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

Maribavir prescription history

Animated chart of estimated U.S. prescriptions per year, Antivirals (non-HIV) (1966–2026). Maribavir enters in 2021 (estimated).

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.

FDA label

Read the full label on DailyMed ↗

NO BOXED WARNINGS

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.

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Self-check

Why should maribavir not be coadministered with ganciclovir?
Its UL97 mechanism antagonizes ganciclovir.
What transplant-associated infection is maribavir used for?
Refractory or resistant CMV infection or disease.