Resistance Summary
Please see additional resistance data below.
*Based on the resistance analysis population or final resistance analysis population, as applicable.
5 years of data in treatment-naïve adults
Studies 1489 and 1490 through Week 240
Among the treatment-naïve adults who participated in Studies 1489 and 1490, 634 participants received BIKTARVY through Week 144 of the double-blind phase, and 1025 participants received BIKTARVY through Week 96 of the extension phase. Of the 1025 treatment-naïve adults who participated in the OLE, 506 participants continued on BIKTARVY, 254 participants switched from ABC/DTG/3TC, and 265 participants switched from DTG+FTC/TAF at Week 144.1-3
In the final resistance analysis population, no amino acid substitutions associated with BIKTARVY resistance emerged in the 11 participants who experienced treatment failure and had evaluable genotypic resistance data.1
3 years of data in virologically suppressed participants
Study 1844 through Week 168 and Study 1878 through Week 96 in adults
Among 572 virologically suppressed adults randomized to BIKTARVY in Studies 1844 and 1878 through Week 48, 2 participants with virologic rebound had genotypic and phenotypic data (1 for RT, 1 for IN and RT), and no treatment-emergent resistance to BIKTARVY was detected through Week 48.1,4-6,*
- 524 virologically suppressed adults participated in an open-label extension (OLE) of Study 1844. 259 were continuing BIKTARVY and 265 switched to BIKTARVY at Week 48. No treatment-emergent resistance to BIKTARVY was detected through Week 168, including in the 1 participant who switched to BIKTARVY and met the criteria for resistance analysis.7,19,*
- 516 virologically suppressed adults participated in an extension phase of Study 1878. 272 were continuing BIKTARVY and 244 switched to BIKTARVY at Week 48. No treatment-emergent resistance to BIKTARVY was detected through Week 96, including in the 3 participants who switched to BIKTARVY and met the criteria for resistance analysis.8,20,*
Study 4030 through Week 48, including those with preexisting M184V/I resistance mutation
Among the 284 virologically suppressed adults randomized to BIKTARVY in Study 4030 through Week 48, 0 participants met the criteria for resistance analysis, and no treatment-emergent resistance to BIKTARVY was detected through Week 48.9
Study 1961 through Week 96 in adult women
Among 234 virologically suppressed adult women randomized to BIKTARVY in Study 1961 through Week 48, 1 participant met the criteria for resistance analysis, and no treatment-emergent resistance to BIKTARVY was detected through Week 48.10,*
- 459 virologically suppressed adult women participated in an extension phase of Study 1961. 231 were continuing BIKTARVY and 228 switched to BIKTARVY at Week 48. Three participants who switched met the criteria for resistance analysis, and no treatment-emergent resistance to BIKTARVY was detected through Week 96.11,*
Study 4449 through Week 96 in adults aged ≥65 years
Among 86 virologically suppressed adults aged ≥65 years in Study 4449 through Week 96, no participants met the criteria for resistance analysis, and no treatment-emergent resistance to BIKTARVY was detected through Week 96.12,13,*
Study 1474 Cohorts 1 & 2 through Week 96 and Cohort 3 through Week 48 in children and adolescents
Among 100 virologically suppressed children and adolescents aged ≥6 to <18 years in Study 1474 in cohorts 1 and 2, 1 participant met the criteria for resistance analysis, and no treatment-emergent resistance to BIKTARVY was detected through Week 96.1,14,15,20,*
Among 22 virologically suppressed children aged ≥2 (weighing ≥14 kg to <25 kg) in Study 1474 (cohort 3), no participants met the criteria for resistance analysis, and no treatment-emergent resistance to BIKTARVY was detected through Week 48.1,15,16,*
BRAAVE through Week 72 in Black American adults
Among 330 virologically suppressed adults randomized to BIKTARVY in BRAAVE through Week 24, 1 participant met criteria for resistance analysis and no treatment emergent resistance to BIKTARVY was detected through Week 24.17,*
- At Week 24, 320 participants continued BIKTARVY and 163 switched to BIKTARVY. Of these participants, 469 participants completed study drug or chose to remain in the extension phase at Week 48. No additional participant was analyzed for resistance, and no treatment emergent resistance to BIKTARVY was detected through Week 72.17,18,21,*
*Based on the resistance analysis population or final resistance analysis population, as applicable.
3TC, lamivudine; ABC, abacavir; DTG, dolutegravir; FTC, emtricitabine; INSTI, integrase strand transfer inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; OLE, open-label extension; TAF, tenofovir alafenamide.
References: 1. BIKTARVY. Prescribing information. Gilead Sciences, Inc.; 2024. 2. Wohl DA, Pozniak A, Workowski K, et al. B/F/TAF five-year outcomes in treatment-naïve adults. Poster presented at: Conference on Retroviruses and Opportunistic Infections; February 12-16, 2022; Virtual. Poster 494. 3. Orkin C, Antinori A, Rockstroh J, et al. Outcomes after switching from 144 weeks of blinded DTG/ABC/3TC or DTG+F/TAF to 96 weeks of open-label B/F/TAF. Poster presented at: HIV Glasgow 2022; October 23-26, 2022; Glasgow UK. Poster P088. 4. Molina J-M, Ward D, Brar I, et al. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet HIV. 2018;5(7):e357-e365. 5. Daar ES, DeJesus E, Ruane P, et al. Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2018;5(7):e347-e356. 6. Andreatta K, William M, Martin R, et al. Resistance analyses of bictegravir/emtricitabine/tenofovir alafenamide switch studies. Poster presented at: Conference on Retroviruses and Opportunistic Infections; March 4-7, 2018; Boston, MA. Poster 506. 7. Brar I, Ruane P, Ward D, et al. Long-term follow-up after a switch to bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir, abacavir, and lamivudine. Poster presented at: IDWeek; October 21-25, 2020; Virtual. Poster 1028. 8. Rockstroh J, Molina J-M, Post F, et al. Long-term follow-up after a switch to bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) from a boosted protease inhibitor-based regimen. Poster presented at: HIV Drug Therapy Glasgow 2020; October 5-8, 2020; Virtual. Poster P036. 9. Sax PE, Rockstroh JK, Luetkemeyer AF, et al; GS-US-380-4030 Investigators. Switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with human immunodeficiency virus. Clin Infect Dis. 2021;73(2):e485-e493. 10. Kityo C, Hagins D, Koenig E, et al. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) in virologically suppressed HIV-1 infected women: a randomized, open-label, multicenter, active-controlled, phase 3, noninferiority trial. J Acquir Immune Defic Syndr. 2019;82(3);321-328. 11. Kityo C, Hagins D, Koenig E, et al. Longer-term (96-week) efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) in women. Oral presentation at: International AIDS Society Conference on HIV Science 2019; July 21-24, 2019; Mexico City, Mexico. Abstract MOAB0106. 12. Maggiolo F, Rizzardini G, Molina J-M, et al. Bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed people with HIV aged ≥65 years: week 48 results of a phase 3b, open-label trial. Infect Dis Ther. 2021;10(2):775-788. 13. Maggiolo F, Rizzardini G, Molina J-M, et al. Switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in adults aged 65 years or older: Week 96 results from an international, phase 3b, open-label trial (GS-US-380-4449). Poster presented at: IAS 2021; July 18-21, 2021; Virtual. Poster PEB160. 14. Gaur AH, Cotton MF, Rodriguez CA, et al. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide in adolescents and children with HIV: week 48 results of a single-arm, open-label, multicentre, phase 2/3 trial. Lancet Child Adolesc Health. 2021;5(9):642-651. 15. Natukunda E, Rodriguez CA, McGrath EJ, et al. B/F/TAF in virologically suppressed adolescents and children: two-year outcomes in 6 to <18 year olds and six-month outcomes in toddlers. Abstract presented at: International Workshop on HIV & Pediatrics. July 16-17, 2021; Virtual. Abstract 2. 16. Rodriguez CA, Strehlau R, Chokephaibulkit K, et al. One year outcome of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in virologically suppressed children ≥ 2 years weighing 14 to < 25 kg. Oral presentation at: International Workshop on HIV & Pediatrics 2022; July 27-28, 2022; Montreal, Quebec, Canada. Oral 2. 17. Hagins D, Kumar P, Saag M, et al. Switching to bictegravir/emtricitabine/tenofovir alafenamide in Black Americans with HIV-1: a randomized phase 3b, multicenter, open-label study. J Acquir Immune Defic Syndr. 2021;88(1):86-95. 18. Kumar P, Stephens JL, Wurapa AK, et al. Week 72 outcomes and Covid-19 impact from the BRAAVE 2020 study: a randomized switch to B/F/TAF in Black American adults with HIV. Poster presented at: International Aids Society Conference on HIV Science; July 18-21, 2021; Virtual. Poster PEB161. 19. Andreatta K, Chang S, Delaney M, et al. Long-term efficacy among participants switched to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir/abacavir/lamivudine with preexisting resistance and viral blips. Poster presented at: International Aids Society Conference on HIV Science; July 18-21, 2021; Virtual. Poster PEB172. 20. Data on file. Gilead Sciences, Inc. 21. Andreatta K, D’Antoni ML, Chang S, et al. High efficacy of bictegravir/emtricitabine/tenofovir alafenamide in African-American adults with HIV including those with preexisting resistance, viral blips, and suboptimal adherence. Presented at: IDWeek 2021; September 29-October 3, 2021; Virtual. Poster 629.
