How can viral dynamics models inform endpoint measures in clinical trials of therapies for acute viral infections?

PLoS ONE

Volumn 11, Issue 7, 2016, Pages

  Vegvari, Carolin ^a   Hadjichrysanthou, Christoforos ^a   Cauët, Emilie ^a   Lawrence, Emma ^a   Cori, Anne ^a   De Wolf, Frank ^b   Anderson, Roy M ^a  

^a IMPERIAL COLLEGE LONDON   (United Kingdom)

^b Janssen Prevention Center   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

OSELTAMIVIR; ANTIVIRUS AGENT;

ANTIVIRAL THERAPY; ARTICLE; BASIC REPRODUCTION NUMBER; BODY TEMPERATURE; CLINICAL TRIAL; DISEASE COURSE; DISEASE DURATION; DISEASE SEVERITY; DRUG EFFICACY; HUMAN; INFLUENZA A; MARKOV CHAIN; MONTE CARLO METHOD; OUTCOME ASSESSMENT; POPULATION DYNAMICS; VIRAL DYNAMICS; VIROGENESIS; VIRUS INFECTION; VIRUS LOAD; ACUTE DISEASE; BIOASSAY; BIOLOGICAL MODEL; CLINICAL TRIAL (TOPIC); DRUG EFFECTS; VIRUS DISEASES;

ACUTE DISEASE; ANTIVIRAL AGENTS; CLINICAL TRIALS AS TOPIC; ENDPOINT DETERMINATION; HUMANS; MARKOV CHAINS; MODELS, BIOLOGICAL; MONTE CARLO METHOD; VIRAL LOAD; VIRUS DISEASES;

EID: 84978162100     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0158237     Document Type: Article

References (27)

1. TCSDD TCftSoDD (2014) Cost to Develop and Win Marketing Approval for a New Drug Is $2.6 Billion.
2. Scannell JW, Blanckley A, Boldon H, Warrington B (2012) Diagnosing the decline in pharmaceutical R&D efficiency. Nat Rev Drug Discov 11: 191-200. doi:10.1038/nrd3681 PMID: 22378269
3. Cleeland CS, Sloan JA, Cella D, Chen C, Dueck AC, et al. (2013) Recommendations for including multiple symptoms as endpoints in cancer clinical trials: a report from the ASCPRO (Assessing the Symptoms of Cancer Using Patient-Reported Outcomes) Multisymptom Task Force. Cancer 119: 411-420. doi:10.1002/cncr.27744 PMID: 22930243
4. Ison MG, de Jong MD, Gilligan KJ, Higgs ES, Pavia AT, et al. (2010) End points for testing influenza antiviral treatments for patients at high risk of severe and life-threatening disease. J Infect Dis 201: 1654-1662. doi:10.1086/652498 PMID: 20423224
5. Jefferson T, Jones M, Doshi P, Spencer EA, Onakpoya I, et al. (2014) Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments. BMJ 348: g2545. doi:10.1136/bmj.g2545 PMID: 24811411
6. Heneghan CJ, Onakpoya I, Thompson M, Spencer EA, Jones M, et al. (2014) Zanamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments. BMJ 348: g2547. doi:10.1136/bmj.g2547 PMID: 24811412
7. Dobson J, Whitley RJ, Pocock S, Monto AS (2015) Oseltamivir treatment for influenza in adults: a meta-analysis of randomised controlled trials. The Lancet 385: 1729-1737.
8. Clinch B, Smith J (2015) Roche perspectives on Tamiflu. Clin Microbiol Infect 21: 226-229. doi:10.1016/j.cmi.2015.01.014 PMID: 25716982
9. Wathen MW, Barro M, Bright RA (2013) Antivirals in seasonal and pandemic influenza - future perspectives. Influenza Other Respir Viruses 7 Suppl 1: 76-80. doi:10.1111/irv.12049 PMID: 23279900
10. Hadjichrysanthou C, Cauët E, Lawrence E, Vegvari C, De Wolf F, et al. (in press) Understanding the within-host dynamics of influenza A virus: from theory to clinical implications. J. R. Soc. Interface.
11. Baccam P, Beauchemin C, Macken CA, Hayden FG, Perelson AS (2006) Kinetics of influenza A virus infection in humans. J Virol 80: 7590-7599. PMID: 16840338
12. Hayden FG, Treanor JJ, Fritz RS, Lobo M, Betts RF, et al. (1999) Use of the oral neuraminidase inhibitor oseltamivir in experimental human influenza: randomized controlled trials for prevention and treatment. JAMA 282: 1240-1246. PMID: 10517426
13. Jackson GG DH, Spiesman IG, Boand AV (1958) Transmission of the common cold to volunteers under controlled conditions. I. The common cold as a clinical entity. AMA Archives of Internal Medicine 101: 267-278. PMID: 13497324
14. Benjamini Y, Hochberg Y (1995) Controlling the false discovery rate: a practical and powerful approach to multiple testing. Journal of the Royal Statistical Society Series B 57: 289-300.
15. Beauchemin CA, McSharry JJ, Drusano GL, Nguyen JT, Went GT, et al. (2008) Modeling amantadine treatment of influenza A virus in vitro. J Theor Biol 254: 439-451. doi:10.1016/j.jtbi.2008.05.031 PMID: 18653201
16. Virlogeux V, Fang VJ, Wu JT, Ho LM, Peiris JS, et al. (2015) Incubation Period Duration and Severity of Clinical Disease Following Severe Acute Respiratory Syndrome Coronavirus Infection. Epidemiology.
17. Hay AJ, Wolstenholme AJ, Skehel JJ, Smith MH (1985) The molecular basis of the specific anti-influenza action of amantadine. The EMBO Journal 4: 3021-3024. PMID: 4065098
18. Palese P, Compans RW (1976) Inhibition of Influenza Virus Replication in Tissue Culture by 2-deoxy-2,3-dehydro-N-trifluoroacetylneuraminic acid (FANA): Mechanism of Action. Journal of General Virology 33: 159-163. PMID: 978183
19. Ekiert DC, Wilson IA (2012) Broadly neutralizing antibodies against influenza virus and prospects for universal therapies. Curr Opin Virol 2: 134-141. doi:10.1016/j.coviro.2012.02.005 PMID: 22482710
20. Kamal MA, Gieschke R, Lemenuel-Diot A, Beauchemin CA, Smith PF, et al. (2015) A Drug-Disease Model Describing the Effect of Oseltamivir Neuraminidase Inhibition on Influenza Virus Progression. Antimicrob Agents Chemother 59: 5388-5395. doi:10.1128/AAC.00069-15 PMID: 26100715
21. Miao H, Xia X, Perelson AS, Wu H (2011) On identifiability of nonlinear ODE models and application in viral dynamics. SIAM Rev Soc Ind Appl Math 53: 3-39. PMID: 21785515
22. Cowling BJ, Chan KH, Fang VJ, Lau LLH, So HC, et al. (2010) Comparative Epidemiology of Pandemic and Seasonal Influenza A in Households. The New England Journal of Medicine 362: 2175-2184. doi:10.1056/NEJMoa0911530 PMID: 20558368
23. Frank AL, Couch RB, Griffis CA, Baxter BD (1979) Comparison of Different Tissue Cultures for Isolation and Quantitation of Influenza and Parainfluenza Viruses. Journal of Clinical Microbiology 10: 32-36. PMID: 227920
24. Atmar RL, Baxter BD, Dominguez EA, Taber LH (1996) Comparison of Reverse Transcription-PCR with Tissue Culture and Other Rapid Diagnostic Assays for Detection of Type A Influenza Virus. Journal of Clinical Microbiology 34: 2604-2606. PMID: 8880531
25. Möhler L, Flockerzi D, Sann H, Reichl U (2005) Mathematical model of influenza A virus production in large-scale microcarrier culture. Biotechnology and Bioengineering 90: 46-58. PMID: 15736163
26. Vega-Avila E, Pugsley MK (2011) An overview of colorimetric assay methods used to assess survival or proliferation of mammalian cells. Proceedings of the Western Pharmacology Society 54: 10-14. PMID: 22423572
27. Price GE, Smith H, Sweet C (1997) Differential induction of cytotoxicity and apoptosis by influenza virus strains of differing virulence. Journal of General Virology 78: 2821-2829. PMID: 9367368