The expirience of IDEAL
https://doi.org/10.22625/2072-6732-2010-2-1-66-74
Abstract
Combination therapy with pegylated interferon-α and ribavirin is the modern standard of chronic hepatitis C treatment [1-3] in Russian Federation [4]. This particular regimen provides achieving of sustained virological response (SVR) in 42-28% of patient with genotype 1 chronic hepatitis C [5,6]. IDEAL (Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy) study was designed to assess the most optimal and effective antiviral therapy regiment. IDEAL was randomized, in parallel groups, multicenter phase IIIb study to assess efficacy and safety of two combination regiment with pegylated interferon alfa-2b (dosing regimens: 1,5 and 1,0 mcg/kg/week) and ribavirin, administered according to body weight (800–1400 mg/day) compared with pegylated interferon alfa-2a 180 mcg/week in combination with ribavirin 1000–1200 mg/day in genotype 1 chronic hepatitis C patients.
About the Author
E. Z. BurnevichRussian Federation
References
1. National Institutes of Health Consensus Development Conference Statement: Management of hepatitis C: 2002-June 10-12, 2002. Hepatology. – 2002. 36(Suppl. 1). – S3–S20.
2. Strader, D.B. Diagnosis, management, and treatment of hepatitis C / D.B. Strader [et al] // Hepatology. – 2004. – 39. – P. 1147–1171.
3. Dienstag, J.L. American Gastroenterological Association technical review on the management of hepatitis C /J.L. Dienstag, J.G. McHutchison // Gastroenterology. – 2006. – 130. –P. 231–264.
4. Приказ министерства здравоохранения и социального развития Российской Федерации от 23 ноября 2004 г. № 260 «Об утверждении стандарта медицинской помощи больным хроническим гепатитом В, хроническим гепатитом С».
5. Manns, M.P. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial / M.P. Manns [et al.] // Lancet. – 2001. – 358 (9286). – P. 958–965.
6. Fried, M.W. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection / M.W. Fried [et al.] //N. Engl. J. Med. – 2002. – 347 (13). – P. 975–982.
7. Lindsay, K.L. A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C / K.L. Lindsay [et al.] // Hepatology. – 2001. – 34. P. 395–403.
8. http://www.fda.gov/cder/foi/appletter/2001/pegsche 080701L.htm
9. Jacobson, I.M. Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: a randomized trial / I.M. Jacobson [et al.] // Hepatology. – 2007. – 46. – Р. 971–981.
10. Sulkowski, M.S. Final results of the IDEAL (Individualzed Dosing Efficacy versus Flat Dosing to Assess Optimal Pegylated Interferon Therapy) phase IIIb study / M.S. Sulkowski [et al.] // J. Hepatol. – 2008. – 48 (Supl. 2). – A. 991.
11. McHutchison, J.G. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. /J.G. McHutchison [et al.] // N. Engl. J. Med. – 2009. – 361. – Р. 580–593.
12. McCone, J. Sustained virologic response and predictors of response in african american patients in the IDEAL (Individualized Dosing Efficacy Versus Flat Dosing to Assess OptimaL Pegylated Interferon Therapy) phase 3b study /J. McCone [et al.] // Hepatology. – 2008. – 48 (Suppl.). – A. 268.
13. Nyberg, L.M. Predicting the ability to achieve a sustained virologic response in the first 12 weeks: results from the IDEAL study / L.M. Nyberg [et al.] // Hepatology. – 2008. – 48 (Suppl.). – A. 1850.
14. Sulkowski, M. Probability of sustained virologic response is associated with the magnitude of HCV RNA reduction at week 4 of treatment with peginterferon plus ribavirin: results of the IDEAL trial / M. Sulkowski [et al.] // Hepatology. – 2008. – 48 (Suppl.). – A. 1868.
15. Sulkowski, M. Treatment-related anemia but not epoetin use is associated with higher SVR rates among persons treated ith peginterferon/ribavirin: results from the IDEAL study /M. Sulkowski [et al.] // Hepatology. – 2008. – 48 (Suppl.). –A. 1851.
16. Reddy, K.R. Impact of ribavirin dose reductions in hepatitis C virus genotype 1 patients completing peginterferon alfa-2a/ribavirint Treatment / K.R. Reddy [et al.] // Clin. Gastroenterol. Hepatol. – 2007. – 5. – 124–129.
17. McHutchison, J.G. Adherence to combination therapy enhances sustained response in genotype-1-infected patients with chronic hepatitis C / J.G. McHutchison [et al.] //Gastroenterology. – 2002. – 123. – Р. 1061–1069.
18. http://www.hivandhepatitis.com/hep_c/news/2007/082207_ideal.html
19. http://www.roche.ru/content/ru/section-2006-03-28-22-09-12/publication-2008-01-31-10-00-55.html
20. Сюткин, В.Е. Так ли идеален «IDEAL»? / В.Е. Сюткин //Инфекционные болезни. – 2008. – 2. – Р. 100–103.
21. Jensen, D.M. Early identification of HCV genotype 1 patients responding to 24 weeks peginterferon alpha-2a/ribavirin therapy / D.M. Jensen [et al.] // Hepatology. – 2006. – 43. – Р. 954–960.
22. Zeuzem, S. Efficacy of 24 weeks treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C infected with genotype 1 and low pretreatment viremia / S. Zeuzem [et al.] // J.Hepatol. – 2006. – 44. – Р. 97–103.
Review
For citations:
Burnevich E.Z. The expirience of IDEAL. Journal Infectology. 2010;2(1):66-74. (In Russ.) https://doi.org/10.22625/2072-6732-2010-2-1-66-74