CROI 2019—Bictegravir/FTC/TAF pill well-tolerated in children, adolescents


  • Jim Kling
  • Conference Reports
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Takeaway

  • 48-week data show that the adult-dose, single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide (B/FTC/TAF) is safe, effective, and palatable in 6-17-year-old patients with HIV.

Why this matters

  • The combination has a high barrier to resistance and no food restrictions.

Study design

  • Prospective, open-label, single-group trial with adolescents (12-17 years; n=50; cohort 1) and children (6-11 years; n=50; cohort 2).
  • Patients had HIV-1 RNA
  • Funding: Gilead.

Key results

  • A previous short-term safety and pharmacokinetics study supported the use of the adult dose of B/FTC/TAF in children.
  • In the combined cohorts, 100% had HIV-1 RNA
  • No treatment-emergent resistance in either cohort.
  • No change in CD4 count through week 48.
  • Abdominal discomfort (2%, grade 1) was the only drug-related adverse event reported by more than 1 patient; 1 patient dropped out at week 16 because of grade 2 insomnia and anxiety.
  • Median pill adherence was 99% (range, 80-100%).

Limitations

  • Small sample size.

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