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Bictegravir, emtricitabine, and tenofovir alafenamide

(Biktarvy®)

Biktarvy®

Drug updated on 12/11/2024

Dosage FormTablet (oral; bictegravir/emtricitabine/tenofovir alafenamide: 50 mg/ 200 mg/ 25 mg); Tablet (oral; bictegravir/emtricitabine/tenofovir alafenamide: 30 mg/ 120 mg/ 15 mg)
Drug ClassHIV integrase strand transfer inhibitors (INSTI), and HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.

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Summary
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  • This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
  • Virologic suppression (human immunodeficiency virus (HIV)-1 RNA < 50 copies/mL) rates at Week 144 were similar across dolutegravir + lamivudine (DTG + 3TC), bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), and DTG/abacavir (ABC)/3TC regimens, with no significant differences in virologic failure (HIV-1 RNA ≥ 50 copies/mL) between the groups.
  • In a pooled analysis of virologically suppressed Asian participants, 100% of those who switched to B/F/TAF maintained virologic suppression at Week 48, similar to those who remained on baseline regimens (95.9%, p = 0.2485).
  • A meta-analysis of seven randomized clinical trials showed no statistically significant difference in efficacy between BIC/FTC/TAF and control regimens at Week 48 [odds ratio (OR) 1.01 (95% confidence interval (CI))].
  • There is no population type or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) Prescribing Information.2024Gilead Sciences, Inc., Foster City, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
An indirect comparison of 144-week efficacy, safety, and tolerability of dolutegravir plus lamivudine and second-generation integrase inhibitor-based, 3-drug, single-tablet regimens in therapy-naive people with HIV-12023AIDS Research and Therapy
Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: A pooled analysis from three international phase III randomized trials2023HIV Medicine
Efficacy, safety and tolerability of Biktarvy in HIV-1 infection: a scoping review.2023Antiviral Therapy
Real-world discontinuations due to neuropsychiatric symptoms in people living with HIV treated with second-generation integrase inhibitors: a systematic review.2023Expert Review of Anti-Infective Therapy
Comparison of the design and methodology of Phase 3 clinical trials of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir-based dual therapy (DTG) in HIV: a systematic review of the literature2023Expert Review of Anti-Infective Therapy
Meta-analysis of efficacy and safety of coformulated bictegravir, emtricitabine, and tenofovir alafenamide among people living with HIV.2021Infectious Diseases and Therapy

Clinical Practice Guidelines

Document TitleYearSource
Guidelines for the use of antiretroviral agents in pediatric HIV infection.2023NIH
Guidelines for the use of antiretroviral agents in adults and adolescents with HIV.2022NIH
BHIVA guidelines on antiretroviral treatment for adults living with HIV-1 20222022HIV Medicine