All About Epclusa

What is Epclusa?

If you’re considering treatment for hepatitis C, your doctor may recommend Epclusa.

It’s a prescription drug that’s used in adults and some children to treat hepatitis C, which is caused by hepatitis C virus. To learn more about hepatitis C and how Epclusa is used for it, see the “What is Epclusa used for?” section below.

Epclusa is an antiviral medication that contains two active drugs: sofosbuvir and velpatasvir. A combination drug made with sofosbuvir and velpatasvir is also available in a generic form.

Epclusa comes as tablets that you’ll swallow. It also comes as pellets that you swallow. The pellets are often prescribed for certain children and can be prescribed for anyone who has trouble swallowing tablets.

Read on to learn more about Epclusa’s side effects, uses, and more.

What are Epclusa’s side effects?

Like most drugs, Epclusa may cause mild or serious side effects. The lists below describe some of the more common side effects that Epclusa may cause. These lists don’t include all possible side effects.

Your doctor or pharmacist can tell you more about the potential side effects of Epclusa. They can also suggest ways to help reduce side effects.

Mild side effects

Here’s a short list of some of the mild side effects that Epclusa can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Epclusa’s prescribing information.

Mild side effects reported with the use of Epclusa include:

• headache
• fatigue (lack of energy)
• nausea*
• trouble sleeping

Mild side effects of many drugs may go away within a few days or a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

* This side effect was more common when people took another medication, ribavirin, along with Epclusa.

Serious side effects

Serious side effects from Epclusa can occur, but they aren’t common. If you have serious side effects from Epclusa, call your doctor right away. However, if you think you’re having a medical emergency, you should call 911 or your local emergency number.

Serious side effects reported with Epclusa use include:

• boxed warning: risk of reactivation of hepatitis B virus*
• allergic reaction*
• depression

* For more information on this side effect, see the “Side effect focus” section below.

SUICIDE PREVENTION

If you think someone is at immediate risk of self-harm or hurting another person:

• Call 911 or your local emergency number.
• Stay with the person until help arrives.
• Remove any guns, knives, medications, or other things that may cause harm.
• Listen, but don’t judge, argue, threaten, or yell.

If you or someone you know is considering suicide, get help from a crisis or suicide prevention hotline. Try the National Suicide Prevention Lifeline at 800-273-8255.

Side effect focus

Learn more about some of the side effects Epclusa may cause.

Boxed warning

Epclusa has a boxed warning about the risk of reactivation of the hepatitis B virus (HBV). A boxed warning is a serious warning from the Food and Drug Administration (FDA).

If you have hepatitis C, and you have hepatitis B or have had it in the past, Epclusa can cause reactivation of HBV.

With reactivation, the virus flares up and causes symptoms of infection. In studies, some people with HBV developed serious symptoms of hepatitis B reactivation. These included liver failure and, in some cases, death.

What might help

Before you start taking Epclusa, your doctor will order blood tests to see if you have HBV or have had it in the past. If you have HBV, your doctor will likely prescribe antivirals. And your doctor may wait until your hepatitis B is resolved before having you start Epclusa treatment.

While you’re taking Epclusa, your doctor will continue to monitor blood tests. And they’ll check you for signs and symptoms of hepatitis B. After you finish treatment with Epclusa, your doctor will continue to check you for hepatitis B infection symptoms for a while.

If you get HBV or have HBV reactivation while you’re taking Epclusa, you’ll need to start treatment for it. Don’t stop taking Epclusa without first talking with your doctor.

Long-term side effects of Epclusa

Long-term side effects of Epclusa haven’t been reported. But some people have cirrhosis (scarring in the liver) that’s due to hepatitis C, which Epclusa is used to treat.

And if you have cirrhosis, you may have some long-lasting symptoms of the condition. These can include:

• feeling tired, weak, or confused
• poor appetite
• weight loss without trying
• nausea and vomiting
• liver pain, which may be mild pain in the upper right side of your belly
• bruising or bleeding more easily than usual
• swelling or bloating from fluid buildup in your belly
• itchy skin
• dark urine
• jaundice (yellowing of your skin or the whites of your eyes)

What might help

During and after treatment with Epclusa, tell your doctor right away if you have any symptoms of cirrhosis.

Keep in mind that liver damage, including that caused by cirrhosis, is permanent. So your doctor may suggest tips to prevent further worsening of your liver health. These tips may include:

• avoiding alcohol
• getting a hepatitis B vaccine
• eating healthy foods
• managing a body weight that’s healthy for you

Side effects after Epclusa treatment

People haven’t reported side effects after finishing with Epclusa treatment.

However, hepatitis C, which Epclusa is used to treat, is a long-lasting condition that gets worse over time. The risk of hepatitis C getting worse is increased if you have:

• alcohol use disorder
• cirrhosis (scarring in the liver)
• hepatitis B

Epclusa lowers the amount of hepatitis C virus in your body. If your levels are low enough not to be seen on a blood test, certain risks become lower. These risks include cirrhosis and death from liver damage.

When you stop taking Epclusa for hepatitis C, your condition may worsen. And this could cause symptoms of hepatitis C, which may include:

• a general feeling of illness
• nausea
• liver pain
• dark urine
• jaundice

What might help

After you finish treatment with Epclusa, your doctor will order a blood test to check if Epclusa was successful in clearing hepatitis C virus from your body. If the blood test shows that Epclusa didn’t fully clear hepatitis C from your body, you and your doctor will determine what steps should be taken next.

If you have any symptoms of hepatitis C after finishing your treatment with Epclusa, talk with your doctor right away. They can order to tests to see if your hepatitis C has worsened.

Allergic reaction

Some people may have an allergic reaction to Epclusa. While allergic reaction wasn’t reported in studies of Epclusa, it can still happen.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under your skin, typically in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing.

Call your doctor right away if you have an allergic reaction to Epclusa. But if you think you’re having a medical emergency, call 911 or your local emergency number.

What does Epclusa cost?

Costs of prescription drugs can vary depending on many factors. These factors include what your insurance plan covers and which pharmacy you use.

If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. You can also visit the Epclusa manufacturer’s website to see if they have support options.

What should be considered before taking Epclusa?

Some important things to discuss with your doctor when considering Epclusa include your overall health and any medical conditions you may have.

Tell your doctor if you’re taking any prescription or over-the-counter medications. This is important because many drugs interact with Epclusa.

These and other considerations to discuss with your doctor are described below.

Interactions

Taking medications, vaccines, foods, and other things with a certain drug can affect how the drug works. These effects are called interactions.

Before taking Epclusa, be sure to tell your doctor about all medications you take (including prescription and over-the-counter types). Also describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any interactions these items may cause with Epclusa.

Interactions with drugs or supplements

Epclusa can interact with several types of drugs, including:

• the antibiotics rifampin, rifabutin (Mycobutin), and rifapentine (Priftin)
• the HIV medications efavirenz (Sustiva), tenofovir (Viread), tipranavir (Aptivus), and ritonavir (Norvir)
• the cancer drug topotecan (Hycamtin)
• the herb St. John’s wort
• the cholesterol medications rosuvastatin (Crestor) and atorvastatin (Lipitor)
• the heart drugs amiodarone (Pacerone) and digoxin (Lanoxin)
• the seizure drugs carbamazepine (Tegretol), phenytoin (Dilantin), and phenobarbital
• stomach-acid-reducing drugs, such as famotidine (Pepcid), aluminum and magnesium hydroxide, and omeprazole (Prilosec)

This list does not contain all types of drugs that may interact with Epclusa. Your doctor or pharmacist can tell you more about these interactions and any others that may occur with use of Epclusa.

Other interactions

You can take Epclusa with or without food. But you may need to avoid certain foods with Epclusa. Food interactions occur when a food interferes with how a medication works.

For instance, grapefruit and grapefruit juice contain chemicals that can interact with Epclusa. If you eat grapefruit or drink its juice while taking Epclusa, the drug may not work as well as usual.

Before taking Epclusa, talk with your doctor or pharmacist about possible food interactions.

Boxed warning

Epclusa has a boxed warning. This is a serious warning from the Food and Drug Administration (FDA) about drug effects that may be dangerous.

If you have hepatitis C and you have hepatitis B virus (HBV) or have had it in the past, Epclusa can cause reactivation of HBV. With reactivation, the virus flares up and causes symptoms of infection. In studies, some people with HBV developed serious symptoms of hepatitis B reactivation. These included liver failure and, in some cases, death.

Before you start treatment with Epclusa, your doctor will order blood tests to see if you have hepatitis B or have had it in the past.

For more information, see the “What are Epclusa’s side effects?” section below.

Other warnings

Epclusa may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before you take Epclusa. Factors to consider include those in the list below.

• Allergic reaction. If you’ve had an allergic reaction to Epclusa or any of its ingredients, you shouldn’t take Epclusa. Ask your doctor what other medications are better options for you.
• Liver problems other than hepatitis C infection. If you have severe liver disease, talk with your doctor. They may need to prescribe another medication in addition to Epclusa to treat your hepatitis C.
• History of a liver transplant. Epclusa has been studied in people who’ve had a liver transplant and certain types of hepatitis C virus. But the drug hasn’t been studied in people with other types of hepatitis C virus who’ve had a liver transplant. If you’ve had a liver transplant, talk with your doctor about whether Epclusa is right for you.
• Past kidney disease. Recent studies in people with severe kidney disease, including people having dialysis treatment, found Epclusa to be safe. And the drug worked just as well as usual. But it’s still important to tell your doctor about any kidney disease you may have. This is because a drug called ribavirin shouldn’t be used in people with a certain level of kidney disease. And ribavirin is sometimes prescribed together with Epclusa to treat hepatitis C infection.
• HIV infection. Certain HIV medications shouldn’t be used with Epclusa. Some medications used to treat HIV can harm your liver. This could affect how well Epclusa works for you. Be sure to tell your doctor if you have HIV, and about all medications you take, before you start taking Epclusa.

Use with alcohol

Epclusa isn’t known to interact with alcohol. But keep in mind that hepatitis C, which Epclusa is used to treat, gets worse over time. And drinking alcohol may worsen hepatitis C more quickly. So your doctor may recommend that you avoid drinking alcohol.

Before starting Epclusa, ask your doctor or pharmacist if it’s safe for you to drink alcohol.

Pregnancy and breastfeeding

It’s not known whether Epclusa is harmful if used during pregnancy. Before starting Epclusa, be sure to tell your doctor if you’re pregnant or considering pregnancy.

Sometimes, Epclusa is prescribed together with ribavirin (Rebetol), another hepatitis C medication. And taking ribavirin during pregnancy is unsafe.

If you or your partner are pregnant or considering pregnancy, talk with your doctor before taking ribavirin. Tell your doctor right away if you or your partner becomes pregnant during or after Epclusa treatment.

It’s not known whether Epclusa passes into breast milk. If you’re breastfeeding, talk with your doctor about whether it’s safe for you to take Epclusa.

Epclusa and alcohol

Epclusa isn’t known to interact with alcohol. But keep in mind that hepatitis C, which Epclusa is used to treat, gets worse over time. And drinking alcohol may worsen hepatitis C more quickly. So your doctor may recommend that you avoid drinking alcohol.

If you drink alcohol, before starting Epclusa, ask your doctor or pharmacist if it’s safe for you to drink it.

What is Epclusa’s dosage?

Your doctor will recommend the dosage of Epclusa that’s right for you. Below are commonly used dosages, but always take the dosage your doctor prescribes.

Form and strengths

Epclusa comes as a tablet that you swallow. The drug also comes as pellets in a packet. The pellets can be swallowed by themselves or with water or another liquid. Or the pellets can be sprinkled onto food and then swallowed.

The pellets are typically prescribed for children, and can be prescribed for anyone who has trouble swallowing tablets.

Epclusa tablets and pellets each contain the same two active drugs. But they come in different strengths, as shown in the below table.

Recommended dosages

You’ll take Epclusa once per day.

Your doctor will recommend a dosing schedule of Epclusa that’s right for you. In general, you’ll take this drug for 12 weeks.

For children ages 3 years and older, doctors will prescribe Epclusa pellets or tablets based on the child’s body weight. Children who are 3 to 6 years of age will typically be prescribed Epclusa pellets to be taken with non-acidic food. See the “How is Epclusa taken?” section below for details.

Questions about Epclusa’s dosage

Below are some common questions about Epclusa’s dosage.

• What if I miss a dose of Epclusa? It is very important not to miss any doses of Epclusa. Missing doses lowers the amount of Epclusa in your body and can make it less likely that your hepatitis C infection will be cured. If you miss a dose of Epclusa, take it as soon as you remember. You should not double your dose if you forget to take a dose of Epclusa. If you’re unsure when to take a missed dose of Epclusa, talk with your doctor or pharmacist.
• Will I need to use Epclusa long term? Your doctor will prescribe Epclusa for 12 weeks to treat hepatitis C.
• How long does Epclusa take to work? Epclusa starts working quickly in your body to stop the hepatitis C virus from making more of itself. But not everyone may have the same experience with Epclusa. Ask your doctor how long it should take for Epclusa to work for you. In studies, many people

How is Epclusa taken?

Your doctor will explain how you should take Epclusa. They’ll also explain how much to take and how often. Be sure to follow your doctor’s instructions. Below are commonly used dosages, but always take the dosage your doctor prescribes.

Taking Epclusa

Epclusa comes as tablets or pellets that you take by mouth.

You should swallow Epclusa tablets whole.

Epclusa pellets are typically prescribed for children. The pellets may also be prescribed for adults who have trouble swallowing Epclusa tablets.

Epclusa pellets can be swallowed by themselves, or with water or another liquid. Or you can sprinkle them onto non-acidic food before eating. For children younger than 6 years, doctors typically recommend taking Epclusa pellets with food.

Examples of foods that aren’t acidic include ice cream and pudding. The pellets should be swallowed within 15 minutes after mixing them with food. Try to avoid chewing the pellets themselves due to their bitter taste.

Taking Epclusa with other drugs

If you have symptoms of cirrhosis (scarring of the liver), your doctor will prescribe Epclusa together with a drug called ribavirin (Rebetol).

Like Epclusa, ribavirin is used for hepatitis C. But unlike Epclusa, which you can take with or without food, ribavirin must be taken with food.

You doctor will prescribe the appropriate dose of ribavirin for you based on your body weight.

Questions about taking Epclusa

Below are answers to some questions you may have about taking Epclusa.

• Can Epclusa be chewed, crushed, or split? It’s unknown whether you can chew, crush, or split Epclusa. The pellets cause a bitter aftertaste, so it’s recommended to avoid chewing them. If you’re having trouble swallowing Epclusa, talk with your doctor or pharmacist. They can give you tips on how to take Epclusa safely.
• Should I take Epclusa with food? You can take Epclusa with or without food. If you have nausea when taking Epclusa, try taking it with food. It’s recommended that children younger than 6 years take Epclusa pellets sprinkled onto a non-acidic food. Examples include ice cream and pudding.
• Is there a best time of day to take Epclusa? There’s no specific recommended time of day to take Epclusa. But taking the drug at about the same time each day can help you remember to take your dose.

Questions for your doctor

You may have questions about Epclusa and your treatment plan. It’s important to discuss all your concerns with your doctor.

Here are a few tips that might help guide your discussion:

• Before your appointment, write down questions like:
  • How will Epclusa affect my body, mood, or lifestyle?
• Bring someone with you to your appointment if doing so will help you feel more comfortable.
• If you don’t understand something related to your condition or treatment, ask your doctor to explain it to you.

Remember, your doctor and other healthcare professionals are available to help you. And they want you to get the best care possible. So don’t be afraid to ask questions or offer feedback on your treatment.

What is Epclusa used for?

If you’re considering treatment for hepatitis C, your doctor may recommend Epclusa. It’s used to treat certain types of long-lasting hepatitis C, which are caused by hepatitis C virus.

Epclusa can be used in adults. It can also be used in children ages 3 years and older.

Epclusa may be prescribed for people with or without cirrhosis (scarring in the liver). With cirrhosis, you may or may not have symptoms. If you do have symptoms, the condition is called decompensated cirrhosis. If you don’t have symptoms, the condition is known as compensated cirrhosis.

If you don’t have cirrhosis, or if you have compensated cirrhosis, your doctor may prescribe Epclusa by itself. But if you have decompensated cirrhosis, your doctor may prescribe Epclusa together with a medication called ribavirin (Rebetol).

Epclusa is an antiviral medication that targets the hepatitis C virus. This virus attacks your liver cells. And it spreads through your liver by making copies of itself. Epclusa works by preventing the virus from copying itself. If the virus doesn’t copy and spread, it eventually dies.

What are some frequently asked questions about Epclusa?

Find answers to some commonly asked questions about Epclusa.

If I stop taking Epclusa, will I have withdrawal symptoms?

No, you won’t have withdrawal symptoms if you stop taking Epclusa. (Withdrawal refers to symptoms that can happen when you stop taking a drug you’re dependent on.) But you must take Epclusa for the entire 12 weeks that it’s prescribed for you.

Missing doses or stopping treatment before then can affect how well Epclusa works to treat and cure hepatitis C. And if your hepatitis C isn’t treated like it should be, it could worsen and cause symptoms. For more information about this, see the “What are Epclusa’s side effects?” section above.

Does Epclusa cause weight loss?

No, Epclusa doesn’t affect your body weight. But weight loss can be a sign of infections, including hepatitis C. And keep in mind that Epclusa is used to treat hepatitis C.

You may also lose weight if you have nausea while you’re taking Epclusa. Talk with your doctor or pharmacist about ways to help reduce your nausea during Epclusa treatment.

If you’re concerned about your weight while you’re taking Epclusa, talk with your doctor.

Can I take ibuprofen with Epclusa?

Yes, you can likely take ibuprofen (Advil, Motrin, others) with Epclusa. There isn’t a known interaction between ibuprofen and Epclusa.

Before taking ibuprofen, talk with your doctor or pharmacist about its safety. They can instruct you on how to safely take ibuprofen with Epclusa.

What should I know about Epclusa vs. Mavyret?

Both Epclusa and Mavyret contain two antiviral medications used to treat hepatitis C. Epclusa contains sofosbuvir and velpatasvir. Mavyret contains glecaprevir and pibrentasvir.

Mavyret and Epclusa each have boxed warnings for risk of reactivation of hepatitis B virus (HBV) in people who have both hepatitis C virus and HBV. A boxed warning is a serious warning from the Food and Drug Administration (FDA).

With reactivation, an infection flares up and causes symptoms. In studies of Epclusa and Mavyret, some people with hepatitis B developed serious symptoms of hepatitis B reactivation. These included liver failure and, in some cases, death. For more information about this side effect, see the “What are Epclusa’s side effects?” section above.

Epclusa and Mavyret are used for certain types of hepatitis C virus, which causes hepatitis C. And both drugs can be used in people ages 3 years and older.

Epclusa is taken for 12 weeks. Mavyret may be taken for 8 weeks, 12 weeks, or 16 weeks. The length of treatment for Mavyret depends on whether you’ve tried any hepatitis C treatments before and what those treatments were.

Your doctor or a pharmacist can give you more details about how these drugs compare.

What should I know about Epclusa vs. Harvoni?

Both Epclusa and Harvoni contain two antiviral medications used to treat hepatitis C. They both contain sofosbuvir. But instead of velpatasvir, Harvoni contains a drug called ledipasvir. Both Epclusa and Harvoni work in the same way to treat hepatitis C.

Both Epclusa and Harvoni have boxed warnings for reactivation of hepatitis B in people who have both hepatitis C and hepatitis B. A boxed warning is a serious warning from the Food and Drug Administration (FDA).

With reactivation, an infection flares up and causes symptoms. In clinical studies of Epclusa and Harvoni, some people with hepatitis B developed serious symptoms of hepatitis B reactivation. These included liver failure and, in some cases, death. For more information about this side effect, see the “What are Epclusa’s side effects?” section above.

Both Epclusa and Harvoni are used for certain types of hepatitis C virus, which causes hepatitis C. Epclusa can be used in people ages 6 years and older who weigh at least 17 kilograms (about 37 pounds). But Harvoni can be used in people ages 12 years and older or those who weigh at least 35 kilograms (77 pounds).

Like Epclusa, Harvoni is taken for 12 weeks, but with two exceptions. Some adults and children must take Harvoni for 24 weeks. This includes people who either:

• already received treatment for hepatitis C, but their treatment didn’t work, or
• have compensated cirrhosis (scarring of the liver with no symptoms)

What should be done in case of overdose?

Don’t take more Epclusa than your doctor prescribes. Using more than this can lead to serious side effects. If you take too much Epclusa, your doctor may closely monitor you for signs and symptoms of overdose.

What to do in case you take too much Epclusa

Call your doctor if you think you’ve taken too much Epclusa. You can also call 800-222-1222 to reach the American Association of Poison Control Centers, or use its online resource. However, if you have severe symptoms, immediately call 911 (or your local emergency number) or go to the nearest emergency room.

What to ask your doctor

If you have questions about taking Epclusa, talk with your doctor or pharmacist. Your doctor can tell you about treatments other than Epclusa for hepatitis C. Here’s a list of articles you might find helpful:

• What Are the Newest Treatments for Hepatitis C?
• How Much Does Treatment for Hepatitis C Cost?
• Then and Now: The Evolution of Treatments for Hepatitis C

Some questions you may want to ask your doctor about Epclusa include:

• How should I store Epclusa?
• Do I need to take other medications with Epclusa to treat hepatitis C?
• Can I still take Epclusa if I tried other hepatitis C drugs in the past that didn’t work?
• What’s the maximum dose of ibuprofen I can take while taking Epclusa?
• How can I prevent nausea while taking Epclusa?