Prescription medicine
Ledipasvir and sofosbuvir Brand names: Harvoni
Ledipasvir and sofosbuvir (Harvoni) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the ledipasvir and sofosbuvir FDA label on DailyMed (effective December 26, 2024, Gilead Sciences, Inc); the NDA 205834 record on Drugs@FDA; every ledipasvir and sofosbuvir label on DailyMed.
Highlights of the record
FDA label of December 26, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV.
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with HARVONI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated [see Warnings and Precautions (5.1) ]. WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV See full prescribing information for complete boxed warning. Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death.
Used for
From the label: indications and usageHARVONI is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) [see Dosage and Administration (2.2 and 2.3) and Clinical Studies (14) ]: 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 tr
Forms and strengths
- 33.75 mg / 150 mg
- 45 mg / 200 mg
- 90 mg / 400 mg
Film-coated tablet; pellet.
On the market
- Earliest approval on file
- October 10, 2014 Harvoni, Gilead Sciences Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 30, 2034 Harvoni tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 19,115 through July 30, 2026
What is ledipasvir and sofosbuvir used for?
From the label: indications and usageHARVONI is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) [see Dosage and Administration (2.2 and 2.3) and Clinical Studies (14) ]: 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, for use in combination with ribavirin HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is […]
Conditions named in the indications of ledipasvir and sofosbuvir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hepatitis C Virus NS5A Inhibitor and Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor.
Source: FDA drug label (Harvoni), Gilead Sciences, Inc, effective December 26, 2024 (SPL set f4ec77e4-bae8-4db0-b3d5-bde09c5fa075), via openFDA; the full label on DailyMed
What does the patient leaflet for ledipasvir and sofosbuvir say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about HARVONI?HARVONI can cause serious side effects, including, Hepatitis B virus reactivation: Before starting treatment with HARVONI, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with HARVONI. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking HARVONI. For more information about side effects, see the section " What are the possible side effects of HARVONI? " What is HARVONI? HARVONI is a prescription medicine used to treat adults and children 3 years of age and older with chronic (lasting a long time) hepatitis C virus (HCV): genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis genotype 1 infection with advanced cirrhosis (decompensated) in combination with ribavirin genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis who have had a liver transplant, in combination with ribavirin It is not known if HARVONI is safe and effective in children with HCV under 3 years of age. Before taking HARVONI, tell your healthcare provider about all of your medical conditions, including if you: have ever had hepatitis B virus infection have liver problems other than hepatitis C infection have had a liver transplant have kidney problems or you are on dialysis have HIV infection are pregnant or plan to become pregnant. It is not known if HARVONI will harm your unborn baby. […]
From the patient leaflet: How should I store HARVONI?Store HARVONI tablets or pellets below 86°F (30°C). Keep HARVONI tablets in the original container. Do not use HARVONI tablets if the seal over the bottle opening is broken or missing. Do not use HARVONI pellets if the carton tamper-evident seal, or the pellets packet seal, is broken or damaged. Keep HARVONI and all medicines out of the reach of children.
Source: FDA drug label (Harvoni), Gilead Sciences, Inc, effective December 26, 2024 (SPL set f4ec77e4-bae8-4db0-b3d5-bde09c5fa075), via openFDA; the full label on DailyMed
Is there a generic for ledipasvir and sofosbuvir (Harvoni)?
No generic ledipasvir and sofosbuvir is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 17 patents for Harvoni tablets: the compound patent runs to January 30, 2034 (pediatric exclusivity to July 30, 2034). A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ledipasvir and sofosbuvir label say about other medicines?
The ledipasvir and sofosbuvir label names 35 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name ledipasvir and sofosbuvir. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Abacavir | drug interactions | … observed or are expected when HARVONI is used with the following drugs [see Clinical Pharmacology (12.3) ]: abacavir, atazanavir/ritonavir, cyclosporine, darunavir/ritonavir, dolutegravir, efavirenz, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, lamivudine, methadone, midazolam, oral … |
| Amiodarone | drug interactions | DRUG INTERACTIONS Coadministration with amiodarone may result in serious symptomatic bradycardia. |
| Atazanavir | drug interactions | Concomitant Drug Class/Drug Name: Regimens containing tenofovir DF and an HIV protease inhibitor/ ritonavir or cobicistat atazanavir/ritonavir or cobicistat + emtricitabine/tenofovir DF darunavir/ritonavir or cobicistat + emtricitabine/tenofovir DF lopinavir/ritonavir + emtricitabine/tenofovir DF; … |
| Atorvastatin | drug interactions | Concomitant Drug Class/Drug Name: atorvastatin; Effect on Concentration ↓ = decrease, ↑ = increase: ↑ atorvastatin; Clinical Comment: Coadministration of HARVONI with atorvastatin may be associated with increased risk of myopathy, including rhabdomyolysis. … |
| Carbamazepine | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine phenytoin phenobarbital; Effect on Concentration ↓ = decrease, ↑ = increase: ↓ ledipasvir ↓ sofosbuvir; Clinical Comment: Coadministration of HARVONI with carbamazepine, phenytoin, or phenobarbital is expected to decrease the concentration of ledipasvir … |
| Cobicistat | drug interactions | Concomitant Drug Class/Drug Name: Regimens containing tenofovir DF without an HIV protease inhibitor/ ritonavir or cobicistat; Effect on Concentration ↓ = decrease, ↑ = increase: ↑ tenofovir; Clinical Comment: Monitor for tenofovir-associated adverse reactions in patients receiving HARVONI concomitantly with a regimen … |
| Cyclosporine | drug interactions | … HARVONI is used with the following drugs [see Clinical Pharmacology (12.3) ]: abacavir, atazanavir/ritonavir, cyclosporine, darunavir/ritonavir, dolutegravir, efavirenz, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, lamivudine, methadone, midazolam, oral contraceptives, pravastatin … |
| Darunavir | drug interactions | Concomitant Drug Class/Drug Name: Regimens containing tenofovir DF and an HIV protease inhibitor/ ritonavir or cobicistat atazanavir/ritonavir or cobicistat + emtricitabine/tenofovir DF darunavir/ritonavir or cobicistat + emtricitabine/tenofovir DF lopinavir/ritonavir + emtricitabine/tenofovir DF; … |
| Digoxin | drug interactions | Concomitant Drug Class/Drug Name: digoxin; Effect on Concentration ↓ = decrease, ↑ = increase: ↑ digoxin; Clinical Comment: Coadministration of HARVONI with digoxin may increase the concentration of digoxin. Therapeutic concentration monitoring of digoxin is recommended when coadministered with HARVONI. |
| Dolutegravir | drug interactions | … drugs [see Clinical Pharmacology (12.3) ]: abacavir, atazanavir/ritonavir, cyclosporine, darunavir/ritonavir, dolutegravir, efavirenz, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, lamivudine, methadone, midazolam, oral contraceptives, pravastatin, raltegravir, rilpivirine, tacrolimus, or … |
| Efavirenz | drug interactions | … Clinical Pharmacology (12.3) ]: abacavir, atazanavir/ritonavir, cyclosporine, darunavir/ritonavir, dolutegravir, efavirenz, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, lamivudine, methadone, midazolam, oral contraceptives, pravastatin, raltegravir, rilpivirine, tacrolimus, or verapamil. |
| Emtricitabine | drug interactions | Concomitant Drug Class/Drug Name: Regimens containing tenofovir DF and an HIV protease inhibitor/ ritonavir or cobicistat atazanavir/ritonavir or cobicistat + emtricitabine/tenofovir DF darunavir/ritonavir or cobicistat + emtricitabine/tenofovir DF lopinavir/ritonavir + emtricitabine/tenofovir DF; … |
| Famotidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -receptor antagonists These interactions have been studied in healthy adults. (e.g., famotidine); Effect on Concentration ↓ = decrease, ↑ = increase: ↓ ledipasvir; … |
| Lamivudine | drug interactions | … darunavir/ritonavir, dolutegravir, efavirenz, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, lamivudine, methadone, midazolam, oral contraceptives, pravastatin, raltegravir, rilpivirine, tacrolimus, or verapamil. |
Every other medicine the ledipasvir and sofosbuvir label names
| Medicine named | Section | What the label says |
|---|---|---|
| Lopinavir and ritonavir | drug interactions | Regimens containing tenofovir DF and an HIV protease inhibitor/ ritonavir or cobicistat atazanavir/ritonavir or cobicistat + emtricitabine/tenofovir DF darunavir/ritonavir or cobicistat + … |
| Magnesium hydroxide | drug interactions | Concomitant Drug Class/Drug Name: Antacids (e.g., aluminum and magnesium hydroxide); Effect on Concentration ↓ = decrease, ↑ = increase: ↓ ledipasvir; … |
| Methadone | drug interactions | … elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, lamivudine, methadone, midazolam, oral contraceptives, pravastatin, raltegravir, rilpivirine, tacrolimus, or verapamil. |
| Midazolam | drug interactions | … elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, lamivudine, methadone, midazolam, oral contraceptives, pravastatin, raltegravir, rilpivirine, tacrolimus, or verapamil. |
| Omeprazole | drug interactions | Concomitant Drug Class/Drug Name: Proton-pump inhibitors (e.g., omeprazole); Effect on Concentration ↓ = decrease, ↑ = increase: ↓ ledipasvir; … |
| Phenobarbital | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine phenytoin phenobarbital; Effect on Concentration ↓ = decrease, ↑ = increase: ↓ ledipasvir ↓ sofosbuvir; … |
| Phenytoin | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine phenytoin phenobarbital; Effect on Concentration ↓ = decrease, ↑ = increase: ↓ ledipasvir ↓ sofosbuvir; … |
| Pravastatin | drug interactions | … emtricitabine, lamivudine, methadone, midazolam, oral contraceptives, pravastatin, raltegravir, rilpivirine, tacrolimus, or verapamil. |
| Raltegravir | drug interactions | … lamivudine, methadone, midazolam, oral contraceptives, pravastatin, raltegravir, rilpivirine, tacrolimus, or verapamil. |
| Ribavirin | contraindications | CONTRAINDICATIONS If HARVONI is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: rifabutin rifampin rifapentine; Effect on Concentration ↓ = decrease, ↑ = increase: ↓ ledipasvir ↓ sofosbuvir; … |
| Rifampin | drug interactions | Use of HARVONI with amiodarone is not recommended. ( 5.2 , 6.2 , 7.2 ) P-gp inducers (e.g., rifampin, St. John's wort): |
| Rifapentine | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: rifabutin rifampin rifapentine; Effect on Concentration ↓ = decrease, ↑ = increase: ↓ ledipasvir ↓ sofosbuvir; … |
| Rilpivirine | drug interactions | … methadone, midazolam, oral contraceptives, pravastatin, raltegravir, rilpivirine, tacrolimus, or verapamil. |
| Ritonavir | drug interactions | Concomitant Drug Class/Drug Name: Regimens containing tenofovir DF without an HIV protease inhibitor/ ritonavir or cobicistat; Effect on Concentration ↓ = decrease, ↑ = increase: ↑ tenofovir; … |
| Rosuvastatin | drug interactions | Concomitant Drug Class/Drug Name: HMG-CoA Reductase Inhibitors: rosuvastatin; Effect on Concentration ↓ = decrease, ↑ = increase: ↑ rosuvastatin; … |
| Tacrolimus | drug interactions | … midazolam, oral contraceptives, pravastatin, raltegravir, rilpivirine, tacrolimus, or verapamil. |
| Tenofovir alafenamide | drug interactions | … darunavir/ritonavir, dolutegravir, efavirenz, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, lamivudine, methadone, midazolam, oral contraceptives, pravastatin … |
| Tenofovir disoproxil | drug interactions | Concomitant Drug Class/Drug Name: Regimens containing tenofovir DF without an HIV protease inhibitor/ ritonavir or cobicistat; Effect on Concentration ↓ = decrease, ↑ = increase: ↑ tenofovir; … |
| Verapamil | drug interactions | … contraceptives, pravastatin, raltegravir, rilpivirine, tacrolimus, or verapamil. |
| Warfarin | drug interactions | Frequent monitoring of relevant laboratory parameters (e.g., International Normalized Ratio [INR] in patients taking warfarin, blood glucose levels in diabetic patients) or drug concentrations of … |
Source: FDA drug label (Harvoni), Gilead Sciences, Inc, effective December 26, 2024 (SPL set f4ec77e4-bae8-4db0-b3d5-bde09c5fa075), via openFDA; the full label on DailyMed
What do FAERS reports show for ledipasvir and sofosbuvir?
The FDA Adverse Event Reporting System holds 19,115 reports that list ledipasvir and sofosbuvir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 779 are coded as a death and 2,708 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2016 (5,147, against a median of 221 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ledipasvir and sofosbuvir?
3 other medicines are given the same way (oral) and in the same FDA class as ledipasvir and sofosbuvir or labeled mainly for the same use (hepatitis c), the same class first. Hepatitis C lists all 8 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Glecaprevir and pibrentasvir | Hepatitis C | none listed | $152.98 per tablet 100-40 mg tablet | No current entry |
| Elbasvir and grazoprevir | Hepatitis C | none listed | n/a | A presentation being discontinued |
| Ribavirin | Hepatitis C | 1 labeler | $0.451 per tablet 200 mg tablet | No current entry |
Every medicine labeled for the same conditions as ledipasvir and sofosbuvir
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ledipasvir and sofosbuvir
- 3 medicines for the same use
- Other hepatitis c virus ns5a inhibitors
- the pharmacologic class, with prices and generics
- Ledipasvir and sofosbuvir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other