GLE/PIB is highly effective for clearing pediatric HCV

  • Jonas MM & al.
  • Hepatology
  • 29/06/2019

  • Yael Waknine
  • Clinical Essentials
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Takeaway

  • The pangenotypic combination of glecaprevir/pibrentasvir (GLE/PIB; Mavyret) is safe and effective for clearing HCV in adolescents ages 12-17 years.

Why this matters

Study design

  • Ongoing phase 2/3 DORA study (part 1) of once-daily GLE/PIB in 47 adolescent patients ages 12-17 (median, 14) years; 85% had acquired HCV perinatally.
  • The majority received an 8-week course (94%); 3 patients (6%) were treated for 16 weeks.
  • Funding: AbbVie.

Key results

  • Most patients were treatment-naive (77%) with genotype (GT) 1 infection (79%; 1a, 51%); GT2, GT3, and GT4 were also represented.
  • 23% had previously received peginterferon/ribavirin.
  • All 47 patients (100%; 95% CI, 92.4%-100.0%) achieved sustained virologic response at 12 weeks posttreatment.
  • There were no on-treatment virologic failures or relapses.
  • Pharmacokinetic exposure to GLE and PIB was comparable to that observed in adult steady-state exposure: 4380 vs 4800 and 1440 vs 1430 ng•h/mL.
  • Safety profile was consistent with that observed in adults, with no serious adverse events or adverse events leading to discontinuation.

Limitations

  • Open-label, nonrandomized design.
  • No patients with cirrhosis.