Quick answers
- What is Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide used for?
- The FDA-approved label (Genvoya, Gilead Sciences, Inc., February 3, 2025) says: “GENVOYA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 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 for at least 6 months with no history of treatment failure and no known …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide have a boxed warning?
- Yes. The FDA label for Genvoya 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 Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide?
- 1 company lists prescription products of Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in the FDA NDC Directory, including Gilead Sciences, Inc..
What Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
GENVOYA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 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 for at least 6 months with no history of treatment failure and no known …
— FDA label: Genvoya, Gilead Sciences, Inc., effective February 3, 2025. 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 | 1 in the FDA NDC Directory |
| Brand names | Genvoya |
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 |
|---|---|---|
| cobicistat 150 mg · elvitegravir 150 mg · emtricitabine 200 mg · tenofovir alafenamide fumarate 10 mg tablet | Brand: Genvoya | $143.36 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.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA207561 GENVOYA | Gilead Sciences Inc | November 5, 2015 | 18, latest January 7, 2022 2022: Efficacy · 2021: Labeling · 2021: Labeling |
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) | 1721613, 1721619 |
|---|---|
| SPL set ID of the quoted label | 34784acf-15ed-4715-b504-eb30430518e9 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA207561 |
| Active ingredients (FDA) | COBICISTAT / ELVITEGRAVIR / EMTRICITABINE / TENOFOVIR ALAFENAMIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Genvoya, Gilead Sciences, Inc., effective February 3, 2025; 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 →