Maribavir

LIVTENCITY

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Maribavir ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Maribavir ballicule

What it isAn oral benzimidazole riboside antiviral that inhibits the cytomegalovirus UL97 protein kinase, blocking viral DNA replication, encapsidation, and nuclear egress.

Why this oneFDA-approved (Livtencity) for post-transplant CMV infection or disease that is refractory or resistant to ganciclovir/valganciclovir, foscarnet, or cidofovir.

What limits itIts UL97 mechanism antagonizes ganciclovir (avoid co-administration), resistance mutations can emerge on therapy, and as a CYP3A substrate it also raises tacrolimus concentrations.

Maribavir molecular structure (skeletal formula) — Molecular structure: Maribavir

FDA label

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FDA dosing	Population	Start	Target	Max
Post-transplant CMV infection/disease refractory (with or without genotypic resistance) to ganciclovir, valganciclovir, foscarnet, or cidofovir	Adults & peds >=12 y and >=35 kg	400 mg BID	400 mg BID

Renal No adjustment needed (mild-severe impairment); not studied in ESRD/dialysis

Hepatic No adjustment needed (Child-Pugh A/B); severe impairment not studied

Increase dose with concomitant CYP3A4 inducers: carbamazepine or rifabutin -> 800 mg BID; phenytoin or phenobarbital -> 1,200 mg BID

Instructions

Take with or without food
Tablets may be swallowed whole, dispersed, or crushed; dispersed tablets may be given by mouth or via NG/OG tube (French size >=10) in drinking water
Prepared suspension may be stored at room temperature up to 8 h

Available strengths

tab 200 mg

Cautions

May antagonize antiviral activity of ganciclovir/valganciclovir (inhibits pUL97 kinase activation) — coadministration not recommended
Virologic failure during treatment and relapse post-treatment (usually within 4-8 wks after stopping): monitor CMV DNA and check for maribavir resistance if not responding; some pUL97 resistance substitutions confer cross-resistance to ganciclovir/valganciclovir
Raises levels of narrow-window immunosuppressants (tacrolimus, cyclosporine, sirolimus, everolimus) — monitor drug levels frequently during, at initiation, and after discontinuation; adjust dose
Strong CYP3A4 inducers reduce maribavir exposure — coadministration not recommended except with dose-adjusted carbamazepine/phenytoin; dose adjust with phenobarbital and rifabutin

Adverse reactions

Most common (>10%): taste disturbance (46%), nausea, diarrhea, vomiting, fatigue

Pregnancy No adequate human data; decreased embryo-fetal survival in rats at exposures below the recommended human dose

Lactation Unknown whether present in milk or effects on infant/production; weigh benefits of breastfeeding vs need for drug

Cost

Maribavir (LIVTENCITY)

Strength		#/mo	generic $/mo	CostPlus
200 mg	tab	60 BID		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Maribavir is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2032 est.

NO BOXED WARNINGS

Principal riskNo FDA boxed warning.

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilityAgent-specific renal, hepatic, hematologic, metabolic and drug-interaction toxicity.

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