All About Harvoni

What is Harvoni?

If you have hepatitis C, your doctor may recommend treatment with Harvoni. It’s a prescription medication used to treat certain forms of hepatitis C in adults and some children.

To learn more about how Harvoni is used to treat hepatitis C, see the section titled “Is Harvoni used for hepatitis C?” below.

Harvoni basics

Harvoni contains two active drugs: ledipasvir and sofosbuvir. (An active drug is an ingredient that makes a medication work.) Harvoni isn’t available as a generic drug.

Harvoni comes as tablets that you swallow. It’s also available as pellets that you can either swallow or mix with certain foods.

For more information on how to use Harvoni, see the “How is Harvoni taken?” section below.

Keep reading to learn more about Harvoni, including the drug’s cost, side effects, dosage, and more.

What does Harvoni 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 Harvoni manufacturer’s website to see if they have support options.

You can also check out this article to learn more about saving money on prescriptions.

What are Harvoni’s side effects?

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

Keep in mind that side effects of a drug can depend on:

• your age
• other health conditions you have
• other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Harvoni. 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 Harvoni can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Harvoni’s prescribing information.

Mild side effects of Harvoni that have been reported include:

• cough
• diarrhea
• dizziness
• fatigue (low energy)
• feeling irritable
• headache
• insomnia (trouble sleeping)
• mild increase in bilirubin level
• muscle pain
• nausea
• shortness of breath
• weakness

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

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

Serious side effects

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

Serious side effects of Harvoni that have been reported include:

• depression*
• boxed warning: risk of hepatitis B reactivation in certain people*
• allergic reaction*
• suicidal thoughts or behaviors

* For more information about 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 Harvoni may cause.

Boxed warning

Harvoni has a boxed warning. A boxed warning is a serious warning from the Food and Drug Administration (FDA).

This boxed warning applies to people who have both hepatitis C and hepatitis B or have had hepatitis B in the past. Hepatitis B is a liver infection caused by the hepatitis B virus (HBV).

Taking Harvoni can cause HBV to reactivate (flare up and cause symptoms). In some cases, HBV flares can lead to liver failure, which may be life threatening.

With HBV reactivation, symptoms of hepatitis B may start suddenly. These can include:

• fatigue (low energy)
• fever
• low appetite
• pain in the right side of your belly
• jaundice (yellowing of your skin or the whites of your eyes)

What might help

Before you begin taking Harvoni, your doctor will test you for current or past HBV infection. If the test shows you have HBV, your doctor will likely want to treat it before prescribing Harvoni. They may also monitor you more closely while you’re taking Harvoni, as well as for some time after you finish treatment.

If you notice symptoms of hepatitis B during your Harvoni treatment, call your doctor right away.

Fatigue

Some people may experience fatigue while taking Harvoni. This was one of the drug’s most common side effects in studies.

Keep in mind that fatigue can also be a symptom of hepatitis C.

What might help

Fatigue may go away on its after you’ve taken Harvoni for a while or once you finish treatment.

If you have fatigue that’s bothersome to you during your Harvoni treatment, let your doctor know. They can suggest ways to help improve your energy levels until you finish taking Harvoni. But if fatigue is affecting your daily life, they may also discuss other treatment options with you.

Depression

It’s possible for some people to experience depression during treatment with Harvoni. But this side effect was rare in the drug’s studies.

It’s also important to note that having hepatitis C may raise your risk of depression.

Symptoms of depression can include:

• feeling sad, hopeless, or “empty”
• fatigue
• changes in appetite or weight
• unexplained aches and pains in your body

In severe cases, depression can cause suicidal thoughts or behaviors, which is also an extremely rare side effect of Harvoni.

What might help

Talk with your doctor if you feel depressed while taking Harvoni. They can suggest treatments to help address this side effect.

If you have thoughts of harming yourself, call 911 or your local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.

For more information and resources, see the “Suicide prevention” section above.

Allergic reaction

Some people may have an allergic reaction to Harvoni. While allergic reaction wasn’t reported in Harvoni’s clinical trials, it has happened since the drug was approved for use.

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 Harvoni. But if you think you’re having a medical emergency, call 911 or your local emergency number.

What is Harvoni’s dosage?

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

Forms and strengths

Harvoni comes as tablets that you swallow. It’s also available as pellets, which come in a packet. You’ll take the contents of one or more packets for each dose, as prescribed by your doctor.

You can either swallow the pellets whole or mix them with certain foods. For more information on how to use Harvoni pellets, see the “How is Harvoni taken?” section below.

Harvoni tablets and pellets contain two active drugs: ledipasvir and sofosbuvir. (An active drug is an ingredient that makes a medication work.) The strength of Harvoni is written as two numbers. The first number is the amount of ledipasvir, and the second number is the amount of sofosbuvir.

Harvoni tablets and pellets are available in the following strengths:

Recommended dosages

You’ll take Harvoni by mouth once daily. You can take it at any time of day, but you should try to take it around the same time each day. This helps keep a consistent level of the drug in your body.

Questions about Harvoni’s dosage

Below are some common questions about Harvoni’s dosage.

• What if I miss a dose of Harvoni? It’s important that you take your Harvoni dose every day at the scheduled time. But if you miss a dose of Harvoni, take it as soon as you remember. You shouldn’t take two doses at once to make up for a missed dose. Doing so could raise your risk of side effects.
• What will the duration of treatment be? Will I need to use Harvoni long term? You won’t use Harvoni long term. You’ll likely take Harvoni for 12 to 24 weeks. Your doctor can tell you more about how long your treatment will last.
• How long does Harvoni take to work? Harvoni begins working as soon as you take a dose. In most people, it typically cures hepatitis C in 12 to 24 weeks.

Is Harvoni used for hepatitis C?

Harvoni is prescribed to treat certain forms of chronic hepatitis C in adults and some children.

Hepatitis C is an infection caused by the hepatitis C virus (HCV). There are different strains of HCV, called genotypes, which are identified with blood tests.

Specifically, Harvoni may be used in adults and in children ages 3 years and older with:

• Genotype 1, 4, 5, or 6 HCV without cirrhosis (scarring of the liver) or with compensated cirrhosis (mild or early stage cirrhosis).
• Genotype 1 HCV with decompensated cirrhosis (severe or late-stage cirrhosis). For this use, you’ll take Harvoni with the drug ribavirin.
• Genotype 1 or 4 HCV without cirrhosis or with compensated cirrhosis, in people who’ve received a liver transplant. For this use, you’ll take Harvoni with the drug ribavirin.

About hepatitis C

Hepatitis C is a liver infection caused by the hepatitis C virus (HCV). It’s spread through contact with blood that carries the virus. In some cases, the body may clear the infection on its own.

For most people who get HCV, it becomes a chronic (long-term) infection. Chronic hepatitis C doesn’t go away on its own.

Hepatitis C is often called a “silent disease.” This is because symptoms either don’t occur or are mild for a long time.

Early symptoms of chronic hepatitis C can include:

• constant fatigue (low energy)
• generally feeling unwell
• mood changes
• aches and pains in your muscles and joints

If not treated, hepatitis C eventually causes severe liver problems, such as cirrhosis (scarring of the liver) and liver failure. Symptoms of severe liver problems generally include:

• pain in the right side of your belly
• jaundice (yellowing of your skin or the whites of your eyes)
• nausea and vomiting
• skin itching
• ascites (swelling in your belly due to fluid buildup)
• confusion

What are some frequently asked questions about Harvoni?

Find answers to some commonly asked questions about Harvoni.

Does Harvoni cause any long-term side effects?

No, Harvoni isn’t known to cause long-term side effects.

If you have questions about how long side effects of Harvoni could last, talk with your doctor or pharmacist.

What is Harvoni’s mechanism of action?

Harvoni’s mechanism of action (how it works) is that it prevents the hepatitis C virus from making copies of itself. When a virus can’t copy itself, the amount of virus in your body will decrease until it’s eventually cleared from your body.

Harvoni can cure hepatitis C in most cases. When blood tests no longer detect the virus in your body, it’s considered cured.

Is it possible to have weight gain or weight loss from Harvoni? What about hair loss?

No, Harvoni shouldn’t cause weight gain, weight loss, or hair loss. These side effects weren’t reported in studies of the drug.

Weight loss and hair loss can be symptoms of hepatitis C. If you experience weight loss or hair loss that concerns you, talk with your doctor.

Are there any reviews of Harvoni that I can read?

To learn more about reviews of Harvoni, you can read patient stories on the drug manufacturer’s website.

It’s important to note that your experience with Harvoni may differ from the experiences of others. To learn more about Harvoni’s success rate and what to expect from your treatment, talk with your doctor.

Does Harvoni cause liver cancer or other kinds of cancer?

No, Harvoni isn’t known to cancer, including liver cancer.

If not treated, hepatitis C can lead to liver cancer. Treating hepatitis C with drugs such as Harvoni can help prevent long-term effects such as liver cancer.

There’s been one report of someone developing liver cancer, even after their hepatitis C was successfully treated with Harvoni. More research is needed to learn about the risk of developing liver cancer after hepatitis C treatment, but it seems to be rare.

If you’re concerned about your risk for cancer, including liver cancer, talk with your doctor.

Is it possible to have joint pain or eye-related side effects from Harvoni?

It’s not likely. Joint pain and eye-related side effects weren’t side effects reported in studies of Harvoni.

Since Harvoni was approved for use, there have been a few reports of eye-related side effects in people taking Harvoni. But it’s not clear whether Harvoni or another factor caused these side effects. And a large study found Harvoni didn’t cause eye-related side effects.

If you’re concerned about your risk of joint pain or eye-related side effects during your Harvoni treatment, talk with your doctor.

What should I know about Epclusa vs. Harvoni?

If you’re prescribed Harvoni, you may be curious about an alternative option such as Epclusa.

Harvoni and Epclusa are both prescription drugs used to treat certain forms of hepatitis C in adults. Harvoni may also be used for treating hepatitis C in some children.

If you’d like to learn more about these drugs, see this detailed comparison. Also, talk with your doctor about the treatment option that’s right for you.

What should be considered before taking Harvoni?

There are important considerations to discuss with your doctor before you begin treatment with Harvoni. It’s important that you tell your doctor about your overall health and any medical conditions you may have.

You should also tell your doctor and pharmacist about all medications you take. They’ll want to check for any interactions with Harvoni.

Interactions

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

Before taking Harvoni, 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 Harvoni.

Interactions with drugs or supplements

Harvoni can interact with several types of drugs. These drugs include:

• certain antibiotics, including:
  • rifampin (Rimactane)
  • rifabutin (Mycobutin)
  • rifapentine (Priftin)
• heartburn and acid reflux drugs, including
  • antacids, such as aluminum and magnesium hydroxide
  • histamine blockers, such as famotidine (Pepcid)
  • proton pump inhibitors including omeprazole (Prilosec)
• the heart rhythm drugs amiodarone (Pacerone) and digoxin (Lanoxin)
• certain epilepsy drugs, including:
  • carbamazepine (Carbatrol, Tegretol, others)
  • phenytoin (Dilantin, Phenytek)
• certain HIV treatments, including:
  • tenofovir disoproxil fumarate (Vemlidy), including:
    • tenofovir and emtricitabine (Truvada)
    • tenofovir, elvitegravir, cobicistat, and emtricitabine (Stribild)
    • tenofovir, emtricitabine, and rilpivirine (Complera)
  • ritonavir (Norvir)
• the cholesterol medications atorvastatin (Lipitor) and rosuvastatin (Crestor)
• the herbal supplement St. John’s wort

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

Boxed warning

Harvoni has a boxed warning. This is a serious warning from the Food and Drug Administration (FDA).

Risk of hepatitis B reactivation in certain people. Taking Harvoni can cause the hepatitis B virus (HBV) to reactivate (flare up and cause symptoms). In rare cases, HBV flares can cause serious liver failure, which may be life threatening.

To learn more, see “Side effect focus” in the “What are Harvoni’s side effects?” section above.

Other warnings

Harvoni 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 Harvoni. Factors to consider include those in the list below.

• Kidney problems or are receiving dialysis. It’s not known whether it’s safe to take Harvoni if you have decompensated cirrhosis (liver problems due to scarring of the liver) and have kidney problems. This includes people who are receiving dialysis. Talk with your doctor about whether it’s safe for you to use Harvoni. If you have kidney problems but don’t have cirrhosis, it’s likely safe for you to take Harvoni. But your doctor will determine whether you can take Harvoni based on your specific condition.
• Allergic reaction. If you’ve had an allergic reaction to Harvoni or any of its ingredients, your doctor will likely not prescribe Harvoni. Ask them what other medications are better options for you.

Harvoni and alcohol

Drinking alcohol may worsen certain side effects of Harvoni. Examples of these side effects include including diarrhea, fatigue (low energy), and headache.

And both hepatitis C and alcohol can cause liver problems, including cirrhosis and liver failure.

If you have questions about drinking alcohol during your hepatitis C treatment, talk with your doctor. They’ll likely suggest that you avoid drinking alcohol during your treatment.

Pregnancy and breastfeeding

It’s not known whether it’s safe to use Harvoni while pregnant or breastfeeding. If you’re pregnant or breastfeeding, or planning to become pregnant or to breastfeed, talk with your doctor before taking this drug. They can discuss the risks and benefits with you.

Harvoni is sometimes prescribed with the drug ribavirin to treat certain kinds of hepatitis C. Ribavirin isn’t safe to use during pregnancy. Talk with your doctor about the best treatment options for you. And to learn more about using ribavirin with Harvoni, see this article.

What should I know about Harvoni vs. Mavyret?

Harvoni and Mavyret are both prescription medications used to treat certain types of hepatitis C in adults and some children.

For a comparison of Harvoni and Mavyret, see this article. Also, talk with your doctor about the treatment option that’s right for you.

How is Harvoni taken?

Your doctor will explain how you should take Harvoni. They’ll also explain how much to take and how often. Be sure to follow your doctor’s instructions.

Taking Harvoni

Harvoni comes as a tablet (pill) that you swallow.

Harvoni is also available as pellets, which come in a packet. You’ll take the contents of one or more packets for each dose, as prescribed by your doctor.

You can either swallow the pellets whole or mix them with non-acidic foods. If you mix the pellets with food, you should eat the mixture within 30 minutes of preparing it. It’s best to swallow the contents without chewing to avoid tasting the pellets.

Examples of non-acidic foods that may be mixed with Harvoni pellets include:

• chocolate syrup
• ice cream
• mashed potatoes
• pudding

If you have questions about how to take Harvoni pellets with food, talk with your doctor or pharmacist.

Accessible medication containers and labels

If it’s hard for you to read the label on your prescription, tell your doctor or pharmacist. Certain pharmacies may provide medication labels that:

• have large print
• use braille
• contain a code you can scan with a smartphone to change the text into audio

Your doctor or pharmacist may be able to recommend a pharmacy that offers these options if your current pharmacy doesn’t.

Also, if you’re having trouble opening your medication bottles, let your pharmacist know. They may be able to put Harvoni in an easy-open container. Your pharmacist may also recommend tools to help make it simpler to open the drug’s container.

Taking Harvoni with other drugs

Harvoni is sometimes prescribed with the drug ribavirin to treat certain types of hepatitis C. Your doctor will determine whether you need to take other drugs with Harvoni. And to learn more about using ribavirin with Harvoni, see this article.

Questions about taking Harvoni

Below are some common questions about taking Harvoni.

• Can Harvoni be chewed, crushed, or split? No, Harvoni tablets should not be chewed, crushed, or split. They’re meant to be swallowed whole. But Harvoni pellets may be mixed with food if you have trouble swallowing pills. (To learn more, see “Taking Harvoni” above.)
• Should I take Harvoni with food? You may take Harvoni tablets with or without food. Harvoni pellets may be mixed with certain foods. (To learn more, see “Taking Harvoni” above.)

Questions for your doctor

You may have questions about Harvoni 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 such as:
  • How will Harvoni 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 should be done in case of overdose?

Don’t take more Harvoni than your doctor prescribes. Using more than this can lead to serious side effects.

What to do in case you take too much Harvoni

Call your doctor if you think you’ve taken too much Harvoni. You can also call 800-222-1222 to reach the American Association of Poison Control Centers or use its online resource. But 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’re considering treatment with Harvoni, talk with your doctor. Ask them questions to help you better understand your treatment options. Some examples of questions you may want to help you get started include:

• Can I drink coffee while taking Harvoni? Do I need to restrict my diet in any way?
• Is it possible to have withdrawal symptoms after Harvoni treatment ends?
• Do any medications I take increase my risk of side effects with Harvoni?

You can also learn more about hepatitis C medications by reading this article. Or see this article for information about treatment options for hepatitis C.