- 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.
- 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.
- 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.
- Retrospective design.
- Low cirrhosis prevalence.