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 Jul 9, 2024.

What is Harvoni?

Harvoni is an oral, 2-drug antiviral treatment containing ledipasvir and sofosbuvir that may be used to treat adults and children aged 3 years and older with chronic (long-lasting) hepatitis C (HCV):

• genotypes 1, 4, 5, or 6 infections without cirrhosis or with compensated cirrhosis
• genotype 1 infection with advanced cirrhosis (decompensated) in combination with ribavirin
• 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 2 antivirals in Harvoni each have a different mechanism of action. Ledipasvir blocks the effects of an HCV protein called NS5A which is required for the virus to multiply (called viral replication). Harvoni also contains sofosbuvir, a prodrug, that is converted in the body to its active metabolite which uses an enzyme called NS5B RNA polymerase to incorporate itself into HCV RNA and acts as a chain terminator. This also prevents the virus from making copies of itself.

Harvoni was FDA-approved on October 10, 2014. One strength of Harvoni is available as a generic: Harvoni 90 mg/400 mg (ledipasvir 90 mg/sofosbuvir 400 mg). Harvoni 45 mg/200 mg and Harvoni oral pellets are not available as generics.

Harvoni side effects

The most common side effects of Harvoni include:

• tiredness
• headache
• weakness.

Serious side effects and warnings

Harvoni can cause serious side effects, including:

Hepatitis B virus reactivation. Before starting treatment with Harvoni, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had a hepatitis B virus infection, 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 some 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 get 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 if 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 not known 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.

Related/similar drugs

Vosevi, Epclusa, Mavyret, sofosbuvir / velpatasvir, ribavirin, Sovaldi

Before taking

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

• have ever had a hepatitis B virus infection
• have liver problems other than hepatitis C infection
• have had a liver transplant
• have kidney problems or you are on dialysis
• have HIV infection
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

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 should I take Harvoni?

Take Harvoni 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.

• Take Harvoni tablets or oral pellets by mouth, with or without food.
• You mustn't miss or skip doses during treatment.
• Harvoni is usually given for 12 weeks.

Usual Harvoni treatment dosage for HCV

• Adults: Harvoni 90 mg/400 mg, 1 tablet each day.
• Children 3 years of age and older: The dosage of Harvoni is based on body weight.

Tell your healthcare provider if your child has problems with swallowing tablets.

If your healthcare provider prescribes Harvoni oral pellets for your child, see below.

How should I give Harvoni oral pellets to my child?

See the Instructions for Use in the Harvoni Package insert for detailed information about how to give or take Harvoni oral pellets. Administer the pellets exactly as instructed by your healthcare provider.

• Do not open the packet until ready to use.
• Hold the Harvoni pellets packet with the cut line on top.
• Shake the pellets packet gently to settle the pellets.
• Tear or cut the packet along the cut line.
• Harvoni oral pellets can be taken with or without food.
• If your healthcare provider has prescribed more than one packet of pellets, take the next packet in the same way.

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.

• Examples of non-acidic foods include pudding, chocolate syrup, mashed potato, and ice cream.
• Take Harvoni pellets within 30 minutes of gently mixing them with food and swallow the entire contents without chewing to avoid a bitter taste.
• Do not store any leftover Harvoni mixture (oral pellets mixed with food) for use at a later time. Throw away any unused portion.

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.

• Water may be taken after swallowing the pellets to avoid a bitter taste. Make sure no pellets remain in the packet.

What to avoid

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

Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent hepatitis C 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, 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:

• Amiodarone, because coadministration may result in a seriously slow heartbeat ( bradycardia). Amiodarone should not be used with Harvoni
• P-gp inducers and/or moderate to strong CYP inducers (such as rifampin, St. John’s wort, and carbamazepine). May decrease concentrations of Harvoni. Use together is not recommended
• Omeprazole (Prilosec) or an antacid. Do not take them for at least 4 hours after you have taken your dose of Harvoni because these may affect the absorption of Harvoni.

Clearance of HCV infection 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.

Storage

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

• Harvoni tablets if the seal over the bottle opening is broken or missing
• Harvoni pellets if the carton tamper-evident seal, or the pellets packet seal, is broken or damaged.

Keep out of the reach of children.

Harvoni ingredients

Active ingredients: ledipasvir and sofosbuvir

Inactive ingredients, Tablets 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, Tablets 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, 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:

• oral tablets 90 mg/ 400 mg and 45 mg/ 200 mg
• oral pellets 45 mg/ 200 mg, 33.75 mg/150 mg.

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

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Further information

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

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