Bioavailability of Interferon Alfa 2b in Chronic Hepatitis C Patients by Using Limited Sampling Strategy

Rukhsana Sher, Tehseen Asghar, Rana, Mohammad Sohail, Arshad Kamal Butt, Col Hafeezuddin, Abdul Hameed Khan
2009 unpublished
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
more » ... s 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.