2017, Number 1
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ABSTRACTSince 1986, the Center for Genetic Engineering and Biotechnology of Havana, Cuba, has produced the recombinant human interferon alpha-2b, marketed as Heberon® Alfa R. The therapeutic use of this product has accumulated a high number of researches carried out in the country’s public health network. For the analysis of its safety profile, 28 years of reports of adverse events were reviewed in 5806 individuals, both children and adults, coming from 147 clinical trials or healthy assistances using the product. This review also contains a safety comparison between lyophilized and liquid formulations. In addition, an analysis of the connection between the occurrence of adverse events and the demographic characteristics of the patients, an analysis of immunogenicity and another on the variation of the thyroid function associated to the use of Heberon® Alfa R were included. Finally, a general analysis of the product’s efficacy based on the number of treated patients and the clinical results obtained are presented. Adverse events were reported in 4864 subjects (84 %). The main adverse events were those corresponding to the flu-like syndrome, with higher frequency in male white patients. Hypothyroidism and immunogenicity behaved lower than similar products in the international pharmaceutical market. Approximately 60 % of the treated patients obtained a relevant therapeutic response and a liquid formulation offered a better benefit/ risk ratio. The extensive clinical information evaluated recognizes a Heberon® Alfa R as a safe and effective drug, 30 years after its first production.
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