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
Subject(s)
Humans , Male , Female , Treatment Outcome , Chemistry, Pharmaceutical , Hepatitis C, ChronicABSTRACT
About 5 million people are infected with hepatitis B virus and about 10 million people harbor the hepatitis C virus in Pakistan. Management of chronic hepatitis in Pakistan carries substantial social impact like fear of tolerability of the drug due to its side effects and the most commonly its affordability. Interferon in combination with Ribavirin is used for the treatment of chronic hepatitis C patients. There are about 60 preparations are available in Pakistan imported from different countries with claim of bioavailability more than 90% . Bioavailability of interferon has not been studied yet in Pakistan. This study was designed to find out the first dose bioavailability of the three formulations of interferon alpha 2b which are commonly prescribed by using limited sampling strategy to help the physician to select the drug with maximum bioavailability
Aim and objectives: the study was conducted to see the bioavailability of interferon in three formulations of interferon alpha 2b in patients with chronic hepatitis C patients
Methods: this was a Quasi - experimental study including sixty patients of either gender. These patients were divided into three groups at random after giving them first dose of three million units of interferon alpha 2b subcutaneously. Group 1: Uniferon [Getz Pharma Brand] Group 2: Ceron-alfa [Biocare Pharma] Group 3: Anferon [CCL Pharmaceuticals] Blood samples were collected at 00, 08, 20 hours according to limiting sampling strategy
Results: the bioavailability was found to be 70% , 60% and 55% in group 1, 2, and 3 respectively. The difference was statistically significant [p < 0.5] based on ANOVA and t-test. Almost all patients reported mild interferon side effects [flu-like symptoms, headache]
Conclusions: different formulations have variable bioavailability and there is a strong reason to choose the best drug with maximum bioavailability to give the patient maximum benefit