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.

Simple Dosing for You and Your Patients.

BIKTARVY® Dosing May Provide Flexibility for Patients' Daily Routines1,2

Icon of pill ONCE-DAILYSTR
Icon of clock TAKEN ANY TIME OF DAY
Icon of no food requirement NO FOOD REQUIREMENT
Icon of no booster NO BOOSTER
  • BIKTARVY is not recommended in patients with severe hepatic impairment (Child-Pugh Class C), and is not recommended in patients with severe renal impairment (estimated CrCl <30 mL/min) except in virologically suppressed patients with CrCl <15 mL/min on chronic hemodialysis.




A Way to Help Patients Keep Track of Treatment



Blister Pack

Image for illustrative purposes only.
Actual packaging may differ.
1
Daily Dosing Markers
One week of pills on each card,* so patients can visually track their daily dose
2
Portable Design
Only slightly larger than a credit card, it may fit in a jacket pocket or small bag to help keep treatment close*
3
Refill Reminders
30-day reminders that may prompt patients to refill prescriptions
*Each card in a pack is 106 mm x 71 mm x 8.5 mm. Four cards hold 7 pills, and one card holds 2 pills, for 30 pills total per pack. Store at room temperature between 68 ˚F and 77 ˚F. Keep each pill in original blister pack until use.

Common Questions

How many pills come in a pack?

Each pack contains 30 pills total: 4 cards carrying 7 pills each, and 1 card that holds 2 pills.


Does the BIKTARVY ANYWHERE™ blister pack cost more?

There is no added cost compared to BIKTARVY dispensed in a bottle.

Please use NDC: 61958-2501-3 for this packaging option

NOTE: The name "Anywhere" will not appear in the EHR system.



Simple Dosing in a Small STR


Purple and brown pill with GSI imprint Purple and brown pill with GSI imprint

Not actual size.
Actual size is 15 mm x 8 mm.

BIKTARVY combines the DESCOVY® (FTC/TAF)* backbone with bictegravir, in a small and powerful unboosted STR

Icon of size comparison

STR Size Comparison

Compare BIKTARVY tablet size to that of other single‐tablet regimen options.

BIKTARVY tablets (30 count) are dispensed in a sealed Gilead-branded bottle or blister pack. Authentic BIKTARVY tablets are purplish brown and capsule shaped imprinted with "9883" on one side and "GSI" on the other.


*emtricitabine 200 mg/tenofovir alafenamide 25 mg.

A small STR with simple dosing may offer your patients the flexibility to take their daily treatment as their schedule allows

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

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: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)—containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. 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.

Please see below for additional Important Safety Information for BIKTARVY.

IMPORTANT SAFETY INFORMATION (cont'd)

Drug interactions (cont'd)

  • 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 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history.
  • 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.

CrCl, creatinine clearance; EHR, electronic health record; FTC, emtricitabine; STR, single-tablet regimen; TAF, tenofovir alafenamide.

References: 1. BIKTARVY. Package insert. Gilead Sciences, Inc.; 2021. 2. Data on file. Gilead Sciences, Inc.