MARIBAVIR TAB

Clinical Criteria Summary

Treatment of adult and pediatric (>12 years and >35 kg) patients with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir, or foscarnet.
Post-hematopoietic-cell transplant (HSCT) or solid-organ transplant (SOT) recipients.

200 mg tablet; standard dose is 400 mg (two 200 mg tablets) PO BID, with or without food.
Dose adjustment required when co-administered with CYP-inducing anticonvulsants: 800 mg PO BID with carbamazepine; 1200 mg PO BID with phenytoin or phenobarbital.
Only available as oral dosage form.

Indicated for treatment of refractory or resistant CMV infections post-transplant.
Not indicated for prophylaxis (Phase 2 trials failed to show efficacy).
May be considered for patients intolerant to ganciclovir/valganciclovir (e.g., treatment-limiting cytopenias), but only in select situations with close consultation due to limited data and risk of recurrence/resistance.
Foscarnet is generally preferred second-line over maribavir for compromised oral absorption or severe/critical illness.
Use cautiously in CMV gastrointestinal disease due to potential reduced absorption.
Appropriate as step-down therapy from foscarnet after clinical improvement.
Appropriate for isolates with known or suspected resistance to foscarnet.

Risk of reduced antiviral activity when co-administered with ganciclovir or valganciclovir (maribavir antagonizes their activation).
Monitor CMV DNA levels and check maribavir resistance if patient is not responding to treatment.
Virologic failure and relapse can occur during treatment and within 4-8 weeks after discontinuation.
Maribavir pUL97 resistance-associated substitution confers cross-resistance to ganciclovir and valganciclovir.
Risk of adverse reactions or loss of virologic response due to drug interactions: Primarily metabolized by CYP3A4; strong inducers decrease plasma concentrations (virologic failure risk). Potential to increase concentrations of immunosuppressants that are CYP3A4 and P-gp substrates (cyclosporine, everolimus, sirolimus, tacrolimus).
Use cautiously with moderate to strong CYP3A4 inducers.
Common adverse effects include dysgeusia, nausea, vomiting, and diarrhea; often treatment-limiting.

No dosage adjustment required for patients >65 years.
No dose adjustments needed for mild to moderate hepatic impairment (Child-Pugh A or B); not studied in severe hepatic impairment (Child-Pugh C).
No dose adjustments for mild, moderate, or severe kidney impairment; not studied in end-stage renal disease including dialysis.
Absorption: 25% to 45% absorbed orally; no data to support use for CMV of the gastro-intestinal tract with compromised gut integrity.

Download CFU PDF