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Harvoni

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

Medically reviewed on February 8, 2018

What is Harvoni?

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

Harvoni is used to treat chronic hepatitis C in adults and children who are at least 12 years old or who weigh at least 77 pounds (35 kilograms). Ledipasvir and sofosbuvir is sometimes given in combination with another medicine called ribavirin.

Harvoni treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.

Harvoni is sometimes used in people who also have HIV. This medicine is not a treatment for HIV or AIDS.

Important Information

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.

Harvoni is sometimes used in combination with other medication. Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice.

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

Before taking this medicine

You should not use Harvoni if you are allergic to ledipasvir or sofosbuvir.

If you take Harvoni with ribavirin: There may be other reasons you should not take this combination treatment. Tell your doctor about all your medical conditions.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • hepatitis B;

  • liver problems other than hepatitis C;

  • kidney disease (or if you are on dialysis);

  • HIV or AIDS;

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

  • if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine "INR" or prothrombin time tests.

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 in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby.

  • If you are a woman, do not use ribavirin if you are pregnant. You may need to have a negative pregnancy test before taking ribavirin and every month during your treatment.

  • If you are a man, do not use ribavirin if your sexual partner is pregnant. An unborn baby could be harmed if you have sex with a pregnant woman while you are taking ribavirin.

While taking Harvoni with ribavirin, use at least 2 effective forms of birth control to prevent pregnancy, whether you are a man or a woman. Ribavirin use by either parent may cause birth defects.

Keep using 2 forms of birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using 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 this medicine with or without food. Take it 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.

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.

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.

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

Recommended Regimen and Duration of Therapy:
GENOTYPE 1:
-Therapy-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks
-Therapy-experienced patients without cirrhosis: Ledipasvir-sofosbuvir for 12 weeks
-Therapy-experienced patients with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 24 weeks
-Therapy-naive and therapy-experienced patients with decompensated cirrhosis (Child-Pugh B or C): Ledipasvir-sofosbuvir plus ribavirin for 12 weeks

GENOTYPE 1 OR 4:
-Therapy-naive and therapy-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir plus ribavirin for 12 weeks

GENOTYPE 4, 5, OR 6:
-Therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks

Comments:
-Relapse rates are affected by baseline host and viral factors and differ between durations of therapy for some subgroups.
-Dose recommendations also apply to HCV/HIV-1-coinfected patients.
-Therapy-naive genotype 1 patients without cirrhosis: Ledipasvir-sofosbuvir for 8 weeks can be considered in those who have pretreatment HCV RNA less than 6 million international units/mL.
-Therapy-experienced patients have failed a peginterferon alfa/ribavirin-based regimen with or without an HCV protease inhibitor.
-Therapy-experienced genotype 1 patients with cirrhosis: Ledipasvir-sofosbuvir plus ribavirin for 12 weeks can be considered in those eligible for ribavirin.
-The manufacturer product information for ribavirin should be consulted regarding dosing and dose adjustments (if applicable).

Use: For the treatment of chronic HCV
-For genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
-In combination with ribavirin: For genotype 1 infection with decompensated cirrhosis
-In combination with ribavirin: For genotype 1 or 4 infection in liver transplant recipients without cirrhosis or with compensated cirrhosis

Usual Pediatric Dose for Chronic Hepatitis C:

12 years and older or weighing at least 35 kg: 1 tablet orally once a day

Recommended Regimen and Duration of Therapy:
GENOTYPE 1:
-Therapy-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks
-Therapy-experienced patients without cirrhosis: Ledipasvir-sofosbuvir for 12 weeks
-Therapy-experienced patients with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 24 weeks

GENOTYPE 4, 5, OR 6:
-Therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks

Comments:
-Dose recommendations also apply to HCV/HIV-1-coinfected patients.
-Therapy-experienced patients have failed an interferon-based regimen with or without ribavirin.

Use: For the treatment of HCV genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis

What other drugs will affect Harvoni?

When you start or stop taking Harvoni, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

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?

If you also take an antacid, do not take it for at least 4 hours after you have taken your dose of Harvoni.

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.

Call your doctor at once if you have new or worsening symptoms such as:

  • loss of appetite, upper stomach pain;

  • dark urine, clay-colored stools; or

  • jaundice (yellowing of the skin or eyes).

If you take Harvoni and you also take a heart rhythm medicine called amiodarone: This combination of medicines can cause dangerous side effects on your heart. Get medical help right away if you take these medicines and you have:

  • very slow heartbeats, chest pain, shortness of breath;

  • confusion, memory problems; or

  • weakness, extreme tiredness, light-headed feeling (like you might pass out.)

Common Harvoni side effects may include:

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?

When you start or stop taking Harvoni, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with ledipasvir and sofosbuvir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Harvoni only for the indication prescribed.

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

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