BIKTARVY Prescribing
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Treatment-Naïve Adults Clinical Trial Overview Study Design Efficacy Resistance

INDICATION

BIKTARVY® is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥14 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of BIKTARVY.

Please see below for Important Safety Information for BIKTARVY.

Stands the Test of Time at 5 Years1-3

Supported by 240 weeks of robust clinical trial data, including 96-week open-label extension data1-3

Chart Studies.
Chart Studies.

BIKTARVY is being studied in additional clinical trials

  • BRAAVE 2020: The first ongoing clinical trial in 495 Black Americans to study their response to HIV-1 treatment regimens4
  • BICSTaR: Ongoing multicountry, multicenter, prospective observational cohort study aimed to evaluate the effectiveness and safety of treatment with BIKTARVY with a planned total enrollment of 1400 people living with HIV5

IMPORTANT SAFETY INFORMATION

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted.

BIKTARVY is being studied in additional clinical trials

  • BRAAVE 2020: The first BIKTARVY clinical trial in 495 Black Americans to study their response to HIV-1 treatment regimens4
  • BICSTaR: Ongoing multicountry, multicenter, prospective observational cohort study aimed to evaluate the effectiveness and safety of treatment with BIKTARVY with a planned total enrollment of 2000 people living with HIV5

BIKTARVY vs ABC/DTG/3TC in Treatment-Naïve Adults1,3,6-8

Study 1489: Phase 3, Randomized, Double-Blind, Active-Controlled Study

Chart Studies.
Chart Studies.

Primary endpoint

Proportion of adults with HIV-1 RNA <50 copies/mL at Week 48 using the FDA snapshot algorithm

Secondary endpoints

Efficacy, safety, and tolerability were assessed through Weeks 96 and 144

Open-label extension

Efficacy in the OLE from Week 144 through Week 240 was calculated using the FDA snapshot algorithm using a missing=excluded (M=E) subject analysis

Baseline Characteristics
Study 14896,7:
Selected Baseline Characteristics		 BIKTARVY®(n=314) ABC/
DTG/3TC(n=315)
Median age, years (range) 31(18-71) 32(18-68)
Sex
Male, % 91 90
Female, % 9 10
Race
White, % 57 57
Black, % 36 36
Asian, % 2 3
Hispanic/Latino, % 23 21
Median HIV-1 RNA, log10 copies/mL (IQR) 4.42(4.03-4.87) 4.51(4.04-4.87)
HIV-RNA >100,000 copies/mL, % 17 16
Median CD4 cell count, cells/μL (IQR) 443(299-590) 450(324-608)
CD4 count <200 cells/μL, % 11 10
Asymptomatic HIV infection, % 91 91
Median creatinine clearance, mL/min (IQR) 126(108-146) 123(107-144)

IMPORTANT SAFETY INFORMATION (cont’d)

Contraindications

  • Coadministration: Do not use BIKTARVY with dofetilide or rifampin.

IQR, interquartile range.

BIKTARVY vs FTC/TAF+DTG in Treatment-Naïve Adults1,3,7,9,10

Study 1490: Phase 3, Randomized, Double-Blind, Active-Controlled Study

Chart Studies.
Chart Studies.

Primary endpoint

Proportion of adults with HIV-1 RNA <50 copies/mL at Week 48 using the FDA snapshot algorithm

Secondary endpoints

Efficacy, safety, and tolerability were assessed through Weeks 96 and 144

Open-label extension

Efficacy in the OLE from Week 144 through Week 240 was calculated using the FDA snapshot algorithm using a missing=excluded (M=E) subject analysis

Baseline Characteristics
Study 14907,9:
Selected Baseline Characteristics		 BIKTARVY®(n=320) FTC/TAF
+DTG(n=325)
Median age, years (range) 33(18-71) 34(18-77)
Sex
Male, % 88 89
Female, % 12 11
Race
White, % 57 60
Black, % 30 31
Asian, % 2 3
Hispanic/Latino, % 26 25
Median HIV-1 RNA, log10 copies/mL (IQR) 4.43(3.95-4.90) 4.45(4.03-4.84)
HIV-RNA >100,000 copies/mL, % 21 17
Median CD4 cell count, cells/μL (IQR) 440(289-591) 441(297-597)
CD4 count <200 cells/μL, % 14 10
Asymptomatic HIV infection, % 89 89
Median creatinine clearance, mL/min (IQR) 120.4(100.8-141.8) 120.6(102.8-145.1)

IMPORTANT SAFETY INFORMATION (cont’d)

Contraindications

  • Coadministration: Do not use BIKTARVY with dofetilide or rifampin.

IQR, interquartile range.

IMPORTANT SAFETY INFORMATION (cont’d)

Contraindications

  • Coadministration: Do not use BIKTARVY with dofetilide or rifampin.

Durability You Can Trust.

5 Years of Durable Viral Suppression1,3,6-10

BIKTARVY was noninferior to ABC/DTG/3TC at Week 144

Virologic Response for Study 14891,6-10

Graph of 1489 study on long-term efficacy data in treatment-naïve adults. Graph of 1489 study on long-term efficacy data in treatment-naïve adults.

§Difference (95% confidence interval).

Treatment outcomes were similar across subgroups, regardless of age, race, baseline viral load, and baseline CD4+ cell count at Week 1443,7,11

In a 96-week open-label extension from Week 144 through Week 240, using an M=E analysis, ≥98% of adults who were initially randomized to BIKTARVY at Week 0 maintained virologic suppression at each study visit through Week 2403||

  • The BIKTARVY safety profile in the OLE in patients who were initially randomized to BIKTARVY was similar to that in the initial randomized phase of Study 14893
SEE THE STUDY DESIGN

Overall Rapid Reduction in Viral Load With BIKTARVY at Week 1446,7,8,11

Study 1489: Missing=Failure (M=F) Analysis

Graph of 1489 study on suppression data in treatment-naïve adults. Graph of 1489 study on suppression data in treatment-naïve adults.

Primary endpoint

Proportion of adults with HIV-1 RNA <50 copies/mL at Week 48 using the FDA snapshot algorithm

Secondary endpoint

Efficacy, safety, and tolerability were assessed through Weeks 96 and 144

  • The M=F analysis was an additional prespecified endpoint of Study 1489. Results of the M=F analysis were consistent with the primary endpoint.

IMPORTANT SAFETY INFORMATION (cont’d)

Adverse reactions

  • Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).
Study 1489
Virologic Outcomes
Week 48:
Study 1489 Virologic Outcomes1,6-8*1,6-8*

Week 48

BIKTARVY®(n=314)
ABC/
DTG/
3TC(n=315)

Week 96

BIKTARVY(n=314)
ABC/
DTG/3TC(n=315)

Week 144

BIKTARVY†®(n=314)
ABC/
DTG/
3TC(n=315)
HIV-1 RNA <50 copies/mL 92% 93% 88% 90% 82% 84%
Treatment difference (95% CI) BIKTARVY vs comparator -0.6%(-4.8% to 3.6%) -1.9%(-6.9% to 3.1%) -2.6%(-8.5% to 3.4%)
HIV-1 RNA ≥50 copies/mL‡ 1% 3% 1% 2% 1% 3%
No virologic data 7% 4% 11% 8% 18% 13%
Discontinued study drug due to AE or death§ 0% 1% <1%   2% 1% 2%
Discontinued study drug due to other reasons and last available HIV-1 RNA <50 copies/mL|| 5% 3% 10% 5% 16% 11%
Missing data during window but on study drug 2% <1%   1% 1% 1% <1%  
Week 96:
Study 1489 Virologic Outcomes1,3**1,6-8*

BIKTARVY(n=314)
ABC/DTG/
3TC(n=315)
HIV-1 RNA <50 copies/mL 88% 90%
Treatment difference (95% CI) BIKTARVY vs comparator -1.9%(6.9% to 3.1%)
HIV-1 RNA ≥50 copies/mL†‡ 1% 2%
No virologic data 11% 8%
Discontinued study drug due to AE or deathठ<1% 2%
Discontinued study drug due to other reasons and last available HIV-1 RNA <50 copies/mL§|| 10% 5%
Missing data during window but on study drug 1% 1%
Week 144:
Study 1489 Virologic Outcomes1,3*1,6-8*

BIKTARVY†(n=314)
ABC/DTG/
3TC(n=315)
HIV-1 RNA <50 copies/mL 82% 84%
Treatment difference (95% CI) BIKTARVY vs comparator -2.6%(-8.5% to 3.4%)
HIV-1 RNA ≥50 copies/mL†‡ 1% 3%
No virologic data 18% 13%
Discontinued study drug due to AE or deathठ1% 2%
Discontinued study drug due to other reasons and last available HIV-1 RNA <50 copies/mL§|| 16% 11%
Missing data during window but on study drug 1% <1%  

*Week 48 window was between Day 295 and 378 (inclusive); Week 96 window was between Day 631 and 714 (inclusive); Week 144 window was between Day 967 and 1050 (inclusive).

†Percents do not total 100% due to rounding.

‡Includes participants who had ≥50 copies/mL in the Week 48, 96, or 144 window; participants who discontinued early due to lack or loss of efficacy; and participants who discontinued for reasons other than an adverse event (AE), death, or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥50 copies/mL.

§Includes participants who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.

||Includes participants who discontinued for reasons other than an AE, death, or lack or loss of efficacy, eg, withdrew consent, loss to follow-up, etc.

IMPORTANT SAFETY INFORMATION (cont’d)

Adverse reactions

  • Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).

CI, confidence interval.

BIKTARVY was noninferior to FTC/TAF+DTG at Week 144

Virologic Response for Study 14901,7,9,10

Graph of 1490 study on long-term efficacy data in treatment-naïve adults. Graph of 1490 study on long-term efficacy data in treatment-naïve adults.

§Difference (95% confidence interval).

Treatment outcomes were similar across subgroups, regardless of age, sex, race, baseline viral load, and baseline CD4+ cell count at Week 1443,7,11

In a 96-week open-label extension from Week 144 through Week 240, using an M=E analysis, ≥99% of adults who were initially randomized to BIKTARVY at Week 0 maintained virologic suppression at each study visit through Week 2403||

  • The BIKTARVY safety profile in the OLE in patients who were initially randomized to BIKTAFVY was similar to that in the initial randomized phase of Study 14903
SEE THE STUDY DESIGN

Overall Rapid Reduction in Viral Load With BIKTARVY at Week 1447,9-11

Study 1490: Missing=Failure (M=F) Analysis

Graph of 1490 study on suppression data in treatment-naïve adults. Graph of 1490 study on suppression data in treatment-naïve adults.

Primary endpoint

Proportion of adults with HIV-1 RNA <50 copies/mL at Week 48 using the FDA snapshot algorithm

Secondary endpoint

Efficacy, safety, and tolerability were assessed through Weeks 96 and 144

  • The M=F analysis was an additional prespecified endpoint of Study 1490. Results of the M=F analysis were consistent with the primary endpoint.

IMPORTANT SAFETY INFORMATION (cont’d)

Adverse reactions

  • Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).
Study 1490
Virologic Outcomes
Week 48:
Study 1490 Virologic Outcomes1,7,9,11*1,7,9,11*

Week 48

BIKTARVY®(n=320)
FTC/TAF
+DTG(n=325)

Week 96

BIKTARVY(n=320)
FTC/TAF
+DTG(n=325)

Week 144

BIKTARVY(n=320)
FTC/TAF
+DTG(n=325)
HIV-1 RNA <50 copies/mL 89% 93% 84% 86% 82% 84%
Treatment difference (95% CI) BIKTARVY vs comparator -3.5%(-7.9% to 1.0%) -2.3%(-7.9% to 3.2%) -1.9%(-7.8% to 3.9%)
HIV-1 RNA ≥50 copies/mL† 4% 1% 4% 3% 5% 3%
No virologic data 6% 6% 12% 11% 13% 13%
Discontinued study drug due to AE or death‡ 1% 1% 3% 2% 3% 3%
Discontinued study drug due to other reasons and last available HIV-1 RNA <50 copies/mL§ 3% 4% 8% 7% 11% 9%
Missing data during window but on study drug 2% 1% 1% 1% 0% 1%
Week 96:
Study 1490 Virologic Outcomes1,5*1,7,9,11*

BIKTARVY(n=320)
FTC/TAF
+DTG(n=325)
HIV-1 RNA <50 copies/mL 84% 86%
Treatment difference (95% CI) BIKTARVY vs comparator -2.3%(-7.9% to 3.2%)
HIV-1 RNA ≥50 copies/mL† 4% 3%
No virologic data 12% 11%
Discontinued study drug due to AE or death‡ 3% 2%
Discontinued study drug due to other reasons and last available HIV-1 RNA <50 copies/mL§ 8% 7%
Missing data during window but on study drug 1% 1%
Week 144:
Study 1490 Virologic Outcomes1,5*1,7,9,11*

BIKTARVY(n=320)
FTC/TAF
+DTG(n=325)
HIV-1 RNA <50 copies/mL 82% 84%
Treatment difference (95% CI) BIKTARVY vs comparator -1.9%(-7.8% to 3.9%)
HIV-1 RNA ≥50 copies/mL† 5% 3%
No virologic data 13% 13%
Discontinued study drug due to AE or death‡ 3% 3%
Discontinued study drug due to other reasons and last available HIV-1 RNA <50 copies/mL§ 11% 9%
Missing data during window but on study drug 0% 1%

*Week 48 window was between Day 295 and 378 (inclusive); Week 96 window was between Day 631 and 714 (inclusive); Week 144 window was between Day 967 and 1050 (inclusive).

†Includes participants who had ≥50 copies/mL in the Week 48, 96, or 144 window; participants who discontinued early due to lack or loss of efficacy; and participants who discontinued for reasons other than an adverse event (AE), death, or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥50 copies/mL.

‡Includes participants who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.

§Includes participants who discontinued for reasons other than an AE, death, or lack or loss of efficacy, eg, withdrew consent, loss to follow-up, etc.

IMPORTANT SAFETY INFORMATION (cont’d)

Adverse reactions

  • Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).

CI, confidence interval.

Zero Cases of Resistance in Clinical Trials Through Week 240.1,3,7#

Zero cases of treatment-emergent resistance in treatment-naïve adults, including INSTI and NRTI resistance

Resistance icon with BIKTARVY® (bictegravir, emtricitabine, tenofovir alafenamide). Resistance icon with BIKTARVY® (bictegravir, emtricitabine, tenofovir alafenamide).
  • Among 634 treatment-naïve adults randomized to BIKTARVY in Studies 1489 and 1490 through Week 144, 8 participants with treatment failure met criteria for resistance testing, and no amino acid substitutions emerged that were associated with BIKTARVY resistance
  • 1025 treatment-naïve adults participated in an OLE of Studies 1489 and 1490. 506 of them continued on BIKTARVY and 519 switched to BIKTARVY at Week 144. Of the 506 patients who were randomized to BIKTARVY at Week 0, 1 participant with treatment failure met criteria for resistance testing, and no treatment-emergent resistance to BIKTARVY was detected through Week 240.

Please see below for additional Important Safety Information for BIKTARVY.

Learn About Initiating BIKTARVY in Appropriate Patients

INDICATION

BIKTARVY® is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥14 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of BIKTARVY.

Please see below for Important Safety Information for BIKTARVY.

IMPORTANT SAFETY INFORMATION (cont’d)

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted.

Contraindications

  • Coadministration: Do not use BIKTARVY with dofetilide or rifampin.

Warnings and precautions

  • Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions.
  • Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
  • New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
    Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus.
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse reactions

  • Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).

Drug interactions

  • Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
  • Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1.
  • Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.

Dosage and administration

  • Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For these pediatric patients, who are unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes.
  • Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min.
  • Hepatic impairment: Not recommended in patients with severe hepatic impairment.
  • Prior to or when initiating: Test patients for HBV infection.
  • Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

Pregnancy and lactation

  • Pregnancy: There is insufficient human data on the use of BIKTARVY during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population.
  • Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

Please see full Prescribing Information for BIKTARVY® and DESCOVY®, including BOXED WARNINGS.

*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 and up and weighing at least 14 kg (n=22).

||HIV-1 RNA ≤50 copies/mL, M=E.

#Based on the final resistance analysis population.

Of the 519 subjects who switched to BIKTARVY in the OLE, 254 switched from ABC/DTG/3TC and 265 switched from FTC/TAF+DTG.

3TC, lamivudine; ABC, abacavir; ATV, atazanavir; BICSTaR, bictegravir single-tablet regimen; C, cobicistat; DRV, darunavir; DTG, dolutegravir; E, elvitegravir; eGFRCG, estimated glomerular filtration rate (Cockcroft-Gault); F, emtricitabine; FTC, emtricitabine; INSTI, integrase strand transfer inhibitor; IQR, interquartile range; NRTI, nucleoside reverse transcriptase inhibitor; OLE, open-label extension; QD, once daily; RNA, ribonucleic acid; RPV, rilpivirine; RTV, ritonavir; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.

References: 1. BIKTARVY. Package insert. Gilead Sciences, Inc.; 2021. 2. 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. 3. 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. 4. 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. 5. Mallolas J, Esposito V, Hocqueloux L, et al. Bictegravir/emtricitabine/tenofovir/alafenamide (B/F/TAF) for the treatment of people living with HIV: 12-month effectiveness, persistence, and safety in a multi-country cohort study. Abstract P010. Presented at: British HIV Association Spring Conference 2022; April 20-22, 2022; Manchester, UK. 6. Wohl DA, Yazdanpanah Y, Baumgarten A, et al. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019;6(6):e355-e363. 7. Orkin C, DeJesus E, Sax PE, et al. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials. Lancet HIV. 2020;7(6):e389-e400. 8. 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. 9. Stellbrink H-J, Arribas JR, Stephens JL, et al. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019;6(6):e364-e372. 10. 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. 11. Data on file. Gilead Sciences, Inc.