Generic Name: sofosbuvir and velpatasvir (soe FOS bue vir and vel PAT as vir)
Brand Name: Epclusa
Drug class: Antiviral combinations
Epclusa contains a combination of sofosbuvir and velpatasvir. Sofosbuvir and velpatasvir are antiviral medications that prevent hepatitis C virus (HCV) from multiplying in your body.
Epclusa is used to treat chronic hepatitis C in adults and children 3 years of age and older (dosage is based on weight). It is sometimes given in combination with another antiviral medicine called ribavirin in people who also have advanced cirrhosis.
Epclusa treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.
Epclusa is sometimes used in people who also have HIV. This medicine is not a treatment for HIV or AIDS.
Warnings
If you have ever had hepatitis B, Epclusa can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function.
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.
Epclusa is sometimes used in combination with ribavirin. 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
You should not use Epclusa if you are allergic to sofosbuvir or velpatasvir.
When taking Epclusa with other medicine: To make sure all medicines are safe for you, tell your doctor about all your medical conditions, and if you are pregnant or breastfeeding.
To make sure Epclusa is safe for you, 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.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Epclusa is sometimes used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby.
- If you are a woman, do not use ribavirin if you are pregnant. You may need to have a negative pregnancy test before taking ribavirin and every month during your treatment.
- If you are a man, do not use ribavirin if your sexual partner is pregnant. An unborn baby could be harmed if you have sex with a pregnant woman while you are taking ribavirin.
While taking Epclusa with ribavirin, use at least 2 effective forms of birth control to prevent pregnancy, whether you are a man or a woman. Ribavirin use by either parent may cause birth defects.
Keep using 2 forms of birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
How should I take Epclusa?
Epclusa is usually taken once per day for 12 weeks. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using this medicine.
You may take this medicine with or without food.
The oral pellets can be taken with food or directly in the mouth. Children younger than 6 years should take the oral pellets with food. The oral pellets should be swallowed whole to avoid a bitter after taste.
You will need frequent blood tests to check your liver function.
Use all medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with chronic hepatitis C should remain under the care of a doctor.
You should not stop using Epclusa suddenly. Stopping suddenly could make your hepatitis C harder to treat with antiviral medicine.
If you have ever had hepatitis B, using sofosbuvir and velpatasvir can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.
Store this medicine in the original container at room temperature away from moisture and heat.
Dosing information
Usual Adult Dose for Chronic Hepatitis C:
Sofosbuvir 400 mg-velpatasvir 100 mg orally once a day
Recommended Regimen and Duration of Therapy:
-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.
Uses: For the treatment of chronic 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 Pediatric Dose for Chronic Hepatitis C:
6 years or older:
-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
Recommended Regimen and Duration of Therapy:
-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 adults received a peginterferon alfa/ribavirin-based regimen with or without an HCV 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.
Uses: For the treatment of chronic 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
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take 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 to avoid
Using Epclusa 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.
Epclusa side effects
Get emergency medical help if you have signs of an allergic reaction to Epclusa: 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:
- loss of appetite, upper stomach pain;
- dark urine, clay-colored stools; 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 these medicines 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 Epclusa side effects may include:
- headache;
- tiredness;
- nausea, diarrhea; or
- sleep problems (insomnia).
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 Epclusa?
When you start or stop taking Epclusa, 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.
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 Epclusa (with food).
Many drugs can interact with 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 your current medicines and any medicine you start or stop using.