Sofosbuvir and velpatasvir

Generic name: sofosbuvir and velpatasvir [ soe-FOS-bue-vir-and-vel-PAT-as-vir ]
Brand name: Epclusa
Dosage forms: oral pellet (150 mg-37.5 mg; 200 mg-50 mg), oral tablet (200 mg-50 mg; 400 mg-100 mg)
Drug class: Antiviral combinations

Medically reviewed by Melisa Puckey, BPharm. Last updated on Feb 26, 2023.

What is Sofosbuvir and Velpatasvir?

Sofosbuvir and velpatasvir is a combination antiviral medicine that prevents the hepatitis C virus (HCV) from multiplying in your body. Sofosbuvir with velpatasvir is the generic name for the medicine Epclusa (brand name). Sofosbuvir and velpatasvir is available as a single once-a-day tablet or film-coated pellets that contain both ingredients. 

Sofosbuvir and velpatasvir is used to treat chronic (long lasting) hepatitis C that is genotype 1, 2, 3, 4, 5, or 6 in patients 3 years of age and older, your doctor will perform tests to find out which hepatitis genotype you have. Sofosbuvir and velpatasvir can be used in hepatitis C patients without cirrhosis or with compensated cirrhosis. If you have decompensated cirrhosis you need to take sofosbuvir velpatasvir in combination with ribavirin.

Sofosbuvir and velpatasvir is sometimes used in people who also have HIV, but this medicine does not treat HIV or AIDS.

Sofosbuvir is also available as a single-ingredient medicine under the brand name Sovaldi and is used for hepatitis C virus (HCV). Sovaldi must be given in combination with other antiviral medications - it should not be used alone, as a single HCV medicine treatment.

Warnings

If you've had hepatitis B, sofosbuvir and velpatasvir can cause this condition to come back or get worse.  Call your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice.

Sofosbuvir and velpatasvir  is used in combination with ribavirin if you have decompensated cirrhosis. Ribavirin can cause birth defects or death in an unborn baby. Do not use ribavirin if you are pregnant, or if you are a man and your sexual partner is pregnant. Use effective birth control to prevent pregnancy while using these medicines together and for at least 6 months after treatment ends.

Before taking this medicine

Sofosbuvir and velpatasvir is sometimes used in combination with other antiviral medication. Read the medication guide or patient instructions provided with each medication in your combination therapy.

When taking sofosbuvir and velpatasvir with other medicine: Tell your doctor about all your medical conditions, and if you are pregnant or breastfeeding.

To make sure sofosbuvir and velpatasvir if safe for you to take, tell your doctor if you have ever had:

• hepatitis B;
• liver problems other than hepatitis C;
• kidney disease (or if you are on dialysis);
• diabetes;
• HIV (human immunodeficiency virus); or
• if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine "INR" or prothrombin time tests.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant

• It is not known if sofosbuvir and velpatasvir will harm your unborn baby.
• Sofosbuvir and velpatasvir is sometimes used in combination with ribavirin. Ribavirin can harm an unborn baby if the mother or father is using ribavirin.
  • Both men and women using ribavirin should use birth control to prevent pregnancy.
  • Keep using birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs.
  • Call your healthcare provider right away if you think you may be pregnant or become pregnant during treatment with sofosbuvir and velpatasvir in combination with ribavirin.
  • Males and females who take sofosbuvir and velpatasvir in combination with ribavirin should also read the ribavirin Medication Guide for important pregnancy, contraception, and infertility information.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. 

• It is not known if sofosbuvir and velpatasvir passes into your breast milk.
• Talk to your healthcare provider about the best way to feed your baby during treatment with this medicine.

How should I take sofosbuvir and velpatasvir?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

How to take sofosbuvir and velpatasvir film-coated pellets 

• Take with or without food.
• Place the oral pellets in your mouth and swallow without chewing. Read and follow Epclusa Dosage and Administration about mixing the pellets with food to improve the taste. Ask your doctor or pharmacist if you need help. Doses are based on weight in children and teenagers. The dose may change if the child gains or loses weight.
• If you've had hepatitis B, it may come back or get worse. You may need liver function tests while using this medicine and for several months after you stop.
• You should not stop using sofosbuvir and velpatasvir suddenly, or your hepatitis C could become harder to treat with antiviral medicine
• Use all medications as directed. Do not change your dose or stop using this medicine without your doctor's advice. Remain under the care of a doctor.

How to take sofosbuvir and velpatasvir tablets

• Take the sofosbuvir and velpatasvir tablet with or without food.
• For adults the usual dose of sofosbuvir and velpatasvir is one 400/100 mg tablet each day.
• For children 3 years of age and older your healthcare provider will prescribe the right dose of EPCLUSA based on your child's body weight.
• If you've had hepatitis B, it may come back or get worse. You may need liver function tests while using this medicine and for several months after you stop.
• You should not stop using sofosbuvir and velpatasvir suddenly, or your hepatitis C could become harder to treat with antiviral medicine
• Use all medications as directed. Do not change your dose or stop using this medicine without your doctor's advice. Remain under the care of a doctor.

Dosing information

Uses: 

• For the treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection
  • In patients without cirrhosis or with compensated cirrhosis.
  • In combination with ribavirin: In patients with decompensated cirrhosis.

Usual Adult Dose for Chronic Hepatitis C:

• Sofosbuvir 400 mg-velpatasvir 100 mg orally once a day

Usual Pediatric Dose for Chronic Hepatitis C (3 years or older):

 

• Weight less than 17kg: Sofosbuvir 150 mg-velpatasvir 37.5 mg oral pellet once a day

• Weight 17 to less than 30 kg: Sofosbuvir 200 mg-velpatasvir 50 mg orally once a day
• Weight at least 30 kg: Sofosbuvir 400 mg-velpatasvir 100 mg orally once a day

Duration of Treatment and recommended regime:

• Therapy-naive and therapy-experienced, without cirrhosis and with compensated cirrhosis (Child-Pugh A): Sofosbuvir-velpatasvir for 12 weeks.
• Therapy-naive and therapy-experienced, with decompensated cirrhosis (Child-Pugh B or C): Sofosbuvir-velpatasvir plus ribavirin for 12 weeks.

Comments:

• Dose recommendations also apply to HCV/HIV-1-coinfected patients.
• In clinical trials, therapy-experienced patients received a peginterferon alfa/ribavirin-based regimen with or without an HCV nonstructural protein 3/4A (NS3/4A) protease inhibitor (boceprevir, simeprevir, or telaprevir).
• If applicable, the manufacturer product information should be consulted for ribavirin dose recommendations; the manufacturer product information for ribavirin should be consulted for further information regarding dosing and dose adjustments.

What happens if I miss a dose?

Take the medicine as soon as you remember, and then go back to your regular schedule. Do not use two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking sofosbuvir and velpatasvir?

Using sofosbuvir and velpatasvir will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Sofosbuvir and velpatasvir side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have new or worsening symptoms such as:

• right-sided upper stomach pain;
• vomiting, loss of appetite, not feeling well; or
• jaundice (yellowing of the skin or eyes).

If you also take a heart rhythm medicine called amiodarone: Taking amiodarone with sofosbuvir and velpatasvir can cause dangerous side effects on your heart. Get medical help right away if you take this medicine and you have:

• very slow heartbeats, chest pain, shortness of breath;
• confusion, memory problems; or
• weakness, extreme tiredness, light-headed feeling (like you might pass out).

Common side effects of sofosbuvir and velpatasvir may include:

• headache, tiredness;
• nausea, vomiting, diarrhea;
• sleep problems (insomnia); or
• low red blood cells (anemia) in people with cirrhosis--pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect sofosbuvir and velpatasvir?

When you start or stop taking sofosbuvir and velpatasvir, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Do not start taking a new medicine or stop a medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take sofosbuvir and velpatasvir with other medicines.

If you also take omeprazole (Prilosec) or an antacid, do not take it for at least 4 hours after you have taken your dose of sofosbuvir and velpatasvir (with food).

Many drugs can affect sofosbuvir and velpatasvir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

To check for interactions with this medicine click the link below.

Storage

Epclusa Brand

• 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.

What are the ingredients in sofosbuvir and velpatasvir?

Epclusa Brand

Active ingredients: sofosbuvir and velpatasvir

Tablets 

• Inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.
• The tablet film-coat contains: iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Oral Pellets

• Inactive ingredients, Oral Pellets: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.
• The oral pellets film-coat contains: amino methacrylate copolymer, colloidal silicon dioxide, hypromellose, L-tartaric acid, polyethylene glycol, stearic acid, talc, and titanium dioxide.

Manufacturer

Gilead Sciences, Inc. Foster City, CA 94404

Popular FAQ

More FAQ

• Can you drink alcohol while taking Epclusa?
• Epclusa vs Harvoni – Which is better?
• How does Epclusa work in the body?

View more FAQ

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer