GLE/PIB safe, highly effective for HCV in elders

  • Foster GR & al.
  • PLoS One
  • 1 Jan 2019

  • curated by Yael Waknine
  • Clinical Essentials
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Takeaway

  • Glecaprevir-pibrentasvir (GLE/PIB; Mavyret) is similarly safe and effective for clearing HCV in patients aged ≥65 years and their younger counterparts.

Why this matters

  • Older age is associated with a greater prevalence of advanced fibrosis and more rapid disease progression, yet elderly patients remain underrepresented in clinical trials.

Study design

  • Pooled data for 2369 treatment-naive and -experienced patients with HCV genotypes 1-6 receiving 8, 12, or 16 weeks of GLE/PIB across 9 phase 2/3 clinical trials.
  • Trials included MAGELLAN-1; SURVEYOR-I, -II; ENDURANCE-1, -2, -3, -4; and EXPEDITION-1, -4.
  • Efficacy endpoint: sustained virologic response at 12 weeks posttreatment (SVR12).
  • Funding: AbbVie funded the trials and provided medical writing support.

Key results

  • 324 patients (14%) were aged ≥65 years; most had HCV-1 (42%) or HCV-2 (34%) and were white (68%), treatment-naive (60%), and noncirrhotic (80%).
  • Compliance rates were similar vs younger patients (88% vs 90%).
  • SVR12 rates were comparably high for patients aged ≥65 years and their younger counterparts (97.9% [95% CI, 96.3%-99.4%] vs 97.3% [95% CI, 96.6%-98.0%], P=.555).
    • Of 7 non-SVR12 elderly patients, 3 stopped treatment, 2 had virologic failure, and 2 were lost to follow-up.
  • Adverse events leading to discontinuation were rare in both age groups (

Limitations

  • Post-hoc analysis.

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