Despite therapeutic advancements, the incidence of refractory or resistant CMV in post-transplant patients remains a challenge1

US Incidence of refractory or resistant CMV in SOT and HCT recipients1

  Refractory CMV Resistant CMV
SOT recipients Up to
21%
Up to
14%
HCT recipients Up to
47%
Up to
19%

Data from a 2020 Takeda systematic review of 86 observational (non-interventional) studies in the US and Europe.

Many factors may be associated with an increased risk of developing refractory or resistant CMV post-transplant3-6


HLA=human leukocyte antigen.

*HCT only.
SOT only.

The incidence of post-transplant refractory or resistant CMV, along with the significant and multifaceted risk factors, illustrate some of the current challenges these patients face.

Learn more about a treatment option in post-transplant refractory or resistant CMV.7

1. Data on file. Takeda Pharmaceuticals U.S.A., Inc. 2. Chemaly RF, Chou S, Einsele H, et al. Clin Infect Dis. 2019;68(8):1420-1426. 3. El Chaer F, Shah DP, Chemaly RF. Blood. 2016;128:2624-2636. 4. Fisher CE, Knudsen JL, Lease ED, et al. Clin Infect Dis. 2017;65(1):57-63. 5. Sandkovsky U, Qiu F, Kalil AC, et al. Transplant Proc. 2018;50(10):3763-3768. 6. Liu J, Kong J, Chang YJ, et al. Clin Microbiol Infect. 2015;21(12):1121.e9-15. 7. Livtencity (maribavir) Prescribing Information. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.

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%) in subjects treated with LIVTENCITY were taste disturbance, nausea, diarrhea, vomiting, and fatigue.

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.

Please click for Full Prescribing Information.