Preliminary results of open comparative randomized study PHG-M3/P01-09 «ORION» on application of «Phosphogliv» in combined therapy of chronic hepatitis C
Abstract
Aim of investigation. To estimate efficacy and safety of «Phosphogliv» in combined therapy of patients with chronic hepatitis C (CHC), that received no previous antiviral treatment.
Preliminary results. Four-week application of phosphogliv (glycirrhizinic acid) in a dose of 2,5 g iv 5 times per week, previous to onset of antiviral therapy (AVT) by standard interferon α-2b/ribavirin in the mode corresponding to revealed genotype, has resulted in statistically significant decrease of serum transaminases: alanineaminotransferase (ALT), asparaginaminotransferase (AST) and gamma-glutamyltranspeptidase (GGT) activity in comparison to the group of the patients, that received only standard interferon α-2b/ribavirin (р <002, Wilcoxon T) to the 4-th week of treatment. At this stage of AVT statistically significant decrease of viral load level in comparison to reference value was observed in both groups. Analysis of cases with rapid virologic response (absence of HCV RNA or its level less than 750 copies/ml) within 4 wks of treatment has shown, that only the group phosphogliv/standard interferon α-2b/ribavirin included 3 such cases and that was especially important – all had the 1-st virus genotype. This fact assumes, that phosphogliv can enhance efficacy of standard treatment as adjuvant to antiviral therapy. In both groups usual side effects of AVT developed, which did not require change of treatment mode.
Conclusion. Final results of the presented study help to estimate the role of rapid virologic response in the treatment of CHC by standard interferon/ribavirin, to define group of patients for which this mode of therapy is associated with favorable prognosis, and to determine the role of phosphogliv as adjuvant agent in antiviral treatment programs.
About the Author
M. V. MayevskayaRussian Federation
References
1. Ивашкин В.Т., Морозова М.А., Маевская М.В. и др. Препараты растительного происхождения в лечении гепатита С // Рос. журн. гастроэнтерол. гепатол. колопроктол. – 2009. – Т. 19, № 3. – С. 70–75.
2. Сторожаков Г.И., Байкова И.Е., Никитин И.Г. и др. Теоретические и практические аспекты применения глицирризина // Клин. перспективы гастроэнтерол. гепатол. 2003. – № 1. – С. 35–39.
3. Ющук Н.Д., Климова Е.А., Знойко О.О. и др. Протокол диагностики и лечения больных вирусными гепатитами В и С // Рос. журн. гастроэнтерол. гепатол. колопроктол. – 2010. – Т. 20, № 6. – С. 4–60.
4. Craxì A. et al. EASL Clinical Practice Guidelines: Management of hepatitis C virus infection // J. Hepatol. – 2011. – Vol. 55. – P. 245–264.
5. http://www.worldgastroenterology.org/
6. Kumada H. Long-term treatment of chronic hepatitis C with glycyrrhizin [Stronger Neo-Minophagen C (SNMC)] for preventing liver cirrhosis and hepatocellular carcinoma // Oncology. – 2002. – Vol. 62 (suppl. 1). – P. 94–100.
7. Thompson A.J., Muir A.J., Sulkowski M.S. et al. Interleukin-28B polymorphism improves viral kinetics and is the strongest pretreatment predictor of sustained virologic response in genotype 1 hepatitis C virus // Gastroenterology. – 2010. – Vol. 139, N 1. – P. 120–9.e18.
8. Wong W., Terrault N. Update on chronic hepatitis C // Clin. Gastroenterol. Hepatol. – 2005. – Vol. 3, N 6. – P. 507–520.
Review
For citations:
Mayevskaya M.V. Preliminary results of open comparative randomized study PHG-M3/P01-09 «ORION» on application of «Phosphogliv» in combined therapy of chronic hepatitis C. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2011;21(4):52-59. (In Russ.)