Harvoni
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What is Harvoni (ledipasvir)?

Harvoni is a prescription medication that is used for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age or older. It is a combination of two direct-acting antiviral agents: ledipasvir and sofosbuvir.

Harvoni belongs to two drug classes: ledipasvir is an NS5A inhibitor, while sofosbuvir is an NS5B polymerase inhibitor. The combination of these two drugs is highly effective in treating chronic hepatitis C infection, including the most common type, genotype 1.

What are the Indications for Harvoni?

Harvoni is indicated for the treatment of chronic hepatitis C virus (HCV) infection. It is used to treat HCV genotypes 1, 4, 5, and 6. Harvoni is not recommended for the treatment of HCV genotype 2 or 3.

The medication is also indicated for those with HCV and human immunodeficiency virus (HIV) co-infection. In these conditions, Harvoni is used as part of a combination antiretroviral therapy regimen.

Usage

Storage

Harvoni should be stored at room temperature between 68° – 77°F(20° – 25°) in a tightly closed container, away from light and moisture.

Keep out of reach of children and pets.

Instruction

Harvoni should be taken by mouth once a day with or without food at the same time every day.

Dosage

Harvoni is available in tablet form in the following strengths (ledipasvir/sofosbuvir):

  • 90mg/400mg
  • 45mg/200mg

Harvoni is also available in oral pellet form in the following strengths (ledipasvir/sofosbuvir):

  • 45mg/200mg
  • 75mg/150mg

The recommended starting dose is dependent on your age and weight:

  • For adults and adolescents aged 12 or older, the recommended dose is 90mg/400mg once per day.
  • If you are 3 years of age or older, the recommended dose is dependent on weight.

Side Effects

It’s important to understand that although Harvoni is FDA-approved, it comes with side effects that may or may not affect you.

Before starting Harvoni, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As your body adjusts to Harvoni, side effects may go away.

Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own:

  • Feeling tired or fatigued
  • Headache
  • Nausea
  • Diarrhea
  • Insomnia
  • Cough

Serious Side Effects

Severe adverse reactions while using Harvoni can occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

  • Severe allergic reaction: severe rash or itching, swelling in the face, lips, tongue, or throat, rapid heartbeat, fainting or dizziness, or problems breathing or swallowing.
  • Reactivation of hepatitis B virus (HBV): liver failure
  • Slow heartbeat or bradycardia

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Before using Harvoni, tell your doctor or pharmacist:

  • If you are allergic to any medications, such as ledipasvir
  • If you have or have had hepatitis B
  • If you have HIV
  • If you have kidney problems or are on dialysis
  • If you have liver problems or have had a liver transplant
  • If you are pregnant or expect to become pregnant
  • If you are breastfeeding or plan to breastfeed

Reactivation of Hepatitis B

If you’ve had a Hepatitis B infection previously, taking Harvoni can cause the hepatitis B virus to become active. This means that the virus could start causing liver problems again. Your doctor will test you for hepatitis B before starting treatment, and should continue to monitor you for signs of hepatitis B reactivation during treatment.

Liver Function

Taking Harvoni can cause a temporary increase in liver enzymes, which can cause serious liver problems in rare cases. Your doctor should monitor your liver function regularly during your treatment.

Pregnant or Planning to Become Pregnant

It is not known if using Harvoni during pregnancy can harm your unborn child. It is recommended to use an effective contraceptive while taking. If you are pregnant or become pregnant while taking this medication, contact your doctor immediately.

Breastfeeding

It is not known if Harvoni passes through breast milk. If you are breastfeeding or considering breastfeeding, speak to a doctor for the best course of action before taking.

Interactions & Contraindications

Before using Harvoni, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.

Amiodarone

Taking Harvoni with amiodarone can lead to bradycardia, where your heart rate is slower than normal. It is not recommended to be taken with amiodarone. Consult with your doctor to determine if a change of therapy is needed.

Rifampin

Taking Harvoni with a P-gp inducer such as rifampin and St. John’s wort can reduce the effect. It is not recommended to be taken with P-gp medications. Consult with your doctor to determine if a change of therapy is needed.

Frequently Asked Questions

The active ingredients in Harvoni is ledipasvir and sofosbuvir. Harvoni may contain the following inactive ingredients for the 90mg/400mg tablet: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablet film-coat contains: FD&C yellow #6/sunset yellow FCF aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Harvoni may contain the following inactive ingredients for the 45mg/200mg tablet: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Harvoni may contain the following inactive ingredients for the oral pellets:  amino-methacrylate copolymer, colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.

Harvoni is a prescription medication used to treat chronic hepatitis C virus (HCV) infection in patients 3 years of age and older.

Harvoni works by stopping the virus from multiplying and spreading in the body, which can lead to a cure for those with chronic HCV infection.

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

The duration of treatment with Harvoni varies depending on the individual patient’s HCV genotype, liver function, and other factors. The typical duration of treatment is 8 to 12 weeks.

Harvoni is approved for use in patients 3 years of age or older with chronic HCV infection, including those with compensated cirrhosis.

Harvoni is approved for children 3 years or age and older.

Harvoni is not recommended if you have severe liver problems, take certain medications that interact with it, or are allergic to any of its ingredients.

The most common side effects of Harvoni include headache, fatigue, nausea, and insomnia. Serious side effects are rare but can include severe allergic reactions, liver problems, and reactivation of hepatitis B.

It is not recommended to take Harvoni during pregnancy as there is not enough information to determine if it can cause harm to the developing fetus. You should use effective birth control during treatment and for six months after treatment ends.

Harvoni can interact with certain medications, including some anticonvulsants, antifungals, and HIV medications. Tell your doctor about all medications you are taking before starting.

Harvoni is highly effective at curing chronic HCV infection however the success rate is dependent on if you have other serious conditions such as advanced liver disease. In clinical trials, cure rates ranged from 94% to 99%.

Harvoni can be taken by people with HIV, but they should be monitored closely by their doctor for possible drug interactions and side effects.

It is recommended to avoid drinking alcohol while taking Harvoni, as alcohol can worsen liver damage and decrease the effectiveness of the medication.

Harvoni is approved for the treatment of chronic HCV infection only and should not be used to treat other types of hepatitis.

Harvoni starts working immediately to stop the virus from multiplying and spreading in the body. It can take several weeks or months to achieve a cure, depending on the individual patient’s HCV genotype and other factors.

If you missed a dose, take it as soon as you remember. But, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your next dose as scheduled. Do not take a double dose of Harvoni to make up for a missed dose.

You should wait for at least six months after completing treatment with Harvoni before having unprotected sex to ensure the virus is fully cleared from your body.

Yes, you can purchase Harvoni online. Buying medications online is convenient and often less expensive than purchasing them at your local pharmacy.

Disclaimer

Pharma Giant provides medical information to help you better understand medications and medical conditions.This content is for informational use only and does not replace advice from a licensed medical practitioner. Consult your doctor or pharmacist before starting or changing any medication. All our partners follow strict safety standards set by their country’s health authorities to make sure you receive safe and high-quality medications.

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Kenneth Fill, PharmD, MBA Fill

Kenneth Fill, PharmD, MBA, is a clinical pharmacist specialist and medical writer with a strong background in ambulatory care, pharmacogenomics, and medical content development. Based in the state of Michigan, he provides expert guidance on chronic disease state management. Kenneth completed his PharmD and MBA at the University of Toledo and pursued post-graduate residency training in ambulatory care and community-based pharmacy. His diverse background also includes academic detailing, clinical education, and interdisciplinary collaboration to enhance patient outcomes.