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Treatment-Naïve Patients

TAMERA, 33, UNDETECTABLE. 

7+ YEARS ON BIKTARVY.

People featured are compensated by Gilead.

Tamera is smiling.

Stands the Test of Time at 5 Years1

BIKTARVY® efficacy, resistance, and safety were studied through 5 years1

On this page

Additional analyses on this page

  • Studies 1489 & 1490: Post Hoc Pooled Analysis: Treatment-Naïve Adults Aged ≥50
  • Studies 1489 & 1490: Post Hoc Pooled Adherence Analysis
  • Studies 1489 & 1490: Post Hoc Pooled Analysis: High Baseline HIV-1 RNA and/or Low CD4 Count

Study 1489: Study Design

BIKTARVY vs ABC/DTG/3TC in treatment-naïve adults1-5

Phase 3, Randomized, Double-Blind, Active-Controlled, Noninferiority Study

Study Conducted: November 2015—July 20216
1489-study-design 1489-study-design
Primary endpoint

Proportion of adults with HIV-1 RNA <50 copies/mL at Week 48 (NI margin 12%) using the FDA snapshot algorithm5

Secondary endpoints

Efficacy, safety, and tolerability were assessed through Weeks 96 and 1443,4

Open-label extension

Efficacy in the OLE from Week 144 through Week 240 was calculated using missing=excluded (M=E) and missing=failure (M=F) analyses1,7

Study 14891,2


BIKTARVY (n=314)

ABC/DTG/
3TC (n=315)

Median age, years (range)

31 (18-71)

32 (18-68)

Male, %

91

90

Female, %

9

10

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, %

91

91

Median eGFRCG, mL/min (IQR)

126 (107.7-146.3)

123 (107.0-144.3)

Retrospective Analysis of Preexisting Resistance at Baseline in Studies 1489 & 14903,*,†

BIKTARVY Arms From Studies 1489 & 1490 N‡=632 (IN) N‡=634 (PR/RT)

INSTI, %

1.1

NRTI, %

3.3

NNRTI, %

12.9

PI, %

3.0

T97A, %0.9
1 or 2 TAMs, %3.0
K103N/S, %6.6
Q148H, %0.2
K65E/R, %0.3
E138A/G/K/Q, %4.4
  • Study participants with preexisting resistance substitutions causing reduced susceptibility to FTC, TAF, ABC, and 3TC were excluded at screening. Retrospective deep sequencing analysis was later attempted on baseline samples from all BIKTARVY-treated participants.

*This list is not inclusive of all RAMs observed in this analysis.3

†BIKTARVY is not indicated for patients with known or suspected substitutions associated with resistance to bictegravir or tenofovir.4

‡Retrospective deep sequencing data were combined with the population sequencing data from screening.

3TC, lamivudine; ABC, abacavir; CD4, cluster of differentiation 4; eGFRCG, estimated glomerular filtration rate (Cockcroft-Gault); FTC, emtricitabine, IN, integrase; INSTI, integrase strand transfer inhibitor; IQR, interquartile range; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PR, protease; RAM, resistance-associated mutation; RT, reverse transcriptase; TAM, thymidine-associated mutation.

References:

  1. 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.
  2. 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.
  3. Acosta RK, Chen GQ, Chang S, et al. Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naïve participants. J Antimicrob Chemother. 2021;76(8):2153-2157.
  4. BIKTARVY. Prescribing information. Gilead Sciences, Inc.; 2025.

Study 1489: Efficacy

5 years of durable viral suppression in treatment-naïve adults1-5

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

Virologic Response in Study 14892-5,*

*Percentages do not total 100% due to rounding.

†Treatment difference in HIV-1 RNA <50 copies/mL (95% confidence interval, P value).

Treatment outcomes were similar across subgroups, regardless of age, sex, race, baseline viral load, and baseline CD4+ cell count at Week 1442
Durable viral suppression at Week 2401

In a 96-week open-label extension from Week 144 through Week 240, virologic suppression at each study visit through Week 240 was assessed for adults who were initially randomized to BIKTARVY at Week 01,7:

  • Using an M=E analysis, 97.7% (n=213) maintained virologic suppression at Week 240
  • Using an M=F analysis, 66.2% (n=314) maintained virologic suppression at Week 240

Virologic suppression was also assessed in participants who switched from ABC/DTG/3TC to BIKTARVY at Week 1447:

  • Using an M=E analysis, 99.5% (n=218) maintained virologic suppression at Week 240
  • Using an M=F analysis, 85.4% (n=254) maintained virologic suppression at Week 240

In an M=E analysis, participants with missing data are excluded when calculating the proportion of participants with HIV-1 RNA <50 copies/mL. In an M=F analysis, all missing data are treated as treatment failures (HIV-1 RNA ≥50 copies/mL).

Overall rapid and sustained reduction in viral load with BIKTARVY1,3-5,7

Study 1489: Missing=Excluded (M=E) Analysis1,3-5,7

‡M=E data for participants who switched from ABC/DTG/3TC to BIKTARVY.

  • In an M=E analysis, participants with missing data are excluded when calculating the proportion of participants with HIV-1 RNA <50 copies/mL
Study 1489: Missing=Failure (M=F) Analysis1,3-5,7

Data is presented from Study Week 0 to Week 240 for participants initially randomized to BIKTARVY. Data for participants who switched to BIKTARVY from ABC/DTG/3TC in the OLE is presented from OLE Week 0 to Week 96.

  • Participants who switched from ABC/DTG/3TC had similar rates of virologic suppression (M=F) to participants initially started on BIKTARVY7
  • In an M=F analysis, all missing data are treated as treatment failures (HIV-1 RNA ≥50 copies/mL)

Study 1489 Virologic Outcomes1-4,*


Week 48

Week 96

Week 144


BIKTARVY
(n=314)

ABC/
DTG/3TC (n=315)

BIKTARVY
(n=314)

ABC/
DTG/3TC (n=315)

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%

Study 1489 Virologic Outcomes1-4,*


Week 48


BIKTARVY
(n=314)

ABC/
DTG/3TC (n=315)

HIV-1 RNA <50
copies/mL

92%

93%

Treatment difference
(95% CI) BIKTARVY vs comparator

-0.6%
(-4.8% to 3.6%)

HIV-1 RNA ≥50
copies/mL‡

1%

3%

No virologic data

7%

4%

Discontinued study drug due to AE or death§

0%

1%

Discontinued study drug due to other reasons and last available HIV-1
RNA <50 copies/mL||

5%

3%

Missing data during
window but on
study drug

2%

<1%

Study 1489 Virologic Outcomes1-4,*

Week 96

BIKTARVY
(n=314)

ABC/
DTG/3TC (n=315)

HIV-1 RNA <50
copies/mL

88%

90%

-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 death§

<1%

2%

Discontinued study drug due to other reasons and last available HIV-1 RNA <50 copies/mL||

10%

5%

1%

1%

Study 1489 Virologic Outcomes1-4,*

Week 144

BIKTARVY†
(n=314)

ABC/
DTG/3TC (n=315)

HIV-1 RNA <50
copies/mL

82%

84%

-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 death§

1%

2%

Discontinued study drug due to other reasons and last available HIV-1 RNA <50 copies/mL||

16%

11%

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).

†Percentages 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.

CI, confidence interval.

References:

  1. BIKTARVY. Prescribing information. Gilead Sciences, Inc.; 2025.
  2. 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.
  3. 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.
  4. 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.
IMPORTANT SAFETY INFORMATION
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: Study Design

BIKTARVY vs DTG+FTC/TAF in treatment-naïve adults1,2,4,9,10

Phase 3, Randomized, Double-Blind, Active-Controlled, Noninferiority Study

Study Conducted: November 2015—July 202111
Primary endpoint

Proportion of adults with HIV-1 RNA <50 copies/mL at Week 48 (NI margin 12%) using the FDA snapshot algorithm10

Secondary endpoints

Efficacy, safety, and tolerability were assessed through Weeks 96 and 1444,9

Open-label extension

Efficacy in the OLE from Week 144 through Week 240 was calculated using missing=excluded (M=E) and missing=failure (M=F) analyses1,7

Study 14901,2


BIKTARVY(n=320)

DTG+FTC/
TAF(n=325)

Median age, years (range)

33 (18-71)

34 (18-77)

Male, %

88*

89

Female, %

13*

11

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, %

89

89

Median eGFRCG, mL/min (IQR)

120.4 (100.8-141.8)

120.6 (102.8-145.1)

Retrospective Analysis of Preexisting Resistance at Baseline in Studies 1489 & 14903,†,‡

BIKTARVY Arms From Studies 1489 & 1490 N§=632 (IN) N§=634 (PR/RT)

INSTI, %

1.1

NRTI, %

3.3

NNRTI, %

12.9

PI, %

3.0

T97A, %0.9
1 or 2 TAMs, %3.0
K103N/S, %6.6
Q148H, %0.2
K65E/R, %0.3
E138A/G/K/Q, %4.4
  • Study participants with preexisting resistance substitutions causing reduced susceptibility to FTC, TAF, ABC, and 3TC were excluded at screening. Retrospective deep sequencing analysis was later attempted on baseline samples from all BIKTARVY-treated participants.

*Percentages do not total 100% due to rounding.

†This list is not inclusive of all RAMs observed in this analysis.3

‡BIKTARVY is not indicated for patients with known or suspected substitutions associated with resistance to bictegravir or tenofovir.4

§Retrospective deep sequencing data were combined with the population sequencing data from screening.

3TC, lamivudine; ABC, abacavir; CD4, cluster of differentiation 4; eGFRCG, estimated glomerular filtration rate (Cockcroft-Gault); FTC, emtricitabine; IN, integrase; INSTI, integrase strand transfer inhibitor; IQR, interquartile range; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; PR, protease; RAM, resistance-associated mutation; RT, reverse transcriptase; TAM, thymidine-associated mutation.

References:

  1. 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.
  2. 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.
  3. Acosta RK, Chen GQ, Chang S, et al. Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naïve participants. J Antimicrob Chemother. 2021;76(8):2153-2157.
  4. BIKTARVY. Prescribing Information. Gilead Sciences, Inc.; 2025.

Study 1490: Efficacy

5 years of durable viral suppression in treatment-naïve adults1,2,4,9,10

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

Virologic Response in Study 14902,4,8-10,*

*Percentages do not total 100% due to rounding.

†Treatment difference in HIV-1 RNA <50 copies/mL (95% confidence interval, P value).

Treatment outcomes were similar across subgroups, regardless of age, sex, race, baseline viral load, and baseline CD4+ cell count at Week 1442

Durable viral suppression at Week 2401

In a 96-week open-label extension from Week 144 through Week 240, virologic suppression at each study visit through Week 240 was assessed for adults who were initially randomized to BIKTARVY at Week 01,7:

  • Using an M=E analysis, 99.5% (n=219) maintained virologic suppression at Week 240
  • Using an M=F analysis, 68.1% (n=320) maintained virologic suppression at Week 240

Virologic suppression was also assessed in participants who switched from DTG+FTC/TAF to BIKTARVY at Week 1447:

  • Using an M=E analysis, 99.1% (n=234) maintained virologic suppression at Week 240
  • Using an M=F analysis, 87.5% (n=265) maintained virologic suppression at Week 240

In an M=E analysis, participants with missing data are excluded when calculating the proportion of participants with HIV-1 RNA <50 copies/mL. In an M=F analysis, all missing data are treated as treatment failures (HIV-1 RNA ≥50 copies/mL).

Overall rapid and sustained reduction in viral load with BIKTARVY1,4,7,9,10

Study 1490: Missing=Excluded (M=E) Analysis1,4,7,9,10

§M=E data for participants who switched from DTG+FTC/TAF to B/F/TAF.

  • In an M=E analysis, participants with missing data are excluded when calculating the proportion of participants with HIV-1 RNA <50 copies/mL
Study 1490: Missing=Failure (M=F) Analysis1,4,7,9,10

Data is presented from Study Week 0 to Week 240 for participants initially randomized to BIKTARVY. Data for participants who switched to BIKTARVY from DTG+FTC/TAF in the OLE is presented from OLE Week 0 to Week 96.

  • Participants who switched from DTG+FTC/TAF regimens had similar rates of virologic suppression (M=F) to participants initially started on BIKTARVY7
  • In an M=F analysis, all missing data are treated as treatment failures (HIV-1 RNA ≥50 copies/mL)

Study 1490 Virologic Outcomes1-4,*


Week 48

Week 96

Week 144


BIKTARVY
(n=320)

DTG/
FTC/TAF (n=325)

BIKTARVY
(n=320)

DTG/
FTC/TAF (n=325)

BIKTARVY
(n=320)

DTG/
FTC/TAF (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%

Study 1490 Virologic Outcomes1-4,*


Week 48


BIKTARVY
(n=320)

DTG/
FTC/TAF (n=325)

HIV-1 RNA <50
copies/mL

89%

93%

Treatment difference
(95% CI) BIKTARVY vs comparator

-3.5%
(-7.9% to 1.0%)

HIV-1 RNA ≥50
copies/mL‡

4%

1%

No virologic data

6%

6%

Discontinued study drug due to AE or death§

1%

1%

Discontinued study drug due to other reasons and last available HIV-1
RNA <50 copies/mL||

3%

4%

Missing data during
window but on
study drug

2%

1%

Study 1490 Virologic Outcomes1-4,*

Week 96

BIKTARVY
(n=320)

DTG/
FTC/TAF(n=325)

84%

86%

-2.3%
(-7.9% to 3.2%)

4%

3%

12%

11%

3%

2%

Discontinued study drug due to other reasons and last available HIV-1 RNA <50 copies/mL||

8%

7%

1%

1%

Study 1490 Virologic Outcomes1-4,*

Week 144

BIKTARVY†
(n=320)

DTG/
FTC/TAF(n=325)

82%

84%

-1.9%
(-7.8% to 3.9%)

5%

3%

13%

13%

3%

3%

Discontinued study drug due to other reasons and last available HIV-1 RNA <50 copies/mL||

11%

9%

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.

CI, confidence interval.

References:

  1. BIKTARVY. Prescribing information. Gilead Sciences, Inc.; 2025.
  2. 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.
  3. 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.
  4. 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.
IMPORTANT SAFETY INFORMATION
Adverse reactions
  • Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).

Studies 1489 & 1490: Numerically similar results between BIKTARVY and comparators in treatment-naïve participants aged ≥50 and <50 years at Week 14412

Post Hoc Subgroup Analysis of Pooled Data at Week 144
  • Efficacy was numerically similar in treatment-naïve study participants in both the ≥50 and <50 years of age group12
  • 20% of adults aged ≥50 years in the BIKTARVY study arm (n=96) had a baseline CD4 count <200 cells/μL12

Studies 1489 & 1490: Post Hoc Pooled Adherence Analysis

Methods
  • A retrospective post hoc pooled analysis of Studies 1489 and 1490 data in treatment-naïve adults8,13
  • Study participants were categorized based on their adherence through Weeks 48, 96, and 1448,13
  • Study participants in the clinical studies were instructed to take one tablet of BIKTARVY once daily, which is recommended in the full Prescribing Information2,4,5,10
Outcomes
  • Treatment adherence through Weeks 48, 96, and 1448,13
  • Virologic response on BIKTARVY treatment (using M=E analysis) at Weeks 48, 96, and 144 in participants initially randomized to BIKTARVY8,13
    • –  The adherence data analysis used an on-treatment M=E analysis that only included patient data collected during BIKTARVY treatment. This varies from other M=E analyses that include all patient data regardless of whether patients discontinued BIKTARVY.
Adherence Calculation8,13
  • Adherence was categorized as high (≥95%), intermediate (≥85% to <95%), or low (<85%)
  • Adherence was calculated by counting the number of pills remaining based on returned pill bottles and only included participants with ≥1 returned pill bottle13
Limitations
  • This analysis was not prespecified and statistical testing for comparison was not conducted
  • Data should be considered descriptive only, and efficacy conclusions based on adherence categories should not be drawn
  • Adherence may be higher in a clinical trial setting compared to real-world experiences for reasons that include regular study visits and being asked to return pill bottles

BIKTARVY Study Participant Adherence Information

Adherence Categories for Study Participants Initially Randomized to BIKTARVY8

Continue to counsel your patients to take BIKTARVY every day as prescribed.2

This analysis was not prespecified and statistical testing for comparison was not conducted. Data should be considered descriptive only.

Adherence calculation was based on returned pill bottle pill count and only included participants with ≥1 returned pill bottle.

Adherence may be higher in a clinical trial setting compared to real-world experiences for reasons that include regular study visits and being asked to return pill bottles.

Total Participants Initially Randomized to BIKTARVY (N=624)8

Adherence
Category

Week 48
Excluded
From M=E
Analysis
(Missing
Virologic
Data)
(n=43)

Week 48
Included in
M=E
Analysis
(n=581)

Week 96
Excluded
From M=E
Analysis
(Missing
Virologic
Data)
(n=78)

Week 96
Included in
M=E
Analysis
(n=546)

Week 144
Excluded
From M=E
Analysis
(Missing
Virologic
Data)
(n=104)

Week 144
Included in
M=E
Analysis
(n=520)

High adherence
(≥95%)

18

458

35

408

49

388

Intermediate
adherence
(≥85% to <95%)

15

100

26

117

36

113

Low adherence
(<85%)*

10

23

17

21

19

19

*Median (IQR) adherence for the low adherence category through Week 48 (n=33) was 78.3% (76.5%, 82.0%), through Week 96 (n=38) was 80.0% (77.0%, 82.7%), through Week 144 (n=38) was 79.6% (77.0%, 81.8%). Median adherence was calculated for all participants, including those with missing virologic data.

Continue to counsel your patients to take BIKTARVY every day as prescribed.2

This analysis was not prespecified and statistical testing for comparison was not conducted. Data should be considered descriptive only, and efficacy conclusions based on adherence categories should not be drawn.

Participants in the clinical studies were instructed to take the study drug once daily.2,4,5,10

Virologic Suppression Rates by Adherence Category Using M=E Analysis8

In an M=E analysis, study participants with missing data are excluded when evaluating virologic suppression.

Continue to counsel your patients to take BIKTARVY every day as prescribed.2

This analysis was not prespecified and statistical testing for comparison was not conducted. Data should be considered descriptive only, and efficacy conclusions based on adherence categories should not be drawn.

Participants in the clinical studies were instructed to take the study drug once daily.2,4,5,10

Total Participants Initially Randomized to BIKTARVY at Week 48 (N=624)8

Adherence Category

Week 48 Excluded From M=E Analysis (Missing Virologic Data) (n=43)

Week 48 Included in M=E Analysis (n=581)

High adherence
(≥95%)

18

458

Intermediate
adherence (≥85% to <95%)

15

100

Low adherence
(<85%)*

10

23

*Median (IQR) adherence for the low adherence category through Week 48 (n=33) was 78.3% (76.5%, 82.0%). Median adherence was calculated for all participants, including those with missing virologic data.

Virologic Suppression Rates by Adherence Category at Week 48 Using M=E Analysis8

In an M=E analysis, study participants with missing data are excluded when evaluating virologic suppression.

Continue to counsel your patients to take BIKTARVY every day as prescribed.2

This analysis was not prespecified and statistical testing for comparison was not conducted. Data should be considered descriptive only, and efficacy conclusions based on adherence categories should not be drawn.

Participants in the clinical studies were instructed to take the study drug once daily.2,4,5,10

Total Participants Initially Randomized to BIKTARVY at Week 96 (N=624)8

Adherence Category

Week 96 Excluded From M=E Analysis (Missing Virologic Data) (n=78)

Week 96 Included in M=E Analysis (n=546)

High adherence (≥95%)

35

408

Intermediate adherence (≥85% to <95%)

26

117

Low adherence (<85%)*

17

21

†Median (IQR) adherence for the low adherence category through Week 96 (n=38) was 80.8% (77.0%, 82.7%). Median adherence was calculated for all participants, including those with missing virologic data.

Virologic Suppression Rates by Adherence Category at Week 96 Using M=E Analysis8

In an M=E analysis, study participants with missing data are excluded when evaluating virologic suppression.

Continue to counsel your patients to take BIKTARVY every day as prescribed.2

This analysis was not prespecified and statistical testing for comparison was not conducted. Data should be considered descriptive only, and efficacy conclusions based on adherence categories should not be drawn.

Participants in the clinical studies were instructed to take the study drug once daily.2,4,5,10

Total Participants Initially Randomized to BIKTARVY at Week 144 (N=624)8

Adherence Category

Week 144 Excluded From M=E Analysis (Missing Virologic Data) (n=104)

Week 144 Included in M=E Analysis (n=520)

High adherence (≥95%)

49

388

Intermediate adherence (≥85% to <95%)

36

113

Low adherence (<85%)*

19

19

‡Median (IQR) adherence for the low adherence category through Week 144 (n=38) was 79.6% (77.0%, 81.8%). Median adherence was calculated for all participants, including those with missing virologic data.

Virologic Suppression Rates by Adherence Category at Week 144 Using M=E Analysis8

In an M=E analysis, study participants with missing data are excluded when evaluating virologic suppression.

Continue to counsel your patients to take BIKTARVY every day as prescribed.2

This analysis was not prespecified and statistical testing for comparison was not conducted. Data should be considered descriptive only, and efficacy conclusions based on adherence categories should not be drawn.

Participants in the clinical studies were instructed to take the study drug once daily.2,4,5,10

IMPORTANT SAFETY INFORMATION

Adverse reactions

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

Studies 1489 and 1490: Post Hoc Pooled Analysis

5 years of viral suppression in treatment-naïve adults with high baseline viral load and low CD4 cell count2,5,10,14

In a post hoc subgroup analysis of pooled data from Studies 1489 and 1490 through Week 240, participants initially randomized to BIKTARVY were stratified by:

  • Baseline viral load (BL VL) <100,000, 100,000 to 400,000, and >400,000 copies/mL
  • Baseline CD4 < or ≥200 cells/μL
  • Baseline viral load ≥100,000 copies/mL and CD4 <200 cells/μL

Post Hoc Pooled Analysis of Studies 1489 and 1490 Using an M=E Analysis14

  • In an M=E analysis, participants with missing data are excluded when calculating the proportion of participants with HIV-1 RNA <50 copies/mL.
Virologic suppression was achieved and maintained in all subgroups at 5 years14

Post Hoc Pooled Analysis of Studies 1489 and 1490 Using an M=F Analysis14

  • In an M=F analysis, all missing data are treated as treatment failures (HIV-1 RNA ≥50 copies/mL).

Studies 1489 and 1490: Resistance

zero-cases-of-resistance zero-cases-of-resistance

Zero cases of resistance to BIKTARVY through 5 years in treatment-naïve adults1,2,7

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 144.1,2,7

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.2

Early Treatment Initiation
Adverse Reactions & Discontinuations
Patient brochure.
Patient brochure.
People With HIV Aged 50 and Older

Explore BIKTARVY clinical trial data.

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

3TC, lamivudine; ABC, abacavir; AE, adverse event; CD4, cluster of differentiation 4; DTG, dolutegravir; eGFRCG, estimated glomerular filtration rate (Cockcroft-Gault); FDA, US Food and Drug Administration; FTC, emtricitabine; HBV, hepatitis B virus; HCV, hepatitis C virus; INSTI, integrase strand transfer inhibitor; IQR, interquartile range; M=E, missing=excluded; M=F, missing=failure; NI, noninferiority; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; OLE, open-label extension; QD, once daily; RNA, ribonucleic acid; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate; TFV, tenofovir.

References:

  1. 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.
  2. BIKTARVY. Prescribing information. Gilead Sciences, Inc.; 2025.
  3. 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.
  4. 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.
  5. 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.
  6. Study to evaluate the safety and efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus abacavir/dolutegravir/lamivudine in human immunodeficiency virus-1 (HIV-1) infected, antiretroviral treatment-naive adults. ClinicalTrials.gov identifier: NCT02607930. Updated March 2, 2022. Accessed January 6, 2023. https://clinicaltrials.gov/ct2/show/NCT02607930
  7. 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.
  8. Data on file. Gilead Sciences, Inc.
  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. Study to evaluate the safety and efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir + emtricitabine/tenofovir alafenamide in human immunodeficiency virus (HIV-1) infected, and antiretroviral treatment-naive adults. ClinicalTrials.gov identifier: NCT02607956. Updated March 7, 2022. Accessed January 6, 2023. https://clinicaltrials.gov/ct2/show/NCT02607956
  12. Mills A, Gupta SK, Brinson C, et al. 144-week efficacy and safety of B/F/TAF in treatment naïve adults age ≥50 years. Poster presented at: Conference on Retroviruses and Opportunistic Infections; March 8-11, 2020; Boston, MA. Poster 2886.
  13. Andreatta K, Sax PE, Wohl D. Efficacy of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG)-based 3-drug regimens in adults with HIV who have suboptimal antiretroviral adherence. Poster presented at: IDWeek 2023; October 11-15, 2023; Boston, MA.
  14. Ramgopal M, Wurapa A, Baumgarten A, et al. 5-year outcomes of bictegravir/emtricitabine/tenofovir alafenamide as initial treatment of HIV-1 in adults with high baseline HIV-1 RNA and/or low CD4 count in two Phase 3 randomized clinical trials. Presented at: Infectious Disease Week 2022; October 19-23, 2022; Washington, DC. Poster 1251.