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BICTEGRAVIR/FTC/TAF SINGLE-TABLET-REGIMEN IN ADOLESCENTS: WEEK 24 RESULTS
Aditya Gaur1, Carina Rodriguez2, Eric J. McGrath3, Elizabeth Hellstrom4, Afaaf Liberty5, Eva Natukunda6, Pope Kosalaraksa7, Kulkanya Chokephaibulkit8, Amy Coluci9, Sophia R. Majeed9, Danielle Porter9, Pamela Wong9, Erin Quirk9, Hiba Graham9, Cheryl Pikora9
1St. Jude Children’s Research Hospital, Memphis, TN, USA,2University of South Florida, Tampa, FL, USA,3Children's Hospital of Michigan, Detroit, MI, USA,4Be Part Yoluntu Centre, Paarl, South Africa,5Chris Hani Baragwanath Hospital, Johannesburg, South Africa,6Joint Clinical Research Centre, Kampala, Uganda,7Khon Kaen University, Khon Kaen, Thailand,8Mahidol University, Bangkok, Thailand,9Gilead Sciences, Inc, Foster City, CA, USA
Bictegravir (BIC), a novel, unboosted integrase strand transfer inhibitor (INSTI) with a high genetic barrier to resistance, has been coformulated with emtricitabine and tenofovir alafenamide (BIC/FTC/TAF; B/F/TAF) into a once daily, single-tablet regimen (STR) of small tablet size that can be taken with/without food. We report pharmacokinetics (PK), safety and efficacy from a planned interim analysis of the first clinical trial of B/F/TAF in HIV-infected adolescents.
Virologically suppressed adolescents (12 to <18 yrs) weighing ≥35 kg 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 (W), single-arm, open-label trial. Steady-state PK parameters in adolescents were compared to those observed in adults treated with B/F/TAF. Adverse events (AE), laboratory tests, and the proportion of subjects with HIV-1 RNA <50 c/mL were assessed through W24.
24 adolescents enrolled; median age 15 yrs (range 12-17 yrs), median weight 48.9 kg (range 36.1-88.6 kg), 79% female, 52% Black, median CD4 count 708 cells/μL, 88% vertically infected. All (100%) had HIV-1 RNA <50 c/mL at W24 and none met criteria for resistance testing. Mean change in CD4 count from baseline was 44 cells/μL. No clinically relevant differences in drug exposures of B/F/TAF components were observed compared with data from adults (Table). Through a median (Q1, Q3) duration of exposure to study drug of 25.6 (24.7, 26.6) weeks, the most common treatment emergent AE was upper respiratory tract infection (21%, 5 of 24); no other AE occurred in >2 participants. No subject discontinued for AE. All participants reported B/F/TAF size and shape to be acceptable, and mean (SD) adherence to study drug was high (97.1% [7.02]). µ µ
The B/F/TAF STR maintained virologic suppression in all adolescent subjects enrolled and was well-tolerated through 24 weeks. Similar to adults treated with B/F/TAF, therapeutic plasma concentrations of all components of B/F/TAF were achieved. The efficacy and safety in adolescents is consistent with phase 3 B/F/TAF results in adults, which showed high proportions with viral suppression and no resistance. These data support further pediatric studies of B/F/TAF, which may be an important unboosted INSTI option for HIV-infected adolescents and children due to its high barrier to resistance, small tablet size and lack of food requirement.