Harvoni

Generic Name: ledipasvir and sofosbuvir (le DIP as vir and soe FOS bue vir)
Brand Names: Harvoni

What is Harvoni?

Harvoni contains a combination of ledipasvir and sofosbuvir. Ledipasvir and sofosbuvir are antiviral medications that prevent hepatitis C virus (HCV) from multiplying in your body.

Harvoni is used to treat hepatitis C genotypes 1, 4, 5, or 6. This medicine is for use in adults and children who are at least 12 years old or who weigh at least 77 pounds (35 kilograms).

Harvoni is sometimes given in combination with another medicine called ribavirin.

Important information

You should not use Harvoni if you are also taking sofosbuvir tablets (Sovaldi).

 The ABC's of Hepatitis: Get to Know This Viral Disease

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The ABC's of Hepatitis: Get to Know This Viral Disease

If you have ever had hepatitis B, Harvoni can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function.

Before taking this medicine

You should not use Harvoni if you are allergic to ledipasvir or sofosbuvir, or if you are also taking sofosbuvir tablets (Sovaldi).

To make sure Harvoni is safe for you, tell your doctor if you have:

a history of hepatitis B;

liver problems other than hepatitis;

a history of liver transplant;

kidney disease (or if you are on dialysis);

HIV or AIDS; or

a heart rhythm problem for which you take a medicine called amiodarone (Cordarone, Pacerone).

You should not use Harvoni with ribavirin if you have:

severe kidney disease;

a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia; or

if you are pregnant, or if you are a man and your sexual partner is pregnant.

Harvoni is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Harvoni is sometimes used together with another medicine called ribavirin. Ribavirin can cause birth defects or death in an unborn baby. You may need to have a negative pregnancy test before taking ribavirin and every month during your treatment.

If you are a woman, do not take ribavirin if you are pregnant. If you are a man, do not take ribavirin if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.

Use at least 2 effective forms of birth control to prevent pregnancy while either sexual partner is taking ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking ribavirin.

It is not known whether ledipasvir and sofosbuvir passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Harvoni is not approved for use by anyone younger than 12 years old or weighing less than 77 pounds.

How should I take Harvoni?

Take Harvoni exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Harvoni.

You may take Harvoni with or without food. Take the medicine at the same time each day.

Harvoni is usually taken once per day for 12 to 24 weeks. Follow your doctor's dosing instructions very carefully.

You will need frequent blood tests to check your liver function.

Hepatitis C is often treated with a combination of drugs. Use all medications as directed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Do not change your doses or medication schedule without your doctor's advice. Every person with chronic hepatitis C should remain under the care of a doctor.

You should not stop using Harvoni suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine.

If you have ever had hepatitis B, Harvoni can cause this condition to come back or get worse. You will need liver function tests during treatment and for several months after you stop using this medicine.

Store this medicine in the original container at room temperature away from moisture and heat.

Harvoni dosing information

Usual Adult Dose for Chronic Hepatitis C:

1 tablet orally once a day

Duration of Therapy:

-Therapy-naive patients without cirrhosis: 12 weeks; 8 weeks can be considered if pretreatment HCV RNA less than 6 million international units/mL

-Therapy-naive patients with cirrhosis: 12 weeks

-Therapy-experienced patients without cirrhosis: 12 weeks

-Therapy-experienced patients with cirrhosis: 24 weeks

Comments:

-Relapse rates are affected by baseline host and viral factors and differ between durations of therapy for some subgroups.

-Therapy-experienced patients are those patients who have failed treatment with either peginterferon alfa/ribavirin or peginterferon alfa/ribavirin/HCV protease inhibitor.

Use: For the treatment of chronic hepatitis C genotype 1 infection

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Harvoni?

Avoid taking an antacid within 4 hours before or 4 hours after you take Harvoni. This especially includes antacids that contain aluminum or magnesium (Acid Gone, Aldroxicon, Alternagel, Di-Gel, Gaviscon, Gelusil, Genaton, Maalox, Maldroxal, Milk of Magnesia, Mintox, Mylagen, Mylanta, Pepcid Complete, Rolaids, Rulox, and others).

Taking Harvoni will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Harvoni side effects

Get emergency medical help if you have signs of an allergic reaction to Harvoni: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

If you also take a heart medication called amiodarone, call your doctor at once if you have:

extreme tiredness;

unusual weakness, general ill feeling;

confusion or memory problems;

a light-headed feeling, like you might pass out;

slowed breathing, feeling short of breath; or

chest pain, slow heartbeats, weak pulse.

Common Harvoni side effects may include:

weakness;

headache; or

tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Harvoni?

Many drugs can interact with ledipasvir and sofosbuvir. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

amiodarone;

digoxin (digitalis);

other drugs to treat hepatitis C, such as simeprevir (Olysio) or sofosbuvir (Sovaldi);

rosuvastatin (Crestor);

St. John's wort;

HIV or AIDS medications - atazanavir, cobicistat, darunavir, elvitegravir, emtricitabine, lopinavir, ritonavir, tenofovir, tipranavir;

seizure medicine - carbamazepine, oxcarbazepine, phenobarbital, phenytoin;

stomach acid reducers - cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid) lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec), pantoprazole (Protonix), ranitidine (Zantac), and others; or

tuberculosis medicine - rifabutin, rifampin, rifapentine.

This list is not complete and many other drugs can interact with ledipasvir and sofosbuvir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.