Sofosbuvir/Velpatasvir (Epclusa)

Pronunciation: so-FOS-byoo-vir / vel-PAT-as-vir.

Generic name
sofosbuvir and velpatasvir
Drug class
Direct-acting antiviral (DAA) combination -- NS5B polymerase inhibitor (sofosbuvir) plus NS5A inhibitor (velpatasvir)
Form
Film-coated tablet (400 mg sofosbuvir/100 mg velpatasvir, and paediatric-strength 200 mg/50 mg); oral pellets/coated granules for younger children
Route
Oral
Legal status
Prescription-only in all markets reviewed

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Epclusa (5) · Full directory

What sofosbuvir and velpatasvir is and how it works

Sofosbuvir/velpatasvir (Epclusa) is a prescription, once-daily, single-tablet combination of two direct-acting antiviral medicines used to treat chronic hepatitis C virus (HCV) infection across all major HCV genotypes (1 through 6), in adults and children from either 3 years old (US/EU) or 12 years old and at least 30 kg (Australia), depending on the market. (1)

Epclusa carries a genuine, serious boxed warning: hepatitis B virus (HBV) reactivation, which can be fatal, in people who also have (or have had) hepatitis B and are not being treated for it. This is why everyone is tested for HBV before starting treatment, and anyone with both HCV and HBV is monitored closely during and after treatment. Epclusa also carries a real, separate risk of dangerously slow heart rate (bradycardia) if taken together with the heart medicine amiodarone.

Mechanism of action: how sofosbuvir and velpatasvir works

Sofosbuvir is a nucleotide analogue NS5B polymerase inhibitor; velpatasvir is an NS5A inhibitor. Together they block two proteins the hepatitis C virus needs to replicate, giving pangenotypic (genotype 1-6) activity in a single fixed-dose combination. (1) (2)

What sofosbuvir and velpatasvir is used for

Chronic hepatitis C virus (HCV) infection, all major genotypes

Used to treat chronic HCV infection (genotypes 1 through 6) in adults and children, without cirrhosis, with compensated (stable) cirrhosis, or with decompensated cirrhosis (when combined with ribavirin). The paediatric age threshold differs by market: 3 years and older in the US and EU sources reviewed, but 12 years and older and at least 30 kg body weight in the Australian source reviewed. (1) (3) (5)

Before taking sofosbuvir and velpatasvir

Do not take / not appropriate for

  • Do not take Epclusa together with ribavirin if ribavirin itself is contraindicated for you. (United States) (1)
  • Do not take Epclusa if you are hypersensitive (allergic) to sofosbuvir, velpatasvir, or any excipient in the tablet. (all countries) (2)
  • Do not take Epclusa together with strong P-glycoprotein and/or strong CYP inducers, such as rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital, or St. John's wort -- these substantially reduce how well Epclusa works. (all countries) (1) (2)

Tell your clinician about

  • Whether you currently have, or have ever had, hepatitis B -- you will be tested for this before starting Epclusa.
  • Whether you take amiodarone or any other heart-rhythm medicine.
  • All other medicines, especially acid-reducing medicines (antacids, H2 blockers, proton pump inhibitors), statins, digoxin, and any HIV medicines.
  • Whether you have any degree of kidney or liver disease.
  • Whether you are pregnant, plan to become pregnant, or are breastfeeding.
(1) (2)

How to take sofosbuvir and velpatasvir

  • Taken as one tablet by mouth once a day, with or without food, exactly as your prescriber directs, usually for 12 weeks.
  • For children who cannot swallow tablets, oral pellets or coated granules are available and should be given with food for children under 6 years, as directed by the prescribing clinician.
  • People with decompensated (more advanced) cirrhosis take Epclusa together with ribavirin, as directed by their specialist.
(1) (2) (5)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

Contact your prescriber or hepatology/infectious-disease care team for guidance on a missed dose rather than deciding on your own how to make it up -- consistent daily dosing supports how well this treatment works.

Overdose

Seek urgent medical attention if you think too much Epclusa has been taken. No specific antidote is described in the sources reviewed; treatment would be supportive care directed by emergency medical staff. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Headache.

What to notice: Headache.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Fatigue.

What to notice: Fatigue.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Vomiting (especially in children aged 3-6 years).

What to notice: Vomiting (especially in children aged 3-6 years).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Nausea, insomnia, and diarrhoea (more often when combined with ribavirin).

What to notice: Nausea, insomnia, and diarrhoea (more often when combined with ribavirin).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Rash.

What to notice: Rash.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Serious warnings

Signs of hepatitis B reactivation — boxed_warning

Symptoms: Yellowing of the skin or eyes (jaundice), dark urine, unusual tiredness, loss of appetite, nausea, or pain in the upper right side of the abdomen.

Action: Contact your clinician immediately -- Epclusa can cause hepatitis B virus reactivation, which can be fatal, in people coinfected with HBV who are not being treated for it. Everyone is tested for HBV before starting Epclusa, and anyone with HBV is monitored closely during and after treatment; report these symptoms to your care team right away. (1) (2)

Signs of a dangerously slow heart rate (bradycardia), especially if taking amiodarone — serious

Symptoms: Fainting or near-fainting, dizziness, extreme tiredness, chest pain, confusion, or memory problems, especially in the days after starting treatment.

Action: Seek emergency medical help immediately -- life-threatening slow heart rate and heart block have occurred when sofosbuvir-containing medicines like Epclusa are combined with amiodarone. Co-administration with amiodarone is not recommended; if your clinician determines there is no alternative, you will need cardiac monitoring, especially in the first 48 hours. (1) (2)

Interactions

  • Amiodarone: risk of life-threatening bradycardia/heart block; co-administration not recommended, and only used under close cardiac monitoring if no alternative exists. (1) (2)
  • Strong P-glycoprotein/CYP inducers (rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital, St. John's wort): substantially reduce Epclusa's effectiveness; avoid combining. (1) (2)
  • Acid-reducing medicines (antacids, H2 blockers, proton pump inhibitors): can lower velpatasvir absorption; your prescriber may advise spacing doses apart or an alternative. (1) (2)
  • Statins (e.g. atorvastatin, rosuvastatin) and digoxin: levels may increase; your clinician will monitor for side effects and may limit or adjust your statin dose. (1) (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Animal studies reviewed in the US source showed no adverse effects at exposures exceeding human doses, but human risk is not established. The UK/EU source reviewed notes a possible link to reproductive toxicity in animal studies with velpatasvir and recommends avoiding use in pregnancy as a precaution. Discuss with your prescriber, especially if Epclusa is combined with ribavirin, which has its own pregnancy risks. (1) (2) (3) (4) (5) (6)

Breastfeeding

The UK/EU source reviewed recommends against breastfeeding while taking this medicine, since it is not known whether the components pass into human breast milk. Discuss feeding options with your clinician. (1) (2) (3) (4) (5) (6)

Children

Approved from 3 years of age in the US and EU sources reviewed (with weight-based dosing and pellet/granule formulations for younger children), but only from 12 years of age and at least 30 kg in the Australian source reviewed -- a real difference preserved here, not merged into one age threshold. (1) (2) (3) (4) (5) (6)

Elderly

No specific dose adjustment based on age alone is described in the sources reviewed. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

No dosage adjustment is required for mild, moderate, or severe hepatic impairment in the sources reviewed. (1) (2) (3) (4) (5) (6)

Renal_impairment

No dosage adjustment is needed for any degree of kidney impairment, including dialysis, in the US source reviewed, though a metabolite of sofosbuvir accumulates in severe impairment; the UK/EU source notes limited data in severe impairment and recommends use only when no alternative exists. (1) (2) (3) (4) (5) (6)

Source_ids

US-DAILYMED-EPCLUSA-2026,UK-EMC-SOFOSBUVIR-VELPATASVIR-2026,AU-TGA-EPCLUSA-ARTG-2026 (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • HBsAg and anti-HBc blood tests for hepatitis B (mandatory before starting)
  • Kidney and liver function assessment
  • Review of other medicines, especially amiodarone and enzyme inducers

During treatment

  • Monitoring for signs of hepatitis B reactivation (liver blood tests, symptom review) in anyone coinfected with HBV, during treatment and for a period afterward.
  • Cardiac monitoring, including in the first 48 hours, for the rare patient who must take amiodarone alongside Epclusa because no alternative exists.
  • General monitoring for treatment response and side effects as directed by the treating specialist.
(1) (2)

Storage

Store at room temperature, in the original container, protected from moisture, and out of reach of children.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information and the EMA's centralised Epclusa EPAR reviewed for this dossier; verify against the current full label before prescribing.

United States / United Kingdom / European Union

Indication: Chronic HCV infection, genotypes 1-6, 3 years and older

Dose summary: Adults/children >=30 kg: 400 mg/100 mg once daily. Children 17-<30 kg: 200 mg/50 mg once daily. 12 weeks standard; decompensated cirrhosis: 12 weeks plus ribavirin.

Renal context: No dose adjustment for any degree of renal impairment (US); limited severe-impairment data, use only if no alternative (UK/EU). (1) (2) (3)

Australia

Indication: Chronic HCV infection, genotypes 1-6, 12 years and older and >=30 kg

Dose summary: 400 mg/100 mg once daily, consistent with adult dosing elsewhere; narrower paediatric indication than US/EU.

Renal context: Not independently detailed beyond the US/EU framing in the source reviewed. (5)

Mechanism of action

Hepatic guidance

No dosage adjustment required across mild, moderate, or severe hepatic impairment per the US/UK sources reviewed.

Overdose note

No specific antidote described in the sources reviewed; manage with supportive care and monitoring. (1) (2)

Frequently asked questions

Is Epclusa (sofosbuvir/velpatasvir) available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes. It is authorised and marketed in all six regions -- as Epclusa in the US, EU, Canada, Australia, and New Zealand, and in the UK as 'Sofosbuvir/Velpatasvir Gilead' (previously known as Epclusa) for one strength, alongside Epclusa-branded granules for younger children. Epclusa has a genuine EU-wide centralised marketing authorisation, granted in 2016. (1) (2) (3) (4) (5) (6)

Why does Epclusa have a boxed warning about hepatitis B?

Because a genuine, serious risk exists: in people who have both hepatitis C and hepatitis B, treating the hepatitis C with a direct-acting antiviral like Epclusa without also treating the hepatitis B can allow the hepatitis B virus to reactivate, sometimes with fatal results. That is why everyone is tested for hepatitis B before starting Epclusa, and anyone with both infections is monitored closely. (1)

Can I take Epclusa if I'm on amiodarone for my heart?

This combination is not recommended because of a real risk of life-threatening slow heart rate (bradycardia) and heart block. If your cardiologist and hepatologist decide there is genuinely no alternative to amiodarone, you would need close cardiac monitoring, especially in the first 48 hours -- this decision must always be made by your specialists together, never on your own. (1) (2)

What is the mechanism of action of sofosbuvir and velpatasvir?

Sofosbuvir is a nucleotide analogue NS5B polymerase inhibitor; velpatasvir is an NS5A inhibitor. Together they block two proteins the hepatitis C virus needs to replicate, giving pangenotypic (genotype 1-6) activity in a single fixed-dose combination. (1) (2)

What is the generic name of Sofosbuvir/Velpatasvir (Epclusa)?

The generic name is sofosbuvir and velpatasvir. (1) (3)

What class of drug is sofosbuvir and velpatasvir?

Sofosbuvir/Velpatasvir (Epclusa) is classed as: Direct-acting antiviral (DAA) combination -- NS5B polymerase inhibitor (sofosbuvir) plus NS5A inhibitor (velpatasvir). (1) (3)

References

  1. EPCLUSA (sofosbuvir and velpatasvir) tablet, film coated; pellet -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Gilead Sciences · United States · dated 2026-01-01 · accessed 2026-07-30 · source 1
  2. Sofosbuvir/Velpatasvir Gilead 200 mg/50 mg film-coated tablets (previously known as Epclusa) -- Summary of Product Characteristics (SmPC)electronic medicines compendium (emc), United Kingdom -- Summary of Product Characteristics · United Kingdom · dated 2026-01-01 · accessed 2026-07-30 · source 2
  3. Epclusa (sofosbuvir/velpatasvir) -- EPAR medicine overview and product informationEuropean Medicines Agency (EMA) -- centralised European Public Assessment Report (EPAR) · European Union · dated 2026-01-01 · accessed 2026-07-30 · source 3
  4. EPCLUSA (sofosbuvir/velpatasvir) tablets -- Product MonographHealth Canada -- Product Monograph (Epclusa, sofosbuvir/velpatasvir) · Canada · dated 2025-01-01 · accessed 2026-07-30 · source 4
  5. EPCLUSA sofosbuvir 400 mg / velpatasvir 100 mg tablet -- ARTG entry 266823Therapeutic Goods Administration (TGA), Australia -- Australian Register of Therapeutic Goods (ARTG) and PBS · Australia · dated 2026-06-01 · accessed 2026-07-30 · source 5
  6. EPCLUSA (sofosbuvir/velpatasvir) tablets -- New Zealand Data Sheet (v8.0, 11 February 2026) and Consumer Medicine Information (v7.0, 11 February 2026)Medsafe (New Zealand Medicines and Medical Devices Safety Authority) -- New Zealand Data Sheet and Consumer Medicine Information · New Zealand · dated 2026-02-11 · accessed 2026-07-30 · source 6

Brand names by country

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

Priority countries

United States

  • Epclusa; Epclusa Access (1)FDA approved currently labeled · 400 mg/100 mg tablet, 200 mg/50 mg and 150 mg/37.5 mg pellets · Gilead Sciences, Inc.

United Kingdom

  • Sofosbuvir/Velpatasvir Gilead (previously known as Epclusa); Epclusa coated granules (2)emc current smpc confirmed · 400 mg/100 mg and 200 mg/50 mg tablets, 150 mg/37.5 mg and 200 mg/50 mg coated granules · Gilead Sciences Ireland UC

Canada

  • Epclusa (4)health canada product monograph confirmed · 400 mg/100 mg tablet · Gilead Sciences Canada, Inc.

Australia

  • Epclusa (5)tga artg registered confirmed · 400 mg/100 mg tablet · Gilead Sciences Pty Ltd

New Zealand

  • Epclusa (6)medsafe datasheet and cmi confirmed existence and currency · 400 mg/100 mg tablet · Gilead Sciences
View brands in additional countries.

European Union

Epclusa (3)

This page provides general reference information about sofosbuvir/velpatasvir (Epclusa) and is not a substitute for advice from the hepatologist, infectious-disease specialist, or prescriber managing your treatment. All treatment decisions should be made with your prescriber.

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