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Working Together: HIV Care Team Strategies and a Treatment Option

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Working Together: HIV Care Team Strategies and a Treatment Option

Program Information

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Working Together: HIV Care Team Strategies and a Treatment Option
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Hear how one HIV care team works together to enhance patient care and information about a treatment option in managing HIV.

  • Overview

    Advances in the HIV regimens compared to initial treatments over a few decades ago have improved clinical outcomes for patients living with HIV. But HIV still affects many aspects of patients' lives. In addition to selecting an appropriate treatment option for patients, it takes a dedicated, knowledgeable team to help guide patients along the way in managing their HIV. In this broadcast, an expert panel of HIV care team professionals and a patient advocate talk about collaborating to establish specific treatment goals for patients, working together to build trust to enhance patient care, and a treatment option.

    Please click here to see full Prescribing Information for BIKTARVY® (bictegravir 50mg/emtricitabine 200mg/ tenofovir alafenamide 25mg tablets) including BOXED WARNING.

  • BIKTARVY® Indication and Important Safety Information

    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: 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 click here to see full Prescribing Information for BIKTARVY, including BOXED WARNING. 

  • Sponsorship

    This non-CME educational program is sponsored by Gilead Sciences, Inc.

    BIKTARVY, GILEAD and the GILEAD Logo are trademarks of Gilead Sciences, Inc., or its related companies. All other marks are the property of their respective owners.
    © 2020 Gilead Sciences, Inc. All rights reserved. BVYP0808 11/20

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Programs 1/22/21