Harvoni is a brand-name prescription medication that’s used to treat hepatitis C.

Harvoni is a type of drug called a direct-acting antiviral (DAA). It was approved by the FDA in 2014 to treat several different genotypes (strains) of hepatitis C.

Specifically, Harvoni is approved to treat hepatitis C in adults and children ages 3 years and older with:

  • hepatitis C genotype 1, 4, 5, or 6 either without cirrhosis (liver scarring) or with cirrhosis that hasn’t affected liver function
  • hepatitis C genotype 1 with cirrhosis that has affected liver function*
  • hepatitis C genotype 1 or 4 who have had a liver transplant and either don’t have cirrhosis or have cirrhosis that hasn’t affected liver function*

* For this purpose, Harvoni is prescribed in combination with ribavirin.

Drug details

Harvoni contains two active drugs: ledipasvir and sofosbuvir. It comes in two oral forms: tablets and pellets.

Harvoni oral tablets are available in two strengths:

  • 90 milligrams (mg) ledipasvir/400 mg sofosbuvir
  • 45 mg ledipasvir/200 mg sofosbuvir

Harvoni oral pellets come in packets that are available in the following strengths:

  • 33.75 mg ledipasvir/150 mg sofosbuvir
  • 45 mg ledipasvir/200 mg sofosbuvir

Effectiveness

For information about the effectiveness of Harvoni, see the “Harvoni uses” section below.

Harvoni contains two active drugs: ledipasvir and sofosbuvir. This combination is also available as a generic medication.

A generic drug is an exact copy of the active drugs in a brand-name medication. The generic is considered to be as safe and effective as the original drug. Generics tend to cost less than brand-name drugs.

If you’re interested in using the generic form of Harvoni, talk with your doctor. They can tell you if it comes in forms and strengths that can be used for your condition.

Harvoni can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Harvoni. This list doesn’t include all possible side effects.

For more information on the possible side effects of Harvoni or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

If your doctor also prescribes ribavirin for you to take with Harvoni, you may have additional side effects. (See the “Harvoni with ribavirin” section below for more information.)

More common side effects

The more common side effects of Harvoni can include:

In some cases, Harvoni can cause a mild allergic reaction. Symptoms can include skin rash, itchiness, and flushing.

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Harvoni aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include the following:

  • Hepatitis B reactivation in people coinfected with hepatitis C and hepatitis B.* Some people who have both hepatitis C and hepatitis B experienced a reactivation of the hepatitis B virus (HBV) when they began treatment with Harvoni. Reactivation means the virus becomes active again. Reactivation of HBV can lead to liver damage, liver failure, or death. Before you start treatment with Harvoni, your doctor will test you for hepatitis B. You may need to take medication to treat hepatitis B.
  • Serious allergic reaction. In rare cases, Harvoni can cause a serious allergic reaction. Symptoms can include:
    • angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
    • swelling of your throat, mouth, and tongue
    • trouble breathing
  • Suicidal thoughts or actions. In rare cases, Harvoni can cause suicidal thoughts or actions when it’s taken in combination with ribavirin or pegylated interferon/ribavirin.

* Harvoni has boxed warning from the FDA for hepatitis B reactivation. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Click here for more links and local resources.

Long-term side effects

Long-term side effects haven’t been reported with Harvoni.

However, people with cirrhosis (liver scarring) may continue to have symptoms of liver damage after their hepatitis C is cured. (Keep in mind that Harvoni is used to treat hepatitis C.)

If you have cirrhosis, your doctor will want to check your liver function regularly during and after treatment with Harvoni.

Side effects after treatment

Side effects after stopping Harvoni treatment haven’t been reported.

However, after finishing treatment with Harvoni, some people may experience flu-like symptoms. These can include muscle aches, chills, fatigue, and trouble sleeping. These side effects are likely caused by the body recovering after the hepatitis C virus is cleared.

If you have flu-like symptoms after you finish treatment with Harvoni, talk with your doctor.

Weight loss or weight gain

Changes in weight during Harvoni treatment weren’t reported in clinical trials. However, some people have lost weight as a symptom of hepatitis C.

If you have severe changes in weight, talk with your doctor.

Withdrawal symptoms

Stopping treatment with Harvoni hasn’t caused withdrawal symptoms.

Some people may experience flu-like symptoms that resemble withdrawal, such as fever, headache, and muscle pains. However, it’s unclear if these symptoms are related to stopping Harvoni treatment. They’re likely related to the body recovering from hepatitis C.

Joint pain

Joint pain wasn’t a side effect of Harvoni in clinical trials.

Many people with hepatitis C experience joint pain as a symptom of hepatitis C, though. This can be the result of chronic inflammation or an autoimmune process attacking your joints.

If you’re having pain in your joints, talk with your doctor about ways to manage it.

Eye effects

In clinical trials, people taking Harvoni did not experience eye problems.

However, there is one report of temporary vision loss after using Harvoni with the drug ribavirin. And another person reported eye inflammation and blurred vision after using sofosbuvir and ribavirin. (Sofosbuvir is one of the active drugs in Harvoni.)

It’s not clear if Harvoni or its ingredients caused the eye problems in these cases. Also, a 2019 study found that these same medications didn’t cause eye problems in people with hepatitis C.

If you experience any eye effects while taking Harvoni, talk with your doctor right away.

Hair loss

Hair loss wasn’t reported as a side effect in clinical trials of Harvoni.

It’s important to note that hair loss can be a symptom of hepatitis C. The hepatitis C virus (HCV) prevents your liver from working properly. You need a healthy liver to get nutrients from the food you eat. So if you can’t obtain the nutrients your body needs, you may experience hair loss.

If you’re concerned about hair loss, talk with your doctor.

Rash or itching

Skin rashes were reported in some people who took Harvoni in clinical trials, but it’s unclear how common they were. In some cases, people had blisters and swelling of the skin, too. These could be caused by allergic reactions to Harvoni.

Itchy skin and rashes are also symptoms of the hepatitis C virus. In addition, they can be signs of serious liver damage. Talk with your doctor if you are experiencing rashes or bothersome itchy skin.

Diarrhea

In clinical trials of Harvoni, between 3% and 7% of people experienced diarrhea during treatment. Diarrhea may go away with continued use of the drug.

If you have severe diarrhea, or diarrhea that lasts more than a couple of days, talk with your doctor right away.

Depression

Depression is an uncommon side effect of Harvoni. In clinical trials, less than 5% of people who took Harvoni experienced depression. In addition, suicidal thoughts occurred in less than 1% of people who took Harvoni with ribavirin or pegylated interferon/ribavirin.

Many people with hepatitis C can feel depressed because of their diagnosis. If you feel depressed, talk with your doctor about ways to improve your mood. And if you have thoughts of harming yourself, call your doctor right away.

Fatigue

Fatigue is a common side effect of Harvoni. In clinical trials, up to 18% of people who took Harvoni experienced fatigue.

Fatigue may go away with continued use of Harvoni. However, if your fatigue is severe and affecting your life, talk with your doctor.

Insomnia

In clinical trials, insomnia occurred in up to 6% of people who took Harvoni. This side effect may go away with continued use of the drug.

Ways to improve your sleep include following a regular sleep schedule and keeping electronics, such as smartphones, out of your bedroom. If your insomnia is bothersome and doesn’t go away, talk with your doctor about other ways to help you sleep.

Headache

Headache is a common side effect of Harvoni. In clinical trials, up to 29% of people who took Harvoni experienced headaches. If you’re having headaches while taking Harvoni, talk with your doctor about ways to help you manage them.

Liver cancer

Harvoni is a type of drug called a direct-acting antiviral (DAA). Treating hepatitis C with DAAs helps to prevent long-term effects, such as liver cancer. However, there have been reports of liver cancer in people who had been cured of hepatitis C with Harvoni treatment.

One clinical study found that people with cirrhosis who took a DAA had a greater risk of developing liver cancer compared to those without cirrhosis. However, people without cirrhosis can still get liver cancer.

If you’re concerned about your risk of developing liver cancer, talk with your doctor.

The Food and Drug Administration (FDA) approves prescription drugs such as Harvoni to treat certain conditions.

Specifically, Harvoni is approved to treat hepatitis C in adults and children ages 3 years and older with:

  • hepatitis C genotype 1, 4, 5, or 6 either without cirrhosis (liver scarring) or with cirrhosis that hasn’t affected liver function
  • hepatitis C genotype 1 with cirrhosis that has affected liver function*
  • hepatitis C genotype 1 or 4 who have had a liver transplant and either don’t have cirrhosis or have cirrhosis that hasn’t affected liver function*

Genotypes are different strains of the virus.

Cirrhosis is serious scarring in the liver that can prevent it from working properly. Compensated cirrhosis generally doesn’t cause symptoms. Decompensated cirrhosis involves liver failure and causes serious health issues.

* For this purpose, Harvoni is prescribed in combination with ribavirin.

Effectiveness for hepatitis C

In most clinical trials for Harvoni, the success rate for curing hepatitis C was greater than 90%. This means that most people who took Harvoni achieved a sustained virologic response (SVR). SVR means that no virus was detected in their body 12 weeks or longer after treatment ended.

For information on how the drug performed in other clinical trials, see Harvoni’s prescribing information or its manufacturer’s website.

As with all medications, the cost of Harvoni can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance

If you need financial support to pay for Harvoni, or if you need assistance understanding your insurance coverage, help is available.

Gilead Sciences, Inc., the manufacturer of Harvoni, offers a program called Harvoni Support Path. For more information and to find out if you’re eligible for support, call 855-769-7284 or visit the program website.

Generic version

A generic form of Harvoni is available. A generic drug is an exact copy of the active drugs in a brand-name medication.

A generic is considered to be as safe and effective as the original drug. And generics tend to cost less than brand-name drugs.

If your doctor has prescribed Harvoni and you’re interested in using its generic form instead, talk with your doctor. They may have a preference for one version or the other. You’ll also need to check your insurance plan, as it may only cover one or the other.

The Harvoni dosage your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition you’re using Harvoni to treat
  • your age
  • body weight, in children
  • the form of Harvoni you take
  • other medical conditions you may have

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Harvoni contains two active drugs: ledipasvir and sofosbuvir. It comes in two oral forms: tablets and pellets.

Harvoni tablets are swallowed. Harvoni pellets are either swallowed alone or mixed in certain soft foods. (Be sure to read the detailed instructions before taking the oral pellets.)

Harvoni oral tablets are available in two strengths:

  • 90 milligrams (mg) ledipasvir/400 mg sofosbuvir
  • 45 mg ledipasvir/200 mg sofosbuvir

Harvoni oral pellets come in packets that are available in the following strengths:

  • 33.75 mg ledipasvir/150 mg sofosbuvir
  • 45 mg ledipasvir/200 mg sofosbuvir

Dosage for hepatitis C

The recommended dosage of Harvoni for hepatitis C in adults is one 90-mg ledipasvir/400-mg sofosbuvir tablet taken once per day.

Children’s dosage

The recommended dosage of Harvoni for hepatitis C in children is based on body weight in kilograms (kg). One kg is equal to 2.2 pounds (lb).

The following dosage table summarizes recommended dosages of Harvoni oral tablets in children.

Body weight Harvoni oral tablet strengthDaily dosage
17 kg to less than 35 kg45 mg/200 mgone tablet once daily
35 kg or more90 mg/400 mgone tablet once daily
35 kg or more45 mg/200 mgtwo tablets once daily

The following dosage table summarizes recommended dosages of Harvoni oral pellets in children.

Body weight Harvoni oral pellet strengthDaily dosage
Less than 17 kg33.75 mg/150 mgone packet once daily
17 kg to less than 35 kg45 mg/200 mgone packet once daily
35 kg or more45 mg/200 mgtwo packets once daily

Duration of treatment

How long you take Harvoni will depend on your hepatitis C genotype (strain of the virus). It will also depend on your liver function, and any hepatitis C treatments you’ve tried in the past.

Most people take Harvoni for 12 weeks, but treatment can also last 8 or 24 weeks. Your doctor will determine the right duration of treatment for you.

What if I miss a dose?

It’s important to take Harvoni every day for the full period of time your doctor prescribes. Missing or skipping doses can cause the virus to become resistant to Harvoni. Resistant means that the drug no longer works for you.

Using a reminder tool can help you remember to take Harvoni every day.

If you do miss a dose, take it as soon as you remember. If you don’t remember until the next day, don’t take two doses of Harvoni at once. This can increase the risk of side effects. Just take your regular dose of Harvoni.

It’s extremely important that you take Harvoni exactly as your doctor prescribes. This is because following your treatment plan increases your chances of curing your hepatitis C virus (HCV). It also helps reduce your risk of the long-term effects of HCV, which include cirrhosis and liver cancer.

Missing doses can make Harvoni less effective in treating HCV. In some cases, if you miss doses, your HCV may not be cured.

Be sure to follow your doctor’s instructions and take Harvoni every day for the full length of your treatment. Using a reminder tool can help you make sure you take Harvoni each day.

If you have any questions or concerns about your treatment, talk with your doctor. They can help resolve any issues for you and help you get the most effective treatment for your hepatitis C.

Drinking alcohol while taking Harvoni can increase the risk of certain side effects from Harvoni. These side effects include:

In addition, both hepatitis C and excessive alcohol use cause scarring and inflammation in your liver. Combining the two increases your risk of cirrhosis and liver failure.

Alcohol may also make you less able to take your medication as directed by your doctor. For instance, it may cause you to forget to take your medication at the right time. Missing doses of Harvoni could make it less effective in treating your HCV.

For all of these reasons, if you drink alcohol, you should avoid it when you have hepatitis C. This is especially true when you’re being treated with Harvoni. If you have trouble avoiding alcohol, talk with your doctor.

Harvoni is usually taken on its own to treat hepatitis C. However, in some cases, it’s taken with another drug called ribavirin (Rebetol).

Your doctor may prescribe ribavirin with Harvoni if you:

Harvoni and ribavirin are used together in these situations because clinical trials showed a higher cure rate with the combination treatment than with Harvoni alone.

Treatment with ribavirin typically lasts 12 weeks. Ribavirin comes as a capsule that you take twice a day. The dose you take will be based on your weight. It may also be based on your kidney function and hemoglobin levels.

Ribavirin side effects

Ribavirin can cause several common and serious side effects. It also comes with important warnings.

Boxed warning

Ribavirin has a boxed warning from the Food and Drug Administration (FDA). A boxed warning is the strongest kind of warning that the FDA requires. Ribavirin’s boxed warning advises that:

  • Ribavirin should not be used alone to treat hepatitis C because it’s not effective by itself.
  • Ribavirin can cause a type of blood disorder called hemolytic anemia. This condition can lead to heart attack or death. Because of this risk, people who have serious or unstable heart disease should not take ribavirin.
  • When ribavirin is used in pregnant people, it can cause serious harm or death to the fetus. Ribavirin should not be taken by pregnant females or their male sexual partners during pregnancy.* Pregnancy should also be avoided for at least 6 months after ribavirin treatment ends. During this time, consider using a backup form of contraception (birth control).

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Other side effects

Ribavirin can also cause some common side effects, such as:

Rare but serious side effects seen in clinical trials included anemia, lung disease, and pancreatitis. They also included eye problems, such as infections and blurry vision. It’s important to note that in these studies, people took ribavirin in combination with interferon or pegylated interferon.

Ribavirin and pregnancy

For information about Ribavirin and pregnancy, see “Boxed warning” above.

Ribavirin and breastfeeding

It’s not known if ribavirin passes into human breast milk. Studies in animals show that ribavirin taken by a lactating animal could be harmful to nursing offspring. However, animal studies don’t always predict what will occur in humans.

If you’re considering ribavirin treatment while you’re breastfeeding, talk with your doctor. They may recommend that you either stop breastfeeding or avoid ribavirin treatment.

Harvoni can interact with several other medications. It can also interact with certain supplements and foods.

Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Harvoni and other medications

Below are lists of medications that can interact with Harvoni. This article doesn’t contain all drugs that may interact with Harvoni.

Before taking Harvoni, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Antacids

Taking Harvoni with antacids, such as Mylanta or Tums, can reduce the amount of Harvoni your body absorbs. This can make Harvoni less effective. To prevent this interaction, separate the dose of Harvoni and antacids by at least 4 hours.

H2 blockers

Taking Harvoni with drugs called H2 blockers can decrease the amount of Harvoni that’s absorbed into your body. This can cause Harvoni to be less effective at treating hepatitis C.

If you need to take an H2 blocker with Harvoni, you should either take them at the same time or take them 12 hours apart. Taking them at the same time allows the drugs to dissolve and be absorbed by your body before the effects of the H2 blocker kicks in. Taking them 12 hours apart also allows each drug to be absorbed by your body without interacting with the other drug.

Examples of H2 blockers include famotidine (Pepcid) and cimetidine (Tagamet HB).

Amiodarone

Taking Harvoni with amiodarone (Pacerone, Nexterone) can cause a dangerously slow heart rate, which is called bradycardia. Some reports have stated that people who took amiodarone and Harvoni together needed a pacemaker to maintain a regular heart rate. They also reported that other people had a fatal heart attack.

Taking amiodarone and Harvoni together isn’t recommended. If you have to take Harvoni and amiodarone together, your doctor will closely monitor your heart function.

Digoxin

Taking Harvoni with digoxin (Lanoxin) can increase the amount of digoxin in your body. Digoxin levels that are too high can lead to dangerous side effects.

If you need to take Harvoni and digoxin together, your doctor will closely monitor your digoxin levels. They may change your digoxin dose to lower the risk of side effects.

Seizure medications

Taking Harvoni with certain seizure medications can decrease the amount of Harvoni your body absorbs. This can reduce the effectiveness of Harvoni. For this reason, you should not take Harvoni with these seizure medications.

Examples of seizure medications to avoid while taking Harvoni include:

Antibiotics

Certain antibiotic medications can decrease Harvoni levels in your body. This can make Harvoni less effective. To prevent this interaction, avoid taking Harvoni with the following antibiotics:

  • rifabutin (Mycobutin)
  • rifampin (Rifadin, Rimactane)
  • rifapentine (Priftin)

HIV medications

Taking Harvoni with certain HIV medications can change your body’s levels of either Harvoni or the HIV medications. These interactions can make the drugs less effective or increase your risk of side effects.

Tenofovir disoproxil fumarate

Taking Harvoni with medications that contain tenofovir disoproxil fumarate can increase levels of tenofovir in your body. This will increase the risk of side effects from tenofovir, such as kidney damage. If you need to take Harvoni with medications that contain tenofovir disoproxil fumarate, your doctor will monitor you more closely for side effects.

Examples of medications that contain tenofovir disoproxil fumarate include:

  • tenofovir (Viread)
  • tenofovir/emtricitabine (Truvada)
  • tenofovir/elvitegravir/cobicistat/emtricitabine (Stribild)
  • tenofovir/emtricitabine/rilpivirine (Complera)
Tipranavir and ritonavir

Taking Harvoni with the HIV medications tipranavir (Aptivus) or ritonavir (Norvir) can decrease levels of Harvoni in your body. This could make Harvoni less effective. Taking Harvoni with tipranavir and ritonavir isn’t recommended.

Cholesterol medications

Taking Harvoni with cholesterol medications called statins can increase the levels of statins in your body. This increases your risk of statin side effects, such as muscle pain and damage.

Statins include drugs such as rosuvastatin (Crestor), atorvastatin (Lipitor), and simvastatin (Zocor). If you take Harvoni with a statin, your doctor will monitor you closely for signs of rhabdomyolysis (muscle breakdown).

Rosuvastatin and Harvoni should not be taken together. Other statins should be used cautiously with Harvoni.

Warfarin

Harvoni may affect your body’s ability to form blood clots. If you need to take warfarin (Jantoven) while you’re being treated with Harvoni, your doctor may test your blood more often. They may also need to increase or decrease your warfarin dose.

Harvoni and ribavirin

There are no interactions between Harvoni and ribavirin (Rebetol). Harvoni is safe to take with ribavirin. In fact, Harvoni is approved to be taken with ribavirin for certain people.

Your doctor may prescribe ribavirin for you to take with Harvoni if you:

Harvoni and ribavirin are used together in people with these conditions because clinical trials showed a higher cure rate with the combination treatment.

Harvoni and omeprazole or other PPIs

Taking Harvoni with omeprazole (Prilosec) or other proton pump inhibitors (PPIs) can decrease the amount of Harvoni in your body. This could make Harvoni less effective.

If possible, avoid taking Harvoni with this class of drugs. If you need a PPI while you’re taking Harvoni, you should take Harvoni and the PPI at the exact same time on an empty stomach.

Examples of other PPIs include:

Harvoni and herbs and supplements

Taking Harvoni with St. John’s wort can decrease the amount of Harvoni in your body. This can make Harvoni less effective. To avoid this interaction, do not take Harvoni with St. John’s wort.

Other herbs or supplements that may decrease the amount of Harvoni in your body include:

During your treatment with Harvoni, check with your doctor before taking any new herbs or supplements.

Harvoni and coffee

There are no reported interactions between Harvoni and coffee. However, some of Harvoni’s side effects may be worsened if you consume too much coffee or caffeine. For instance, drinking coffee in the afternoon or evening could make your sleep problems worse. And caffeine can worsen headaches.

If you drink coffee or consume caffeine regularly, talk with your doctor about whether or not this is safe for you during your treatment with Harvoni.

Other drugs are available that can treat hepatitis C. Some may be better suited for you than others. If you’re interested in finding an alternative to Harvoni, talk with your doctor to learn more about other medications that may work well for you.

Hepatitis C can be treated using several other drugs or drug combinations. The drug treatment your doctor chooses for you will depend on your hepatitis C genotype, your liver function, and whether you have received treatment for hepatitis C in the past.

Examples of other drugs that may be used to treat hepatitis C include:

  • velpatasvir/sofosbuvir (Epclusa)
  • glecaprevir/pibrentasvir (Mavyret)
  • paritaprevir/ombitasvir/ritonavir/dasubuvir (Viekira Pak)
  • velpatasvir/sofosbuvir/voxilaprevir (Vosevi)
  • elbasvir/grazoprevir (Zepatier)
  • ribavirin (Rebetol), which is used in combination with other drugs

Interferons are older medications that were once commonly used to treat hepatitis C. However, the newer medications such as Harvoni cause fewer side effects and have higher cure rates than interferons. For these reasons, today interferons aren’t typically used to treat hepatitis C.

You may wonder how Harvoni compares to other medications that are prescribed for similar uses. Below are comparisons between Harvoni and several medications.

Harvoni vs. Epclusa

Harvoni contains two active drugs: ledipasvir and sofosbuvir. Epclusa also contains two active drugs: velpatasvir and sofosbuvir.

Both medications contain the drug sofosbuvir, which is considered the “backbone” of the treatment. This means that the treatment plan is based on the backbone drug, with other drugs added in combination.

Uses

Harvoni and Epclusa are both FDA-approved to treat hepatitis C. Harvoni can treat hepatitis C genotypes 1, 4, 5, and 6, while Epclusa can treat all six genotypes.

Specifically, Harvoni is approved to treat hepatitis C in adults and children ages 3 years and older with:

  • hepatitis C genotype 1, 4, 5, or 6 either without cirrhosis (liver scarring) or with cirrhosis that hasn’t affected liver function
  • hepatitis C genotype 1 with cirrhosis that has affected liver function*
  • hepatitis C genotype 1 or 4 who have had a liver transplant and either don’t have cirrhosis or have cirrhosis that hasn’t affected liver function*

Epclusa is approved to treat hepatitis C with any genotype in adults and children ages 3 years and older who:

  • don’t have cirrhosis or have cirrhosis that hasn’t affected liver function
  • have cirrhosis that has affected liver function*

* For this purpose, Harvoni is prescribed in combination with ribavirin.

Drug forms and administration

Harvoni and Epclusa are both taken once daily. They can be taken with food or on an empty stomach.

These medications each come in two oral forms: tablets and pellets.

The duration of treatment for Harvoni is either 8, 12, or 24 weeks. How long you take Harvoni will depend on your genotype of hepatitis C and your liver function. It will also depend on your past hepatitis C treatments.

The duration of treatment for Epclusa is 12 weeks.

Side effects and risks

Harvoni and Epclusa are both drugs called direct-acting antivirals (DAA) and have similar effects in the body. Because of this, they cause many of the same side effects. Below are some examples of these side effects.

More common side effects

More common side effects that can occur with both Harvoni and Epclusa include:

Harvoni and EpclusaHarvoniEpclusa
More common side effectsfatigue
headache
• nausea
insomnia
• muscle weakness
• irritability
diarrhea
• cough
• muscle pain
• dyspnea (shortness of breath)
• dizziness
(few unique common side effects)
Serious side effects

Serious side effects that can occur with both Harvoni and Epclusa include:

  • hepatitis B virus (HBV) reactivation (the virus becomes active again), which can lead to liver failure or death (see “Boxed warnings” below)
  • serious allergic reactions, with symptoms that can include trouble breathing and angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
Boxed warnings

Harvoni and Epclusa both have a boxed warning from the Food and Drug Administration (FDA). A boxed warning is the strongest warning the FDA requires.

The warning describes a risk of hepatitis B virus (HBV) reactivation after starting treatment with either drug. Reactivation of HBV can lead to serious liver damage, liver failure, or death.

Your doctor will test you for HBV before you start taking Harvoni or Epclusa. If you test positive for HBV, you may need to take medication to treat it.

Effectiveness

According to treatment guidelines, Harvoni and Epclusa are both first-choice medication options for the treatment of hepatitis C genotypes 1, 4, 5, and 6. Additional recommendations include the following:

  • Harvoni is a first-choice option for treating genotypes 1, 4, 5, and 6 in children ages 12 years and older (or weighing 77 pounds [lb] and greater).
  • Epclusa is a first-choice option for treating genotypes 2 and 3.

Harvoni and Epclusa have been compared in clinical trials. Both were found to be highly effective at curing hepatitis C. However, Epclusa may cure a greater percentage of people than Harvoni.

Your doctor will use several factors to determine which drug is the best option for you. These factors include your HCV genotype, your liver health, other treatments you’ve had, your age, and other medications you take.

Costs

Harvoni and Epclusa are both brand-name medications. There is a generic form of both Harvoni and Epclusa. Brand-name medications generally cost more than generics.

The actual price you pay for either drug will depend on your insurance plan and the pharmacy you choose.

Harvoni vs. Mavyret

Harvoni contains two active drugs: ledipasvir and sofosbuvir. Mavyret also contains two active drugs: glecaprevir and pibrentasvir.

Uses

Harvoni and Mavyret are both approved by the FDA to treat hepatitis C. However, they’re used to treat different genotypes in varying situations.

Specifically, Harvoni is approved to treat hepatitis C in adults and children ages 3 years and older with:

  • hepatitis C genotype 1, 4, 5, or 6 either without cirrhosis (liver scarring) or with cirrhosis that hasn’t affected liver function
  • hepatitis C genotype 1 with cirrhosis that has affected liver function*
  • hepatitis C genotype 1 or 4 who have had a liver transplant and either don’t have cirrhosis or have cirrhosis that hasn’t affected liver function*

Mavyret is approved to treat hepatitis C in adults and children ages 3 years and older who have:

  • hepatitis C genotype 1, 2, 3, 4, 5, or 6 either without cirrhosis or with cirrhosis that hasn’t affected liver function
  • hepatitis C genotype 1 that has been treated in the past with a certain type of treatment

* For this purpose, Harvoni is prescribed in combination with ribavirin.

Drug forms and administration

Harvoni and Mavyret each come in two oral forms: tablets and pellets.

Harvoni can be taken with or without food, but Mavyret should be taken with a meal.

Harvoni may be prescribed for 8, 12, or 24 weeks of treatment. Mavyret’s treatment duration may be 8, 12, or 16 weeks. The length of treatment your doctor prescribes will be based on your hepatitis C genotype, liver function, and history of past hepatitis C treatments.

Side effects and risks

Harvoni and Mavyret have similar effects on the body. This means they also cause similar side effects. Below are examples of some of these side effects.

More common side effects

More common side effects that can occur with both Harvoni and Mavyret include:

Harvoni and MavyretHarvoniMavyret
More common side effectsheadache
fatigue
• nausea
diarrhea
• weakness
insomnia
• cough
• muscle pain
• trouble breathing
• irritability
• dizziness
• itchy skin (in people on dialysis)
Serious side effects

Serious side effects that can occur with both Harvoni and Mavyret include:

  • hepatitis B virus (HBV) reactivation (the virus becomes active again), which can lead to severe liver damage, liver failure, or death (see “Boxed warnings” below)
  • serious allergic reaction, with symptoms that can include trouble breathing and angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
Boxed warnings

Harvoni and Mavyret both have boxed warnings from the Food and Drug Administration (FDA). A boxed warning is the strongest warning the FDA requires.

The warning describes a risk of hepatitis B virus (HBV) reactivation after starting treatment with either drug. Reactivation of HBV can lead to serious liver damage, liver failure, or death.

Your doctor will test you for HBV before you start taking Harvoni or Mavyret. If you test positive for HBV, you may need to take medication to treat it.

Effectiveness

Harvoni and Mavyret haven’t been compared in clinical trials, but both are effective for treating hepatitis C.

According to treatment guidelines, Harvoni and Mavyret are both first-choice treatment options for hepatitis C genotypes 1, 4, 5, and 6. Mavyret is also a first-choice option for genotypes 2 and 3. In addition to these considerations, there are certain medical conditions where one drug would be recommended over the other:

  • Children ages 12 years and older or who weigh 77 pounds (lb) or more: Harvoni is a first-choice option for treating these children with genotypes 1, 4, 5, and 6. Mavyret isn’t recommended for use in children.
  • Severe kidney disease: Mavyret is a first-choice option for treating hepatitis C in people with this condition. Harvoni isn’t recommended for people with severe kidney disease.
  • Decompensated cirrhosis: For people with decompensated cirrhosis, Harvoni is recommended to be used with ribavirin. Mavyret isn’t recommended for people with this condition.
  • Kidney transplant: For people who’ve received a kidney transplant, both drugs are recommended as a first-line option for people with genotypes 1 or 4. (Harvoni is used off-label for this purpose.) Mavyret is also recommended for people with genotypes 2, 3, 5, or 6 who’ve had a kidney transplant, but Harvoni isn’t.
  • Liver transplant: Treatment recommendations for use of Harvoni and Mavyret are different for people with a liver transplant. They are based on genotype and liver function.

Costs

Harvoni and Mavyret are both brand-name medications. A generic form of Harvoni is available, but there’s no generic form of Mavyret. Brand-name medications usually cost more than generics.

The actual cost you pay for either drug will depend on your insurance plan and the pharmacy you use.

Harvoni vs. Sovaldi

Harvoni and Sovaldi are both used to treat hepatitis C. Harvoni contains two active drugs: ledipasvir and sofosbuvir. Sovaldi contains one active drug: sofosbuvir.

Uses

Harvoni is FDA-approved to treat hepatitis C in people with genotypes 1, 4, 5, or 6. Specifically, it’s approved to treat hepatitis C in adults and children ages 3 years and older with:

  • hepatitis C genotype 1, 4, 5, or 6 either without cirrhosis (liver scarring) or with cirrhosis that hasn’t affected liver function
  • hepatitis C genotype 1 with cirrhosis that has affected liver function*
  • hepatitis C genotype 1 or 4 who have had a liver transplant and either don’t have cirrhosis or have cirrhosis that hasn’t affected liver function*

Sovaldi is approved to treat hepatitis C in:

  • adults with hepatitis C genotype 1, 2, 3, or 4, either without cirrhosis or with cirrhosis that hasn’t affected liver function†
  • children ages 3 years and older with hepatitis C genotype 2 or 3, either without cirrhosis or with cirrhosis that hasn’t affected liver function*

* For this purpose, Harvoni is prescribed in combination with ribavirin.
† For this purpose, Sovaldi is prescribed in combination with another hepatitis C treatment.

Drug forms and administration

Harvoni and Sovaldi each come in two oral forms: tablets and pellets.

Harvoni is taken once daily for 8, 12, or 24 weeks. Sovaldi is also taken once daily, but for 12 or 24 weeks.

Both medications contain sofosbuvir, but Harvoni is a combination medication that can be used by itself for some people. Sovaldi isn’t used by itself to treat hepatitis C. It’s prescribed with other drugs, including pegylated interferon and ribavirin (Rebetol). The active drug in Sovaldi is also found in other combination medications for hepatitis C.

Side effects and risks

Both medications contain sofosbuvir, so they will cause many of the same side effects. However, Sovaldi is always taken in combination with other medications, which may work differently from Harvoni. Because of this, the side effects seen with Sovaldi treatment depend on the drug it’s used with.

Common and serious side effects for Harvoni and Sovaldi are shown below. The Sovaldi side effects described are seen when Sovaldi is used with other hepatitis C drugs such as ribavirin and pegylated interferon.

Harvoni and SovaldiHarvoniSovaldi combination treatment
More common side effectsfatigue
headache
• nausea
insomnia
• muscle weakness
diarrhea
• muscle pain
• irritability
• cough
dyspnea (shortness of breath)
• itchy skin
• rash
• decrease in appetite
• chills
• flu-like symptoms
• fever
Serious side effectshepatitis B
• reactivation*
serious allergic reactions, including angioedema (severe swelling)
(few unique serious side effects)• low red blood cells (anemia)
• low white blood cell count (neutropenia)
• severe depression

* Harvoni and Sovaldi have a boxed warning from the FDA for hepatitis B reactivation. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Harvoni and Sovaldi have different FDA-approved uses, but they’re both used to treat hepatitis C. Harvoni is effective against the virus when used alone or with ribavirin. Sovaldi is effective at treating hepatitis C only when used in combination with other drugs, such as ribavirin and pegylated interferon.

According to treatment guidelines, Harvoni is a first-choice option to treat hepatitis C in people with genotypes 1, 4, 5, or 6. It’s also a first-choice option in children ages 12 years and older or who weigh at least 77 pounds (lb).

Sovaldi is no longer recommended by treatment guidelines as a first-choice option to treat hepatitis C. This is because newer drugs such as Harvoni are considered more effective. The newer drugs also cause fewer serious side effects.

However, Sovaldi is sometimes recommended as a second-choice treatment for certain people, but it has to be used in combination with other medications.

Costs

Harvoni and Sovaldi are brand-name medications. A generic form of Harvoni is available, but there’s no generic form of Sovaldi. Brand-name medications usually cost more than generics.

The actual price you pay for either drug will depend on your insurance and the pharmacy you use.

Harvoni vs. Zepatier

Harvoni contains two active drugs: ledipasvir and sofosbuvir. Zepatier also contains two active drugs: elbasvir and grazoprevir.

Uses

Harvoni is FDA-approved to treat hepatitis C in people with genotypes 1, 4, 5, or 6. Specifically, it’s approved to treat hepatitis C in adults and children ages 3 years and older with:

  • hepatitis C genotype 1, 4, 5, or 6 either without cirrhosis (liver scarring) or with cirrhosis that hasn’t affected liver function
  • hepatitis C genotype 1 with cirrhosis that has affected liver function*
  • hepatitis C genotype 1 or 4 who have had a liver transplant and either don’t have cirrhosis or have cirrhosis that hasn’t affected liver function*

Zepatier is approved to treat hepatitis C in adults and children ages 12 years or older who weigh at least 30 kilograms (kg). It’s used for hepatitis C genotype 1 or 4. In certain cases, Zepatier is given in combination with ribavirin.

* For this purpose, Harvoni or Zepatier is prescribed in combination with ribavirin.

Drug forms and administration

Harvoni comes in two oral forms: tablets and pellets. Zepatier comes as tablets that are swallowed.

Each medication is taken once per day, with or without food.

Harvoni treatment lasts for 8, 12, or 24 weeks. Zepatier treatment lasts for 12 or 16 weeks. The duration of treatment your doctor prescribes will be based on your genotype, liver function, and history of past hepatitis C treatments.

Side effects and risks

Harvoni and Zepatier are similar medications and their effects on the body are alike. Therefore, they cause many of the same side effects. Below are some examples of their side effects.

Harvoni and ZepatierHarvoniZepatier
More common side effectsfatigue
headache
• irritability
diarrhea
• nausea
insomnia
• cough
• weakness
• muscle pain
• difficulty breathing
• dizziness
• stomach pain
Serious side effectshepatitis B
• reactivation*
serious allergic reactions, including angioedema (severe swelling)
(few unique serious side effects)• elevated liver enzyme (alanine aminotransferase)

* Harvoni and Zepatier have a boxed warning from the FDA for hepatitis B reactivation. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Harvoni and Zepatier haven’t been compared in clinical trials, but both are effective for treating hepatitis C.

According to treatment guidelines, both Harvoni and Zepatier are recommended as first-choice options to treat hepatitis C in adults with genotypes 1 and 4. Harvoni is also a first-choice option for treating genotypes 5 and 6, but Zepatier isn’t.

Guideline recommendations for Harvoni and Zepatier also differ in the following conditions:

  • Children ages 12 years and older or who weigh 77 pounds (lb) or more: Harvoni is a first-choice option for treating these children who have genotypes 1, 4, 5, and 6. Zepatier isn’t recommended for use in children.
  • Severe kidney disease: Zepatier is recommended as a first-choice option for people with this condition, while Harvoni isn’t.
  • Decompensated cirrhosis: In people with decompensated cirrhosis, Harvoni is recommended as a first-choice option. Zepatier isn’t recommended for people with this condition.
  • Liver or kidney transplant: Harvoni is a first-choice option for treating hepatitis C in people who’ve had a liver or kidney transplant. Zepatier isn’t recommended for people with these conditions.

Costs

Harvoni and Zepatier are brand-name medications. A generic form of Harvoni is available, but there’s no generic form of Zepatier. Brand-name medications usually cost more than generics.

The actual cost you pay for either drug will depend on your insurance plan and the pharmacy you use.

You should take Harvoni according to your doctor’s or another healthcare professional’s instructions.

Harvoni comes in two oral forms: tablet and pellets.

Timing

Harvoni can be taken at any time of the day. However, you should try to take Harvoni at the same time every day. This can help you remember to take it and help keep a consistent amount of the drug in your system.

If you experience fatigue during your treatment with Harvoni, try taking the drug at night. This might help you avoid the side effect.

Taking Harvoni with food

Harvoni oral tablets and oral pellets can be taken with or without food.

Harvoni oral pellets can be mixed with nonacidic soft foods if desired. Examples of nonacidic soft foods include pudding, chocolate syrup, and mashed potatoes.

If you experience nausea after taking Harvoni, you may avoid this side effect by taking the drug with food.

Can Harvoni be crushed or chewed?

It’s not known whether it’s safe to crush Harvoni tablets or pellets, so it’s best to avoid crushing them. If you have trouble swallowing Harvoni tablets, talk with your doctor about other medications that may work better for you. Or they may switch you to Harvoni oral pellets.

Harvoni oral pellets should be swallowed without chewing. When mixing the pellets into a soft food, be sure to mix gently to help keep the pellets intact. Also, avoiding chewing Harvoni oral pellets can help prevent their bitter taste.

Harvoni is used to treat hepatitis C, which is caused by the hepatitis C virus (HCV).

About hepatitis C

HCV is transmitted through blood or body fluids. The virus primarily attacks cells in your liver and causes inflammation. This leads to symptoms such as:

Some people’s immune systems can fight HCV without treatment. However, many people need medication to clear the virus and reduce long-term effects. Serious, long-term effects of hepatitis C include cirrhosis (liver scarring) and liver cancer.

How does Harvoni treat hepatitis C?

Harvoni is a direct-acting antiviral (DAA). These types of drugs treat HCV by stopping the virus from reproducing (making copies of itself). Viruses that can’t make copies eventually die and are cleared from the body.

Clearing the virus from your body will decrease liver inflammation and prevent additional liver scarring.

How long does it take to work?

Some people start feeling better within a few days or weeks of starting treatment with Harvoni. However, you’ll still need to take Harvoni for the entire time that your doctor prescribes.

In clinical trials, more than 86% of people who took Harvoni were cured after 3 months of treatment.

Your doctor will test your blood for the virus before and during treatment. They will also test it 12 weeks after you finish treatment. If there is no detectable virus in your body 12 weeks after your treatment ends, you have achieved sustained virologic response (SVR). Achieving SVR means you’re considered cured of hepatitis C.

There haven’t been enough studies in humans to know if Harvoni is safe to take during pregnancy. In animal studies, there was no harm to a fetus when a pregnant animal received Harvoni. However, animal studies don’t always predict what will happen in humans.

If you’re pregnant or planning to become pregnant, talk with your doctor about whether Harvoni is right for you.

Note: If you’re taking Harvoni with ribavirin, that treatment isn’t safe to use during pregnancy. See the “Harvoni with ribavirin” section above to learn more.

It isn’t known if Harvoni passes into human breast milk. In animal studies, Harvoni passed into breast milk but didn’t cause harmful effects in offspring. However, animal studies don’t always predict what will happen in humans.

If you’re breastfeeding or planning to breastfeed, talk with your doctor. They can discuss potential risks and benefits of taking Harvoni while breastfeeding.

Note: If you’re taking Harvoni with ribavirin, you should talk with your doctor about whether you can safely continue to breastfeed. See the “Harvoni with ribavirin” section above to learn more.

Here are answers to some frequently asked questions about Harvoni.

Do I need to follow a special diet while taking Harvoni?

No, there is no special diet required while you take Harvoni.

However, if you experience nausea or stomach pain as a side effect of Harvoni, it may be helpful to eat smaller meals and avoid foods that are greasy, spicy, or acidic. Taking Harvoni with a small snack may also lessen nausea.

Harvoni oral pellets can be mixed with nonacidic soft foods if desired. Examples of nonacidic soft foods include pudding, chocolate syrup, and mashed potatoes.

How long will Harvoni take to get rid of my hepatitis C?

Harvoni will start working right away to fight the virus. However, in order to clear the hepatitis C virus, you will need to take Harvoni for the full length of time that your doctor prescribes. This may be 8, 12, or 24 weeks, depending on your medical history.

In clinical trials, nearly all people who took Harvoni had sustained virologic response (SVR) after the full treatment. SVR means that the virus was no longer detectable in their blood. When a person achieves SVR, they are considered cured of hepatitis C.

What is the cure rate for Harvoni?

The cure rate for Harvoni depends on certain aspects of your hepatitis C. This includes whether or not you have cirrhosis, what past hepatitis C treatments you may have tried, and what genotype of the virus you have. (Cirrhosis is scarring of the liver.)

For example, in clinical trials of Harvoni, 96% of people who met the following description were cured of hepatitis C after 12 weeks:

  • had genotype 1
  • had no cirrhosis
  • had no history of other hepatitis C treatments

In the same clinical trials, between 86% and 100% of people with different medical histories were cured of hepatitis C.

Can hepatitis C come back after taking Harvoni?

If you take Harvoni every day as directed by your doctor and you maintain a healthy lifestyle, the virus shouldn’t return.

However, it’s possible to relapse (have the infection reappear). This happens when a medication has cured a person of hepatitis C, but blood tests detect the virus again months to years after treatment. In clinical trials, up to 6% of people who took Harvoni had a relapse.

Also, if you’re exposed to hepatitis C again after you take any hepatitis C medication, including Harvoni, you can become reinfected with the virus. Reinfection can occur in the same way the original infection was contracted.

Sharing needles used for injecting drugs and having intercourse without a condom are possible routes of reinfection. Avoiding these behaviors can help prevent reinfection with hepatitis C.

What is a hepatitis C genotype?

There are six different strains, or types, of hepatitis C viruses that are known to infect people. These strains are called genotypes.

Genotypes are identified by differences in the genetic code of the viruses. The most common hepatitis C strain in the United States is genotype 1, but other strains are also seen here.

Your doctor will order a blood test to determine which genotype you have. Your hepatitis C genotype will help your doctor decide which medication is right for you.

Do not take more Harvoni than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Harvoni

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or go to the nearest emergency room right away.

This drug comes with several warnings.

FDA warning: Reactivation of hepatitis B virus

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

If people with both hepatitis C and hepatitis B start taking Harvoni, there is a risk of reactivation of the hepatitis B virus (HBV). Reactivation means the virus becomes active again. Reactivation of HBV can lead to liver failure or death.

Your doctor will test you for HBV before you start Harvoni treatment. If you’re found to have HBV, you may need to take medication to treat it.

Other warnings

Before taking Harvoni, talk with your doctor about your health history. Harvoni may not be right for you if you have certain medical conditions.

It’s not known if Harvoni is safe or effective in people with severe kidney disease. This includes people with severe kidney impairment or with end-stage kidney disease that requires hemodialysis. However, people with severe kidney disease who took Harvoni in a 2018 clinical study were treated effectively and had no severe negative effects.

If you have severe kidney disease, talk with your doctor about whether Harvoni is right for you.

When Harvoni is dispensed from the pharmacy, the pharmacist will add an expiration date to the label on the bottle or package. This date is typically 1 year from the date the medication was dispensed.

The purpose of such expiration dates is to guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications.

How long a medication remains good can depend on many factors, including how and where the medication is stored. Harvoni should be stored below 86⁰F (30⁰C) and kept in the container they came in.

If you have unused medication that has gone past its expiration date, talk with your pharmacist about whether you might still be able to use it.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.