45: The novel PEGylated interferon-alpha (“Algeron”) plus ribavirin for treatment of chronic hepatitis C virus infection: Results from a Phase II Study
Introduction Novel PEG-IFN alpha 2b (“Algeron”) was developed by attaching 20 kDa PEG to the α -amino group of the N-terminal cysteine of IFN. The Phase 1 results demonstrated that “Algeron” has delayed clearance and increased half life compared with unmodified IFN. The doses selected for further studies in HCV-infected patients were 1.5 and 2.0 μg/kg weekly. Methods Multicenter open-label randomized prospective phase II study of efficacy and safety of “Algeron” in comparison with “Peg-Intron” within combination therapy of hepatitis C. 150 treatment-naive patients with genotype 1, 2, and 3 HCV were randomized into 3 groups received subcutaneously: “Algeron” (1.5 and 2.0 μg/kg) and “Peg-Intron” (1.5 μg/kg) weekly in combination with ribavirin 800–1400 mg/day. Results Comparative ITT-analysis of rapid virologic response (RVR) rate (RNA HCV level below the detection limit of 15 IE/mL after 4 weeks of treatment) did not showed any statistically significant differences between the treatment groups. Early virologic response (EVR) rate (RNA HCV level below the detection limit of 15 IE/mL after 12 weeks of treatment) in “Algeron” groups was 94%, in the “Peg-Intron” group – 88%. In patients with HCV genotype 2 and 3, EVR was achieved in 100% of patients in group 1, in 95.7% of patients in group 2, and in 95.5% of patients receiving “Peg-Intron”. In patients with HCV genotype 1, EVR was observed in 88.5% and 92.6% of patients receiving “Algeron” 1.5 and 2.0 μg/kg weekly vs. 82.1% in “Peg-Intron” group. There were no statistically significant differences between groups where patients received “Algeron” in different doses and the reference group, with or without genotype stratification. Conclusions “Algeron” is at least non-inferior to “Peg-Intron” in regard to frequency of RVR and EVR. Overall, adverse events occurring during the treatment with “Algeron” are dose-dependent; however, their frequency is no more than in patients receiving standard doses of “Peg-Intron”.