Generic name: sofosbuvir and velpatasvir [ soe-fos-bue-vir-and-vel-pat-as-vir ]
Drug class: Antiviral combinations
Availability: Prescription only
Pregnancy & Lactation: Risk data available
Brand names: Epclusa
What is Sofosbuvir and velpatasvir?
Sofosbuvir and velpatasvir are used to treat chronic hepatitis C virus (HCV), it is the generic name for the medicine Epclusa (brand name). Sofosbuvir and velpatasvir are both antiviral ingredients that work by helping to prevent the hepatitis C virus to make copies of itself. The single once-a-day tablet or film-coated pellets contain the two antiviral medicine, sofosbuvir and velpatasvir.
Sofosbuvir and velpatasvir can be used by patients 3 years of age and older who have chronic (long lasting) hepatitis C that is genotype 1-6, 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 and velpatasvir in combination with another medicine called ribavirin.
Sofosbuvir and velpatasvir is sometimes used in people who have hepatitis C and 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. Sovaldi must be given in combination with other antiviral medications - it should not be used alone, as a single HCV medicine treatment.
Sofosbuvir and velpatasvir became an FDA-approved medicine on June 28, 2016.
Warnings
If you've had hepatitis B, this medicine 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 with 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.
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
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Take sofosbuvir and velpatasvir film-coated pellets with or without food.
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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.
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Doses are based on weight in children and teenagers. The dose may change if the child gains or loses weight.
How to take sofosbuvir and velpatasvir tablets
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Take the sofosbuvir and velpatasvir tablet with or without food.
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For adults the usual dose of sofosbuvir and velpatasvir is one 400/100 mg tablet each day.
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For children 3 years of age and older your healthcare provider will prescribe the right dose based on your child's body weight.
General information
- 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 this medicine 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
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Sofosbuvir 400 mg-velpatasvir 100 mg orally once a day
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Weight less than 17kg: Sofosbuvir 150 mg-velpatasvir 37.5 mg oral pellet once a day
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Weight 17 to less than 30 kg: Sofosbuvir 200 mg-velpatasvir 50 mg orally once a day
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Weight at least 30 kg: Sofosbuvir 400 mg-velpatasvir 100 mg orally once a day
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Therapy-naive and therapy-experienced, without cirrhosis and with compensated cirrhosis (Child-Pugh A): Sofosbuvir-velpatasvir for 12 weeks.
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Therapy-naive and therapy-experienced, with decompensated cirrhosis (Child-Pugh B or C): Sofosbuvir-velpatasvir plus ribavirin for 12 weeks.
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Dose recommendations also apply to HCV/HIV-1-coinfected patients.
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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).
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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.
Before Taking
Sofosbuvir with velpatasvir is sometimes used in combination with other antiviral medications. 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 this medicine is safe for you to take, tell your doctor if you have ever had:
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hepatitis B;
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liver problems other than hepatitis C;
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kidney disease (or if you are on dialysis);
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diabetes;
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HIV (human immunodeficiency virus); or
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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.
- Men and women using ribavirin should use birth control to prevent pregnancy, while taking ribavirin and until at least 6 months after your last dose of ribavirin.
- If you become pregant while taking ribavirin and in the 6 months after your last dose, you should tell your doctor right away.
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.
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 using Sofosbuvir and 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 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:
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right-sided upper stomach pain;
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vomiting, loss of appetite, not feeling well; or
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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:
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very slow heartbeats, chest pain, shortness of breath;
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confusion, memory problems; or
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weakness, extreme tiredness, light-headed feeling (like you might pass out).
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headache, tiredness;
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nausea, vomiting, diarrhea;
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sleep problems (insomnia); or
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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.
See more: Sofosbuvir and velpatasvir Side EffectsWhat other drugs will affect Sofosbuvir and velpatasvir?
When you start or stop taking this medicine, 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.