Generic Name: ledipasvir and sofosbuvir (le DIP as vir and soe FOS bue vir)
Brand Names: Harvoni
Medically reviewed by Sanjai Sinha, MD Last updated on Mar 14, 2019.
What is Harvoni?
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.
You should not use Harvoni if you are also taking sofosbuvir tablets (Sovaldi).
If you've ever had hepatitis B, using Harvoni can cause this virus to become active or get worse. Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.
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.
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 Harvoni is safe for you, tell your doctor if you have ever had:
liver problems other than hepatitis (including a liver transplant);
kidney disease (or if you are on dialysis);
HIV or AIDS;
Both men and women using Harvoni with ribavirin should use at least 2 effective forms of birth control to prevent pregnancy. Ribavirin can cause birth defects or death in an unborn baby if the mother or father is using this medicine.
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 sex partner is pregnant.
Keep using 2 forms of birth control while using ribavirin, and for at least 6 months after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
Harvoni is not approved for use by anyone younger than 3 years old.
How should I take Harvoni?
Take Harvoni exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
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.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Do not chew the oral pellets.
Harvoni doses are based on weight (especially in children and teenagers). Your dose needs may change if you gain or lose weight.
You will need frequent blood tests to check your liver function.
If you've ever had hepatitis B, using Harvoni can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.
Use all medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with chronic hepatitis C should remain under the care of a doctor.
Store this medicine in the original container at room temperature away from moisture and heat. Do not open the packet of oral pellets until you are ready to use the medicine.
You should not stop using Harvoni suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine.
What happens if I 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?
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.
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 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:
right-sided upper stomach pain;
vomiting, loss of appetite; or
jaundice (yellowing of the skin or eyes), and not feeling well.
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.
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 here. Tell your doctor about all your current medicines and any medicine you start or stop using.
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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More about Harvoni (ledipasvir / sofosbuvir)
- Side Effects
- During Pregnancy
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- Drug class: antiviral combinations
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