HCV: GLE/PIB achieves 99.3% clearance in real-world Italian study

  • D'Ambrosio R & al.
  • J Hepatol
  • 22 Nov 2018

  • curated by Yael Waknine
  • Univadis Clinical Summaries
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Takeaway

  • Glecaprevir/pibrentasvir (GLE/PIB) demonstrated excellent safety and over 99% efficacy in the first real-world study of patients with HCV treated according to international guidelines.

Why this matters

  • Findings are in line with that reported in registration trials.

Study design

  • Italian study of 723 consecutive patients (50% male; median age, 58 years) receiving GLE/PIB for HCV within the NAVIGATORE-Lombardia Network.
  • 83% had F0-2 fibrosis (F3, 9%; F4, 8%), and 15% were interferon-experienced.
  • Primary endpoint: sustained virologic response at 12 weeks posttherapy (SVR12).
  • Funding: MSD, AbbVie, Gilead.

Key results

  • HCV genotypes (GT) included GT1 (49%), GT2 (28%), GT3 (10%), and GT4 (13%); mean baseline HCV-RNA was 1,063,109 IU/mL.
  • 89% of patients received an 8-week regimen (12 weeks, 11%; 16 weeks, 1%).
  • Intent-to-treat and per-protocol (PP; n=685) SVR12 were 94% and 99.3%, respectively.
  • PP SVR12 was:
    • High with 8-week (99.2%) and 12-16-week course (100%).
    • Lower in males (98.5% vs 100%; P=.027), independent of duration.
    • Lower with an 8-week course for GT3 (96.0% vs non-GT3, 99.5%; P=.046).
  • SVR12 was independent of treatment duration, fibrosis stage, baseline HCV-RNA, HIV coinfection, kidney impairment, and viral kinetics.
  • 8.3% of patients reported ≥1 adverse event.
  • 5 patients with GT2/3 relapsed.

Limitations

  • Retrospective design.
  • Low cirrhosis prevalence.

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