Assessing the Safety of Direct-Acting Antiviral Agents for Hepatitis C

Key Points Question Are patients with hepatitis C who receive direct-acting antivirals at increased risk for adverse events compared with those who do not receive these agents? Findings In this cohort study of 33 808 patients in 3 health systems, direct-acting antiviral exposure was associated with lower odds of experiencing the following adverse events: death, multiple organ failure, hepatic decompensation, acute-on-chronic liver event, and arrhythmia. Meaning Concerns about safety risks based on analyses of the US Food and Drug Administration’s Adverse Events Reporting System did not appear to be confirmed, suggesting that dispensed direct-acting antivirals may be safe for patients with hepatitis C.