INDICATIONS

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.
DESCOVY®, a component of BIKTARVY, is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in patients weighing at least 35 kg.

IMPORTANT SAFETY INFORMATION FOR BIKTARVY AND DESCOVY

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 or DESCOVY. 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 or DESCOVY. If appropriate, anti-hepatitis B therapy may be warranted.

Please see below for additional Important Safety Information for BIKTARVY and DESCOVY.

Please see below for additional Important Safety Information for BIKTARVY and DESCOVY.

When Choosing an HIV Regimen: Components Matter1-5

BIKTARVY® is the only triple therapy STR that pairs the trusted DESCOVY (FTC/TAF) backbone with the power of bictegravir


Bictegravir, a novel and unboosted INSTI

  • Long plasma half-life of 17.3 hours*
  • Long integrase binding half-life of 38 hours in vitro

The clinical relevance of these data has not been established.

+

A DHHS-recommended backbone

DESCOVY® (FTC/TAF) is a dual-NRTI that can be used as a backbone in 3 DHHS-recommended initial regimens for most people with HIV

Backed by over 1.4 million patient-years of experience

DHHS recommended as an initial regimen for most people with HIV-14


*Plasma half-life: the time for the plasma concentration of bictegravir to fall to half its original value.
Integrase binding: the residence time of bictegravir on the integrase-DNA complex.
Estimated postmarketing exposure for all TAF-containing HIV products, cumulative to May 2019.

INDICATIONS

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.
DESCOVY®, a component of BIKTARVY, is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in patients weighing at least 35 kg.

IMPORTANT SAFETY INFORMATION FOR BIKTARVY AND DESCOVY

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 or DESCOVY. 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 or DESCOVY. If appropriate, anti-hepatitis B therapy may be warranted.

Please see below for additional Important Safety Information for BIKTARVY and DESCOVY.

IMPORTANT SAFETY INFORMATION FOR BIKTARVY AND DESCOVY (cont'd)

Contraindications

Contraindications for BIKTARVY:

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

Warnings and precautions

Warnings and precautions for BIKTARVY and DESCOVY:

  • 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 emtricitabine and tenofovir alafenamide (TAF) with other ARVs, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate 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 in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
    Renal monitoring: Prior to or when initiating 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 if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Additional warnings and precautions for BIKTARVY:

  • 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.

Adverse reactions

Adverse reactions for BIKTARVY:

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

Adverse reactions for DESCOVY:

  • Most common adverse reaction (incidence ≥10%; all grades) in clinical studies was nausea (10%).

Drug interactions

Drug interactions for BIKTARVY and DESCOVY:

  • Prescribing information: Consult the full prescribing information for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
  • Drugs affecting renal function: Coadministration 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.

Additional drug interactions for BIKTARVY:

  • 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.

Additional drug interactions for DESCOVY:

  • Metabolism: Drugs that inhibit P-gp can increase the concentrations of components of DESCOVY. Drugs that induce P-gp can decrease the concentrations of components of DESCOVY, which may lead to loss of efficacy and development of resistance.

Dosage and administration

Information for BIKTARVY:

  • Dosage: Patients weighing ≥25 kg: 1 tablet taken once daily with or without food.

Information for DESCOVY:

  • Dosage: Patients weighing ≥35kg: 1 tablet taken once daily with or without food.

Information for BIKTARVY and DESCOVY:

  • Renal impairment: Not recommended in patients with CrCl <30 mL/min.
  • 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.

Additional Information for BIKTARVY:

  • Hepatic impairment: Not recommended in patients with severe hepatic impairment.

Pregnancy and lactation

Information for BIKTARVY and DESCOVY:

  • Pregnancy: There is insufficient human data on use 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.

FTC, emtricitabine; INSTI, integrase strand transfer inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; STR, single-tablet regimen; TAF, tenofovir alafenamide.

References: 1. BIKTARVY [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2019. 2. 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. 3. 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. 4. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Updated July 10, 2019. Accessed July 16, 2019. 5. Data on file. Gilead Sciences, Inc.