Prescription medicine
Sofosbuvir and velpatasvir Brand names: Epclusa
Sofosbuvir and velpatasvir (Epclusa) is a prescription medicine with an FDA approval on record since 2016. No generic is listed; pharmacies paid $278.03 per unit (Sofosbuvir-velpatasvir 400-100) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the sofosbuvir and velpatasvir FDA label on DailyMed (effective June 5, 2024, Gilead Sciences, Inc.); the NDA 208341 record on Drugs@FDA; every sofosbuvir and velpatasvir label on DailyMed.
Highlights of the record
FDA label of June 5, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 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 EPCLUSA. 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 usageEPCLUSA 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 [see Dosage and Administration (2.2 , 2.3 , 2.4) and Clinical Studies (14) ]: without cirrhosis or with compensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin.
Forms and strengths
- 37.5 mg / 150 mg
- 50 mg / 200 mg
- 100 mg / 400 mg
Film-coated tablet; pellet.
On the market
- Earliest approval on file
- June 28, 2016 Epclusa, Gilead Sciences Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 Epclusa tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $278.03 per unit Sofosbuvir-velpatasvir 400-100
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2025 0 Class I among all firms' recalls; latest March 7, 2025
- FAERS reports
- 12,759 through July 30, 2026
What is sofosbuvir and velpatasvir used for?
From the label: indications and usageEPCLUSA 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 [see Dosage and Administration (2.2 , 2.3 , 2.4) and Clinical Studies (14) ]: without cirrhosis or with compensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin. […]
Conditions named in the indications of sofosbuvir and velpatasvir'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 (Epclusa), Gilead Sciences, Inc., effective June 5, 2024 (SPL set 7f30631a-ee3b-4cfe-866b-964df3f0a44f), via openFDA; the full label on DailyMed
What does the patient leaflet for sofosbuvir and velpatasvir 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 EPCLUSA?EPCLUSA can cause serious side effects, including: Hepatitis B virus reactivation: Before starting treatment with EPCLUSA, 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 EPCLUSA. 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 EPCLUSA. For more information about side effects, see the section " What are the possible side effects of EPCLUSA? " What is EPCLUSA? EPCLUSA 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, 2, 3, 4, 5, or 6 infection: without cirrhosis or with compensated cirrhosis. with advanced cirrhosis (decompensated) in combination with ribavirin. EPCLUSA contains the two medicines: sofosbuvir and velpatasvir. It is not known if EPCLUSA is safe and effective in children under 3 years of age. Before taking EPCLUSA, 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-1 infection are pregnant or plan to become pregnant. It is not known if EPCLUSA will harm your unborn baby. Females who take EPCLUSA in combination with ribavirin should avoid becoming pregnant during treatment and for 6 months after stopping treatment. […]
From the patient leaflet: How should I store EPCLUSA?Store EPCLUSA tablets or oral pellets below 86°F (30°C). Keep EPCLUSA tablets in the original container. Do not use EPCLUSA oral pellets if the carton tamper-evident seal or the packet has been opened or damaged. Keep EPCLUSA and all medicines out of the reach of children.
Source: FDA drug label (Epclusa), Gilead Sciences, Inc., effective June 5, 2024 (SPL set 7f30631a-ee3b-4cfe-866b-964df3f0a44f), via openFDA; the full label on DailyMed
Is there a generic for sofosbuvir and velpatasvir (Epclusa)?
No generic sofosbuvir and velpatasvir is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 15 patents for Epclusa tablets: the compound patent runs to November 16, 2032 (pediatric exclusivity to May 16, 2033), and the last listed entry 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.
- 2016 earliest approval on file
- 2034 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for sofosbuvir and velpatasvir (Epclusa)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $278.03 per unit (Sofosbuvir-velpatasvir 400-100), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Sofosbuvir-velpatasvir 400-100 (generic)
- Epclusa 400 mg-100 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Sofosbuvir-velpatasvir 400-100 | Generic | $278.03 per unit | n/a | -0.1% |
| Epclusa 400 mg-100 mg tablet | Brand | $865.89 per tablet | $25,976.76 | +0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has sofosbuvir and velpatasvir been recalled?
The FDA's Enforcement Report lists 1 recall naming sofosbuvir and velpatasvir since 2025: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 7, 2025 | Class II | ASEGUA THERAPEUTICS LLC | Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sofosbuvir and velpatasvir label say about other medicines?
The sofosbuvir and velpatasvir label names 33 other medicines in its interaction, contraindication or warning sections. The labels of 13 other medicines name sofosbuvir and velpatasvir. 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 |
|---|---|---|
| Amiodarone | drug interactions | Concomitant Drug Class/Drug Name: Antiarrhythmics: amiodarone; Effect on Concentration ↓ = decrease, ↑ = increase.: Effect on amiodarone, sofosbuvir, and velpatasvir concentrations unknown; Clinical Effect/Recommendation: Coadministration of amiodarone with a sofosbuvir-containing regimen may result in serious … |
| Atazanavir | drug interactions | EPCLUSA: atazanavir/ritonavir, buprenorphine/naloxone, cyclosporine, darunavir/ritonavir, dolutegravir, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, methadone, naltrexone, raltegravir, or rilpivirine. |
| Atorvastatin | drug interactions | Concomitant Drug Class/Drug Name: atorvastatin; Effect on Concentration ↓ = decrease, ↑ = increase.: ↑ atorvastatin; Clinical Effect/Recommendation: Coadministration of EPCLUSA with atorvastatin may be associated with increased risk of myopathy, including rhabdomyolysis. … |
| Buprenorphine and naloxone | drug interactions | EPCLUSA: atazanavir/ritonavir, buprenorphine/naloxone, cyclosporine, darunavir/ritonavir, dolutegravir, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, methadone, naltrexone, raltegravir, or rilpivirine. |
| Carbamazepine | drug interactions | DRUG INTERACTIONS P-gp inducers and/or moderate to strong CYP inducers (e.g., rifampin, St. John's wort, carbamazepine): |
| Cobicistat | drug interactions | EPCLUSA: atazanavir/ritonavir, buprenorphine/naloxone, cyclosporine, darunavir/ritonavir, dolutegravir, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, methadone, naltrexone, raltegravir, or rilpivirine. |
| Cyclosporine | drug interactions | EPCLUSA: atazanavir/ritonavir, buprenorphine/naloxone, cyclosporine, darunavir/ritonavir, dolutegravir, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, methadone, naltrexone, raltegravir, or rilpivirine. |
| Darunavir | drug interactions | EPCLUSA: atazanavir/ritonavir, buprenorphine/naloxone, cyclosporine, darunavir/ritonavir, dolutegravir, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, methadone, naltrexone, raltegravir, or rilpivirine. |
| Digoxin | drug interactions | Concomitant Drug Class/Drug Name: digoxin; Effect on Concentration ↓ = decrease, ↑ = increase.: ↑ digoxin; Clinical Effect/Recommendation: Therapeutic concentration monitoring of digoxin is recommended when coadministered with EPCLUSA. … |
| Dolutegravir | drug interactions | EPCLUSA: atazanavir/ritonavir, buprenorphine/naloxone, cyclosporine, darunavir/ritonavir, dolutegravir, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, methadone, naltrexone, raltegravir, or rilpivirine. |
| Efavirenz | drug interactions | Concomitant Drug Class/Drug Name: HIV Antiretrovirals: efavirenz; Effect on Concentration ↓ = decrease, ↑ = increase.: ↓ velpatasvir; Clinical Effect/Recommendation: Coadministration of EPCLUSA with efavirenz-containing regimens is not recommended. |
| Emtricitabine | drug interactions | EPCLUSA: atazanavir/ritonavir, buprenorphine/naloxone, cyclosporine, darunavir/ritonavir, dolutegravir, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, methadone, naltrexone, raltegravir, or rilpivirine. |
| Famotidine | drug interactions | H 2 -receptor antagonists These interactions have been studied in healthy adults. (e.g., famotidine) H 2 -receptor antagonists may be administered simultaneously with or 12 hours apart from EPCLUSA at a dose that does not exceed doses comparable to famotidine 40 mg twice daily. |
| Ketoconazole | drug interactions | Velpatasvir: ethinyl estradiol/norgestimate, ketoconazole, or pravastatin. |
Every other medicine the sofosbuvir and velpatasvir label names
| Medicine named | Section | What the label says |
|---|---|---|
| Magnesium hydroxide | drug interactions | Antacids (e.g., aluminum and magnesium hydroxide) Separate antacid and EPCLUSA administration by 4 hours. |
| Methadone | drug interactions | … elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, methadone, naltrexone, raltegravir, or rilpivirine. |
| Naltrexone | drug interactions | … elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, methadone, naltrexone, raltegravir, or rilpivirine. |
| Omeprazole | drug interactions | Proton-pump inhibitors (e.g., omeprazole) Coadministration of omeprazole or other proton-pump inhibitors is not recommended. |
| Phenobarbital | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine phenytoin phenobarbital; Effect on Concentration ↓ = decrease, ↑ = increase.: ↓ sofosbuvir ↓ velpatasvir; … |
| Phenytoin | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine phenytoin phenobarbital; Effect on Concentration ↓ = decrease, ↑ = increase.: ↓ sofosbuvir ↓ velpatasvir; … |
| Pravastatin | drug interactions | Velpatasvir: ethinyl estradiol/norgestimate, ketoconazole, or pravastatin. |
| Raltegravir | drug interactions | … elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, methadone, naltrexone, raltegravir, or rilpivirine. |
| Ribavirin | contraindications | CONTRAINDICATIONS EPCLUSA and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated. |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: rifabutin rifampin rifapentine; Effect on Concentration ↓ = decrease, ↑ = increase.: ↓ sofosbuvir ↓ velpatasvir; … |
| Rifampin | drug interactions | DRUG INTERACTIONS P-gp inducers and/or moderate to strong CYP inducers (e.g., rifampin, St. John's wort, carbamazepine): |
| Rifapentine | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: rifabutin rifampin rifapentine; Effect on Concentration ↓ = decrease, ↑ = increase.: ↓ sofosbuvir ↓ velpatasvir; … |
| Rilpivirine | drug interactions | … alafenamide, emtricitabine, methadone, naltrexone, raltegravir, or rilpivirine. |
| Ritonavir | drug interactions | Concomitant Drug Class/Drug Name: tipranavir/ritonavir; Effect on Concentration ↓ = decrease, ↑ = increase.: ↓ sofosbuvir ↓ velpatasvir; … |
| Rosuvastatin | drug interactions | Concomitant Drug Class/Drug Name: HMG-CoA Reductase Inhibitors: rosuvastatin; Effect on Concentration ↓ = decrease, ↑ = increase.: ↑ rosuvastatin; … |
| Tacrolimus | drug interactions | Sofosbuvir: ethinyl estradiol/norgestimate, or tacrolimus. |
| Tenofovir alafenamide | drug interactions | … darunavir/ritonavir, dolutegravir, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, methadone, naltrexone, raltegravir, or rilpivirine. |
| Topotecan | drug interactions | Concomitant Drug Class/Drug Name: Anticancers: topotecan; Effect on Concentration ↓ = decrease, ↑ = increase.: ↑ topotecan; Clinical Effect/Recommendation: Coadministration is not recommended. |
| 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 … |
Other labels that name sofosbuvir and velpatasvir
Source: FDA drug label (Epclusa), Gilead Sciences, Inc., effective June 5, 2024 (SPL set 7f30631a-ee3b-4cfe-866b-964df3f0a44f), via openFDA; the full label on DailyMed
What do FAERS reports show for sofosbuvir and velpatasvir?
The FDA Adverse Event Reporting System holds 12,759 reports that list sofosbuvir and velpatasvir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 587 are coded as a death and 1,426 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 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 sofosbuvir and velpatasvir?
3 other medicines are given the same way (oral) and in the same FDA class as sofosbuvir and velpatasvir 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 sofosbuvir and velpatasvir
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to sofosbuvir and velpatasvir
- 3 medicines for the same use
- Other hepatitis c virus ns5a inhibitors
- the pharmacologic class, with prices and generics
- Sofosbuvir and velpatasvir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other