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Harvoni

Pronunciation: har-VOE-nee
Generic name: ledipasvir and sofosbuvir
Dosage form: oral tablets, oral pellets
Drug class: Antiviral combinations

Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 20, 2024.

What is Harvoni?

Harvoni is used to treat hepatitis C virus (HCV) infections in adults and children aged 3 years and older.

Harvoni's mechanism of action involves preventing HCV from replicating (making copies of itself) in the body. Harvoni contains 2 antivirals, ledipasavir and sofosbuvir. Each has a different mechanism of action. Ledipasvir blocks the effects of an HCV protein required for HCV replication. Sofosbuvir is converted in the body to its active metabolite which incorporates itself into the RNA of HCV, also preventing HCV replication.  from making copies of itself. See What is the mechanism of action of Harvoni? for more information.

Harvoni gained FDA approval for HCV on October 10, 2014. A Harvoni generic is available as ledipasvir 90 mg and sofosbuvir 400 mg. There is no Harvoni generic for the other strength of Harvoni (ledipasvir 45 mg sofosbuvir 200 mg) or Harvoni oral pellets.

Harvoni uses

Harvoni is used for HCV genotypes 1, 4, 5, or 6 infections without cirrhosis or with compensated cirrhosis.

Harvoni also treats HCV genotype 1 infection with advanced cirrhosis (decompensated) in combination with ribavirin and people with HCV genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis who have had a liver transplant, in combination with ribavirin.

Your doctor will perform tests to find out which hepatitis genotype you have. The treatment duration of Harvoni is usually 12 weeks.

Harvoni cost

Most insurance companies and Medicare cover the cost of Harvoni; however, you may have to meet certain criteria and you should always check with your insurance company first before you and your doctor make it your preferred treatment. There may also be a co-pay.

See How Much Does Harvoni Cost? for more information about the cost of Harvoni as well as Gilead's Support Path patient assistance program for Harvoni.

Harvoni side effects

The most common side effects of Harvoni include:

Serious side effects and warnings

Harvoni carries a Boxed Warning for the risk of hepatitis B (HBV) reactivation in people coinfected with HCV and HBV. 

Hepatitis B virus (HBV) reactivation. Before starting treatment with Harvoni, your healthcare provider will do blood tests to check for HBV. If you have ever had HBV, the hepatitis B virus could become active again during or after treatment of HCV with Harvoni. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking Harvoni. Call your healthcare provider right away if you develop right-sided upper abdominal pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Slow heart rate (bradycardia). Harvoni may slow your heart rate and cause other symptoms when taken alongside other heart medications such as amiodarone (Cordarone, Nexterone, Pacerone). In some cases, this has led to death or the need for a heart pacemaker. Get medical help right away if you take amiodarone with Harvoni and develop any of the following symptoms fainting or near-fainting, weakness, chest pains, dizziness or lightheadedness, extreme tiredness, confusion, not feeling well, shortness of breath, or memory problems.

Harvoni is used in combination with ribavirin in people with decompensated cirrhosis. Ribavirin can cause birth defects or death in an unborn baby. Do not use ribavirin if you are pregnant, or if you are a man and your sexual partner is pregnant. Use effective birth control to prevent pregnancy while using these medicines together and for at least 6 months after treatment ends.

It is unknown if Harvoni is safe and effective in children under 3 years of age.

These are not all the possible side effects of Harvoni. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking

Before taking Harvoni, tell your healthcare provider about all of your medical conditions, including if you:

Pregnancy

It is not known if Harvoni will harm your unborn baby. Males and females who take Harvoni in combination with ribavirin should also read the Ribavirin Medication Guide for important pregnancy, contraception, and infertility information.

Breastfeeding

It is not known if Harvoni passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Harvoni.

How do I take Harvoni?

Take Harvoni treatment exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to. Do not stop taking Harvoni without first talking with your healthcare provider.

Harvoni treatment

The usual dosage of Harvoni to treat HCV in adults is Harvoni 90 mg/400 mg, 1 tablet each day.

The usual dosage of Harvoni to treat HCV in children 3 years of age and older is based on body weight.

How should I give Harvoni oral pellets to my child?

See the Instructions for Use in the Harvoni Package insert for detailed information about giving or taking Harvoni oral pellets if you or your child are prescribed Harvoni treatment. Administer the pellets exactly as instructed by your healthcare provider.

Taking Harvoni pellets with food 

If Harvoni pellets are taken with food, sprinkle the pellets on one or more spoonfuls of non-acidic soft food at or below room temperature.

Taking Harvoni pellets without food

If Harvoni pellets are taken without food, sprinkle the entire contents of the packet directly into the mouth and swallow without chewing to avoid a bitter taste.

What to avoid

Ask your doctor before using an antacid or stomach acid-reducing medicine with Harvoni. Use only the type and amount your doctor recommends.

Using Harvoni will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes if you have HCV. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drugs or medicine needles is never safe, even for a healthy person.

What happens if I miss a dose?

Do not miss a dose of Harvoni. Missing a dose lowers the amount of medicine in your blood. Refill your Harvoni prescription before you run out of medicine.

If you miss a dose of Harvoni, take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

If you take too much Harvoni, call your healthcare provider, call the Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away.

What other drugs will affect Harvoni?

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

Clearance of HCV with direct-acting antivirals may lead to changes in liver function, which may impact the safe and effective use of other medications. Frequent laboratory monitoring (INR and blood glucose) and dose adjustments may be necessary.

This is not a full list of interactions. Ask your healthcare provider or pharmacist for a list of medicines that interact with Harvoni. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Harvoni with other medicines.

Does Harvoni interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.

Storage

Store Harvoni tablets or pellets below 86°F (30°C). Keep them in their original container. Do not use:

Keep out of the reach of children.

Harvoni ingredients

Active ingredients: ledipasvir and sofosbuvir

Inactive ingredients, Harvoni 90/400 mg: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Tablet film-coating contains FD&C yellow #6/sunset yellow FCF aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Inactive ingredients, Harvoni 45/200 mg: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Tablet film-coat contains polyethylene glycol, polyvinyl alcohol partially hydrolyzed, talc, and titanium dioxide.

Inactive ingredients, Harvoni Oral Pellets: amino-methacrylate copolymer, colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.

Who makes Harvoni?

Gilead Sciences, Inc., makes Harvoni.

Asegua Therapeutics LLC., a subsidiary of Gilead Sciences Inc., makes generic Harvoni tablets under the name ledipasvir 90 mg/ sofosbuvir 400 mg.

Popular FAQ

What is the difference between hepatitis B and C?

Some of the main differences between hepatitis B and C are:

  • Hepatitis B virus can be prevented with a vaccine, but not hepatitis C.
  • Hepatitis B and C are different viruses, but you can have both hepatitis B and hepatitis C at the same time.
  • Over 90% of people infected with hepatitis C who have not received treatment can be cured with 8 to 12 weeks of oral medications, but treatment for hepatitis B, if needed, may be long-term or lifelong.
  • There is no cure for hepatitis B, but once you recover from acute hepatitis B, you develop antibodies that protect you from the virus for life.
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What are the new drugs for the treatment of hepatitis C?

The newest drugs for the treatment of hepatitis C include Mavyret (glecaprevir and pibrentasvir), Vosevi (sofosbuvir, velpatasvir, and voxilaprevir), and Epclusa (sofosbuvir and velpatasvir). All are FDA-approved for the treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A), as well as other uses. Continue reading

Is Mavyret better than Harvoni?

Mavyret is reported to have some advantages over Harvoni including the number of hepatitis C virus (HCV) genotypes it covers, the length of treatment required, and the cost of a course of treatment. Continue reading

What is the mechanism of action of Harvoni?

Harvoni (ledipasvir and sofosbuvir) works in 2 ways to kill the hepatitis C virus (HCV). Ledipasvir works by interfering with a protein that is needed by the virus to replicate itself. Sofosbuvir interferes with the reproduction of genetic material of the hepatitis C virus, by inhibiting an enzyme which is also needed by the virus to replicate itself. After 12 weeks of Harvoni treatment, Harvoni will eliminate HCV in 95% of people who take it, technically curing them. Continue reading

Does Harvoni cause liver cancer or liver damage?

Liver cancer has been reported with direct-acting HCV antivirals, such as Harvoni, but these reports are rare. There are also reports of worsening liver function or liver failure that have mostly been reported in people with pre-existing liver disease. The FDA considers the risk of serious liver injury or liver cancer is rare and the hepatitis C virus itself can cause liver damage. Continue reading

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.