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.

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

Please see below for additional Important Safety Information for BIKTARVY.

Guideline Recommendations for BIKTARVY®

Department of Health and Human Services (DHHS)

BIKTARVY is a recommended initial antiretroviral therapy (ART) regimen for most people with HIV-11 (evidence rating AI, strong recommendation based on ≥1 randomized trials with clinical outcomes and/or validated laboratory endpoints)


BIKTARVY is a recommended treatment option for persons with acute or recent HIV infection in cases where ART will be initiated before genotypic drug resistance testing results are available1 (evidence rating: AIII, strong recommendation based on expert opinion)


Additional DHHS guidance1

  • ARV therapy should be initiated immediately (or as soon as possible) in patients diagnosed with HIV, regardless of CD4 cell count
  • When initiating therapy, it is important to educate patients on the benefits and considerations of treatment and adherence
Rating Scheme for Recommendations1 Strength of Recommendation: A, Strong recommendation for the statement; B, Moderate recommendation for the statement; C, Optional recommendation for the statement. Quality of Evidence for Recommendation: I, One or more randomized trials with clinical outcomes and/or validated laboratory endpoints; II, One or more well-designed, non-randomized trials or observational cohort studies with long-term clinical outcomes; III, Expert opinion.

International Antiviral Society—USA (IAS—USA) Panel

BIKTARVY is a recommended initial ART regimen for most people with HIV-11 (evidence rating: AIa, strong panel support from ≥1 RCTs published in the peer-reviewed literature)

Strength of Recommendation and Quality of Evidence Rating Scale1 Strength of Recommendation: A, Strong panel support; B, Moderate panel support; C, Limited or weak panel support. Quality of Evidence: Ia, Evidence from ≥1 RCTs published in the peer-reviewed literature; Ib, Evidence from ≥1 RCTs presented in abstract form at peer-reviewed scientific meetings; IIa, Evidence from cohort or case-control studies published in the peer-reviewed literature; IIb, Evidence from cohort or case-control studies presented in abstract form at peer-reviewed scientific meetings; III, Based on the panel’s analysis of the available evidence.

These clinical guidelines recommend BIKTARVY as an initial regimen for most people with HIV-1 with no listed exceptions for immediate initiation, HBV status, high viral load, or low CD4 count.

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.

Please see below for additional Important Safety Information for BIKTARVY.

IMPORTANT SAFETY INFORMATION (cont'd)

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.

Please see below for additional Important Safety Information for BIKTARVY.

IMPORTANT SAFETY INFORMATION (cont'd)

Warnings and precautions (cont'd)

  • 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.
  • 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.

ARV, antiretroviral; RCT, randomized control trial.

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. Updated June 3, 2021. Accessed June 21, 2021. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/AdultandAdolescentGL.pdf