Quick answers
- What is Ledipasvir and sofosbuvir used for?
- The FDA-approved label (Harvoni, Gilead Sciences, Inc, December 26, 2024) says: “HARVONI is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) […]: genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ledipasvir and sofosbuvir have a boxed warning?
- Yes. The FDA label for Harvoni 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 Ledipasvir and sofosbuvir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ledipasvir and sofosbuvir been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ledipasvir and sofosbuvir?
- 2 companies list prescription products of Ledipasvir and sofosbuvir in the FDA NDC Directory, including Gilead Sciences, Inc. and Asegua Therapeutics LLC.
What Ledipasvir and sofosbuvir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
HARVONI is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) […]: genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis …
— FDA label: Harvoni, Gilead Sciences, Inc, effective December 26, 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 | Harvoni |
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 |
|---|---|---|---|
| NDA205834 HARVONI | Gilead Sciences Inc | October 10, 2014 | 20, latest December 19, 2024 2024: Labeling · 2020: Labeling · 2019: Efficacy |
| NDA212477 HARVONI | Gilead Sciences Inc | August 28, 2019 | 5, latest December 19, 2024 2024: Labeling · 2020: Labeling · 2019: 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Harvoni, Gilead Sciences, Inc, effective December 26, 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 →