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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
About the data
Data from a 2020 systematic review of observational (non-interventional) studies in the US and Europe. Takeda conducted a study using methods proposed by the Cochrane Group and the Institute of Medicine of the National Academy of Medicine. Abstract screening was conducted independently by two reviewers and discrepancies were resolved by a third reviewer. Overall, 86 studies were included in the systematic review. The majority of studies were retrospective cohort analyses (n=75).1
Summary of studies included in this systematic review1:
| Patient type | Study population size | Timing of assessment |
SOT recipients
| Patient type | Refractory CMV |
|---|---|
| Study population size | 100 to 500 patients (2 studies) |
| Timing of assessment | ≥1 year post-transplant (2 studies) |
| Patient type | Resistant CMV |
| Study population size | ≤100 patients (3 studies) 100 to 500 patients (6 studies) |
| Timing of assessment | Unknown (4 studies) ≥1 year post-transplant (5 studies) |
HCT recipients
| Patient type | Refractory CMV |
|---|---|
| Study population size | ≤100 patients (2 studies) |
| Timing of assessment | ≤100 days post-transplant (2 studies) |
| Patient type | Resistant CMV |
| Study population size | ≤100 patients (1 study) 100 to 500 patients (7 studies) |
| Timing of assessment | During follow-up, variable time period (2 studies) ≤100 days post-transplant (2 studies) >100 days <1 year post-transplant (1 study) ≥1 year post-transplant (3 studies) |
Consensus definitions of refractory or resistant CMV
Refractory or resistant CMV is typically diagnosed after failure to respond to 2 weeks of appropriate antiviral therapy2
Probable refractory CMV infection:
- Persistent viral load after at least 2 weeks of appropriately dosed antiviral therapy
- CMV viral load at the same level or higher than the peak viral load within 1 week but <1 log10 increase in CMV DNA titers done in the same laboratory and with the same assay
Definite Refractory CMV infection:
- Increase in CMV DNA or failure to achieve decrease in CMV DNA level (>1 log10) in whole blood or plasma after 2 or more weeks of treatment with appropriately dosed antiviral therapy
- May occur in the presence or absence of an identified mutation
Resistant CMV infection:
- Confirmation of an alteration in the viral genetic sequence that decreases susceptibility to 1 or more antiviral CMV treatments
- Must also meet the definition of refractory CMV infection
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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.
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.