First dose response of treatment of three formulations of interferon alpha in patients using limited sampling strategy

ABSTRACT

The study was conducted to observe the comparative response of three commercially formulations of interferon alpha 2b in three groups of patients with chronic hepatitis C. The objective was to see best response after first dose of interferon Alfa 2b. This was a quasi - experimental study in which patients of both sexes between ages 20 -49 were randomly allocated to receive three different formulations of interferon alpha 2b in three groups, I, II, and III, after giving them first dose of three million units of interferon alpha 2b subcutaneously. Sixty patients were selected in three groups according to the formulation injected. Blood samples were collected at 00, 08, 20 hours according to limiting sampling strategy. All samples were analyzed by ELISA. The response of serum drug level was different between three groups. Statistically significance differences were observed between group I and II, and group I and III, based on ANOVAs and t-test. Comparison between three groups was significant. Almost all subjects [98%] reported typical mild interferon side effects [flu - like symptoms, headache]. Different formulations have variable response of serum drug level