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
BIKTARVY (n=314)
vs
ABC/DTG/3TC
(n=315)
BIKTARVY (n=320)
vs
FTC/TAF+DTG
(n=325)
Virologically Suppressed Adults
Switched to BIKTARVY (n=282) or continued on ABC/DTG/3TC (n=281)
Switched to BIKTARVY (n=290) or stayed on baseline regimen* (n=287)
Virologically Suppressed Adult Women
Switched to BIKTARVY (n=234) or
stayed on baseline regimen† (n=236)
Virologically Suppressed Pediatric Patients
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
(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
Study 14893,9: Selected Baseline Characteristics |
BIKTARVY®(n=314) | ABC/ DTG/3TC(n=315) |
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|
IMPORTANT SAFETY INFORMATION
Contraindications
- Coadministration: Do not use BIKTARVY with dofetilide or rifampin.
IQR, interquartile range.
BIKTARVY vs FTC/TAF+DTG in Treatment-Naïve Adults1,5,6
Study 1490: Phase 3, Randomized, Double-Blind, Active-Controlled Study
(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
Study 14906,10: Selected Baseline Characteristics |
BIKTARVY®(n=320) | FTC/TAF +DTG(n=325) |
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|
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 1441,3-8
Results noninferior to comparators
Study 1489: Virologic Response
§95% confidence interval.
Overall Rapid Reduction in Viral Load With BIKTARVY®3,5
Study 1489: Missing=Failure (M=F) Analysis
- 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%).
Week 48: Study 1489 Virologic Outcomes1,3,5,7*1* |
BIKTARVY®(n=314)
ABC/
DTG/ 3TC(n=315) |
Week 96 BIKTARVY(n=314)
ABC/
DTG/3TC(n=315) |
BIKTARVY†®(n=314)
ABC/
DTG/ 3TC(n=315) |
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|
*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 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.
Study 1490: Virologic Response
§95% confidence interval.
Overall Rapid Reduction in Viral Load With BIKTARVY®5,6
Study 1490: Missing=Failure (M=F) Analysis
- 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%).
Week 48: Study 1490 Virologic Outcomes1,5-8*8* |
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) |
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|
*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.
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 BIKTARVY1,3,5-7
In two large phase 3 clinical trials in treatment-naïve adults through Week 144
- 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
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 ≥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
Contraindications
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; E, elvitegravir; eGFRCG, estimated glomerular filtration rate (Cockcroft-Gault); F, emtricitabine; FTC, emtricitabine; 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. Orkin C, Sax PE, Arribas J, et al. Long-term efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide in ART-naïve adults. Presented at: 17th European AIDS Conference; November 6-9, 2019; Basel, Switzerland. 8. 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. 9. 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. 10. 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.
During these unprecedented times, Gilead is focused on being a resource and supporting the efforts of healthcare providers, colleagues, and partners who are on the front lines of the COVID-19 fight. Gilead continues to be dedicated to ensuring people living with HIV have access to the HIV medications and support needed.
We are also working to ensure continuity of supply and continued access to our existing medicines. There are no manufacturing concerns or supply shortages with any Gilead products. We have adequate supply of our products and do not foresee any threat to our supply chain for the foreseeable future.
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