HCV DAAs: no evidence for serious liver events

  • McGlynn EA & al.
  • JAMA Netw Open
  • 05.06.2019

  • von Yael Waknine
  • Clinical Essentials
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Takeaway

  • 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.

Study design

  • 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.  

Key results

  • 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.

Limitations

  • Retrospective design.
  • Reliance on claims data.