The results of open-label study evaluating the efficacy and safety of the drug Alfapeg® (recombinant human peginterferon alfa-2b) in adults with chronic hepatitis C in the complex therapy (accordingly the limited program)

Abstract

The paper presents the study results of the domestic human recombinant peginterferon alfa-2b – Alfapeg® application in adult patients with chronic hepatitis C in the complex therapy with ribavirin. It provides the information on compliance with ICH GCP and ethics of the conducted study. The methods of research used in the study are characterized in details. A scheme design, procedures and phases of the study are presented. The detailed results show the eff ectiveness of the drug during the trial in patients with no-1-genotype HCV, the assessment of total tolerability, including the frequency of treatment cessation, dose reduction, adverse reactions/events. During the analysis we valuated the biochemical and whole-blood parameters. On the basis of the conducted tests, the conclusion about satisfactory and fi ne tolerability of the studied drug, its high compliance due to suitable application and high antiviral activity, grat effi ciacy and safety in adult patients with chronic hepatitis C is made.