Enough said.

Learn if BIKTARVY® is right for your 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.

Please see below for Important Safety Information for BIKTARVY.

See Why BIKTARVY is the #1 Prescribed Regimen for HIV-1

Source: Ipsos Healthcare US HIV Therapy Monitor & Scope Study Oct-Dec 2019.

High barrier to resistance1-7

Resistance Profile

No treatment-emergent resistance—including INSTI and NRTI resistance—was associated with BIKTARVY in treatment-naïve clinical trials through Week 144 and in virologically suppressed clinical trials through Week 48.*

See resistance results See the data

Long-term efficacy and safety profile7

Safety Profile

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

View the results View results

*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. 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 through Week 48. 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 through Week 48. Among 100 virologically suppressed children in Study 1474, 2 of 50 subjects in cohort 1 were evaluated for the development of resistance through Week 48; no amino acid substitutions known to be associated with resistance to BIKTARVY, FTC, or TFV were detected. No subjects in cohort 2 met criteria for resistance analyses.1-7


DHHS recommended8

Dosing

  • As an initial regimen for
    most people with HIV-1
  • As a treatment option
    appropriate for immediate
    treatment initiation
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Broadly studied3,5

Clinical Trials

BIKTARVY has been studied in 6 clinical trials with over 1500 people, including various age groups and ethnicities.

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Contraindications

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

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Patient support for those on BIKTARVY

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#1 prescribed and DHHS recommended

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.

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.

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.

DHHS, Department of Health and Human Services; FTC, emtricitabine; IN, integrase; INSTI, integrase strand transfer inhibitor; NRTI; nucleoside reverse transcriptase inhibitor; RT, reverse transcriptase; TFV, tenofovir.

References: 1. Tsiang M, Jones GS, Goldsmith J, et al. Antiviral activity of bictegravir (GS-9883), a novel potent HIV-1 integrase strand transfer inhibitor with an improved resistance profile. Antimicrob Agents Chemother. 2016;60(12):7086-7097. 2. Data on file. Gilead Sciences, Inc. 3. BIKTARVY [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2019. 4. 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. 5. 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. 6. White K, Niedziela-Majka A, Novikov N, et al. Bictegravir dissociation half-life from HIV-1 G140S/Q148H integrase-DNA complexes. Poster presented at: Conference on Retroviruses and Opportunistic Infections; February 13-16, 2017; Seattle, WA. 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. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Updated December 18, 2019. Accessed June 14, 2020.

DHHS, Department of Health and Human Services.

Reference: 1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Updated December 18, 2019. Accessed June 14, 2020.