Safety of Direct-Acting Antiviral Medications for Hepatitis C

This study will investigate the safety of direct-acting antiviral medications in patients who have a laboratory-confirmed diagnosis of hepatitis C. The intervention group will be those who had a prescription filled for a new antiviral medication after October 10, 2014. The comparison group will be those who have not been treated for hepatitis C. Incidence of the following types of adverse events will be measured: acute or acute-on-chronic or uncertain-cause liver failure (including liver transplant), acute kidney failure, myocardial infarction, liver cancer, multiple organ failure, stroke, and death. For liver failure in particular, a chart review will be conducted to validate the outcome. Initial analysis will use a Poisson model that includes exposure time (time to adverse event or censoring event). Other analytic methods may be employed to address channeling by indication.

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