Scientific rationale and study design of the individualized dosing efficacy vs flat dosing to assess optimal pegylated interferon therapy (IDEAL) trial: Determining optimal dosing in patients with genotype 1 chronic hepatitis C

Journal of Viral Hepatitis

Volumn 15, Issue 7, 2008, Pages 475-481

  McHutchison, J ^a   Sulkowski, M ^b  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Chronic hepatitis C; Genotype 1; Hepatitis C virus; Pegylated interferon alfa; Ribavirin; United States

Indexed keywords

ALPHA INTERFERON; PEGINTERFERON ALPHA2A; PEGINTERFERON ALPHA2B; RIBAVIRIN; VIRUS RNA;

ANEMIA; ARTICLE; CLINICAL TRIAL; COMPARATIVE STUDY; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG SAFETY; DRUG WITHDRAWAL; GENOTYPE; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; METHODOLOGY; PRIORITY JOURNAL; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; VIROLOGY;

ANTIVIRAL AGENTS; DESIGNER DRUGS; DOSE-RESPONSE RELATIONSHIP, DRUG; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; INTERFERON ALFA-2A; POLYETHYLENE GLYCOLS; RESEARCH DESIGN; RIBAVIRIN;

EID: 44849097562     PISSN: 13520504     EISSN: 13652893     Source Type: Journal    
DOI: 10.1111/j.1365-2893.2008.00973.x     Document Type: Article

References (19)

1. World Health Organization. Hepatitis C. World Health Organization: 13. Available at: http://www.who.int/mediacentre/factsheets/fs164/en/, accessed April 12, 2006.
2. Manns MP, McHutchison JG, Gordon SC et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001 358 : 958 965.
3. Fried MW, Shiffman ML, Reddy KR et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002 347 : 975 982.
4. Lindsay KL, Trepo C, Heintges T et al. A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C. Hepatology 2001 34 : 395 403.
5. McHutchison JG, Dev A, Patel K. A comparison of landmark trials for the current treatment of hepatitis C and the need for a head-to-head comparison. Hepatol Rev 2004 1 : 49 56.
6. Davis GL, Wong JB, McHutchison JG, Manns MP, Harvey J, Albrecht J. Early virologic response to treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C. Hepatology 2003 38 : 645 652.
7. European Medicines Agency. Pegasys European Public Assessment Report. Scientific Discussion. European Medicines Agency web site available at: http://www.emea.europa.int/humandocs/Humans/EPAR/pegasys/pegasys.htm, accessed July 12, 2006.
8. ® Combination Therapy for Chronic Hepatitis C: Retrospective Analysis of Data From Schering-Plough Protocol No. C/I98-580, 2003 : 1 88.
9. ® in Combination With Copegus™ Treatment of Chronic Hepatitis C. US Food and Drug Administration web site available at http://www.fda.gov/ohrms/dockets/ac/ 02/briefing/3909b1.htm, accessed December 13, 2006.
10. Jacobson IM, Brown RS Jr, Freilich B et al. Peginterferon alfa-2b and weight-based versus flat dosing of ribavirin in patients with chronic hepatitis C: a randomized trial. Hepatology 2007 46 : 771 781.
11. ® (Ribavirin, USP) Capsules and Oral Solution (Prescribing Information). Kenilworth, NJ, USA : Schering Corporation, 2004.
12. Grace MJ, Lee S, Bradshaw S et al. Site of pegylation and polyethylene glycol molecule size attenuate interferon-alfa antiviral and antiproliferative activities through the JAK/STAT signaling pathway. J Biol Chem 2005 280 : 6327 2336.
13. Bordens R, Xie L, Wylie D, Grace M, Schreiber G. Site and size of interferon pegylation alters affinity to the IFNAR2-extracellular domain. Eur Cytokine Netw 2007 17 (Suppl. abstract 06-09/P.
14. Bruno R, Sacchi P, Maiocchi L et al. Area-under-the-curve for peginterferon alfa-2a and peginterferon alfa-2b is not related to body weight in treatment-naive patients with chronic hepatitis C. Antivir Ther 2005 10 : 201 205.
15. Almasio PL, Cavalletto L, Chemello L et al. Efficacy of peginterferon alfa-2b (PEGintron) vs. peginterferon alfa-2a (Pegasys) plus ribavirin regimens in treatment-naive chronic HCV patients: a meta-analysis (abstract). Hepatology 2005 42 (Suppl. 1 671A.
16. Sporea I, Danila M, Sirli R, Popescu A, Laza A, Baditoiu L. Comparative study concerning the efficacy of Peg-IFN alfa-2a versus Peg-IFN alfa-2b on the early virological response (EVR) in patients with chronic viral C hepatitis. J Gastrointestin Liver Dis 2006 15 : 125 130.
17. Luise S, Bernardinello E, Cavalletto L et al. Kinetic of virological response during PEG-IFNs in chronic hepatitis C (abstract). J Hepatol 2004 40 (Suppl. 1 140.
18. Poordad F, Tran T, Ayoub W, Patel Y, Chan L. A comparison of sustained virologic resonse in patients with chronic hepatitis C virus treated with peginterferon alfa-2a versus peginterferon alfa-2b, plus ribavirin (abstract). Am J Gastroenterol 2005 100 (Suppl. 9 S130.
19. Di Bisceglie AM, Ghalib RH, Hamzeh FM, Rustgi VK. Early virologic response after peginterferon alfa-2a plus ribavirin or peginterferon alfa-2b plus ribavirin treatment in patients with chronic hepatitis C. J Viral Hepat 2007 14 (10 721 729.