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Managing Refractory Cytomegalovirus After Hematopoietic Cell Transplant

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Explore the use of a treatment option for patients who develop refractory cytomegalovirus after hematopoietic cell transplantation.

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  • Overview

    Over 22,000 hematopoietic cell transplants (HCTs) were performed in the United States in 2020,1 and unfortunately, it’s not uncommon for patients to develop cytomegalovirus (CMV) post-transplant. Although refractory CMV is a leading cause of morbidity and mortality after HCT,2 the treatment option LIVTENCITY® (maribavir) can be an effective approach for post-transplant refractory CMV based on data from the SOLSTICE trial.3,4 Joining Dr. Jennifer Caudle to talk about that data and how LIVTENCITY was used to treat a hypothetical patient with post-transplant refractory CMV is Dr. Amir Ali, Adjunct Clinical Professor of Pharmacy Practice at the University of Southern California School of Pharmacy.

  • INDICATION

    LIVTENCITY is indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with  ganciclovir, valganciclovir, cidofovir or foscarnet.

  • IMPORTANT SAFETY INFORMATION

    Risk of Reduced Antiviral Activity When Co-administered with Ganciclovir and Valganciclovir
    LIVTENCITY may antagonize the antiviral activity of ganciclovir and valganciclovir by inhibiting human CMV pUL97 kinase, which is required for activation/phosphorylation of ganciclovir and valganciclovir. Coadministration of LIVTENCITY with ganciclovir or valganciclovir is not recommended.

    Virologic Failure During Treatment and Relapse Post-Treatment
    Virologic failure due to resistance can occur during and after treatment with LIVTENCITY. Virologic relapse during the posttreatment period usually occurred within 4-8 weeks after treatment discontinuation. Some maribavir pUL97 resistance-associated substitutions confer cross-resistance to ganciclovir and valganciclovir. Monitor CMV DNA levels and check for maribavir resistance if the patient is not responding to treatment or relapses.

    Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions.

    • The concomitant use of LIVTENCITY and certain drugs may result in potentially significant drug interactions, some of which may lead to reduced therapeutic effect of LIVTENCITY or adverse reactions of concomitant drugs. Consider the potential for drug interactions prior to and during LIVTENCITY therapy; review concomitant medications during LIVTENCITY therapy and monitor for adverse reactions. Refer to the full prescribing information of LIVTENCITY for important drug interactions.
    • Maribavir is primarily metabolized by CYP3A4. Drugs that are strong inducers of CYP3A4 are expected to decrease maribavir plasma concentrations and may result in reduced virologic response; therefore, coadministration of LIVTENCITY with these drugs is not recommended, except for selected anticonvulsants.

    Use with Immunosuppressant Drugs
    LIVTENCITY has the potential to increase the drug concentrations of immunosuppressant drugs that are CYP3A and/or P-gp substrates where minimal concentration changes may lead to serious adverse events (including tacrolimus, cyclosporine, sirolimus and everolimus). Frequently monitor immunosuppressant drug levels throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust immunosuppressant dose, as needed.

    Adverse Reactions
    The most common adverse events (all grades, >10 percent) in subjects treated with LIVTENCITY were taste disturbance, nausea, diarrhea, vomiting, and fatigue.

    Please click for Full Prescribing Information.

  • References:

    1. HRSA Donation and Transplantation Statistics.  Available at: https://bloodstemcell.hrsa.gov/data/donation-and-transplantation-statistics. Accessed January 20, 2024.
    2. Schuster MG, Cleveland AA, Dubberke ER, et al. Infections in Hematopoietic Cell Transplant Recipients: Results From the Organ Transplant Infection Project, a Multicenter, Prospective, Cohort Study. Open Forum Infect Dis. 2017;4(2):ofx050. Published 2017 Mar 22. doi:10.1093/ofid/ofx050
    3. Livtencity (maribavir) Prescribing Information. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
    4. Avery RK, Alain S, Alexander BD, et al. Maribavir for refractory cytomegalovirus infections with or without resistance post-transplant: results from a phase 3 randomized clinical trial [published correction appears in Clin Infect Dis. 2023 Feb 8;76(3):560]. Clin Infect Dis. 2022;75(4):690-701. doi:10.1093/cid/ciab988

    ©2024 Takeda Pharmaceuticals U.S.A., Inc., 95 Hayden Avenue, Lexington, MA 02421. 1-877-TAKEDA-7 (1-877-825-3327). All rights reserved. TAKEDA® and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company Limited. LIVTENCITY® and the LIVTENCITY Logo® are registered trademarks of Takeda Pharmaceuticals International AG.
    US-MAR-0641v1.0 02/24 

Schedule6 Oct 2024