HCV DAAs: no evidence for serious liver events

  • McGlynn EA & al.
  • JAMA Netw Open
  • 5 Jun 2019

  • International Clinical Digest
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

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.

Please confirm your acceptance

To gain full access to GPnotebook please confirm:

By submitting here you confirm that you have accepted Terms of Use and Privacy Policy of GPnotebook.

Submit