Harvoni

(Ledipasvir/Sofosbuvir)

The active ingredients in Harvoni are ledipasvir and sofosbuvir. Ledipasvir works by decreasing the activity of NS5A, and sofosbuvir works by decreasing the activity of NS5B polymerase.

The 2 mechanisms of action for these two antiviral agents work together to stop the hepatitis C virus from multiplying in the body, which helps reduce the amount of virus in the blood and supports long-term viral clearance.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Harvoni. However, the following is a synopsis of the general guidelines for the use of Harvoni:

• Harvoni is taken by mouth once daily.
• It may be taken with or without food.
• Tablets should be swallowed whole and not crushed or chewed.
• The dose of Harvoni and treatment duration depend on HCV genotype, liver disease status, and prior treatment history.
• Treatment duration is commonly 8, 12, or 24 weeks.
• Harvoni should be taken at the same time each day.

If a dose is missed, take it as soon as remembered on the same day and continue the next dose at the regular time.

Some mild or most common side effects of Harvoni seen in clinical trials include:

• Fatigue.
• Headache.
• Nausea.
• Diarrhea.
• Trouble sleeping.

Some individuals may experience serious side effects while using Harvoni. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Reactivation of the hepatitis B virus in people previously infected.
• Slow heart rate when taken with amiodarone.
• Severe tiredness, dizziness, or fainting.
• Shortness of breath or chest discomfort.
• Signs of liver problems include dark urine, yellowing of the skin or eyes, or abdominal pain.

These are not all of the possible side effects of Harvoni. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Harvoni, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Current or past hepatitis B virus infection.
• Liver disease, including cirrhosis or decompensated cirrhosis.
• A history of liver transplant.
• Heart problems, especially if taking amiodarone.
• Kidney disease.
• Use of antiretrovirals or other hepatitis C treatments.

Your healthcare provider may perform blood tests before, during, and after treatment to monitor liver function and viral levels.

Boxed Warning

Harvoni carries a boxed warning for hepatitis B virus reactivation. Reactivation of the hepatitis B virus has been reported in patients treated with direct-acting antivirals for hepatitis C infection. Some cases have resulted in serious liver problems or death. All patients should be tested for current or prior hepatitis B infection before starting Harvoni, and monitored during and after treatment.

Harvoni should not be used in patients who have known hypersensitivity to ledipasvir, sofosbuvir, or any component of the formulation. Certain drug combinations are contraindicated due to the risk of reduced effectiveness or serious adverse reactions.

Harvoni begins working soon after treatment starts. Viral levels often decrease within the first few weeks of therapy. Cure is determined by achieving a sustained virologic response, which is measured by undetectable HCV RNA in the blood 12 weeks after completing treatment.

When Harvoni is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Coadministration of amiodarone may cause serious bradycardia.
• Rifampin, rifabutin, or rifapentine may reduce antiviral effectiveness.
• Carbamazepine, phenytoin, and phenobarbital may lower Harvoni levels.
• St. John’s wort may decrease treatment effectiveness.
• Antacids, famotidine, or omeprazole may affect ledipasvir absorption.
• Rosuvastatin may increase the risk of muscle-related side effects.
• Ritonavir.
• Other drugs containing sofosbuvir, including Sovaldi.

Harvoni is available as an oral tablet containing a fixed-dose combination of ledipasvir and sofosbuvir. Pediatric formulations may include oral pellets for eligible patients.

If you miss a dose of Harvoni, take the missed dose as soon as you remember the same day. Do not take more than 1 tablet of Harvoni in a day.

It should be stored at room temperature, away from the reach of children or pets.

Harvoni is manufactured by Gilead Sciences.

No. Harvoni is a brand-name medication. There is no generic equivalent available in some regions.

Do not stop taking Harvoni unless instructed by your healthcare provider. Stopping treatment early may reduce the chance of a cure. Once the full course is completed, no tapering is required.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. There is limited data on Harvoni use during pregnancy. If Harvoni is taken with ribavirin, pregnancy must be avoided due to a serious birth defect risk. Ask your doctor about other treatment options.

It is not known if Harvoni passes into breast milk. Your healthcare provider will weigh the benefits and potential risks.