HCV: GLE/PIB achieves 96% clearance rate in OST-treated patients

  • Grebely J & al.
  • Int J Drug Policy
  • 5 Feb 2019

  • curated by Yael Waknine
  • Clinical Essentials
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Takeaway

  • Glecaprevir/pibrentasvir (GLE/PIB; Mavyret) is highly effective for clearing HCV genotypes (GT) 1-6 in patients receiving opioid substitution therapy (OST).

Why this matters

  • This pooled analysis of 8 clinical trials showed similarly high rates of treatment adherence and completion in OST and non-OST patients.

Study design

  • Pooled data for 2256 patients (OST, 157 [7%]) with GT 1-6 receiving GLE/PIB in SURVEYOR-1/2; ENDURANCE-1/2/3/4; EXPEDITION-1/4.
  • Primary endpoint: sustained virologic response at 12 weeks posttherapy (SVR12).
  • Funding: AbbVie.

Key results

  • OST-treated patients were more commonly younger (mean, 46.8 vs 52.8 years), male (69% vs 54%), white (93% vs 80%), treatment-naive (86% vs 72%), with GT3 (60% vs 26%), and with a history of depression/bipolar disorder (43% vs 19%).
  • OST and non-OST patients had high adherence (98%, 99%) and completion rates (98%, 99%).
  • Intent-to-treat SVR12 for OST and non-OST patients was 96.2% and 97.9%, respectively.
    • Rates were similar for GT1 (98% vs 99%), GT2 (100% vs 99%), GT3 (both 95%), GT4 (100% vs 98%), GT6 (100% vs 98%).
  • Per-protocol SVR12 for OST and non-OST patients was 99.3% and 98.9%, respectively.
  • No HCV reinfections through 12-week follow-up.

Limitations

  • Post hoc analysis.
  • Exclusion of patients with drug/alcohol use within 6 months of enrollment.
  • On-study use not captured.
  • No long-term follow-up.

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