Maribavir: A novel antiviral agent with activity against cytomegalovirus

Annals of Pharmacotherapy

Volumn 42, Issue 10, 2008, Pages 1447-1457

  Trofe, Jennifer ^a,b   Pote, Lindsey ^b   Wade, Erin ^b   Blumberg, Emily ^a   Bloom, Roy D ^a,c  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

^c Penn Kidney/Pancreas Transplant Program

Author keywords

Cytomegalovirus; Epstein Barr virus; HIV; Maribavir; Solid organ transplantation; Stem cell transplantation

Indexed keywords

4469W94; ACICLOVIR; BENZIMIDAVIR; CARVEDILOL; CIDOFOVIR; CLOPIDOGREL; CYTOCHROME P450 2C19; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; CYTOCHROME P450 3A4; CYTOMEGALOVIRUS ANTIBODY; DIAZEPAM; DRUG METABOLITE; FOSCARNET; GANCICLOVIR; HALOPERIDOL; KETOCONAZOLE; LEFLUNOMIDE; METOCLOPRAMIDE; METOPROLOL; NELFINAVIR; OXYCODONE; PLACEBO; PROTON PUMP INHIBITOR; SEROTONIN UPTAKE INHIBITOR; TRAMADOL; UNCLASSIFIED DRUG; UNINDEXED DRUG; VALACICLOVIR; VALGANCICLOVIR; VENLAFAXINE; VP 41263; VP 44469; WARFARIN;

ABDOMINAL PAIN; ANTIVIRAL ACTIVITY; BLOOD TOXICITY; CLINICAL TRIAL; CYTOMEGALOVIRUS; CYTOMEGALOVIRUS INFECTION; DIARRHEA; DIZZINESS; DOSAGE SCHEDULE COMPARISON; DROWSINESS; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG INDICATION; DRUG METABOLISM; DRUG SAFETY; EPSTEIN BARR VIRUS; FATIGUE; FEVER; GASTROINTESTINAL SYMPTOM; HEADACHE; HEMATOLOGIC DISEASE; HEMODIALYSIS; HERPES SIMPLEX; HUMAN; IMMUNE COMPLEX NEPHRITIS; INFECTION PREVENTION; KIDNEY FAILURE; MAXIMUM PLASMA CONCENTRATION; MEDLINE; NAUSEA; NEPHROTOXICITY; ORGAN TRANSPLANTATION; PRIORITY JOURNAL; PRURITUS; QT PROLONGATION; RASH; REVIEW; SORE THROAT; STEM CELL TRANSPLANTATION; TASTE DISORDER; VIRUS INHIBITION; VOMITING;

ANTIVIRAL AGENTS; BENZIMIDAZOLES; CLINICAL TRIALS AS TOPIC; CYTOMEGALOVIRUS; CYTOMEGALOVIRUS INFECTIONS; DRUG RESISTANCE, VIRAL; EPSTEIN-BARR VIRUS INFECTIONS; HERPESVIRUS 4, HUMAN; HUMANS; PHOSPHOTRANSFERASES (ALCOHOL GROUP ACCEPTOR); RIBONUCLEOSIDES;

EID: 52949146407     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1L065     Document Type: Review

References (50)

1. Ho M. The history of cytomegalovirus and its diseases. Med Microbiol Immunol 2007;197:65-73.
2. Biron KK. Antiviral drugs for cytomegalovirus diseases. Antiviral Res 2006;71:154-63.
3. Rowshani AT, Bemelman FJ, van Leeuwen EM, van Lier RA, ten Berge IJ. Clinical and immunologic aspects of cytomegalovirus infection in solid organ transplant recipients. Transplantation 2005;79:381-6.
4. Cytomegalovirus. Am J Transplant 2004;4(suppl 10):51-8.
5. Fishman JA. Infection in solid-organ transplant recipients. N Engl J Med 2007;357:2601-14.
6. Preiksaitis JK, Brennan DC, Fishman J, Allen U. Canadian Society of Transplantation consensus workshop on cytomegalovirus management in solid organ transplantation: final report. Am J Transplant 2005;5:218-27.
7. Hodson EM, Barclay PG, Craig JC, et al. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev 2005(4):CD003774.
8. Fishman JA, Emery V, Freeman R, et al. Cytomegalovirus in transplantation - challenging the status quo. Clin Transplant 2007;21:149-58.
9. Asberg A, Humar A, Rollag H, et al. Oral valganciclovir is noninferior to intravenous ganciclovir for the treatment of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant 2007;7:2106-13.
10. Limaye AP, Corey L, Koelle DM, Davis CL, Boeckh M. Emergence of ganciclovir-resistant cytomegalovirus disease among recipients of solid-organ transplants. Lancet 2000;356:645-9.
11. Product information. Valcyte (valganciclovir). Nutley, NJ: Roche Laboratories, Inc., January 2006.
12. Paya C, Humar A, Dominguez E, et al. Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant 2004;4:611-20.
13. Cochrane AB. Antiviral dosing and efficacy for prophylaxis of cytomegalovirus disease in solid organ transplant recipients. Am J Health Syst Pharm 2006;63(19 suppl 5):S17-21.
14. Czock D, Scholle C, Rasche FM, Schaarschmidt D, Keller F. Pharmacokinetics of valganciclovir and ganciclovir in renal impairment. Clin Pharmacol Ther 2002;72:142-50.
15. Product information. Cytovene (ganciclovir). Nutley, NJ: Roche Laboratories Inc., January 2006.
16. Pescovitz MD, Pruett TL, Gonwa T, et al. Oral ganciclovir dosing in transplant recipients and dialysis patients based on renal function. Transplantation 1998;66:1104-7.
17. Product information. Zovirax (acyclovir). Research Triangle Park, NC: GlaxoSmithKline, June 2005.
18. Flechner SM, Avery RK, Fisher R, et al. A randomized prospective controlled trial of oral acyclovir versus oral ganciclovir for cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Transplantation 1998;66:1682-8.
19. Fletcher CV, Chinnock BJ, Chace B, Balfour HH Jr. Pharmacokinetics and safety of high-dose oral acyclovir for suppression of cytomegalovirus disease after renal transplantation. Clin Pharmacol Ther 1988;44:158-63.
20. Product information. Valtrex (valacyclovir). Greenville, NC: GlaxoSmithKline, October 2007.
21. Lowance D, Neumayer HH, Legendre CM, et al. Valacyclovir for the prevention of cytomegalovirus disease after renal transplantation. International Valacyclovir Cytomegalovirus Prophylaxis Transplantation Study Group. N Engl J Med 1999;340:1462-70.
22. Product information. Vistide (cidofovir). Foster City, CA: Gilead Sciences, Inc., September 2000.
23. Product information. Foscavir (foscarnet). Wilmington, DE: AstraZeneca, August 2006.
24. Mattes FM, Hainsworth EG, Geretti AM, et al. A randomized, controlled trial comparing ganciclovir to ganciclovir plus foscarnet (each at half dose) for preemptive therapy of cytomegalovirus infection in transplant recipients. J Infect Dis 2004;189:1355-61.
25. Snydman DR, Werner BG, Dougherty NN, et al. Cytomegalovirus immune globulin prophylaxis in liver transplantation. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 1993;119:984-91.
26. Glowacki LS, Smaill FM. Use of immune globulin to prevent symptomatic cytomegalovirus disease in transplant recipients - a meta-analysis. Clin Transplant 1994;8:10-8.
27. John GT, Manivannan J, Chandy S, et al. A prospective evaluation of leflunomide therapy for cytomegalovirus disease in renal transplant recipients. Transplant Proc 2005;37:4303-5.
28. Hodson EM, Jones CA, Webster AC, et al. Antiviral medications to prevent cytomegalovirus disease and early death in recipients of solid-organ transplants: a systematic review of randomised controlled trials. Lancet 2005;365:2105-15.
29. Lu H, Thomas S. Maribavir (ViroPharma). Curr Opin Investig Drugs 2004;5:898-906.
30. Maribavir: 1263W94, Benzimidavir, GW 1263, GW 1263W94, VP41263. Drugs R D 2007;8:188-92.
31. Biron KK, Harvey RJ, Chamberlain SC, et al. Potent and selective inhibition of human cytomegalovirus replication by 1263W94, a benzimidazole L-riboside with a unique mode of action. Antimicrob Agents Chemother 2002;46:2365-72.
32. Krosky PM, Baek MC, Coen DM. The human cytomegalovirus UL97 protein kinase, an antiviral drug target, is required at the stage of nuclear egress. J Virol 2003;77:905-14.
33. Crumpacker CS. Ganciclovir. N Engl J Med 1996;335:721-9.
34. Drew WL, Miner RC, Marousek GI, Chou S. Maribavir sensitivity of cytomegalovirus isolates resistant to ganciclovir, cidofovir or foscarnet. J Clin Virol 2006;37:124-7.
35. Chou S, Marousek GI. Accelerated evolution of maribavir resistance in a cytomegalovirus exonuclease domain II mutant. J Virol 2008;82:246-53.
36. Chou S. Cytomegalovirus UL97 mutations in the era of ganciclovir and maribavir. Rev Med Virol 2008;18:233-46.
37. Williams SL, Hartline CB, Kushner NL, et al. In vitro activities of benzimidazole D- and L-ribonucleosides against herpesviruses. Antimicrob Agents Chemother 2003;47:2186-92.
38. Wang LH, Peck RW, Yin Y, Allanson J, Wiggs R, Wire MB. Phase I safety and pharmacokinetic trials of 1263W94, a novel oral anti-human cytomegalovirus agent, in healthy and human immunodeficiency virus-infected subjects. Antimicrob Agents Chemother 2003;47:1334-42.
39. Lalezari JP, Aberg JA, Wang LH, et al. Phase I dose escalation trial evaluating the pharmacokinetics, anti-human cytomegalovirus (HCMV) activity, and safety of 1263W94 in human immunodeficiency virus-infected men with asymptomatic HCMV shedding. Antimicrob Agents Chemother 2002;46:2969-76.
40. Swan SK, Smith WB, Marbury TC, et al. Pharmacokinetics of maribavir, a novel oral anticytomegalovirus agent, in subjects with varying degrees of renal impairment. J Clin Pharmacol 2007;47:209-17.
41. Goldwater DR, Dougherty C, Schumacher M, Villano SA. Effect of ketoconazole on the pharmacokinetics of maribavir in healthy adults. Antimicrob Agents Chemother 2008;52:1794-8.
42. Ma JD, Nafziger AN, Villano SA, Gaedigk A, Bertino JS Jr. Maribavir pharmacokinetics and the effects of multiple-dose maribavir on cytochrome P450 (CYP) 1A2, CYP 2C9, CYP 2C19, CYP 2D6, CYP 3A, N-acetyltransferase-2, and xanthine oxidase activities in healthy adults. Antimicrob Agents Chemother 2006;50:1130-5.
43. Winston DJ, Young JA, Pullarkat V, et al. Maribavir prophylaxis for prevention of cytomegalovirus infection in allogeneic stem cell transplant recipients: a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study. Blood 2008;111:5403-10.
44. Hendrix C, Kuppermann B, Dunn J, et al. A phase I trial to evaluate the ocular (intravitreal) penetration of 1263W94 after multiple dose, oral administration in AIDS patients with CMV retinitis (abstract 511). In: ICAAC; 2000. www.asm.org/memonly/abstracts/AbstractView.asp?AbstractID=33395 (accessed 2008 Jan 14).
45. Maribavir versus ganciclovir for the prevention of cytomegalovirus (CMV) disease in liver transplant recipients. 2007. www.clinicaltrials.gov/ct/show/ NCT00497796 (accessed 2007 Nov 8).
46. Lynch T, Price A. The effect of cytochrome P450 metabolism on drug response, interactions, and adverse effects. Am Fam Physician 2007;76:391-6.
47. Selleseth DW, Talarico CL, Miller T, Lutz MW, Biron KK, Harvey RJ. Interactions of 1263W94 with other antiviral agents in inhibition of human cytomegalovirus replication. Antimicrob Agents Chemother 2003;47:1468-71.
48. Chou S, Marousek GI. Maribavir antagonizes the antiviral action of ganciclovir on human cytomegalovirus. Antimicrob Agents Chemother 2006;50:3470-2.
49. Prophylactic use of maribavir for the prevention of cytomegalovirus (CMV) disease in stem cell transplant recipients. 2007. www.clinicaltrials.gov/ct/ show/NCT00411645 (accessed 2008 Nov 8).
50. Emery VC, Hassan-Walker AF. Focus on new drugs in development against human cytomegalovirus. Drugs 2002;62:1853-8.