Clinical immunogenic profile of Heberon® alpha

Introduction: Interferons are a heterogeneous family of natural proteins described as agents capable of interfering with viral replication. The production of interferon as a drug began by recombinant DNA in microorganisms since the seventies of the 20 th century. Patients who receive interferon products, the result of genetic engineering, develop neutralizing antibodies for the biological activity of this protein and, therefore, are able to prevent or reverse treatment response. Objectives: To analyze the immunogenicity profile of recombinant human interferon alfa-2b produced in the Center for Genetic Engineering and Biotechnology in Havana, Cuba. Methods: The analysis of the immunogenicity profile of recombinant human interferon alfa-2b was performed in 952 patients from 23 clinical studies, performed with the lyophilized formulation with albumin. The experimental design was started with a “sandwich” type enzyme-linked immunosorbent assay (ELISA) for detecting the presence of the antibody and its confirmation of specificity (IFN alpha-2b/sample/conjugate protein A-peroxidase), and then we investigated, through a biological assay in cells, the ability of the antibody to neutralize the antiviral activity of interferon alpha. Results: The development of antibodies with neutralizing capacity for the antiviral action occurred in 22 patients, representing 2.3% of those evaluated. This percentage of immunogenicity of recombinant human interferon alfa-2b, produced by the Center for Genetic Engineering and Biotechnology, is below the reported 2.7% for recombinant human interferon alfa-2b and 25.7% for interferon alfa-2a in the international market. Conclusions: Recombinant human interferon alfa-2b produced at the Center for Genetic Engineering and Biotechnology can be used as a safe drug for the treatment of all diseases included in its therapeutic indications.