at post-transplant refractory CMV
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.
Efficacy and safety were evaluated in 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 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 8.1,2
Post-transplant patients experience challenges with refractory or resistant CMV.
CMV=cytomegalovirus; HCT=hematopoietic cell transplant; IAT=investigator-assigned treatment; SOT=solid organ transplant.
*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.1,2
†As assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test.1
‡Cochran-Mantel-Haenszel weighted average approach was used for the adjusted difference in proportion of responders (MBV-IAT), 95% CI, and p-value, after adjusting for transplant type and baseline plasma CMV DNA level concentration. Computation included only those with both stratification factors.1
1. Livtencity (maribavir) Prescribing Information. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc. 2. Data on file. Takeda Pharmaceuticals U.S.A., Inc. 3. Avery RK, Alain S, Alexander BD, et al. Clin Infect Dis. 2022;75(4):690-701. 4. Avery RK, Alain S, Alexander BD, et al. Clin Infect Dis. Supplement. 2022. doi.org/10.1093/cid/ciab988. 5. Shannon-Lowe CD, Emery VC. Herpesviridae. 2010;1(4):1-13. 6. Steingruber M, Marschall M. Microorganisms. 2020;8(4):515. 7. Biron KK, Harvey RJ, Chamberlain SC, et al. Antimicrob Agents Chemother 2002;46:2365-2372. 8. Wolf DG, Courcelle CT, Prichard MN, Mocarski ES. Proc Natl Acad Sci U S A. 2001;98(4):1895-1900. 9. Krosky PM, Baek MC, Coen DM. J Virol. 2003;77:905-914. 10. Bigley TM, Reitsma JM, Mirza SP, Terhune SS. J Virol. 2013;87(13):7393-7408.
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