jofinЖурнал инфектологииJournal Infectology2072-6732IPO “АIDSSPbR"10.22625/2072-6732-2010-2-1-66-74jofin-287Research ArticleДискуссионные статьиDiscussion ArticlesУРОКИ ИССЛЕДОВАНИЯ IDEALThe expirience of IDEALБурневичЭ. З.BurnevichE. Z.

доцент кафедры нефрологии, внутренних и профессиональных болезней им. Е.М. Тареева, Московская медицинская академия им. И.М. Сеченова, тел.: +7-903-661-13-98

eduard.z.burnevich@mtu-net.ruМосковская медицинская академия им. И.М. Сеченова, МоскваРоссияMoscow Medical Academy by I.M. Setchenov, MoscowRussian Federation201023092014216674Copyright © Бурневич Э.З., 20142014Бурневич Э.З.Burnevich E.Z.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://journal.niidi.ru/jofin/article/view/287

Современным стандартом лечения хронического гепатита С (ХГС) является комбинация пегилированного ИФН-α (Пег-ИФН-α) и рибавирина [1–3], в том числе в Российской Федерации [4], обеспечивающая формирование стойкого вирусологического ответа (СВО) у 42–48% больных ХГС при инфицировании 1 генотипом HCV [5, 6]. Для определения наиболее эффективной ПВТ в этой категории больных было предпринято исследование IDEAL (Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy) – рандомизированное, в параллельных группах, мультицентровое клиническое исследование IIIb фазы по оценке эффективности и безопасности комбинации Пег-ИФН-α2b в двух дозировках (1,5 и 1,0 мкг/кг/нед) с рибавирином, назначаемом по массе тела (800–1400 мг/сут) в сравнении с Пег-ИФН-α2а 180 мкг/нед в комбинации с рибавирином 1000–1200 мг/сут у больных ХГС, инфицированных HCV 1 генотипа.

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.

хронический гепатит Слечениепегилированный интерферон-αрибавиринchronic hepatitis Ctreatmentpegylated interferon-αribavirinReferencesNational Institutes of Health Consensus Development Conference Statement: Management of hepatitis C: 2002-June 10-12, 2002. Hepatology. – 2002. 36(Suppl. 1). – S3–S20.National Institutes of Health Consensus Development Conference Statement: Management of hepatitis C: 2002-June 10-12, 2002. Hepatology. – 2002. 36(Suppl. 1). – S3–S20.Strader, D.B. Diagnosis, management, and treatment of hepatitis C / D.B. Strader [et al] // Hepatology. – 2004. – 39. – P. 1147–1171.Strader, D.B. Diagnosis, management, and treatment of hepatitis C / D.B. Strader [et al] // Hepatology. – 2004. – 39. – P. 1147–1171.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.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.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».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».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.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.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.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.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.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.http://www.fda.gov/cder/foi/appletter/2001/pegsche 080701L.htmhttp://www.fda.gov/cder/foi/appletter/2001/pegsche 080701L.htmJacobson, 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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.http://www.hivandhepatitis.com/hep_c/news/2007/082207_ideal.htmlhttp://www.hivandhepatitis.com/hep_c/news/2007/082207_ideal.htmlhttp://www.roche.ru/content/ru/section-2006-03-28-22-09-12/publication-2008-01-31-10-00-55.htmlhttp://www.roche.ru/content/ru/section-2006-03-28-22-09-12/publication-2008-01-31-10-00-55.htmlСюткин, В.Е. Так ли идеален «IDEAL»? / В.Е. Сюткин //Инфекционные болезни. – 2008. – 2. – Р. 100–103.Сюткин, В.Е. Так ли идеален «IDEAL»? / В.Е. Сюткин //Инфекционные болезни. – 2008. – 2. – Р. 100–103.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.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.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.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.

The authors declare that there are no conflicts of interest present.