Harvoni

Harvoni treats chronic hepatitis C infection. Harvoni is officially the first interferon-free and ribavirin-free hepatitis C treatment.

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Harvoni Overview

Reviewed: October 10, 2014
Updated: 

Harvoni is a prescription medication used to treat chronic hepatitis C virus (HCV) genotype 1, 4, 5 or 6 infection. Harvoni is also used to treat people simultaneously infected with HCV and HIV. Harvoni may also be used with the medication ribavirin to treat people with HCV and cirrhosis.

It comes as a single tablet that contains 2 medications: ledipasvir and sofosbuvir. Harvoni belongs to a group of drugs called antiviral medications. It works by targeting certain proteins in the Hep C virus to keep it from reproducing in the body.

This medication comes in tablet form and is taken once daily.

Common side effects of Harvoni include tiredness, headache, and weakness.

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Harvoni Cautionary Labels

precautionsprecautionsprecautions

Uses of Harvoni

Harvoni is a prescription medication used to treat the following:

  • Chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection
  • Chronic HCV/HIV co-infections

Harvoni is given with ribavirin to treat: 

  • HCV genotype 1 infection with advanced cirrhosis, or
  • HCV genotype 1 or 4 infection with or without cirrhosis who have had a liver transplant

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Manufacturer

Harvoni Drug Class

Harvoni is part of the drug class:

Side Effects of Harvoni

Common side effects of Harvoni include the following:

  • fatigue (tiredness)
  • headache
  • weakness

This is not a complete list of Harvoni side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Harvoni Interactions

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Harvoni may affect the way other medicines work, and other medicines may affect how Harvoni works.

You should not take Harvoni if you also take other medicines that contain sofosbuvir (Sovaldi).

Especially tell your healthcare provider if you take any of the following medicines: 

  • amiodarone (Cordarone)
  • an antacid that contains aluminum or magnesium hydroxide. If you take an antacid during treatment with Harvoni, take the antacid 4 hours before or 4 hours after you take Harvoni. 
  • carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
  • digoxin (Lanoxin)
  • efavirenz, emtricitabine, tenofovir disoproxil fumarate (Atripla)
  • elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate (Stribild)
  • medicines for indigestion, heartburn, or stomach ulcers, such as nizatidine (Axid), famotidine (Pepcid AC), cimetidine (Tagamet), ranitidine (Zantac), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), rabeprazole (Aciphex), or pantoprazole (Protonix)
  • oxcarbazepine (Trileptal, Oxtellar XR)
  • phenytoin (Dilantin, Phenytek)
  • phenobarbital (Luminal)
  • rifabutin (Mycobutin)
  • rifampin (Rifadin, Rifamate, Rifater, Rimactane)
  • rifapentine (Priftin)
  • rosuvastatin (Crestor)
  • simeprevir (Olysio)
  • St. John’s wort (Hypericum perforatum) or a product that contains St. John’s wort
  • tipranavir (Aptivus) used in combination with ritonavir (Norvir)
  • tenofovir disoproxil fumarate (Viread, Truvada) used in combination with atazanavir (Reyataz) and ritonavir (Norvir), darunavir (Prezista) and ritonavir (Norvir), or used in combination with lopinavir and ritonavir (Kaletra

This is not a complete list of Harvoni drug interactions. Ask your doctor or pharmacist for more information.

Harvoni Precautions

Contact your healthcare provider immediately if you develop weakness, fatigue, nausea, vomiting, yellow eyes or skin, loss of appetite, or light-colored stools. These may be signs and symptoms of a serious liver problem. 

Do not take Harvoni if you:

  • are allergic to Harvoni or to any of its ingredients
  • are taking medications containing sofosbuvir, including Solvadi

Harvoni Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Harvoni, there are no specific foods that you must exclude from your diet when receiving this medication.

Inform MD

Before taking Harvoni, tell your healthcare provider if you:

  • have liver problems other than hepatitis C infection
  • if you have a history of hepatitis B infection
  • have severe kidney problems or you are on dialysis
  • have any other medical condition
  • are pregnant or plan to become pregnant. It is not known if Harvoni will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Harvoni passes into your breast milk.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Harvoni may affect the way other medicines work, and other medicines may affect how Harvoni works.

Harvoni and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Harvoni falls into category B. There are no well-done studies that have been done in humans with this medication. In animal studies, pregnant animals were given Harvoni, and the babies did not show any medical issues related to this medication.

Harvoni and Lactation

It is not known if Harvoni crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Harvoni.

Harvoni Usage

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. If you think there is a reason to stop taking it, talk to your healthcare provider before doing so.
  • Take Harvoni once daily, with or without food.
  • If you miss a dose, take the missed dose as soon as you remember the same day. Do not take more than 1 tablet of Harvoni in a day. Take your next dose at your regular time the next day.

Harvoni Dosage

Harvoni is a two-drug fixed-dose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet.

The recommended dosage of Harvoni is one tablet taken orally once daily with or without food.

Harvoni Overdose

If you take too much Harvoni call your local poison control center or seek medical attention right away.

Other Requirements

  • Store this medication at room temperature below 86°F (30°C).
  • Keep it in its original container.
  • Do not use the medication within if the seal over the bottle opening is broken or missing.

 

Harvoni FDA Warning

There is a risk of hepatitis B virus (HBV) becoming an active infection in those who have a current or previous infection with HBV and is treated with a certain antiviral medication (a direct-acting antiviral) to treat hepatitis C virus. Your healthcare provider will screen and monitor for HBV in those taking a direct-acting antiviral. Tell your healthcare provider if you have a history of hepatitis B infection or other liver problems before you are treated for hepatitis C.