Velpatasvir

VOSEVI is a fixed-dose combination of sofosbuvir, velpatasvir, and voxilaprevir which are DAA agents against the hepatitis C virus [see Microbiology (12.4) ].

• VOSEVI 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.ICD-10: B18.2

• VOSEVI is contraindicated with rifampin [see Drug Interactions (7.3) , and Clinical Pharmacology (12.3) ]. Coadministration with rifampin.contraindicated

Testing: Prior to initiating VOSEVI, test all patients for HBV infection by measuring HBsAg and anti-HBc. ( 2.1 ) Recommended dosage: One tablet (400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir) taken orally once daily with food. ( 2.2 ) See recommended treatment regimen and duration in table below ( 2.2 ): Genotype Patients Previously Treated with an HCV Regimen Containing: VOSEVI Duration 1, 2, 3, 4, 5, or 6 An NS5A inhibitor In clinical trials, prior NS5A inhibitor experience included daclatasvir, elbasvir, ledipasvir, ombitasvir, or velpatasvir. 12 weeks 1a or 3 Sofosbuvir without an NS5A inhibitor In clinical trials, prior treatment experience included sofosbuvir with or without any of the following: peginterferon alfa/ribavirin, ribavirin, HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir). 12 weeks For patients with renal impairment including end stage renal disease on dialysis, follow the dosage recommendations in the table above. ( 2.3 ) VOSEVI is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C). ( 2.4 , 5.2 ) 2.1 Testing Prior to the Initiation of Therapy Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with VOSEVI [see Warnings and Precautions (5.1) ]. 2.2 Recommended Dosage The recommended dosage of VOSEVI is one tablet, taken orally, once daily with food [see Clinical Pharmacology (12.3) ].

Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment. Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated. ( 5.1 ) Risk of Hepatic Decompensation/Failure in Patients with Evidence of Advanced Liver Disease: Hepatic decompensation/failure, including fatal outcomes, have been reported mostly in patients with cirrhosis and baseline moderate or severe liver impairment (Child-Pugh B or C) treated with HCV NS3/4A protease inhibitor-containing regimens. Monitor for clinical and laboratory evidence of hepatic decompensation. Discontinue VOSEVI in patients who develop evidence of hepatic decompensation/failure. ( 5.2 ) Bradycardia with Amiodarone Coadministration: Serious symptomatic bradycardia may occur in patients taking amiodarone with VOSEVI, a sofosbuvir-containing regimen, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone with VOSEVI is not recommended. In patients without alternative viable treatment options, cardiac monitoring is recommended.

The following serious adverse reactions are described below and elsewhere in labeling: Serious Symptomatic Bradycardia When Coadministered with Amiodarone [see Warnings and Precautions (5.3) ]. The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with VOSEVI for 12 weeks were headache, fatigue, diarrhea, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in HCV-Infected Subjects without Cirrhosis or with Compensated Cirrhosis The adverse reactions data for VOSEVI were derived from two Phase 3 clinical trials (POLARIS-1 and POLARIS-4) that evaluated a total of 445 subjects infected with genotype 1, 2, 3, 4, 5, or 6 HCV, without cirrhosis or with compensated cirrhosis (Child-Pugh A), who received VOSEVI for 12 weeks. VOSEVI was studied in placebo- and active-controlled (sofosbuvir/velpatasvir) trials [see Clinical Studies (14.1 and 14.2) ]. The proportion of subjects who permanently discontinued treatment due to adverse events was 0.2% for subjects who received VOSEVI for 12 weeks.

8.1 Pregnancy Risk Summary No adequate human data are available to establish whether or not VOSEVI poses a risk to pregnancy outcomes. In animal reproduction studies, no evidence of adverse developmental outcomes was observed with the components of VOSEVI (sofosbuvir, velpatasvir, or voxilaprevir) at exposures greater than those in humans at the recommended human dose (RHD) [see Data ] . During organogenesis in the mouse, rat, and rabbit, systemic exposures (AUC) of velpatasvir were approximately 23 (mice), 4 (rats), and 0.5 (rabbits) times the exposure in humans at the RHD, while exposures of voxilaprevir were approximately 141 (rats) and 4 (rabbits) times the exposure in humans at the RHD. Exposures of the predominant circulating metabolite of sofosbuvir (GS-331007) were approximately 6 (rats) and 16 (rabbits) times the exposure in humans at the RHD. In rat pre/postnatal development studies, maternal systemic exposures (AUC) for each component of VOSEVI were approximately 7 (sofosbuvir metabolite GS-331007), 3 (velpatasvir), and 238 (voxilaprevir) times the exposure in humans at the RHD. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Metabolism

The pharmacokinetic properties of the components of VOSEVI are provided in Table 4. The multiple dose pharmacokinetic parameters of sofosbuvir and its metabolite GS-331007, velpatasvir, and voxilaprevir are provided in Table 5.

No specific antidote is available for overdose with VOSEVI. If overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose with VOSEVI consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. Hemodialysis can efficiently remove the predominant circulating metabolite of sofosbuvir, GS-331007, with an extraction ratio of 53%. Hemodialysis is unlikely to result in significant removal of velpatasvir or voxilaprevir since velpatasvir and voxilaprevir are highly bound to plasma protein.

• Jun 28, 2016NDANDA208341Gilead Sciences Inc
• Jul 18, 2017NDANDA209195Gilead Sciences Inc
• Jun 10, 2021NDANDA214187Gilead Sciences Inc

1. 1Fatigue2,81821%
2. 2Headache2,34617%
3. 3Nausea1,2779.3%
4. 4Diarrhoea7435.4%
5. 5Drug Ineffective6264.6%
6. 6Insomnia5393.9%
7. 7Hepatitis C4783.5%
8. 8Treatment Failure4253.1%
9. 9Vomiting3632.6%
10. 10Death3162.3%
11. 11Dizziness2942.1%
12. 12Rash2692.0%
13. 13Abdominal Discomfort2621.9%
14. 14Product Dose Omission Issue2571.9%
15. 15Intentional Dose Omission2361.7%

The 10 most recently updated of 127 ClinicalTrials.gov registrations naming Velpatasvir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
  Active not recruiting · Phase 4 · Interventional · 121 enrolled · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  NCT03520660updated 2026-06-03
• Lung Transplant HCV, Pilot Study
  Active not recruiting · Early phase 1 · Interventional · 26 enrolled · University Health Network, Toronto
  NCT03112044updated 2026-05-11
• Combating Related Epidemics in HCV
  Not yet recruiting · Phase 4 · Interventional · 1,280 enrolled · Duke University
  NCT07560046updated 2026-05-05
• Sofosbuvir/Velpatasvir/Voxilaprevir Salvage Therapy in Hepatitis C Patients Who Relapsed After DAA Treatment
  Active not recruiting · Observational · 200 enrolled · Xiangya Hospital of Central South University
  NCT07565948updated 2026-05-04
• The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients
  Completed · Phase 2 · Interventional · 5 enrolled · Fernanda P Silveira, MD, MS
  NCT03819322updated 2026-04-30
• Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
  Active not recruiting · Phase 4 · Interventional · 100 enrolled · Catherine Anne Chappell
  NCT05140941updated 2026-04-15
• C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV
  Recruiting · Phase 3 · Interventional · 880 enrolled · Atea Pharmaceuticals, Inc.
  NCT07037277updated 2026-04-13
• A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients
  Completed · Phase 2 · Interventional · 201 enrolled · University of Pennsylvania
  NCT04075916updated 2026-03-12
• Implementing Low-Barrier HCV Treatment in a Jail Setting
  Recruiting · Phase 4 · Interventional · 40 enrolled · Lifespan
  NCT06953479updated 2026-02-27
• Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients
  Recruiting · Interventional · 120 enrolled · Johns Hopkins University
  NCT05653232updated 2026-02-17

Frequently asked questions

How does Velpatasvir work?

VOSEVI is a fixed-dose combination of sofosbuvir, velpatasvir, and voxilaprevir which are DAA agents against the hepatitis C virus [see Microbiology (12.4) ].

What is Velpatasvir used for?

According to FDA labeling, Velpatasvir carries indications including: VOSEVI 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Velpatasvir?

Velpatasvir is classified as Hepatitis C Virus NS5A Inhibitor, Breast Cancer Resistance Protein Inhibitors, Organic Anion Transporting Polypeptide 1B1 Inhibitors, Organic Anion Transporting Polypeptide 1B3 Inhibitors, Organic Anion Transporting Polypeptide 2B1 Inhibitors, P-Glycoprotein Inhibitors, Unknown Physiological Effect.

What are the brand names for Velpatasvir?

Velpatasvir is marketed under brand names including Epclusa, Vosevi.

What are the contraindications for Velpatasvir?

Velpatasvir labeling lists contraindications including: VOSEVI is contraindicated with rifampin [see Drug Interactions (7.3) , and Clinical Pharmacology (12.3) ]. Coadministration with rifampin.. Always consult the full prescribing information and a clinician.