MedicalResearch.com Interview with:
Elizabeth A. McGlynn, PhD
Vice President for Kaiser Permanente Research
Kaiser Permanente Center for Effectiveness and Safety
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: A report from the Institute for Safe Medication Practices based on FDA data and observations from a Kaiser Permanente physician leader raised questions about whether direct acting antiviral medications for the treatment of Hepatitis C posed any significant safety risks for patients. Since the decision to take medications requires making tradeoffs between benefits (which had been clearly established in clinical trials) and risks (which are often harder to ascertain until drugs are in widespread use in the real world) we decided this was an important question to pursue. We found no evidence of increased risks of significant side effects associated with taking these drugs. In this cohort study of 33,808 patients in three large health systems we found lower adjusted odds of experiencing the following adverse events: death, multiple organ failure, hepatic decompensation, acute-on-chronic liver event, and arrhythmia.
MedicalResearch.com: What should readers take away from your report?
Response: Direct acting antiviral medications were not associated with higher risks of adverse liver, cardiovascular, or kidney related events. They were also not associated with higher rates of hospitalization or emergency department use.
MedicalResearch.com: Is there anything else you would like to add?
Response: One of the secondary purposes of this study was to demonstrate the utility of using real-world data for investigating questions related to drug safety. We were able to do this study relatively quickly and provide some reassurance to clinicians and patients because of the high quality data maintained by the participating health systems. As we look to find a balance between speed and safety in the process of approving new drugs, these types of studies play an important role.
McGlynn EA, Adams JL, Kramer J, et al. Assessing the Safety of Direct-Acting Antiviral Agents for Hepatitis C. JAMA Netw Open. Published online June 07, 20192(6):e194765. doi:10.1001/jamanetworkopen.2019.4765
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