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.

Early and Effective HIV Treatment Is Crucial1-5

Verified person icon representing undetectable HIV status Verified person icon representing undetectable HIV status

According to the CDC, starting people living with HIV (PLWH) on HIV treatment as soon as possible so they may reach undetectable status is critical

US Map icon representing 38,000 HIV infections each year

Each year, ~38,000 NEW HIV INFECTIONS are diagnosed in the US

Icon of virus representing 8 in 10 new HIV infections come from PLWH not in care Icon of virus representing 8 in 10 new HIV infections come from PLWH not in care

NEW HIV INFECTIONS come from PLWH not in care

The NIH recommends starting PLWH on treatment early, while their CD4 counts may still be high, in order to reduce their risk of developing AIDS or other serious illnesses.

When starting PLWH on ARV therapy, consider the benefits of initiating treatment as soon as possible

Only half of the >1.1 million PLWH in the US are in care and virologically
suppressed, according to 2016 CDC data.

Icon of multiple viruses representing 1 in 5 infections are transmitted from PLWH in care but not virologically suppressed Icon of multiple viruses representing 1 in 5 infections are transmitted from PLWH in care but not virologically suppressed

1

in

5

INFECTIONS

were transmitted from PLWH who were in care but not virologically suppressed*

*2016 data.

According to DHHS guidelines, when people with HIV achieve and maintain an undetectable viral load for at least 6 months, it prevents sexual transmission of HIV to their partners

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: 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.

Please see below for additional Important Safety Information for BIKTARVY.

IMPORTANT SAFETY INFORMATION (cont'd)

Warnings and precautions (cont'd)

  • 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 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.

CDC, Centers for Disease Control and Prevention; DHHS, Department of Health and Human Services; NIH, National Institutes of Health.

References: 1. Zihao L, Purcell DW, Sansom SL, Hayes D, Hall HI. Vital Signs: HIV transmission along the continuum of care—United States, 2016. MMWR Morb Mortal Wkly Rep. 2019;68(11):267-272. 2. Centers for Disease Control and Prevention. Vital Signs. Ending the HIV epidemic. Accessed June 14, 2020. https://www.cdc.gov/vitalsigns/end-HIV/ 3. US Department of Health and Human Services. U.S. statistics. HIV.gov website. Accessed June 14, 2020. https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics 4. US Department of Health and Human Services. National Institutes of Health News Releases. Starting antiretroviral treatment early improves outcomes for HIV-infected individuals. Released May 2015. Accessed June 14, 2020. https://www.nih.gov/news-events/news-releases/starting-antiretroviral-treatment-early-improves-outcomes-hiv-infected-individuals 5. 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. Updated June 3, 2021. Accessed June 21, 2021. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/AdultandAdolescentGL.pdf