Velpatasvir

Pronunciation: Not established from the reviewed source..

Generic name: velpatasvir
Brand names: Epclusa
Drug class: HCV NS5A inhibitor
Form: Film-coated tablet or oral pellets as the fixed-dose sofosbuvir/velpatasvir combination
Route: Oral
Legal status: Prescription antiviral medicine used in fixed-dose combination treatment

Availability and supply rules vary by country

Trade names by country: India

What velpatasvir is and how it works

Velpatasvir is the HCV NS5A inhibitor component of EPCLUSA, a fixed-dose combination with sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor. The combination is used to treat chronic hepatitis C. (1)

Velpatasvir is used only as part of a prescribed fixed-dose antiviral combination, not as a standalone medicine. The documented US EPCLUSA regimen treats chronic HCV genotypes 1, 2, 3, 4, 5, or 6 in eligible adults and children aged 3 years and older. The exact regimen depends on cirrhosis status, body weight for children, and whether ribavirin is required.

Mechanism of action: how velpatasvir works

In the reviewed US EPCLUSA label, velpatasvir is identified as the HCV NS5A inhibitor component and sofosbuvir as an HCV nucleotide analog NS5B polymerase inhibitor. No standalone velpatasvir-only pharmacology information was reviewed. (1)

What velpatasvir is used for

Chronic hepatitis C without cirrhosis or with compensated cirrhosis

The US EPCLUSA label indicates the sofosbuvir/velpatasvir fixed-dose combination for chronic HCV genotypes 1, 2, 3, 4, 5, or 6 in adults and pediatric patients aged 3 years and older without cirrhosis or with compensated cirrhosis. (1)

Chronic hepatitis C with decompensated cirrhosis

For adults and pediatric patients aged 3 years and older with chronic HCV genotypes 1, 2, 3, 4, 5, or 6 and decompensated cirrhosis, the US EPCLUSA label specifies use in combination with ribavirin. (1)

Before taking velpatasvir

Do not take / not appropriate for

The EPCLUSA-plus-ribavirin regimen is contraindicated for people in whom ribavirin is contraindicated, including pregnant women. (US EPCLUSA used with ribavirin) (1)
Coadministration with amiodarone is not recommended because serious symptomatic bradycardia can occur when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral, including velpatasvir-containing regimens. (US EPCLUSA combination) (1)
Coadministration with rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, efavirenz-containing HIV regimens, tipranavir/ritonavir, or St. John's wort is not recommended because these medicines can reduce sofosbuvir and/or velpatasvir concentrations and reduce therapeutic effect, or raise safety risk. (US EPCLUSA combination) (1)

Tell your clinician about

Any current or prior hepatitis B virus infection, because hepatitis B can reactivate during or after HCV direct-acting antiviral treatment.
All prescription medicines, non-prescription medicines, supplements, and herbal products, especially amiodarone, acid-reducing medicines, seizure medicines, rifamycin antibiotics, HIV medicines, St. John's wort, statins, digoxin, tenofovir disoproxil fumarate, and warfarin.
Any cirrhosis, especially decompensated cirrhosis, kidney impairment or dialysis, or liver impairment.
Pregnancy, plans for pregnancy, or breastfeeding. Ribavirin-containing treatment has additional pregnancy restrictions.
Diabetes, because blood glucose monitoring may be needed during treatment.

(1)

How to take velpatasvir

Velpatasvir is taken only within the prescribed fixed-dose sofosbuvir/velpatasvir combination regimen.
For adults, the documented US EPCLUSA dose is one tablet containing sofosbuvir 400 mg and velpatasvir 100 mg by mouth once daily, with or without food.
For eligible children aged 3 years and older, the prescribed combination strength is based on body weight.
Treatment is 12 weeks for most patient groups; the prescriber determines whether ribavirin is required for decompensated cirrhosis.
Do not change the prescribed combination product, strength, schedule, or use of ribavirin without direction from the prescribing clinician.

(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)

Missed dose

Missed-dose instructions were not captured in the reviewed source. Contact the prescribing clinician or pharmacist for advice; do not take an extra dose or alter the treatment schedule without professional advice.

Overdose

Overdose-management instructions were not captured in the reviewed source. If more than the prescribed amount may have been taken, contact a poison-information service or seek urgent medical advice. (1)

Side effects

Reported adverse reactions vary by cirrhosis status and whether ribavirin is used. The adverse-reaction information below applies to the documented US EPCLUSA fixed-dose combination, not to standalone velpatasvir.

Headache, fatigue, nausea, asthenia, or insomnia

What to notice: In people without cirrhosis receiving the 12-week regimen, reported reactions included headache (22%), fatigue (15%), nausea (9%), asthenia (5%), and insomnia (5%).

What to do: Tell the prescribing team about persistent, severe, or troublesome symptoms. (1)

Fatigue, anemia, nausea, headache, insomnia, or diarrhea with ribavirin

What to notice: In people with decompensated cirrhosis receiving EPCLUSA with ribavirin, reported reactions included fatigue (32%), anemia (26%), nausea (15%), headache (11%), insomnia (11%), and diarrhea (10%).

What to do: Contact the prescribing team for assessment, particularly for symptoms that may suggest anemia or are severe or persistent. (1)

Vomiting or difficulty retaining the dose in children under 6 years

What to notice: Reported pediatric reactions in children under 6 years included vomiting (15%) and product-use issues such as spitting up the dose (10%).

What to do: Contact the prescribing team or pharmacist for guidance if a child vomits or spits up a dose; do not give an additional dose unless a clinician advises it. (1)

Possible hepatitis B virus reactivation or hepatitis flare

What to notice: New symptoms of hepatitis or a hepatitis flare during or after treatment in a person with current or prior HBV infection.

What to do: Seek prompt medical assessment. HBV/HCV-coinfected patients require monitoring for hepatitis flare during and after treatment. (1)

Possible muscle toxicity with certain statins

What to notice: Symptoms that may suggest myopathy while taking rosuvastatin or atorvastatin.

What to do: Contact the prescribing clinician promptly for assessment. (1)

Serious warnings

Hepatitis B virus reactivation — serious

Symptoms: Hepatitis B virus can reactivate in people coinfected with HCV and HBV during or after HCV direct-acting antiviral treatment. Reported cases have included fulminant hepatitis, hepatic failure, and death.

Action: Testing for HBsAg and anti-HBc is required before treatment. People with current or prior HBV infection need clinical and laboratory monitoring for hepatitis flare during and after treatment. (1)

Serious symptomatic bradycardia with amiodarone — emergency

Symptoms: Serious symptomatic slow heart rate can occur when amiodarone is coadministered with sofosbuvir in combination with another HCV direct-acting antiviral, including velpatasvir-containing regimens.

Action: Coadministration is not recommended. If no alternative exists, the label advises inpatient cardiac monitoring for the first 48 hours, followed by daily outpatient or self-monitoring of heart rate through at least the first 2 weeks; seek urgent medical care for concerning cardiac symptoms. (1)

Interactions

Medicine or test	Effect	Action
Acid-reducing medicines	Antacids can reduce absorption if taken too close to EPCLUSA. H2-receptor antagonists and proton pump inhibitors also have administration restrictions.	Separate antacids by 4 hours. H2-receptor antagonists may be taken at the same time as or 12 hours apart from EPCLUSA, at no more than a famotidine 40 mg twice-daily equivalent. Proton pump inhibitors are not recommended; if their use is necessary, the label directs EPCLUSA with food 4 hours before the proton pump inhibitor dose. (1)
P-gp inducers and moderate-to-strong CYP inducers	Rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, and St. John's wort may significantly decrease sofosbuvir and/or velpatasvir concentrations, reducing therapeutic effect.	Coadministration is not recommended. Give the prescriber and pharmacist a complete medicine and supplement list before treatment. (1)
Amiodarone	Coadministration can cause serious symptomatic bradycardia.	Coadministration is not recommended. The prescriber must assess alternatives and, if no alternative exists, arrange the label-specified cardiac monitoring. (1)
Statins	Rosuvastatin exposure can increase, raising myopathy risk; atorvastatin also requires close monitoring for myopathy.	The rosuvastatin dose should not exceed 10 mg daily with EPCLUSA. The clinician should monitor people taking atorvastatin closely for myopathy. (1)
Digoxin, tenofovir disoproxil fumarate, warfarin, and diabetes treatment	Digoxin requires therapeutic drug monitoring. Tenofovir disoproxil fumarate requires monitoring for tenofovir-associated adverse reactions and renal function. INR monitoring may be needed for warfarin, and blood glucose monitoring may be needed for diabetes.	The prescribing clinician should monitor these medicines and relevant laboratory values as clinically appropriate. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Children and adolescents

The documented US EPCLUSA indication includes children aged 3 years and older. Dosing is based on body weight: under 17 kg uses oral pellets containing sofosbuvir/velpatasvir 150 mg/37.5 mg once daily; 17 kg to under 30 kg uses 200 mg/50 mg once daily; and 30 kg or more uses 400 mg/100 mg once daily. A pediatric prescriber must select the appropriate regimen. (1)

Pregnancy and breastfeeding

Animal reproduction studies found no adverse fetal-development effects at exposures exceeding the human dose, but adequate data in pregnant humans are unavailable. EPCLUSA with ribavirin is contraindicated in pregnant women. It is unknown whether sofosbuvir, velpatasvir, or their metabolites are present in human breast milk; breastfeeding decisions should weigh breastfeeding benefits, the mother's clinical need for treatment, and potential effects on the breastfed child. (1)

Kidney or liver impairment

No EPCLUSA dosage adjustment is required for any degree of renal impairment, including end-stage renal disease requiring dialysis, or for mild, moderate, or severe hepatic impairment. In severe renal impairment, the sofosbuvir metabolite GS-331007 accumulates significantly. People with decompensated cirrhosis require clinical and laboratory monitoring, including direct bilirubin. (1)

Monitoring

Before starting

Test every patient for current or prior HBV infection using HBsAg and anti-HBc.
Confirm chronic HCV genotype, cirrhosis status, age, body weight where relevant, and whether ribavirin is required.
Review all medicines, including medicines with narrow therapeutic indices, acid-reducing medicines, herbal products, and HIV treatment.
Assess pregnancy considerations and ribavirin contraindications where the EPCLUSA-plus-ribavirin regimen is planned.

During treatment

Monitor HCV/HBV-coinfected patients for hepatitis flare during and after treatment.
Monitor hemoglobin, creatinine clearance, INR for people taking warfarin, and blood glucose for people with diabetes as clinically appropriate.
Frequently monitor concomitant medicines with narrow therapeutic indices during treatment.
For decompensated cirrhosis, undertake clinical and laboratory monitoring, including direct bilirubin.
Use the specified cardiac-monitoring approach if amiodarone coadministration cannot be avoided.

(1)

Storage

Storage instructions were not captured in the reviewed source. Follow the current product packaging and pharmacist's instructions for the exact EPCLUSA tablet or oral-pellet product supplied.

Professional information

Clinician-facing context only. This draft is limited to the reviewed US EPCLUSA label and does not provide standalone velpatasvir dosing or Vosevi-specific information. Use the current local product information and individual clinical assessment.

United States

Indication: Chronic HCV genotypes 1, 2, 3, 4, 5, or 6 in eligible adults and pediatric patients aged 3 years and older

Dose summary: EPCLUSA is dosed as the fixed sofosbuvir/velpatasvir combination. Adults receive 400 mg/100 mg orally once daily, with or without food. Pediatric dosing is 150 mg/37.5 mg once daily for body weight under 17 kg, 200 mg/50 mg once daily for 17 kg to under 30 kg, and 400 mg/100 mg once daily for 30 kg or more. Treatment is 12 weeks for most groups; add ribavirin for decompensated cirrhosis.

Renal context: No dosage adjustment is required for any degree of renal impairment, including ESRD requiring dialysis. GS-331007, a sofosbuvir metabolite, accumulates significantly in severe renal impairment; monitor renal function when clinically indicated, including with tenofovir disoproxil fumarate. (1)

Other regions

Renal context: Not established from the sources reviewed: use current local product information. (1)

Mechanism of action

Hepatic guidance

No dosage adjustment is required for mild, moderate, or severe hepatic impairment, including Child-Pugh Class A, B, or C. For decompensated cirrhosis, conduct clinical and laboratory monitoring, including direct bilirubin.

Overdose note

Overdose-management information was not captured in the reviewed source; obtain urgent poison-information or medical advice for a suspected overdose. (1)

Frequently asked questions

Can velpatasvir be taken on its own?

No. Velpatasvir is not marketed or dosed as a standalone single-ingredient product. The reviewed source documents it only in the fixed-dose sofosbuvir/velpatasvir combination EPCLUSA. (1)

Can I take EPCLUSA with heartburn medicines?

Some acid-reducing medicines require timing restrictions. Antacids should be separated by 4 hours; H2-receptor antagonists have dose and timing limits; proton pump inhibitors are not recommended unless necessary under the label-specified administration approach. Ask the prescriber or pharmacist to review the exact product. (1)

Why is hepatitis B testing needed before treatment?

Hepatitis B can reactivate during or after HCV direct-acting antiviral treatment in people coinfected with HCV and HBV. Reported cases have included fulminant hepatitis, hepatic failure, and death. The label requires HBsAg and anti-HBc testing before treatment. (1)

What is the mechanism of action of velpatasvir?

What is the generic name of Velpatasvir?

The generic name is velpatasvir. It is sold under brand names including Epclusa. (1)

What class of drug is velpatasvir?

Velpatasvir is classed as: HCV NS5A inhibitor. (1)

References

EPCLUSA (sofosbuvir and velpatasvir) tablet, film coated/pellet — prescribing informationU.S. Food and Drug Administration · United States · accessed 2026-08-05 · source 1
EPCLUSA ACCESS (VELPATASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 2
Vosevi — FDA approval record (Drugs@FDA NDA209195)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 3
velpatasvir — RxNorm normalized drug concept (RXCUI 1799206)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 4

Brand names by country

Single-ingredient velpatasvir names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

India

Velpanat400 mg + 100 mg · Natco Pharma Ltd
Sovihep V400 mg + 100 mg · Zydus Cadila
Myhep All400 mg + 100 mg · Mylan Pharmaceuticals Pvt Ltd
Resof Total400 mg + 100 mg · Dr Reddy's Laboratories Ltd
Velakast400 mg + 100 mg · Aprazer Healthcare Pvt Ltd
Velpas S400 mg + 100 mg · Samarth Life Sciences Pvt Ltd
Velpaclear400 mg + 100 mg · Abbott
Sofocure-V400 mg + 100 mg · Emcure Pharmaceuticals Ltd

View brands in additional countries.