OVERVIEW

PRODUCT INFORMATION

REPRESENTATIVE TRADE NAMES

Maribavir – Livtencity®

DRUG CLASS

Antiviral Agents

COMPLETE LABELING

Product labeling at DailyMed, National Library of Medicine, NIH

CHEMICAL FORMULA AND STRUCTURE

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DRUG	CAS REGISTRY NUMBER	MOLECULAR FORMULA	STRUCTURE
Maribavir	176161-24-3	C15-H19-Cl2-N3-O4

ANNOTATED BIBLIOGRAPHY

References updated: 14 November 2022

Abbreviations: CMV, cytomegalovirus; HSCT, hematopoietic stem cell transplantation.

• Núñez M. Herpesviridae treatment. Hepatic toxicity of antiviral agents. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2013, pp. 512-3.

  (Review of hepatotoxicity of antiviral agents published in 2013, before the availability of maribavir).
• Acosta EP. Antiviral agents (nonretroviral). In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1105-35.

  (Textbook of pharmacology and therapeutics).
• FDA. https://www​.accessdata​.fda.gov/drugsatfda_docs​/nda/2021/215596Orig1s000IntegratedR.pdf.

  (FDA Drug Approval website that has product labels [package inserts], letters of approval and full FDA scientific reviews of the new drug applications for safety and efficacy; mentions that one of 234 patients with post-transplant CMV infection treated with maribavir developed hepatic failure, but specific details were not provided and overall rate of ALT elevations above 5 times ULN was 3% versus 0% in patients treated with comparator agents).
• Marty FM, Ljungman P, Papanicolaou GA, Winston DJ, Chemaly RF, Strasfeld L, Young JA, et al. Maribavir 1263-300 Clinical Study Group. Maribavir prophylaxis for prevention of cytomegalovirus disease in recipients of allogeneic stem-cell transplants: a phase 3, double-blind, placebo-controlled, randomised trial. Lancet Infect Dis. 2011;11:284–92. [PubMed: 21414843]

  (Among 681 adults undergoing allogenic hematopoietic stem cell transplantation [HSCT] given prophylaxis for CMV infection with either maribavir or placebo for up to 12 weeks, CMV disease developed in similar proportions of patients [4% vs 5%] and adverse event rates were similar except for dysgeusia [15% vs 6%]; no mention of ALT elevations or hepatotoxicity).
• Papanicolaou GA, Silveira FP, Langston AA, Pereira MR, Avery RK, Uknis M, Wijatyk A, et al. Maribavir for refractory or resistant cytomegalovirus infections in hematopoietic-cell or solid-organ transplant recipients: a randomized, dose-ranging, double-blind, phase 2 study. Clin Infect Dis. 2019;68:1255–1264. [PMC free article: PMC6451997] [PubMed: 30329038]

  (Among 120 patients with refractory or resistant CMV infection after hematopoietic or solid organ transplantation treated with maribavir [400, 800 or 1200 mg] twice daily for up to 24 weeks, the overall response rate at 6 weeks was 67% and was similar in all dose groups while adverse events led to dose discontinuation in 34% of patients, but there was no mention of liver related adverse events or ALT elevations).
• Maertens J, Cordonnier C, Jaksch P, Poiré X, Uknis M, Wu J, Wijatyk A, et al. Maribavir for preemptive treatment of cytomegalovirus reactivation. N Engl J Med. 2019;381:1136–1147. [PubMed: 31532960]

  (Among 156 patients with CMV reactivation after hematopoietic or solid organ transplantation treated with maribavir [400, 800 or 1200 mg] or valganciclovir [900 mg] twice daily for up to 12 weeks, response rates were similar with both drugs [62% vs 56%] but serious adverse events were more common with maribavir [44% vs 32%] as was dysgeusia [40% vs 2%], while neutropenia was less [4% vs 15%]; no mention of ALT elevations or hepatotoxicity).
• Kang C. Maribavir: first approval. Drugs. 2022;82:335–340. [PubMed: 35147913]

  (Review of the mechanism of action, history of development, pharmacology, clinical efficacy and safety of maribavir shortly after its approval in the US; mentions common adverse events of dysgeusia, nausea, diarrhea, vomiting, fatigue and abdominal pain, but does not mention ALT elevations or hepatotoxicity).
• Avery RK, Alain S, Alexander BD, Blumberg EA, Chemaly RF, Cordonnier C, Duarte RF, et al. SOLSTICE Trial Investigators. Maribavir for refractory cytomegalovirus infections with or without resistance post-transplant: Results from a phase 3 randomized clinical trial. Clin Infect Dis. 2022;75:690–701. [PMC free article: PMC9464078] [PubMed: 34864943]

  (Among 320 patients with refractory CMV infection after HCST treated with maribavir [400, 800 or 1200 mg twice daily] or valganciclovir for up to 12 weeks, response rates were higher with maribavir [79% vs 67%] and adverse events were mostly mild-to-moderate gastrointestinal symptoms; no mention of ALT elevations or hepatotoxicity).