Maribavir

(Livtencity®)

Maribavir

Drug updated on 5/17/2024

Dosage FormTablet (oral; 200 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

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

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Summary
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  • Maribavir (Livtencity) is approved for the treatment of adults and pediatric patients who are 12 years or older, weigh at least 35 kg, and have post-transplant CMV infection/disease that is refractory to treatment with ganciclovir, valganciclovir, cidofovir, or foscarnet.
  • Two studies provided information on the safety and effectiveness of Livtencity in comparison with other antiviral strategies for managing Cytomegalovirus (CMV), particularly in transplant recipients.
  • Compared to traditional strategies like ganciclovir, valganciclovir, cidofovir, or foscarnet, which target viral polymerase but often face issues of toxicity and resistance, maribavir offers a new approach specifically addressing management of refractory or resistant infections in transplant recipients.
  • The need for new antiviral drugs stems from the critical requirement to find molecules capable of inhibiting CMV replication while minimizing toxicity. This highlights a broader challenge within CMV management - balancing efficacy against safety, especially given emerging multidrug resistance complexities associated with congenital CMV infection treatments.
  • A study on kidney transplant recipient's prevention strategies showed prophylaxis significantly lowered rates of CMV infection/disease compared to no prophylaxis. Preemptive therapy also demonstrated favorable outcomes by reducing disease rates as well as medical costs despite higher instances of hematological adverse events linked to these measures.
  • While maribavir provides promising results in treating difficult-to-treat cases among immunocompromised individuals such as adult and pediatric patients aged 12+ weighing over 35kg suffering from post-transplant refractory/resistant infections, there are a variety of preventive measures each having unique efficacy rates and safety profiles, requiring further clinical validation regarding long-term outcomes beyond just resistant/refractory infections.

Product Monograph / Prescribing Information

Document TitleYearSource
Livtencity (maribavir) Prescribing Information.2024Takeda Pharmaceuticals America Inc., Lexington, MA

Health Technology Assessments

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines