BIKTARVY
BIKTARVY is a three-drug combination of bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg. It is approved for use in patients with no prior antiretroviral treatment history or to replace a current stable antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA < 50 copies/mL). For patients switching regimens, there must be no known or suspected substitutions associated with resistance to bictegravir or tenofovir.
How BIKTARVY Works
BIKTARVY combines three antiretroviral agents to inhibit HIV-1 replication through two distinct mechanisms: * **Bictegravir:** An integrase strand transfer inhibitor (INSTI) that binds to the integrase active site and blocks the strand transfer step of retroviral DNA integration, which is essential for the HIV replication cycle. * **Emtricitabine and Tenofovir Alafenamide:** Both are nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs). After intracellular phosphorylation, they compete with natural substrates for incorporation into viral DNA, acting as chain terminators to inhibit the activity of HIV-1 reverse transcriptase.
Details
- Status
- Prescription
- First Approved
- 2018-02-07
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
BIKTARVY Approval History
What BIKTARVY Treats
1 indicationsBIKTARVY is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Human Immunodeficiency Virus
BIKTARVY 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 ap...
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 [see Warnings and Precautions (5.1) ] . WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. 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 in these patients. If appropriate, anti-hepatitis B therapy may be warranted. ( 5.1 )
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BIKTARVY FDA Label Details
ProIndications & Usage
FDA Label (PDF)BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (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. BIKTARVY is a three-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase s...
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 discon...
BIKTARVY Patents & Exclusivity
Patents (36 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.