Pharmacokinetics and pharmacodynamics of ASP2151, a helicase-primase inhibitor, in a murine model of herpes simplex virus infection

Antimicrobial Agents and Chemotherapy

Volumn 57, Issue 3, 2013, Pages 1339-1346

  Katsumata, Kiyomitsu ^a   Chono, Koji ^a   Kato, Kota ^a   Ohtsu, Yoshiaki ^a   Takakura, Shoji ^a   Kontani, Toru ^a   Suzuki, Hiroshi ^a  

^a ASTELLAS PHARMA INC   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

AMENAMEVIR;

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ANTIBODY TITER; ANTIVIRAL ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CONCENTRATION RESPONSE; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG HALF LIFE; FEMALE; HERPES SIMPLEX; HERPES SIMPLEX VIRUS 1; HERPES SIMPLEX VIRUS 2; IN VITRO STUDY; LIMIT OF DETECTION; MAXIMUM PLASMA CONCENTRATION; MOLECULAR WEIGHT; MOUSE; NONHUMAN; PRIORITY JOURNAL; VARICELLA ZOSTER VIRUS; VIRUS REPLICATION;

ANIMALS; ANTIVIRAL AGENTS; AREA UNDER CURVE; DNA HELICASES; DNA PRIMASE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; ENZYME INHIBITORS; FEMALE; HERPES SIMPLEX; HERPESVIRUS 1, HUMAN; MICE; MICE, HAIRLESS; OXADIAZOLES; SKIN; VIRAL PLAQUE ASSAY; VIRAL PROTEINS; VIRUS REPLICATION;

EID: 84874070549     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.01803-12     Document Type: Article

References (38)

1. Pellet PE, Roizman B. 2007. The family Herpesviridae: a brief introduction, p 2479-2499. In Knipe DM, Howley PM, Griffin DE, Lamb RA, Martin MA, Roizman B, Straus SE, et al (ed), Fields virology, 5th ed, vol 2. Lippincott Williams & Wilkins, Philadelphia, PA.
2. Roizman B, Knipe D, Whitley R. 2007. Herpes simplex viruses, p 2501- 2601. In Knipe DM, Howley PM, Griffin DE, Lamb RA, Martin MA, Roizman B, Straus SE, et al (ed), Fields virology, 5th ed, vol 2. Lippincott Williams & Wilkins, Philadelphia, PA.
3. Levin MJ, Schmader K. 2007. Prevention strategies: herpes zoster, postherpetic neuralgia and immunogenicity. Herpes 14(Suppl 2):45- 47.
4. De Clercq E. 1993. Antivirals for the treatment of herpesvirus infections. J. Antimicrob. Chemother. 32:121-132.
5. De Clercq E, Field HJ. 2006. Antiviral prodrugs-the development of successful prodrug strategies for antiviral chemotherapy. Br. J. Pharmacol. 147:1-11.
6. Chono K, Katsumata K, Kontani T, Kobayashi M, Sudo K, Yokota T, Konno K, Shimizu Y, Suzuki H. 2010. ASP2151, a novel helicase-primase inhibitor, possesses antiviral activity against varicella-zoster virus and herpes simplex virus types 1 and 2. J. Antimicrob. Chemother. 65:1733-1741.
7. Crute JJ, Grygon CA, Hargrave KD, Simoneau B, Faucher Bolger A-MG, Kibler P, Liuzzi M, Cordingley MG. 2002. Herpes simplex virus helicase-primase inhibitors are active in animal models of human disease. Nat. Med. 8:386 -391.
8. Kleymann G, Fischer R, Betz UA, Hendrix M, Bender W, Schneider U, Handke G, Eckenberg P, Hewlett G, Pevzner V, Baumeister J, Weber O, Henninger K, Keldenich J, Jensen A, Kolb J, Bach U, Popp A, Maben J, Frappa I, Haebich D, Lockhoff O, Rubsamen-Waigmann H. 2002. New helicase-primase inhibitors as drug candidates for the treatment of herpes simplex disease. Nat. Med. 8:392-398.
9. Tyring S, Wald A, Zadeikis N, Dhadda S, Takenouchi K, Rorig R. 2012. ASP2151 for the treatment of genital herpes: a randomized, double-blind, placebo- and valacyclovir-controlled, dose-finding study. J. Infect. Dis. 205:1100 -1110.
10. Bilello JA, Bauer G, Dudley MN, Cole GA, Drusano GL. 1994. Effect of 2=, 3=-didehydro-3=-deoxythymidine in an in vitro hollow-fiber pharmacodynamic model system correlates with results of dose-ranging clinical studies. Antimicrob. Agents Chemother. 38:1386 -1391.
11. Jumbe N, Louie A, Leary R, Liu W, Deziel MR, Tam VH, Bachhawat R, Freeman C, Kahn JB, Bush K, Dudley MN, Miller MH, Drusano GL. 2003. Application of a mathematical model to prevent in vivo amplification of antibiotic-resistant bacterial populations during therapy. J. Clin. Invest. 112:275-285.
12. Louie A, Kaw P, Liu W, Jumbe N, Miller MH, Drusano GL. 2001. Pharmacodynamics of daptomycin in a murine thigh model of Staphylococcus aureus infection. Antimicrob. Agents Chemother. 45:845- 851.
13. Preston SL, Piliero PJ, Bilello JA, Stein DS, Symonds WT, Drusano GL. 2003. In vitro-in vivo model for evaluating the antiviral activity of amprenavir in combination with ritonavir administered at 600 and 100 milligrams, respectively, every 12 hours. Antimicrob. Agents Chemother. 47: 3393-3399.
14. Craig WA. 1998. Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin. Infect. Dis. 26:1-10.
15. Mouton JW, Dudley MN, Cars O, Derendorf H, Drusano GL. 2005. Standardization of pharmacokinetic/pharmacodynamic (PK/PD) terminology for anti-infective drugs: an update. J. Antimicrob. Chemother. 55:601- 607.
16. Burger D, Hugen P, Reiss P, Gyssens I, Schneider M, Kroon F, Schreij G, Brinkman K, Richter C, Prins J, Aarnoutse R, Lange J. 2003. Therapeutic drug monitoring of nelfinavir and indinavir in treatmentnaive HIV-1-infected individuals. AIDS 17:1157-1165.
17. Durant J, Clevenbergh P, Garraffo R, Halfon P, Icard S, Del Giudice P, Montagne N, Schapiro JM, Dellamonica P. 2000. Importance of protease inhibitor plasma levels in HIV-infected patients treated with genotypicguided therapy: pharmacological data from the Viradapt Study. AIDS 14: 1333-1339.
18. Fletcher CV, Anderson PL, Kakuda TN, Schacker TW, Henry K, Gross CR, Brundage RC. 2002. Concentration-controlled compared with conventional antiretroviral therapy for HIV infection. AIDS 16:551-560.
19. Gatti G, Pontali E, Boni S, De Pascalis CR, Bassetti M, Bassetti D. 2002. The relationship between ritonavir plasma trough concentration and virological and immunological response in HIV-infected children. HIV Med. 3:125-128.
20. Marzolini C, Telenti A, Decosterd LA, Greub G, Biollaz J, Buclin T. 2001. Efavirenz plasma levels can predict treatment failure and central nervous system side effects in HIV-1-infected patients. AIDS 15:71-75.
21. Sadler BM, Gillotin C, Lou Y, Stein DS. 2001. Pharmacokinetic and pharmacodynamic study of the human immunodeficiency virus protease inhibitor amprenavir after multiple oral dosing. Antimicrob. Agents Chemother. 45:30 -37.
22. Drusano GL, Bilello JA, Preston SL, O'Mara E, Kaul S, Schnittman S, Echols R. 2001. Hollow-fiber unit evaluation of a new human immunodeficiency virus type 1 protease inhibitor, BMS-232632, for determination of the linked pharmacodynamic variable. J. Infect. Dis. 183:1126 -1129.
23. de Clercq E. 1984. Topical treatment of cutaneous herpes simplex virus infection in hairless mice with (E)-5-(2-bromovinyl)-2=-deoxyuridine and related compounds. Antimicrob. Agents Chemother. 26:155-159.
24. Simmons A, Nash A. 1984. Zosteriform spread of herpes simplex virus as a model of recrudescence and its use to investigate the role of immune cells in prevention of recurrent disease. J. Virol. 52:816-821.
25. Himaki T, Masui Y, Chono K, Daikoku T, Takemoto M, Haixia B, Okuda T, Suzuki H, Shiraki K. 2012. Efficacy of ASP2151, a helicaseprimase inhibitor, against thymidine kinase-deficient herpes simplex virus type 2 infection in vitro and in vivo. Antiviral Res. 93:301-304.
26. Katsumata K, Chono K, Sudo K, Shimizu Y, Kontani T, Suzuki H. 2011. Effect of ASP2151, a herpesvirus helicase-primase inhibitor, in a guinea pig model of genital herpes. Molecules 16:7210 -7223.
27. Katsumata K, Weinberg A, Chono K, Takakura S, Kontani T, Suzuki H. 2012. Susceptibility of herpes simplex virus isolated from genital herpes lesions to ASP2151, a novel helicase-primase inhibitor. Antimicrob. Agents Chemother. 56:3587-3591.
28. Derendorf H, Meibohm B. 1999. Modeling of pharmacokinetic/pharmacodynamic (PK/PD) relationships: concepts and perspectives. Pharm. Res. 16:176 -185.
29. Holford NH, Sheiner LB. 1981. Understanding the dose-effect relationship: clinical application of pharmacokinetic-pharmacodynamic models. Clin. Pharmacokinet. 6:429-453.
30. Craig WA. 1995. Interrelationship between pharmacokinetics and pharmacodynamics in determining dosage regimens for broad-spectrum cephalosporins. Diagn. Microbiol. Infect. Dis. 22:89 -96.
31. Wharton SB, Meyers NL, Nash AA. 1995. Experimental herpes simplex virus type 1 (HSV-1) infection of the spinal cord and dorsal root ganglia. Neuropathol. Appl. Neurobiol. 21:228 -237.
32. McLaren C, Corey L, Dekket C, Barry DW. 1983. In vitro sensitivity to acyclovir in genital herpes simplex viruses from acyclovir-treated patients. J. Infect. Dis. 148:868-875.
33. Patel R, Bell AR. 1998. Valaciclovir for the suppression of recurrent genital herpes: relationship between efficacy and pharmacokinetic parameters. Antiinfect. Drugs Chemother. 16:19.
34. Saiag P, Praindhui D, Chastang C. 1999. A double-blind, randomized study assessing the equivalence of valacyclovir 1000 mg once daily versus 500 mg twice daily in the episodic treatment of recurrent genital herpes. J. Antimicrob. Chemother. 44:525-531.
35. Spruance SL, Tyring SK, DeGregorio B, Miller C, Beutner K. 1996. A large-scale, placebo-controlled, dose-ranging trial of peroral valaciclovir for episodic treatment of recurrent herpes genitalis. Arch. Intern. Med. 156:1729 -1735.
36. Tod M, Lokiec F, Bidault R, De Bony F, Petitjean O, Aujard Y, Grp APF. 2001. Pharmacokinetics of oral acyclovir in neonates and in infants: a population analysis. Antimicrob. Agents Chemother. 45:150 -157.
37. Andes D, Craig WA. 2002. Animal model pharmacokinetics and pharmacodynamics: a critical review. Int. J. Antimicrob. Agents 19:261- 268.
38. Drusano GL. 2004. Antimicrobial pharmacodynamics: critical interactions of 'bug and drug'. Nat. Rev. Microbiol. 2:289 -300.