Various races and ethnicities*
Clinical Trial Experience
Over 970 participants assigned female at birth†
Participants aged 3 to 80 years
People featured are real patients who take BIKTARVY and are compensated by Gilead; they did not participate in clinical trials.
*Including Black, White, Hispanic/Latino, and Asian populations.
†Including adults, adolescents, and children.
Studies included participants with high baseline viral load and low CD4 count11,12
High baseline viral load with HIV RNA >100k copies/mL11,12
Study 1489 (n=314): 53 participants (17%)
Study 1490 (n=320): 66 participants (21%)
Low baseline CD4 count with CD4 cell count <200 cells/μL11,12
Study 1489 (n=314): 36 participants (11%)
Study 1490 (n=320): 44 participants (14%)
BIKTARVY was studied across 8 phase 3 clinical trials in treatment-naïve and virologically suppressed study participants1,5,7
Virologically Suppressed Studies
Switched to BIKTARVY (n=282) or continued on ABC/DTG/3TC
(n=265) switched to BIKTARVY at Week 48View Study 1844
Switched to BIKTARVY (n=290) or stayed on baseline regimen‡ (n=287)
(n=244) switched to BIKTARVY at Week 48View Study 1878
Switched to BIKTARVY (n=234) or stayed on baseline regimen§ (n=236)
(n=228) switched to BIKTARVY at Week 48View Study 1961
Adults Aged ≥65
Switched to BIKTARVY
BIKTARVY is being studied in additional clinical trials, including:
BICSTaR: Ongoing multicountry, multicenter, prospective observational cohort study aimed to evaluate the effectiveness and safety of treatment with BIKTARVY with enrollment of over 2300 people living with HIV.13,14
‡ABC/3TC or FTC/TDF + boosted ATV or DRV regimen (cobicistat or ritonavir).
§E/C/F/TAF or E/C/F/TDF or ATV+RTV+FTC/TDF.
||Switched from E/C/F/TAF or F/TDF + a third agent.
¶Open-label, single-arm trial included virologically suppressed adolescents, aged ≥12 to <18 years weighing at least 35 kg (n=50), virologically suppressed children aged ≥6 to <12 years weighing at least 25 kg (n=50), and virologically suppressed children, aged ≥2 years and weighing at least 14 kg (n=22).1
3TC, lamivudine; ABC, abacavir; ATV, atazanavir; BICSTaR, bictegravir single-tablet regimen; C, cobicistat; CD4, cluster of differentiation 4; DRV, darunavir; DTG, dolutegravir; E, elvitegravir; FTC, emtricitabine; RNA, ribonucleic acid; RTV, ritonavir; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.
References: 1. BIKTARVY. Prescribing information. Gilead Sciences, Inc.; 2022. 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. 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. 4. 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. 5. 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. 6. 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. 7. 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. 8. 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. 9. 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. 10. Workowski K, Orkin C, Sax P, et al. Four-year outcomes of B/F/TAF in treatment-naïve adults. Presented at: 28th Conference on Retroviruses and Opportunistic Infections; March 6-10, 2021; Virtual. Abstract 415. 11. Gallant J, Lazzarin A, Mills A, et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017;390(10107):2063-2072. 12. Sax PE, Pozniak A, Montes ML, et al. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017;390(10107):2073-2082. 13. Spinner CD, Stoehr A. Wong A, et al. Starting or switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in clinical practice: pooled 12-month results from the global BICSTaR study. Poster presented at: HIV Glasgow 2020; October 5-8, 2020; Glasgow, UK. Poster P046K. 14. Trottier B, Antinori A, De Wet J, et al. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for the treatment of people living with HIV: 24-month analyses by age, race, sex, adherence and late diagnosis in a multi-country cohort study. Poster presented at: HIV Glasgow 2022; October 23-26, 2022; Glasgow, UK. Poster P067.