Sofosbuvir/velpatasvir

Pronunciation: so-fos-boo-vear/vell-pat-is-vear
Generic name: sofosbuvir/velpatasvir
Brand name: Epclusa (ep-KLOO-suh)
Dosage form: oral tablet, oral pellets
Drug class: Antiviral combinations

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 16, 2024.

What is sofosbuvir/velpatasvir?

Sofosbuvir/velpatasvir is an oral, fixed-dose, antiviral, combination treatment that may be used to treat chronic hepatitis C (HCV) genotype 1, 2, 3, 4, 5, or 6 infections, in adults and children 3 years of age and older:

• without cirrhosis or with compensated cirrhosis
• with decompensated cirrhosis when used in combination with ribavirin.

Your doctor will perform tests to find out which hepatitis genotype you have

The ingredients in sofosbuvir/velpatasvir each have a different antiviral action and a different way of working. Sofosbuvir is a prodrug that is converted in the body to its active metabolite which is incorporated into HCV RNA by an enzyme called NS5B RNA polymerase and acts as a chain terminator. Velpatasvir blocks the effects of an HCV protein called NS5A, which is also required for viral replication.

Sofosbuvir/velpatasvir was FDA-approved under the brand Epclusa on June 28, 2016. A generic is available.

Warnings

If you've had hepatitis B (HBV), sofosbuvir/velpatasvir can cause this condition to come back or get worse. Your healthcare provider will test you for HBV before starting sofosbuvir/velpatasvir. Call your healthcare provider right away if you develop right-sided upper abdominal pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

A very slow heartbeat (bradycardia) may occur in those patients also administered amiodarone who also take beta-blockers, have underlying cardiovascular conditions, or advanced liver disease.

Sofosbuvir/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.

It is not known if sofosbuvir/velpatasvir is safe and effective in children under 3 years of age.

Related/similar drugs

Harvoni, Vosevi, Epclusa, Mavyret, sofosbuvir, Sovaldi

What are the side effects of sofosbuvir/velpatasvir?

Sofosbuvir/velpatasvir may cause serious side effects (see warnings above).

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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, or not feeling well
• jaundice (yellowing of the skin or eyes).

Common side effects of sofosbuvir/velpatasvir, affecting 10% or more patients were:

• Adults and children 6 years of age and older: headache and fatigue
• Children less than 6 years of age: vomiting and spitting up the drug
• When used together with ribavirin in adults with decompensated cirrhosis: fatigue, anemia, nausea, headache, insomnia, and diarrhea.

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 Gilead Sciences, Inc. at 1-800-GILEAD-5FDA or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before taking

Before taking sofosbuvir/velpatasvir tell your healthcare provider if you:

• have ever had a hepatitis B virus infection
• have liver problems other than hepatitis C infection
• have had a liver transplant
• have kidney problems or you are on dialysis
• have HIV-1 infection
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if sofosbuvir/velpatasvir will harm your unborn baby. Females who take sofosbuvir/velpatasvir in combination with ribavirin should avoid becoming pregnant during treatment and for 6 months after stopping treatment. Call your healthcare provider right away if you think you may be pregnant or become pregnant during treatment or within 6 months of the last dose of sofosbuvir/velpatasvir in combination with ribavirin.

Males and females who take sofosbuvir/velpatasvir in combination with ribavirin should also read the ribavirin Medication Guide for important pregnancy, contraception, and infertility information. Ribavirin can harm an unborn baby if the father is using ribavirin. Men using ribavirin should use birth control to prevent pregnancy while taking ribavirin and until at least 6 months after their last dose of ribavirin.

Breastfeeding

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

How is sofosbuvir/velpatasvir administered?

Take sofosbuvir/velpatasvir exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to.

• Do not stop taking sofosbuvir/velpatasvir without first talking with your healthcare provider.

Take the oral tablets or oral pellets by mouth

• May be taken with or without food.
• For adults, the usual dose of sofosbuvir/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 sofosbuvir/velpatasvir oral pellets or tablets based on your child’s body weight.
  • The dose may change if the child gains or loses weight.

Tell your healthcare provider if your child has problems with swallowing tablets.

How should I give sofosbuvir/velpatasvir oral pellets to my child?

Administer sofosbuvir/velpatasvir oral pellets exactly as instructed by your healthcare provider.

• The oral pellets can be taken with food or placed directly in the mouth.
• For children younger than 6 years, give them the oral pellets with food.
• The sofosbuvir/velpatasvir oral pellets should be swallowed whole. Instruct your child not to chew them because they have a bitter aftertaste.
• Do not open the packet of oral pellets until ready to use.

Read and follow the Epclusa Oral Pellets Dosage and Administration guide. Ask your doctor or pharmacist if you need help.

What happens if I miss a dose?

Do not miss a dose of sofosbuvir/velpatasvir. Missing a dose lowers the amount of medicine in your blood. Refill your prescription before you run out of medicine.

If you do happen to forget a dose, take the dose as soon as you remember. But if it is almost time for your next dose, skip that dose. Do not take 2 doses at once.

What happens if I overdose?

If you take too much sofosbuvir/velpatasvir, call your healthcare provider, go to the nearest hospital emergency room right away, or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking sofosbuvir/velpatasvir?

Using this medicine 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 drugs or medicine needles is never safe, even for a healthy person.

What other drugs will affect sofosbuvir/velpatasvir?

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

• omeprazole (Prilosec) or an antacid. Do not take them for at least 4 hours after you have taken your dose of sofosbuvir/velpatasvir
• amiodarone. Get medical help right away if you take this medicine and you have very slow heartbeats, chest pain, shortness of breath, confusion, memory problems, weakness, extreme tiredness, or a light-headed feeling (like you might pass out).
• P-gp inducers and/or moderate to strong CYP inducers (such as rifampin, St. John’s wort, and carbamazepine). May decrease concentrations of sofosbuvir/velpatasvir. Use together is not recommended

Clearance of HCV infection with direct-acting antivirals may lead to changes in liver function, which may impact the safe and effective use of other medications. Frequent laboratory monitoring and dose adjustments may be necessary.

Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with sofosbuvir/velpatasvir. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take sofosbuvir/velpatasvir with other medicines.

Storage

Store Epclusa tablets or oral pellets below 86°F (30°C). Keep them in the original container. Do not use the oral pellets if the carton tamper-evident seal or the packet has been opened or damaged.

Throw away (dispose of) any unused portion. Do not store and reuse any leftover Epclusa oral pellets or mixture (oral pellets mixed with food).

Keep out of the reach of children.

Ingredients

Epclusa tablets

Active ingredients: sofosbuvir and velpatasvir

Inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.

Film coating: iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Epclusa tablets are a fixed-dose tablet in two strengths:

• 400 mg of sofosbuvir and 100 mg of velpatasvir
• 200 mg of sofosbuvir and 50 mg of velpatasvir.

Epclusa oral pellets

Active ingredients: sofosbuvir and velpatasvir

Inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

Film-coating: amino methacrylate copolymer, colloidal silicon dioxide, hypromellose, L-tartaric acid, polyethylene glycol, stearic acid, talc, and titanium dioxide.

Epclusa oral pellets are available in two strengths:

• 200 mg of sofosbuvir and 50 mg of velpatasvir
• 150 mg of sofosbuvir and 37.5 mg of velpatasvir.

Manufacturer

Gilead Sciences, Inc.

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Further information

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

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