug resistance,antiviral therapy

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