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BICTEGRAVIR/FTC/TAF SINGLE-TABLET REGIMEN IN ADOLESCENTS & CHILDREN: WEEK 48 RESULTS
Aditya Gaur1, Mark Cotton2, Carina Rodriguez3, Eric J. McGrath4, Elizabeth Hellstrom5, Afaaf Liberty6, Eva Natukunda7, Pope Kosalaraksa8, Kulkanya Chokephaibulkit9, Heather Maxwell10, Sophia R. Majeed10, Danielle Porter10, Pamela Wong10, Hiba Graham10, Cheryl Pikora10
1St. Jude Children's Research Hospital, Memphis, TN, USA,2Stellenbosch University, Cape Town, South Africa,3University of South Florida, Tampa, FL, USA,4Children's Hospital of Michigan, Detroit, MI, USA,5Be Part Yoluntu Centre, Paarl, South Africa,6Chris Hani Baragwanath Hospital, Johannesburg, South Africa,7Joint Clinical Research Centre, Kampala, Uganda,8Khon Kaen Hospital, Khon Kaen, Thailand,9Mahidol University, Bangkok, Thailand,10Gilead Sciences, Inc, Foster City, CA, USA
B/F/TAF, approved for adults living with HIV-1, is a single-tablet regimen (STR) containing the novel integrase strand transfer inhibitor (INSTI) bictegravir (B) 50 mg, emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 25 mg. B/F/TAF has a high barrier to resistance and no food restriction. Short-term safety and pharmacokinetics (PK) of B/F/TAF in children and adolescents, reported previously, support the use of the full adult strength tablet in this population. The 48-week (W) safety and efficacy data for 6- to <18-year-olds receiving B/F/TAF are reported.
Virologically suppressed adolescents (12 to <18 yrs) weighing ≥35 kg (Cohort 1) and children (6 to <12 yrs) weighing ≥25 kg (Cohort 2) with HIV-1 RNA <50 c/mL for ≥6 months before screening and CD4 ≥200 cells/μL received B/F/TAF once daily, in a prospective, 48-week, single-arm, open-label trial. Adverse events (AEs), laboratory results, and HIV-1 RNA <50 c/mL were assessed.
Fifty adolescents and fifty children (total n=100) were enrolled. At baseline for Cohort 1, median age was 15 yrs (range 12-17 yrs), weight 44.7 kg (range 35-123 kg), 64% female, 65% Black, median CD4 count 751 cells/μL, 90% vertically infected. For Cohort 2, median age was 10 yrs (range 6-11 yrs), median weight 29 kg (range 25-69 kg), 54% female, 72% Black, median CD4 count 930 cells/μL, and 96% vertically infected. All 100 participants (100%, 100/100) had HIV-1 RNA <50 c/mL at W24 and 98% (74/75) at W48 by US FDA Snapshot Algorithm; no participant had treatment-emergent resistance. CD4 count remained stable to W48. With a 50-week (range 20-93 wks) median duration of exposure to study drug, the only study drug-related AE reported with greater than single participant incidence was abdominal discomfort (2%, 2 participants; grade 1). One participant discontinued after W16 due to an AE (grade 2 insomnia and anxiety). All participants reported B/F/TAF size and shape as acceptable and taste as palatable; median percent adherence (pill counts) to study drug was high at 99% (range 80-100%).
This 48-week efficacy, safety, acceptability, and palatability data, combined with the previously reported PK data, support the use of the first, unboosted, INSTI-based STR of B/F/TAF 50/200/25 mg for the treatment of adolescents and children (6 to <18 years of age and weighing ≥25 kg) living with HIV-1 and prompts further pediatric studies of appropriate formulations of B/F/TAF for children weighing <25 kg.