Comparing adverse effects of Hepatitis C drugs using FAERS data

Abstract

Hepatitis C is a chronic infection that affects more than 100 million people in the world. In the United States, hepatitis C is the number one cause of liver cancer and the most common indication for liver transplantation. Recent advance in hepatitis C research have developed new drugs as a cure for hepatitis C. However, concerns have also been raised over safety of these new hepatitis C drugs. In this study, we presented a statistical procedure to compare the difference in adverse events among multiple hepatitis C drugs using data from the US Food and Drug Administration Adverse Event Reporting System. We reported the identified difference in adverse event rates among users of different hepatitis C drugs and estimated the difference attributable to different distributions in age and gender across groups of drug users. Moreover, the proposed procedure is a general pipeline that can be used to test and visualize difference of adverse events among multiple drugs to support regulatory decision-makings.