Российский журнал гастроэнтерологии, гепатологии, колопроктологии (Nov 2012)
Results of the ORION open comparative randomized trial: evaluation of efficacy of the Russian drugs Altevir and Phosphogliv in combined treatment of chronic hepatitis C
Abstract
Aim of investigation. To estimate efficacy and safety of application of «Phosphogliv»® (glycyrrhizinic acid) within combined therapy of patients with chronic hepatitis C (CHC) who received no previous antiviral therapy (AVT).Material and methods. Overall 80 out-patients over 18 years of age with the diagnosis of CHC confirmed by laboratory and instrumental methods have been included in original study. Patients in group A (n=40) prior to onset of AVT received phosphogliv intravenously (iv) 2,5 g 5 infusions per week for 4 wks, in the subsequent 4 wks it was applied iv on a background of AVT by Altevir® and ribavirin. Altevir was injected subcutaneously in a dose of 3 million IU 3 times per week in combination to ribavirin dosed according to body weight. After the termination of phosphogliv infusions oral intake of phosphogliv forte of 1 capsule tid along with ongoing AVT was prescribed to patients. Total duration of treatment by studied drug for the 1-st HCV genotype patients was 52 wks, with 2nd and 3rd genotypes – 28 wks. The patient of the group B received no phosphogliv treatment, they received only standard AVT according to revealed virus genotype.Results. Intravenous injection of phosphogliv, prior to beginning of standard AVT, resulted in essential decrease of serum transaminase activity in group A, that was statistically significantly different from initial level. In group B patients with same HCV genotype no dynamics of serum transaminases level prior to AVT was found. Significant decrease of histological activity index in patients with 2/3 genotype of CHC in both groups and change of this score in the group, that received standard AVT in combination to phosphogliv was revealed as well, was much more significant in comparison to the group receiving standard treatment alone. Statistically significant differences in dynamics of viral load and frequency of achievement of sustained virologic response in patients with identical HCV genotype between groups A and B was revealed. No difference in adverse events rate of between groups was observed.Conclusions. Efficacy of domestic standard IFN-α altevir in combination to ribavirin in CHC treatment at 2nd and 3rd HCV genotypes, and at 1-st genotype HCV in patients with low viral load as well can be considered as high. Addition of phosphogliv to treatment leads to more rapid improvement of biochemical and histological scores.
