Sofosbuvir and Velpatasvir

Generic name: Sofosbuvir And Velpatasvir
Brand names: Epclusa
Drug class: Antiviral combinations

Usage of 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.

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.

Before taking Sofosbuvir and Velpatasvir

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:

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.

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.

Relate drugs

How to use Sofosbuvir and Velpatasvir

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.

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.

What 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.

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