- 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
- Approved pediatric options are limited, with durations of 12-24 weeks; pangenotypic, ribavirin-free regimens remain an unmet need.
- GLE/PIB has already been approved for use in adolescents by the European Medicines Agency.
- 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.
- 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.
- Open-label, nonrandomized design.
- No patients with cirrhosis.