Possibilities of using cepeginterferon alpha-2b in double (cepeginterferon alfa-2b and ribavirin) and triple (simeprevir, cepeginterferon alpha-2b, and ribavirin) antiviral therapy regimens for chronic hepatitis C. A review of clinical trials and experience of everyday clinical practice

Abstract

Since the incidence of chronic hepatitis C (CHC) increases steadily, the priority of national health care is to provide antiviral therapy (AVT) for the maximum number of patients infected with hepatitis C virus (HCV). The regimens including pegylated interferons (PEG-IFN) are still in demand in the Russian Federation. A number of clinical trials have been conducted to evaluate the efficacy and safety of cepeginterferon alpha-2b (cePEG-IFN alpha-2b), an original PEG-IFN-α developed in the Russian Federation. Their results have shown that cePEG-IFN alpha-2b in the two-component AVT regimen has at least no less clinical efficacy than PEG-IFN alpha-2b and PEG-INF alpha-2a in HCV monoinfected and HCV/HIV co-infected patients. The pooled analysis of data has indicated that the use of cePEG-IFN alpha-b in combination with ribavirin allows an average of 80% of the patients with HCV genotypes 2 and 3 and 62% of those with HCV genotype 1 to achieve a sustained virological response (SVR). In clinical practice when the two-component AVT regimen (cePEG-IFN alpha-b and ribavirin) was used in patients with early-stage CHC and mild fibrosis, SVR was recorded in 90.7% of the patients with HCV genotype 2/3 and in 75% of those with HCV genotype 1. The experience in using cePEG-IFN alpha-2b as a component of the three-component AVT regimen (simeprevir, cePEG IFN alfa-2b, and ribavirin) has been published. The observational program manly covered young patients with mild or moderate fibrosis. SVR was observed in 94% of the patients. Another paper describes the experience with the triple AVT therapy (simeprevir, cePEG-IFN alfa-2b, and ribavirin) in 22 patients, the majority of whom had advanced fibrosis. SVR was recorded in 71.4% of those who had completed treatment. Thus, an individual approach and assessment of predictive response factors to two- or three-component AVT regimens including cePEG-IFN alpha 2b can achieve successful treatment outcomes in most patients with CHC, which is, in some cases, more economically sound than interferon-free regimens used as first-line therapy.

References

  1. Global, regional, and national age-sex-specific all-cause and cause-specific mortality for 240 causes of death, 1990—2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;385(9963):117-171. doi: 10.1016/s0140-6736(14)61682-2
  2. Федеральная служба по надзору в сфере защиты прав потребителей и благополучия человека. Инфекционная заболеваемость в Российской Федерации за январь—декабрь 2015 года (по данным формы №1 «Сведения об инфекционных и паразитарных заболеваниях»). Ссылка активна на 05.09.2016. Доступно по: http://rospotrebnadzor.ru/activities/statistical-materials/statictic_details.php?ELEMENT_ID=5525
  3. Клинические рекомендации: Хронический гепатит С у ВИЧ-инфицированных взрослых. ННОИ; 2015
  4. Simmons B, Saleem J, Heath K, Cooke G, Hill A. Long-Term Treatment Outcomes of Patients Infected With Hepatitis C Virus: A Systematic Review and Meta-analysis of the Survival Benefit of Achieving a Sustained Virological Response. Clin Infect Dis. 2015;61(5):730-740. doi: 10.1093/cid/civ396
  5. EASL Recommendations on Treatment of Hepatitis C 2015. JHepatol. 2015;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025
  6. Buonfiglioli F. Abstract LBP506. The International Liver Congress. Barcelona, Spain. 2016. J Hepatol. 2016;64(1):ii. doi: 10.1016/s0168-8278(15)00686-8
  7. Ющук Н.Д., Знойко О.О., Дудина К.Р. и соавт. Социально-экономическое бремя гепатита С: методология оценки и трудности расчета в Российской Федерации. Ссылка активна на 05.09.16. Доступно по: http://www.healtheconomics.ru/item/14159-sotsialno-ekonomicheskoe-bremya-gepatita-s-metodologiya-otsenki-i-trudnosti-rascheta-v-rossijskoj-federatsii
  8. Маевская М.В., Знойко О.О., Климова Е.А. Лечение больных хроническим гепатитом С препаратом цепэгинтерферон альфа-2b в сочетании с рибавирином (Итоговые результаты рандомизированного сравнительного клинического исследования). РЖГГК. 2014;2(24):53-64.
  9. Ссылка активна на 05.09.16. https://clinicaltrials.gov/ct2/show/NCT01889433?term=NCT01889433&rank=1
  10. Нагимова Ф.И., Рассохин В.В., Линькова Ю.Н. и др. Цепэгинтерферон альфа-2b в терапии хронического гепатита С у ВИЧ инфицированных пациентов (итоговые результаты многоцентрового рандомизированного клинического исследования. Инфекционные болезни. 2016;14(1):5-13. doi: 10.20953/1729-9225-2016-1-5-13
  11. Блохина Н.П., Нурмухаметова Е.А., Русанова М.Г. и др. Эффективность и безопасность применения цепэгинтерферона альфа 2b в составе двойной (цепэгинтерферон альфа 2b и рибавирин) и тройной (симепревир, цепэгинтерферон альфа 2b и рибавирин) схемы противовирусной терапии у пациентов с хроническим гепатитом С. Опыт реальной клинической практики. Журналинфектологии. 2016;8(2):48-55.
  12. Jacobson I, Dore G, Foster G et al. Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomized, double-blind, placebo-controlled trial. Lancet. 2014;384(9941):403-413. doi: 10.1016/s0140-6736(14)60494-3
  13. Manns M, Marcellin P, Poordad F et al. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2014;384(9941):414-426. doi: 10.1016/s0140-6736(14)60538-9
  14. Знойко О.О. и др. Клинический опыт применения схемы тройной терапии, включающей цепэгинтерферон альфа-2b, симепревир и рибавирин, у пациентов с хроническим гепатитом С генотипа 1. Инфекционные болезни: новости, мнения, обучение. 2016;2:100-109.
  15. Maylin S, Martinot-Peignoux M, Moucari R et al. Eradication of Hepatitis C Virus in Patients Successfully Treated for Chronic Hepatitis C. Gastroenterology. 2008;135(3):821-829. doi: 10.1053/j.gastro.2008.05.044
  16. D’Ambrosio R, Aghemo A, Rumi M et al. A morphometric and immunohistochemical study to assess the benefit of a sustained virological response in hepatitis C virus patients with cirrhosis. Hepatology. 2012;56(2):532-543. doi: 10.1002/hep.25606
  17. Roberts S, Gordon A, McLean C et al. Effect of Sustained Viral Response on Hepatic Venous Pressure Gradient in Hepatitis C0Related Cirrhosis. ClinicalGastroenterol Hepatol. 2007;5(8):932-937. doi: 10.1016/j.cgh.2007.02.022
  18. D’Ambrosio R, Aghemo A, Rumi M et al. The course of esophageal varices in patients with hepatitis C cirrhosis responding to interferon/ribavirin therapy. Antivir Ther. 2011;16(5):677-684. doi: 10.3851/imp1807
  19. Bruno S, Di Marco V, Iavarone M et al. Survival of patients with HCV cirrhosis and sustained virologic response is similar to the general population. J Hepatol. 2016;64(6):1217-1223. doi: 10.1016/j.jhep.2016.01.034
  20. Vezali E, Aghemo A, Lampertico P, Colombo M. Does interferon therapy prevent hepatocellular carcinoma in patients with chronic viral hepatitis?. Clin Res Hepatol Gastroenterol. 2011;35(6-7):455-464. doi: 10.1016/j.clinre.2011.02.008
  21. Toyoda H, Kumada T, Tada T et al. Risk factors of hepatocellular carcinoma development in non-cirrhotic patients with sustained virologic response for chronic hepatitis C virus infection. J Gastroenterol Hepatol. 2015;30(7):1183-1189. doi: 10.1111/jgh.12915

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