Quick answers
- What is Bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate used for?
- The FDA-approved label (Biktarvy, A-S Medication Solutions, April 30, 2024) says: “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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate have a boxed warning?
- Yes. The FDA label for Biktarvy has a boxed warning (“WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate?
- 2 companies list prescription products of Bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate in the FDA NDC Directory, including Gilead Sciences, Inc. and A-S Medication Solutions.
What Bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 …
— FDA label: Biktarvy, A-S Medication Solutions, effective April 30, 2024. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Biktarvy |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| bictegravir sodium 30 mg · emtricitabine 120 mg · tenofovir alafenamide fumarate 15 mg tablet | Brand: Biktarvy | $136.63 per tablet |
| bictegravir sodium 50 mg · emtricitabine 200 mg · tenofovir alafenamide fumarate 25 mg tablet | Brand: Biktarvy | $136.75 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Gilead Sciences, Inc.3 products
- A-S Medication Solutions1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA210251 BIKTARVY | Gilead Sciences Inc | February 7, 2018 | 15, latest May 21, 2026 2026: Manufacturing (CMC) · 2025: Efficacy · 2024: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1999667, 1999673 |
|---|---|
| SPL set ID of the quoted label | 0476d7eb-1024-4821-bbe7-abaacfda32a2 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA210251 |
| Active ingredients (FDA) | BICTEGRAVIR / EMTRICITABINE / TENOFOVIR ALAFENAMIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Biktarvy, A-S Medication Solutions, effective April 30, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →