INDICATION

BIKTARVY® is indicated as a complete regimen for the treatment of HIV-1 infection in adults 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 for ≥3 months with no history of treatment failure and no known resistance to any component of BIKTARVY.

BIKTARVY® is Backed by Robust Clinical Trial Experience1-6

Extensive clinical trials with over 1400 adults 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)

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 Virologically Suppressed Adults1,4


Study 1844: Phase 3, Randomized, Double-Blind, Active-Controlled Study

Virologically Suppressed Adults (N=563)
ABC/3TC+DTG or ABC/DTG/3TC
  • HIV-1 RNA <50 copies/mL
  • eGFRCG ≥50 mL/min

1:1

n=282

n=281

Switched to
BIKTARVY QD

Continued on
ABC/DTG/3TC QD

Week 48
Primary endpoint

Primary endpoint

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

  • Stably suppressed on baseline regimen for at least 3 months prior to trial entry and no history of treatment failure


BIKTARVY vs ATV- or DRV-Based Regimen in Virologically Suppressed Adults1,5


Study 1878: Phase 3, Randomized, Open-Label, Active-Controlled Study

Virologically Suppressed Adults (N=577)
ABC/3TC or FTC/TDF
+ boosted DRV or ATV regimen
  • HIV-1 RNA <50 copies/mL
  • eGFRCG ≥50 mL/min

1:1

n=290

n=287

Switched to
BIKTARVY QD

Stayed on Baseline
Regimen (SBR)

Week 48
Primary endpoint

Primary endpoint

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

  • Stably suppressed on baseline regimen for at least 6 months, not previously treated with any INSTI, and no history of treatment failure


BIKTARVY vs an INSTI- or PI-Based Regimen in Virologically Suppressed Adult Women6,7


Study 1961: Phase 3, Randomized, Open-Label, Active-Controlled Study

Virologically Suppressed Adult Women (N=470)
E/C/F/TAF or E/C/F/TDF or ATV+RTV+FTC/TDF
  • HIV-1 RNA <50 copies/mL
  • eGFRCG ≥50 mL/min

1:1

n=234

n=236

Switched to
BIKTARVY QD

Stayed on Baseline
Regimen (SBR)

Week 48
Primary endpoint

Primary endpoint

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

  • Stably suppressed on baseline regimen for at least 3 months

IMPORTANT SAFETY INFORMATION (cont'd)

Contraindications

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

Powerful Efficacy in Virologically Suppressed Adults1,4-7

≥92% of adults who switched to BIKTARVY maintained virologic suppression at Week 48


Virologic Response


Virologic Response in Study 1844 and Study 1878

Study 1844

§95% confidence interval.


Study 1878

§95% confidence interval.


BIKTARVY was also studied in an additional Week 48 phase 3 clinical trial comprised of adult women


Virologic Response


Study 1961

Virologic Response in Study 1961

Study 1961

§95% confidence interval


  • In all studies, treatment outcomes were similar across subgroups by age, sex, race, and region

No Treatment-Emergent Resistance Associated With BIKTARVY1,4-8

In three large phase 3 clinical trials in virologically suppressed adults through Week 48

0
cases of resistance with
BIKTARVY
  • Among 572 virologically suppressed adults in Studies 1844 and 1878, 2 virologic rebound subjects had genotypic and phenotypic data (1 for RT, 1 for IN and RT) and no virologically suppressed subjects had treatment-emergent genotypic or phenotypic resistance to BIKTARVY
  • Among 234 virologically suppressed adult women in Study 1961, 1 participant met the criteria for resistance testing, was tested, and no amino acid substitutions emerged that were associated with BIKTARVY resistance

INDICATION

BIKTARVY® is indicated as a complete regimen for the treatment of HIV-1 infection in adults 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 for ≥3 months 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, also 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 96 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: 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. 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.

*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.

cobicistat or ritonavir.

3TC, lamivudine; ABC, abacavir; ATV, atazanavir; C, cobicistat; DRV, darunavir; DTG, dolutegravir; eGFRCG, estimated glomerular filtration rate; E, elvitegravir; F, emtricitabine; FTC, emtricitabine; IN, integrase; INSTI, integrase strand transfer inhibitor; PI, protease inhibitor; QD, once daily; RT, reverse transcriptase; RTV, ritonavir; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.

References: 1. BIKTARVY [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2018. 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. 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. 4. Molina JM, 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. 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. 7. Data on file. Gilead Sciences, Inc. 8. Andreatta K, Willkom 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.