- 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.
- 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.
- 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%).
- Small sample size.