How does the risk of refractory CMV affect your clinical approach to already vulnerable, post-transplant patients?

Current challenges in post-transplant refractory CMV:

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Despite therapeutic advancements, the incidence of post-transplant refractory or resistant CMV remains a challenge for both solid organ transplant (SOT) and hematopoietic cell transplant (HCT) recipients.1

Many factors may be associated with an increased risk of developing refractory or resistant CMV post-transplant.2-5

  • Significant and multifaceted risk factors include2-5:

    • Treatment related
    • Patient related
    • Transplant related

CMV=cytomegalovirus.

LIVTENCITY (maribavir) packaging

What is LIVTENCITYTM (maribavir)?

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.

Get in touch with a Takeda Transplant Account Manager to learn more.

Frequently Asked Questions about LIVTENCITY:

How was LIVTENCITY evaluated in clinical studies?

The efficacy and safety of LIVTENCITY were evaluated in SOLSTICE: a Phase 3, multicenter, randomized, open-label, active-controlled superiority trial of 352 adult SOT or HCT transplant recipients with refractory or resistant CMV. Patients were randomized and treated with LIVTENCITY (N=235, 400 mg twice daily) or investigator-assigned treatment (IAT*; N=117, as dosed by the investigator) for 8 weeks, with a 12-week follow-up. Primary endpoint was defined as confirmed CMV DNA level <LLOQ (ie, <137 IU/mL in 2 consecutive samples tested ≥5 days apart) at the end of Week 8.1,6

LIVTENCITY in pediatric population6:

Only patients ≥18 years of age were enrolled in the study. Use of LIVTENCITY in pediatric patients 12 years of age and older and weighing at least 35 kg is based on the following:

  • Evidence from controlled studies of LIVTENCITY in adults
  • Population pharmacokinetic modeling and simulation demonstrating that age and body weight had no clinically meaningful effect on plasma exposures of LIVTENCITY
  • LIVTENCITY exposure is expected to be similar between adults and children 12 years of age and older and weighing at least 35 kg
  • The course of the disease is similar between adults and pediatric patients to allow extrapolation of data in adults to pediatric patients
  • The safety and effectiveness of LIVTENCITY have not been established in children younger than 12 years of age

IAT=investigator-assigned treatment; LLOQ=lower limit of quantification.

*Investigator-assigned anti-CMV treatment with 1 or 2 of the conventional CMV antivirals: Ganciclovir, valganciclovir, foscarnet, and/or cidofovir. Combination therapy with cidofovir and foscarnet was not permitted. Changes to dose or dosing schedule were permitted. Discontinuation of one of the combination agents was permitted. Only switches between ganciclovir and valganciclovir were permitted.

References

1. Chemaly RF, Chou S, Einsele H, et al. Clin Infect Dis. 2019;68(8):1420-1426. 2. El Chaer F, Shah DP, Chemaly RF. Blood. 2016;128:2624-2636. 3. Fisher CE, Knudsen JL, Lease ED, et al. Clin Infect Dis. 2017;65(1):57-63. 4. Sandkovsky U, Qiu F, Kalil AC, et al. Transplant Proc. 2018;50(10):3763-3768. 5. Liu J, Kong J, Chang YJ, et al. Clin Microbiol Infect. 2015;21(12):1121.e9-15. 6. Livtencity (maribavir) Prescribing Information. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc. 7. Avery RK, Alain S, Alexander BD, et al. Clin Infect Dis. 2022;75(4);690-701. 8. Avery RK, Alain S, Alexander BD, et al. Clin Infect Dis. Supplement. 2022. doi.org/10.1093/cid/ciab988. 9. Shannon-Lowe CD, Emery VC. Herpesviridae. 2010;1(4):1-13. 10. Steingruber M, Marschall M. Microorganisms. 2020;8(4):515. 11. Biron KK, Harvey RJ, Chamberlain SC, et al. Antimicrob Agents Chemother. 2002;46:2365-2372. 12. Wolf DG, Courcelle CT, Prichard MN, Mocarski ES. Proc Natl Acad Sci U S A. 2001;98(4):1895-1900. 13. Krosky PM, Baek MC, Coen DM. J Virol. 2003;77:905-914. 14. Bigley TM, Reitsma JM, Mirza SP, Terhune SS. J Virol. 2013;87(13):7393-7408.

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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.

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