Effektivnost' tsepeginterferona al'fa-2b v terapii khronicheskogo gepatita S


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Abstract

The article presents the results of a comparative evaluation of the efficacy and safety of cepeginterferon alfa-2b (Algeron) and peginterferon alfa-2b in combination with ribavirin as a part of combination therapy of chronic hepatitis C (CHC), followed by the definition of a therapeutic dose of Algeron. The study included 150 treatment-naive adult patients (all genotypes) with chronic hepatitis C. Patients were randomized into 3 treatment groups. Patients in the two main groups have received Algeron at a dose of 1,5 or 2,0 mg/kg/week in combination with ribavirin (800-1,400 mg/day), in the active control group - peginterferon alfa-2b 1,5 yg/kg/week in combination with ribavirin (800-1,400 mg/day). Comparative analysis of the frequency of achievement of virological response at 4 th and 12 th weeks of therapy, end-of-treatment response, sustained virological response (SVR), and biochemical response in the groups did not show statistically significant differences between the groups. The frequency of SVR in patients treated with Algeron was 75 %, in the comparison group - 68 % (p > 0,05). In patients infected with 2 or 3 HCV genotypes, treated with Algeron, SVR was observed in 83 % of cases, in the comparison group - in 81,8 %. Among patients with genotype 1 HCV, SVR was observed in 67,9 and 57,1 % of cases, respectively (p > 0,05). The safety profile of Algeron was similar to that of peginterferon alfa-2b. Complex assessment of efficacy and safety allowed to make the conclusion about the optimal therapeutic dose of Algeron, equal to 1,5 yg/kg/week. The results of study provide evidence of the high efficacy and safety of Algeron for suppression of HCV replication and make it possible to recommend Algeron 1,5 yg/kg weekly in combination with ribavirin for the treatment of chronic hepatitis C in treatment-naive patients for 24-48 weeks depending on the HCV genotype.

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