BIKTARVY Prescribing Information DESCOVY Prescribing Information Important Safety
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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 ≥25 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.

BIKTARVY® Is Backed by Robust Clinical Trial Experience1,2

Extensive clinical trials with over 1500 people including various age groups and ethnicities

Treatment-Naïve Adults

STUDY 1489

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

STUDY 1490

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

Virologically Suppressed Adults

STUDY 1844

Switched to BIKTARVY (n=282) or continued on ABC/DTG/3TC (n=281)

STUDY 1878

Switched to BIKTARVY (n=290) or stayed on baseline regimen* (n=287)


Virologically Suppressed Adult Women

STUDY 1961

Switched to BIKTARVY (n=234) or
stayed on baseline regimen† (n=236)

Virologically Suppressed Pediatric Patients

STUDY 1474

Switched to BIKTARVY (n=100)‡

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 vs ABC/DTG/3TC in Treatment-Naïve Adults1,3-5


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

Treatment-Naïve Adults
(N=629)
  • HIV-1 RNA ≥500 copies/mL
  • eGFRCG ≥50 mL/min

1:1

n=314

n=315

BIKTARVY QD

ABC/DTG/3TC QD

Week 48
Primary
endpoint

Week 96
Secondary
endpoint

Week 144
Secondary
endpoint

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

Baseline Characteristics
Study 14893,8:
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/Ethnicity
White, % 57 57
Black, % 36 36
Hispanic/Latino, % 23 21
Asian, % 2 3
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

Contraindications

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

IQR, interquartile range.



BIKTARVY vs FTC/TAF+DTG in Treatment-Naïve Adults1,5-7


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

Treatment-Naïve Adults
(N=645)
  • HIV-1 RNA ≥500 copies/mL
  • eGFRCG ≥30 mL/min

1:1

n=320

n=325

BIKTARVY QD

FTC/TAF+DTG QD

Week 48
Primary
endpoint

Week 96
Secondary
endpoint

Week 144
Secondary
endpoint

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

Baseline Characteristics
Study 14906,9:
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/Ethnicity
White, % 57 60
Black, % 30 31
Hispanic/Latino, % 26 25
Asian, % 2 3
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

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.

Durable Power: Long-Term Efficacy in Treatment-Naïve Adults at Week 1441,3-7

Results noninferior to comparators


Study 1489: Virologic Response

Virologic Response in Study 1489 and Study 1490

§95% confidence interval.

Study 1489 M=F Analysis

Overall Rapid Reduction in Viral Load With BIKTARVY®3-5

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


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

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

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 Response

Virologic Response in Study 1489 and Study 1490

§95% confidence interval.

Study 1490 M=F Analysis

Overall Rapid Reduction in Viral Load With BIKTARVY®5-7

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


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

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

Adverse reactions

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

In both studies, treatment outcomes were similar across subgroups, regardless of age, sex, race, baseline viral load, and baseline CD4 cell count5

No Treatment-Emergent Resistance Associated With BIKTARVY1,3,5,6

In two large phase 3 clinical trials in treatment-naïve adults through Week 144

0
cases of resistance with
BIKTARVY
  • Among 634 treatment-naïve adults in Studies 1489 and 1490, 8 treatment-failure subjects were tested and no amino acid substitutions emerged that were associated with BIKTARVY resistance through Week 144
Study 1489 Virologic Outcomes
Week 48:
Study 1489 Virologic Outcomes1,3-5*1,4*

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**3*

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 death‡ <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*5*

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 death‡ 1% 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 754 (inclusive); Week 144 window was between Day 967 and 1050 (inclusive).

†Percents do not total 100% due to rounding.

‡†Includes subjects who had ≥50 copies/mL in the Week 48, 96, or 144 window; subjects who discontinued early due to lack or loss of efficacy; and subjects 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 subjects 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 subjects who discontinued for reasons other than an AE, death, or lack or loss of efficacy, eg, withdrew consent, loss to follow-up, etc.

||Percents do not total 100% due to rounding.

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%).

CI, confidence interval.

Study 1490 Virologic Outcomes
Week 48:
Study 1490 Virologic Outcomes1,5-7*1,7*

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*6*

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*5*

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 subjects who had ≥50 copies/mL in the Week 48, 96, or 144 window; subjects who discontinued early due to lack or loss of efficacy; and subjects 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 subjects 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 subjects 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

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.


Please see below for additional Important Safety Information for BIKTARVY.

Efficacy & Resistance in Virologically Suppressed Adults

INDICATION

BIKTARVY® is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥25 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.

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: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of BIKTARVY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min. 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: Patients weighing ≥25 kg: 1 tablet taken once daily with or without food.
  • Renal impairment: 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.

‡Open-label, single-arm trial included virologically suppressed adolescents, ages 12 to less than 18 years weighing at least 35 kg (n=50) and virologically suppressed children, ages 6 to less than 12 years weighing at least 25 kg (n=50).

3TC, lamivudine; ABC, abacavir; AE, adverse event; ATV, atazanavir; C, cobicistat; DRV, darunavir; DTG, dolutegravir; eGFRCG, estimated glomerular filtration rate (Cockcroft-Gault); E, elvitegravir; F, emtricitabine; FTC, emtricitabine; M=F, missing equals failure; QD, once daily; RTV, ritonavir; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.

References: 1. BIKTARVY [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2019. 2. Kityo C, Hagins D, Koenig E, et al. Switching to bictegravir/emtricitabine/tenofovir alafenamide in women. Poster presented at: Conference on Retroviruses and Opportunistic Infections; March 4-7, 2018; Boston, MA. 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. 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. 5. Data on file. Gilead Sciences, Inc. 6. Stellbrink HJ, 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. 7. Sax PE, Pozniak A, Montes ML, et al. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for the initial treatment of HIV-1 infection (GS-US-1490): a randomised, double-blind, multicenter, phase 3, non-inferiority trial. Lancet. 2017;390(10107):2073-2082. 8. Wohl DA, Yazdanpanah Y, Baumgarten A, et al. A phase 3, randomized, controlled clinical trial of bictegravir in a fixed-dose combination, B/F/TAF, vs DTG/ABC/3TC in treatment-naïve adults at week 96. Oral presentation at: IDWeek; October 3-7, 2018; San Francisco, CA. 9. Stellbrink HJ, Arribas JR, Stephens JL, et al. Phase III randomized, controlled clinical trial of bictegravir coformulated with FTC/TAF in a fixed-dose combination (B/F/TAF) versus dolutegravir (DTG) + F/TAF in treatment-naïve HIV-1 positive adults: week 96. Oral presentation at: HIV Drug Therapy; October 28-31, 2018; Glasgow, UK.