HCV: GLE/PIB is 93% effective in active drug users

  • Foster GR & al.
  • Drug Alcohol Depend
  • 24 Nov 2018

  • curated by Yael Waknine
  • Clinical Essentials
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Takeaway

  • HCV treatment with glecaprevir/pibrentasvir (GLE/PIB; Mavyret) is 93% effective among active drug users and 97% effective among former drug users.

Why this matters

  • Treatment of people who use drugs (PWUD) remains suboptimal because of concerns about adherence, efficacy, and reinfection.

Study design

  • Pooled data from ENDURANCE 1-3 and EXPEDITION 1-4 evaluating 8/12 weeks of GLE/PIB in 1819 patients with HCV genotypes 1-6.
  • Treatment-experienced and -naive patients with/without cirrhosis were included.  
  • Categories:
    • Recent PWUD: (5%: injection drug use [IDU] ≤12 months ago, positive urine drug screen [UDS] and/or drug-related event).
    • Former PWUD: (34%: IDU >12 months ago, negative UDS).
    • Non-PWUD: (61%).
  • Funding: AbbVie.

Key results

  • HCV-3 frequency was higher in recent/former PWUD than non-PWUD (40% vs 13%).
  • Treatment adherence/completion rates, ≥96% across groups.
  • Sustained viral response at 12 weeks posttherapy (SVR12) rate was lower in recent and former PWUD vs non-PWUD (93% and 97% vs >99%; both P<.0001>
  • Modified intent-to-treat (mITT) SVR12 rates were 99%, 99%, and >99%, respectively, after excluding nonresponses unrelated to failure.
  • Virologic failure rates, ≤1.5% across groups.
  • No HCV reinfections reported in recent PWID.
  • Rate of serious adverse events, or adverse events leading to discontinuation, ≤1%.

Limitations

  • Enrollment bias.
  • Proportion of injection vs other drug use not captured.

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