Quick answers
- What is Velpatasvir and sofosbuvir used for?
- The FDA-approved label (Epclusa, Gilead Sciences, Inc., June 5, 2024) says: “EPCLUSA is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection […]: without cirrhosis or with compensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Velpatasvir and sofosbuvir have a boxed warning?
- Yes. The FDA label for Epclusa has a boxed warning (“WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Velpatasvir and sofosbuvir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Velpatasvir and sofosbuvir been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 7, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Velpatasvir and sofosbuvir?
- 2 companies list prescription products of Velpatasvir and sofosbuvir in the FDA NDC Directory, including Gilead Sciences, Inc. and Asegua Therapeutics LLC.
What Velpatasvir and sofosbuvir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
EPCLUSA is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection […]: without cirrhosis or with compensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin. …
— FDA label: Epclusa, Gilead Sciences, Inc., effective June 5, 2024. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
. Read it on the full label →
2 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Pellet |
|---|---|
| Route | Oral |
| Prescription products | 5 in the FDA NDC Directory |
| Brand names | Epclusa |
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 |
|---|---|---|
| sofosbuvir 400 mg · velpatasvir 100 mg tablet, film coated | Generic | $277.96 per tablet |
| sofosbuvir 400 mg · velpatasvir 100 mg tablet, film coated | Brand: Epclusa | $864.99 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.4 products
- Asegua Therapeutics LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA208341 EPCLUSA | Gilead Sciences Inc | June 28, 2016 | 11, latest December 14, 2022 2022: Manufacturing (CMC) · 2022: Efficacy · 2021: Efficacy |
| NDA214187 EPCLUSA | Gilead Sciences Inc | June 10, 2021 | 1, latest April 27, 2022 2022: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 7, 2025 · Class II · Terminated · D-0313-2025
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an affiliate of Gilead Sciences, Inc., Foster City, CA 94404, Made in Ireland, NDC# 72 — ASEGUA THERAPEUTICS LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Epclusa, Gilead Sciences, Inc., effective June 5, 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 →