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Velpatasvir and Sofosbuvir: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Boxed warning
Strength:
100 mg, 400 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Velpatasvir and Sofosbuvir

What is the most important information I should know about sofosbuvir and velpatasvir?

Sofosbuvir and velpatasvir can cause serious side effects, including:

Hepatitis B virus reactivation: Before starting treatment with sofosbuvir and velpatasvir, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with sofosbuvir and velpatasvir. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking sofosbuvir and velpatasvir.

For more information about side effects, see the section "What are the possible side effects of sofosbuvir and velpatasvir?"

What is sofosbuvir and velpatasvir?

Sofosbuvir and velpatasvir is a prescription medicine used to treat adults and children 3 years of age and older with chronic (lasting a long time) hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection:

  • without cirrhosis or with compensated cirrhosis.
  • with advanced cirrhosis (decompensated) in combination with ribavirin.

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

Before taking sofosbuvir and velpatasvir, tell your healthcare provider about all of your medical conditions, including if you:

  • have ever had 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. It is not known if sofosbuvir and velpatasvir tablets will harm your unborn baby.

    • Females who take sofosbuvir and 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 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.

  • 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 sofosbuvir and velpatasvir.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sofosbuvir and velpatasvir and other medicines may affect each other. This can cause you to have too much or not enough sofosbuvir and velpatasvir or other medicines in your body. This may affect the way sofosbuvir and velpatasvir or your other medicines work or may cause side effects.

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 and 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 and velpatasvir with other medicines.

How should I take sofosbuvir and velpatasvir?

  • Take sofosbuvir and 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 and velpatasvir without first talking with your healthcare provider.

  • Take sofosbuvir and velpatasvir by mouth, 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 sofosbuvir and velpatasvir based on your child's body weight.

    • Tell your healthcare provider if your child has problems with swallowing tablets.
    • If your healthcare provider prescribes sofosbuvir and velpatasvir (EPCLUSA) oral pellets for your child, see "How should I give sofosbuvir and velpatasvir (EPCLUSA) oral pellets to my child?"
  • Do not miss a dose of sofosbuvir and velpatasvir. Missing a dose lowers the amount of medicine in your blood. Refill your sofosbuvir and velpatasvir prescription before you run out of medicine.
  • If you take too much sofosbuvir and velpatasvir, call your healthcare provider or go to the nearest hospital emergency room right away.

How should I give sofosbuvir and velpatasvir (EPCLUSA) oral pellets to my child?

See the detailed Instructions for Use for information about how to give or take a dose of sofosbuvir and velpatasvir (EPCLUSA) oral pellets.

  • Administer sofosbuvir and velpatasvir (EPCLUSA) oral pellets exactly as instructed by your healthcare provider.
  • Sofosbuvir and velpatasvir (EPCLUSA) oral pellets can be taken with food or directly in the mouth.
  • For children younger than 6 years, take sofosbuvir and velpatasvir (EPCLUSA) oral pellets with food.
  • Sofosbuvir and velpatasvir (EPCLUSA) oral pellets should be swallowed whole. Do not chew sofosbuvir and velpatasvir (EPCLUSA) oral pellets to avoid a bitter aftertaste.
  • Do not open the sofosbuvir and velpatasvir (EPCLUSA) oral pellets packet until ready to use.

What are the possible side effects of sofosbuvir and velpatasvir?

Sofosbuvir and velpatasvir can cause serious side effects, including:

  • Hepatitis B virus reactivation. See "What is the most important information I should know about sofosbuvir and velpatasvir?"
  • Slow heart rate (bradycardia). Sofosbuvir and velpatasvir treatment may result in slowing of the heart rate along with other symptoms when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems. In some cases bradycardia has led to death or the need for a heart pacemaker when amiodarone is taken with medicines similar to sofosbuvir and velpatasvir tablets that contain sofosbuvir. Get medical help right away if you take amiodarone with sofosbuvir and velpatasvir tablets and get any of the following symptoms:
  • fainting or near-fainting
  • dizziness or lightheadedness
  • not feeling well
  • weakness
  • extreme tiredness
  • shortness of breath
  • chest pains
  • confusion
  • memory problems
  • The most common side effects of sofosbuvir and velpatasvir in adults and children 6 years of age and older include headache and tiredness.
  • The most common side effects of sofosbuvir and velpatasvir when used with ribavirin in adults with decompensated cirrhosis are tiredness, low red blood cells, nausea, headache, trouble sleeping, and diarrhea.
  • The most common side effects of sofosbuvir and velpatasvir in children younger than 6 years of age are vomiting and problems with spitting up the medicine.

These are not all the possible side effects of sofosbuvir and velpatasvir.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store sofosbuvir and velpatasvir tablets?

  • Store sofosbuvir and velpatasvir tablets below 86°F (30°C).

Keep sofosbuvir and velpatasvir tablets and all medicines out of the reach of children.

General information about the safe and effective use of sofosbuvir and velpatasvir

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use sofosbuvir and velpatasvir for a condition for which it was not prescribed. Do not give sofosbuvir and velpatasvir to other people, even if they have the same symptoms you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about sofosbuvir and velpatasvir that is written for health professionals.

What are the ingredients in sofosbuvir and velpatasvir tablets (400 mg/100 mg)?

Active ingredients: sofosbuvir and velpatasvir

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.

Manufactured for:

Asegua Therapeutics LLC, an affiliate of Gilead Sciences, Inc., Foster City, CA 94404

For more information, call 1-800-445-3235 or go to www.asegua.com.

Asegua is a trademark of Asegua Therapeutics LLC. All other trademarks referenced herein are the property of their respective owners.

208341-AG-010

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA AUTHORIZED GENERIC 208341 · View the label on DailyMed

Revision date stated in the text: June 2021

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Velpatasvir and Sofosbuvir

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Hepatitis C Virus NS5A Inhibitor, Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Active ingredients Velpatasvir 100 mg, Sofosbuvir 400 mg
Dosage form Tablet, film coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) GILEAD SCIENCES INC
FDA approval NDA AUTHORIZED GENERIC 208341NDA authorized generic Approved June 28, 2016
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Recalls
  • March 7, 2025: Class II recall: Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Packages (NDC)
Package
100 mg, 400 mg – 14 in 1 blister pack / 2 in 1 carton NDC 72626-2701-1

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.