- A large cohort study alleviates concerns regarding the safety of HCV direct-acting antivirals (DAAs) stemming from FDA Adverse Events Reporting system data.
- DAA exposure was tied to lower odds of death, multiple organ failure, hepatic decompensation, acute-on-chronic liver failure (ACLF), and arrhythmia.
Why this matters
- FDA previously issued a warning regarding DAA-related risks for liver failure and severe liver injury based on reports.
- Report limitations included lack of detailed patient history and misclassification of natural HCV complications.
- Data for 33,808 treatment-naive HCV+ individuals (61.8% men; mean age, 57.2±10.6 years) in 3 National Patient-Centered Clinical Research Network (PCORnet) systems during 2012-2017; 45.9% received DAAs.
- Funding: PCOR Institute.
- Unadjusted analysis: 8 adverse event rate ratios (RR) were
- In adjusted analysis, DAAs yielded lower odds of:
- Death: aOR=0.42; 95% CI, 0.30-0.59,
- Multiorgan failure: aOR=0.67; 95% CI, 0.49-0.90,
- Hepatic decompensation: aOR=0.61; 95% CI, 0.49-0.76,
- ACLF: aOR=0.71; 95% CI, 0.56-0.91, and
- Arrhythmia: aOR=0.47; 95% CI, 0.25-0.88.
- Hospitalizations and emergency department visits also favored the DAA group.
- Retrospective design.
- Reliance on claims data.