Drug updated on 5/17/2024
Dosage Form | Tablet (oral; 200 mg) |
Drug Class | Kinase 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.
Latest News
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Summary
- 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 Title | Year | Source |
---|---|---|
Livtencity (maribavir) Prescribing Information. | 2024 | Takeda Pharmaceuticals America Inc., Lexington, MA |
Health Technology Assessments
Document Title | Year | Source |
---|---|---|
Clinical and pharmacoeconomic combined report. | 2023 | CADTH |
Assessment report: Livtencity. | 2022 | EMA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Anti-CMV therapy, what next? A systematic review. | 2023 | Frontiers in Microbiology |
Antiviral treatment approaches for cytomegalovirus prevention in kidney transplant recipients: a systematic review of randomized controlled trials. | 2021 | Transplantation Reviews |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Guidelines for the management of cytomegalovirus infection in patients with haematological malignancies and after stem cell transplantation from the 2017 European Conference on Infections in Leukaemia (ECIL 7). | 2019 | The Lancet: Infectious Diseases |