Prescription medicine
Sofosbuvir and velpatasvir and voxilaprevir Brand names: Vosevi
Sofosbuvir and velpatasvir and voxilaprevir (Vosevi) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the sofosbuvir and velpatasvir and voxilaprevir FDA label on DailyMed (effective July 14, 2025, Gilead Sciences, Inc.); the NDA 209195 record on Drugs@FDA; every sofosbuvir and velpatasvir and voxilaprevir label on DailyMed.
Highlights of the record
FDA label of July 14, 2025; 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 VOSEVI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals (DAA) 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 usageVOSEVI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have [see Dosage and Administration (2.2) and Clinical Studies (14) ]: genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor.
Forms and strengths
- 400 mg / 100 mg / 100 mg
Film-coated tablet.
On the market
- Earliest approval on file
- July 18, 2017 Vosevi, Gilead Sciences Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 1, 2037 Vosevi 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
- 1,084 through July 30, 2026
What is sofosbuvir and velpatasvir and voxilaprevir used for?
From the label: indications and usageVOSEVI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have [see Dosage and Administration (2.2) and Clinical Studies (14) ]: genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor. genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. Additional benefit of VOSEVI over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor. […]
Conditions named in the indications of sofosbuvir and velpatasvir and voxilaprevir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hepatitis C Virus NS3/4A Protease Inhibitor, Hepatitis C Virus NS5A Inhibitor and Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor.
Source: FDA drug label (Vosevi), Gilead Sciences, Inc., effective July 14, 2025 (SPL set 17ffc094-8ca7-45d2-80d8-fd043bc9a221), via openFDA; the full label on DailyMed
What does the patient leaflet for sofosbuvir and velpatasvir and voxilaprevir 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 VOSEVI?VOSEVI can cause serious side effects, including, Hepatitis B virus reactivation: Before starting treatment with VOSEVI, 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 VOSEVI. 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 VOSEVI. For more information about side effects, see the section " What are the possible side effects of VOSEVI? " What is VOSEVI? VOSEVI is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis who have: genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor. genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. It is not known if VOSEVI is safe and effective in children. Do not take VOSEVI: if you also take any medicines that contain rifampin (Rifater ® , Rifamate ® , Rimactane ® , Rifadin ® ) Before taking VOSEVI, tell your healthcare provider about all your medical conditions, including if you: have ever had hepatitis B infection have liver problems other than hepatitis C infection are pregnant or plan to become pregnant. It is not known if VOSEVI will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if VOSEVI passes into your breast milk. […]
From the patient leaflet: How should I store VOSEVI?Store VOSEVI below 86 °F (30 °C). Keep VOSEVI in its original container. Keep VOSEVI and all medicines out of the reach of children.
Source: FDA drug label (Vosevi), Gilead Sciences, Inc., effective July 14, 2025 (SPL set 17ffc094-8ca7-45d2-80d8-fd043bc9a221), via openFDA; the full label on DailyMed
Is there a generic for sofosbuvir and velpatasvir and voxilaprevir (Vosevi)?
No generic sofosbuvir and velpatasvir and voxilaprevir is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 18 patents for Vosevi tablets: the compound patent runs to July 17, 2034, and the last listed entry to December 1, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the sofosbuvir and velpatasvir and voxilaprevir label say about other medicines?
The sofosbuvir and velpatasvir and voxilaprevir label names 43 other medicines in its interaction, contraindication or warning sections. The labels of 15 other medicines name sofosbuvir and velpatasvir and voxilaprevir. 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: amiodarone; Effect on Concentration ↓ = decrease, ↑ = increase.: Effect on amiodarone, sofosbuvir, velpatasvir, and voxilaprevir concentrations unknown; Clinical Effect/Recommendation: Coadministration of amiodarone with VOSEVI may result in serious symptomatic bradycardia. … |
| Atazanavir | drug interactions | Concomitant Drug Class/Drug Name: atazanavir lopinavir; Effect on Concentration ↓ = decrease, ↑ = increase.: ↑ voxilaprevir; Clinical Effect/Recommendation: Coadministration of VOSEVI with atazanavir- or lopinavir-containing regimens is not recommended. |
| Atorvastatin | drug interactions | Concomitant Drug Class/Drug Name: atorvastatin fluvastatin lovastatin simvastatin; Effect on Concentration ↓ = decrease, ↑ = increase.: ↑ atorvastatin ↑ fluvastatin ↑ lovastatin ↑ simvastatin; Clinical Effect/Recommendation: Coadministration with VOSEVI may increase the concentrations of atorvastatin, fluvastatin … |
| Carbamazepine | drug interactions | DRUG INTERACTIONS P-gp inducers and/or moderate to strong CYP inducers (e.g., St. John's wort, carbamazepine): |
| Cobicistat | drug interactions | VOSEVI: cobicistat, darunavir, elvitegravir, emtricitabine, ethinyl estradiol/norgestimate, gemfibrozil, rilpivirine, ritonavir, tenofovir alafenamide, voriconazole Sofosbuvir/velpatasvir: dolutegravir, ketoconazole, raltegravir Sofosbuvir: methadone, tacrolimus |
| Cyclosporine | drug interactions | The use of OATP inhibitors which may substantially increase exposure of voxilaprevir (e.g., cyclosporine) with VOSEVI is not recommended [see Clinical Pharmacology (12.3) ]. |
| Dabigatran | drug interactions | Concomitant Drug Class/Drug Name: dabigatran etexilate; Effect on Concentration ↓ = decrease, ↑ = increase.: ↑ dabigatran; Clinical Effect/Recommendation: Clinical monitoring of dabigatran is recommended when coadministered with VOSEVI. … |
| Darunavir | drug interactions | VOSEVI: cobicistat, darunavir, elvitegravir, emtricitabine, ethinyl estradiol/norgestimate, gemfibrozil, rilpivirine, ritonavir, tenofovir alafenamide, voriconazole Sofosbuvir/velpatasvir: dolutegravir, ketoconazole, raltegravir Sofosbuvir: methadone, tacrolimus |
| 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 VOSEVI. … |
| Dolutegravir | drug interactions | VOSEVI: cobicistat, darunavir, elvitegravir, emtricitabine, ethinyl estradiol/norgestimate, gemfibrozil, rilpivirine, ritonavir, tenofovir alafenamide, voriconazole Sofosbuvir/velpatasvir: dolutegravir, ketoconazole, raltegravir Sofosbuvir: methadone, tacrolimus |
| Efavirenz | drug interactions | Concomitant Drug Class/Drug Name: efavirenz; Effect on Concentration ↓ = decrease, ↑ = increase.: ↓ velpatasvir ↓ voxilaprevir; Clinical Effect/Recommendation: Coadministration of VOSEVI with efavirenz-containing regimens is not recommended. |
| Emtricitabine | drug interactions | VOSEVI: cobicistat, darunavir, elvitegravir, emtricitabine, ethinyl estradiol/norgestimate, gemfibrozil, rilpivirine, ritonavir, tenofovir alafenamide, voriconazole Sofosbuvir/velpatasvir: dolutegravir, ketoconazole, raltegravir Sofosbuvir: methadone, tacrolimus |
| Famotidine | drug interactions | H 2 -receptor antagonists may be administered simultaneously with or staggered from VOSEVI at a dose that does not exceed doses comparable with famotidine 40 mg twice daily. |
| Fluvastatin | drug interactions | Concomitant Drug Class/Drug Name: atorvastatin fluvastatin lovastatin simvastatin; Effect on Concentration ↓ = decrease, ↑ = increase.: ↑ atorvastatin ↑ fluvastatin ↑ lovastatin ↑ simvastatin; Clinical Effect/Recommendation: Coadministration with VOSEVI may increase the concentrations of atorvastatin, fluvastatin … |
Every other medicine the sofosbuvir and velpatasvir and voxilaprevir label names
| Medicine named | Section | What the label says |
|---|---|---|
| Gemfibrozil | drug interactions | VOSEVI: cobicistat, darunavir, elvitegravir, emtricitabine, ethinyl estradiol/norgestimate, gemfibrozil, rilpivirine, ritonavir, tenofovir alafenamide, voriconazole Sofosbuvir/velpatasvir … |
| Imatinib | drug interactions | Coadministration of VOSEVI with BCRP substrates (e.g., methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, topotecan) is not recommended [see Clinical … |
| Irinotecan | drug interactions | Coadministration of VOSEVI with BCRP substrates (e.g., methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, topotecan) is not recommended [see Clinical … |
| Ketoconazole | drug interactions | … tenofovir alafenamide, voriconazole Sofosbuvir/velpatasvir: dolutegravir, ketoconazole, raltegravir Sofosbuvir: methadone, tacrolimus |
| Lovastatin | drug interactions | Concomitant Drug Class/Drug Name: atorvastatin fluvastatin lovastatin simvastatin; Effect on Concentration ↓ = decrease, ↑ = increase.: ↑ atorvastatin ↑ fluvastatin ↑ lovastatin ↑ simvastatin; … |
| Magnesium hydroxide | drug interactions | Antacids (e.g., aluminum and magnesium hydroxide) Separate antacid and VOSEVI administration by 4 hours. |
| Methadone | drug interactions | … Sofosbuvir/velpatasvir: dolutegravir, ketoconazole, raltegravir Sofosbuvir: methadone, tacrolimus |
| Methotrexate | drug interactions | Coadministration of VOSEVI with BCRP substrates (e.g., methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, topotecan) is not recommended [see Clinical … |
| Mitoxantrone | drug interactions | Coadministration of VOSEVI with BCRP substrates (e.g., methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, topotecan) is not recommended [see Clinical … |
| Omeprazole | drug interactions | Proton-pump inhibitors (e.g., omeprazole) Omeprazole 20 mg can be administered with VOSEVI. |
| Phenobarbital | drug interactions | Concomitant Drug Class/Drug Name: carbamazepine phenytoin phenobarbital; Effect on Concentration ↓ = decrease, ↑ = increase.: ↓ sofosbuvir ↓ velpatasvir ↓ voxilaprevir; … |
| Phenytoin | drug interactions | Concomitant Drug Class/Drug Name: carbamazepine phenytoin phenobarbital; Effect on Concentration ↓ = decrease, ↑ = increase.: ↓ sofosbuvir ↓ velpatasvir ↓ voxilaprevir; … |
| Pitavastatin | drug interactions | Concomitant Drug Class/Drug Name: pitavastatin; Effect on Concentration ↓ = decrease, ↑ = increase.: ↑ pitavastatin; Clinical Effect/Recommendation: Coadministration with VOSEVI may increase the … |
| Pravastatin | drug interactions | Concomitant Drug Class/Drug Name: pravastatin; Effect on Concentration ↓ = decrease, ↑ = increase.: ↑ pravastatin; Clinical Effect/Recommendation: Coadministration of VOSEVI with pravastatin has been … |
| Raltegravir | drug interactions | … alafenamide, voriconazole Sofosbuvir/velpatasvir: dolutegravir, ketoconazole, raltegravir Sofosbuvir: methadone, tacrolimus |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: rifabutin rifapentine; Effect on Concentration ↓ = decrease, ↑ = increase.: ↓ sofosbuvir ↓ velpatasvir ↓ voxilaprevir; … |
| Rifampin | contraindications | CONTRAINDICATIONS VOSEVI is contraindicated with rifampin [see Drug Interactions (7.3), and Clinical Pharmacology (12.3) ]. |
| Rifapentine | drug interactions | Concomitant Drug Class/Drug Name: rifabutin rifapentine; Effect on Concentration ↓ = decrease, ↑ = increase.: ↓ sofosbuvir ↓ velpatasvir ↓ voxilaprevir; … |
| Rilpivirine | drug interactions | VOSEVI: cobicistat, darunavir, elvitegravir, emtricitabine, ethinyl estradiol/norgestimate, gemfibrozil, rilpivirine, ritonavir, tenofovir alafenamide, voriconazole Sofosbuvir/velpatasvir … |
| 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: rosuvastatin; Effect on Concentration ↓ = decrease, ↑ = increase.: ↑ rosuvastatin; Clinical Effect/Recommendation: Coadministration of VOSEVI with rosuvastatin may … |
| Simvastatin | drug interactions | Concomitant Drug Class/Drug Name: atorvastatin fluvastatin lovastatin simvastatin; Effect on Concentration ↓ = decrease, ↑ = increase.: ↑ atorvastatin ↑ fluvastatin ↑ lovastatin ↑ simvastatin; … |
| Sulfasalazine | drug interactions | Coadministration of VOSEVI with BCRP substrates (e.g., methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, topotecan) is not recommended [see Clinical … |
| Tacrolimus | drug interactions | … Sofosbuvir/velpatasvir: dolutegravir, ketoconazole, raltegravir Sofosbuvir: methadone, tacrolimus |
| Tenofovir alafenamide | drug interactions | VOSEVI: cobicistat, darunavir, elvitegravir, emtricitabine, ethinyl estradiol/norgestimate, gemfibrozil, rilpivirine, ritonavir, tenofovir alafenamide, voriconazole Sofosbuvir/velpatasvir … |
| Tenofovir disoproxil | drug interactions | Concomitant Drug Class/Drug Name: tenofovir disoproxil fumarate (tenofovir DF); Effect on Concentration ↓ = decrease, ↑ = increase.: ↑ tenofovir; … |
| Topotecan | drug interactions | Coadministration of VOSEVI with BCRP substrates (e.g., methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, topotecan) is not recommended [see Clinical … |
| Voriconazole | drug interactions | … estradiol/norgestimate, gemfibrozil, rilpivirine, ritonavir, tenofovir alafenamide, voriconazole Sofosbuvir/velpatasvir: dolutegravir, ketoconazole, raltegravir Sofosbuvir: methadone, tacrolimus |
| 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 and voxilaprevir
Check sofosbuvir and velpatasvir and voxilaprevir against other medicines
Source: FDA drug label (Vosevi), Gilead Sciences, Inc., effective July 14, 2025 (SPL set 17ffc094-8ca7-45d2-80d8-fd043bc9a221), via openFDA; the full label on DailyMed
What do FAERS reports show for sofosbuvir and velpatasvir and voxilaprevir?
The FDA Adverse Event Reporting System holds 1,084 reports that list sofosbuvir and velpatasvir and voxilaprevir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 35 are coded as a death and 81 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 and voxilaprevir?
3 other medicines are given the same way (oral) and in the same FDA class as sofosbuvir and velpatasvir and voxilaprevir 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 and voxilaprevir
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to sofosbuvir and velpatasvir and voxilaprevir
- 3 medicines for the same use
- Other hepatitis c virus ns3/4a protease inhibitors
- the pharmacologic class, with prices and generics
- Sofosbuvir and velpatasvir and voxilaprevir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other