Pharmacokinetic-pharmacodynamic determinants of oseltamivir efficacy using data from phase 2 inoculation studies

Antimicrobial Agents and Chemotherapy

Volumn 57, Issue 8, 2013, Pages 3478-3487

  Rayner, C R ^a,b,c   Bulik, C C ^d   Kamal, M A ^a   Reynolds, D K ^d   Toovey, S ^a,c,e   Hammel, J P ^d   Smith, P F ^a,c,f   Bhavnani, S M ^d,f   Van Wart, S A ^d,f   Ambrose, P G ^d,f   Forrest, A ^d,f  

^a HOFFMANN LA ROCHE INC   (United States)

^b MONASH UNIVERSITY   (Australia)

^c D3 Limited   (Hong Kong)

^d INSTITUTE FOR CLINICAL PHARMACODYNAMICS   (United States)

^e ROYAL FREE AND UNIVERSITY COLLEGE MEDICAL SCHOOL   (United Kingdom)

^f UNIVERSITY AT BUFFALO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

4 ACETAMIDO 5 AMINO 3 (1 ETHYLPROPOXY) 1 CYCLOHEXENE 1 CARBOXYLIC ACID; OSELTAMIVIR; PLACEBO; SIALIDASE; SIALIDASE INHIBITOR;

ADULT; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG ELIMINATION; DRUG EXPOSURE; DRUG HALF LIFE; ENZYME ACTIVITY; EXPOSURE; FEMALE; HUMAN; IC 50; INFLUENZA A; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PHARMACODYNAMICS; PHARMACOKINETICS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; VIRUS SHEDDING;

ADULT; ANTIVIRAL AGENTS; AREA UNDER CURVE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA B VIRUS; INFLUENZA, HUMAN; MALE; MULTIVARIATE ANALYSIS; NEURAMINIDASE; OSELTAMIVIR; TIME FACTORS; TREATMENT OUTCOME; VIRAL LOAD; VIRUS SHEDDING; YOUNG ADULT;

EID: 84880260334     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.02440-12     Document Type: Article

References (17)

1. F. Hoffmann-La Roche, Ltd. 2011. Tamiflu summary of product characteristics (SmPC). F. Hoffmann-La Roche, Ltd., Basel, Switzerland. Available at http://www.medicines.org.uk/emc/. Accessed 25 August 2011.
2. Hoffmann-La Roche, Inc. 2012. Tamiflu (oseltamivir phosphate) prescribing information. Hoffmann-La Roche, Inc., Nutley, New Jersey.
3. McSharry JJ, Weng Q, Brown AN, Kulawy R, Drusano GL. 2009. Prediction of the pharmacodynamically linked variable of oseltamivir carboxylate for influenza A virus using an in vitro hollow-fiber infection model system. Antimicrob. Agents Chemother. 53:2375-2381.
4. Brown AN, Bulitta JB, McSharry JJ, Weng Q, Adams JR, Kulawy R, Drusano GL. 2011. Effect of half-life on the pharmacodynamic index of zanamivir against influenza virus delineated by a mathematical model. Antimicrob. Agents Chemother. 55:1747-1753.
5. Brown AN, McSharry JJ, Weng Q, Adams JR, Kulawy R, Drusano GL. 2011. Zanamivir, at 600 milligrams twice daily, inhibits oseltamivirresistant 2009 pandemic H1N1 influenza virus in an in vitro hollow-fiber infection model system. Antimicrob. Agents Chemother. 55:1740-1746.
6. Govorkova EA, Ilyushina NA, Boltz DA, Douglas A, Yilmaz N, Webster RG. 2007. Efficacy of oseltamivir therapy in ferrets inoculated with different clades of H5N1 influenza virus. Antimicrob. Agents Chemother. 51: 1414-1424.
7. Yen HL, Monto AS, Webster RG, Govorkova EA. 2005. Virulence may determine the necessary duration and dosage of oseltamivir treatment for highly pathogenic A/Vietnam/1203/04 influenza virus in mice. J. Infect. Dis. 192:665-672.
8. Yang K, Rao G, Reddy M, Pamulapati C, Marathe BM, Govorkova EA, Rayner CR, Forrest A. 2012. Pharmacokinetic-pharmacodynamic model for neuraminidase inhibitor oseltamivir in the ferret, abstr A-1243. Abstr. 52nd Intersci Conf. Antimicrob. Agents Chemother.
9. Hayden FG, Treanor JJ, Fritz RS, Logo M, Betts RF, Miller M, Kinnersley N, Mills RG, Ward P, Straus SE. 1999. Use of the oral neuraminidase inhibitor oseltamivir in experimental human influenza: randomized controlled trials for prevention and treatment. JAMA 282:1240-1246.
10. Hayden FG, Jennings L, Robson R, Schiff G, Jackson H, Rana B, McClelland G, Ipe D, Roberts N, Ward P. 2000. Oral oseltamivir in human experimental influenza B infection. Antivir. Ther. 5:205-213.
11. Kamal MA, Van Wart SA, Rayner CR, Subramoney V, Reynolds DK, Bulik CC, Smith PF, Bhavnani SM, Ambrose PG, Forrest A. 2013. Population pharmacokinetics of oseltamivir: pediatrics through geriatrics. Antimicrob. Agents Chemother. 57:3470-3477.
12. R Development Core Team. 2010. R: a language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. http://.R-project.org.
13. Hurvich CM, Tsai CL. 1989. Regression and time series model selection in small samples. Biometrika 76:297-307.
14. Reference deleted.
15. Treanor JJ, Hayden FG, Vrooman PS, Barbarash R, Bettis R, Riff D, Singh S, Kinnersley N, Ward P, Mills RG. 2000. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized controlled trial. U.S. Oral Neuraminidase Study Group. JAMA 283:1016-1024.
16. Nicholson KG, Aoki FY, Osterhaus AD, Trottier S, Carewicz O, Mercier CH, Rode A, Kinnersley N, Ward P. 2000. Efficacy and safety of oseltamivir in treatment of acute influenza: a randomized controlled trial. Neuraminidase Inhibitor Flu Treatment Investigator Group. Lancet 355:1845-1850. (Erratum, 356:1856.)
17. South East Asia Infectious Disease Clinical Research Network. 2013. Effect of double dose oseltamivir on clinical and virological outcomes in children and adults admitted to hospital with severe influenza: double blind randomised controlled trial. BMJ 346:f3039.