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Harvoni (Ledipasvir and Sofosbuvir) – Oral

What Is Harvoni? Harvoni (ledipasvir and sofosbuvir) is a prescription medicine that treats chronic hepatitis C virus (HCV), an infectious liver disease. Harvoni is one product that contains two drugs: ledipasvir and sofosbuvir. It belongs to a

  • Posted on 20th Apr, 2022 14:00 PM
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Harvoni (Ledipasvir and Sofosbuvir) – Oral Image

What Is Harvoni?

Harvoni (ledipasvir and sofosbuvir) is a prescription medicine that treats chronic hepatitis C virus (HCV), an infectious liver disease. Harvoni is one product that contains two drugs: ledipasvir and sofosbuvir. It belongs to a class of drugs called direct-acting antivirals (DAAs). Ledipasvir and sofosbuvir are both antiviral drugs that inhibit proteins that HCV needs in order to replicate and survive.

Harvoni comes as a tablet and as pellets, both taken by mouth. It is available generically. This medication is a prescription product, so you can’t purchase it over the counter. You’ll need a prescription from your healthcare provider to get the medication from your pharmacy.

Drug Facts

Generic Name: Ledipasvir and sofosbuvir

Brand Name: Harvoni 

Drug Availability: Prescription

Therapeutic Classification: Direct-acting antiviral

Available Generically: Yes

Controlled Substance: N/A

Administration Route: Oral

Active Ingredient: Ledipasvir and sofosbuvir

Dosage Form: Tablet, oral pellets

What Is Harvoni Used For?

Harvoni is used to treat hepatitis C. Hepatitis C is a liver infection caused by the hepatitis C virus (HCV). HCV can lead to severe liver damage.

HCV affects everyone differently. For some individuals, the infection is mild and clears spontaneously. In others, it becomes a persistent infection that can progress to a life-threatening condition. The goal of treating HCV with medicines like Harvoni is to suppress the hepatitis C virus to the point at which it is not detectable in your blood.

How to Take Harvoni

Take Harvoni at the same time every day with or without food. Take it when you are most able to remember it so that you don’t accidentally miss doses. It’s important to take Harvoni according to the regimen prescribed by your healthcare provider.

In addition to a tablet, Harvoni is available as oral pellets. You can sprinkle the pellets on nonacidic foods that are at or below room temperature (between 68 and 77 degrees Fahrenheit), such as pudding, mashed potatoes (cooled down), or ice cream. Take Harvoni pellets within 30 minutes of mixing them with food. Swallow the food without chewing to avoid a bitter aftertaste from the pellets.

Storage

Store Harvoni at room temperature (below 86 degrees) in the original container with the lid on. Keep out of reach of children and pets. Avoid storing your pill bottle in an area with a lot of heat and moisture, like the bathroom.

If you’re traveling by plane, keep Harvoni in your carry-on luggage so that you aren’t separated from it if your checked bag happens to go missing. If you’re traveling by car, do not leave your pill bottle in hot or cold temperatures for long periods, like overnight, in the car.

How Long Does Harvoni Take to Work?

Harvoni must be taken for a specified time to treat hepatitis C. The length of treatment may be different depending on the individual and the type of hepatitis C they have, but it ranges from eight to 24 weeks. After this period, the hepatitis C level is often undetectable, meaning there is not enough virus for lab tests to detect it. This lack of virus in your system is called a sustained virologic response (SVR).

What Are the Side Effects of Harvoni?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the Food and Drug Administration (FDA) at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Common side effects when taking Harvoni include:

  • Headache
  • Fatigue, or feeling generally tired and sleepy
  • Weakness

Severe Side Effects

Potential side effects of Harvoni that were rarer in clinical trials but potentially more severe include:

  • Hepatitis B reactivation
  • Psychiatric disorders such as depression, especially in individuals with a history of psychiatric illness
  • Abnormal lab testing results such as bilirubin, lipase, or creatine kinase elevations
  • Serious bradycardia (slow heart rate) in people who start Harvoni while they are also taking a drug called amiodarone

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or think you’re having a medical emergency.

Long-Term Side Effects

Harvoni must be taken for a specified amount of time to treat hepatitis C. This time frame is different depending on the individual but generally ranges from eight to 24 weeks. The side effects mentioned above apply to this time range. There are no other side effects particularly associated with long-term use of the medicine.

Report Side Effects

Harvoni may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

(800) 332-1088

Dosage: How Much Harvoni Should I Take?

Drug Content Provided and Reviewed byIBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (pellets or tablets):
    • For hepatitis C virus infection:
      • Adults—1 tablet once a day, taken for 12 or 24 weeks. Each tablet contains ledipasvir 90 milligrams (mg) and sofosbuvir 400 mg.
      • Children 3 years of age and older weighing at least 35 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is usually 1 tablet (containing ledipasvir 90 mg and sofosbuvir 400 mg) once a day, or two tablets (containing ledipasvir 45 mg and 200 mg sofosbuvir) once a day, or two packets of pellets (containing ledipasvir 45 mg and 200 mg sofosbuvir) once a day, taken for 12 or 24 weeks.
      • Children 3 years of age and older weighing 17 to less than 35 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually one tablet (containing ledipasvir 45 mg and 200 mg sofosbuvir) once a day, or one packet of pellets (containing ledipasvir 45 mg and 200 mg sofosbuvir) once a day, taken for 12 or 24 weeks.
      • Children 3 years of age and older weighing less than 17 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually one packet of pellets (containing ledipasvir 33.75 mg and 150 mg sofosbuvir) once a day, taken for 12 or 24 weeks.
      • Children younger than 3 years of age—Use and dose must be determined by your doctor.

Modifications

Harvoni comes in two dosage forms: tablets and oral pellets. If you or your child has trouble swallowing tablets, oral pellets may be an better option. Harvoni pellets can be mixed into soft food. However, it must be taken within 30 minutes of mixing into food, and the entire contents must be swallowed without chewing to avoid a bitter taste.

In the following circumstances, special precautions will have to be taken when using Harvoni.

Pregnancy

Harvoni is often taken along with another medicine called ribavirin to treat hepatitis C. This combination of drugs is contraindicated in pregnancy, which means it should never be taken by pregnant women, or even in men whose female partners are pregnant.

Data on whether Harvoni taken alone causes any risk to pregnancy are not sufficient to make a recommendation. The importance of using Harvoni in a pregnant woman should be evaluated and weighed against any risk.

Breastfeeding

It is not known whether either of the drugs in Harvoni passes into breast milk. The benefits of breastfeeding should be considered along with the mother’s need for Harvoni and any potential side effects on the breastfed child.

Children

Harvoni has been established as safe and effective in treating hepatitis C in children 3 years of age and older.

Older Adults

There have not been specific studies to determine whether older adults (above age 65) respond more or differently to Harvoni compared to younger adults. In clinical trials of Harvoni, 225 people were 65 or older (9% of a total number of people), and no overall differences in safety or effectiveness were observed between older and younger populations.

Missed Dose

If you forget to take a dose of Harvoni, you can take it as soon as you remember. If you are closer to your next dose than the dose you missed, go ahead and skip the missed dose and wait for your next scheduled one.

For example, if you normally take Harvoni at 8 a.m., and you remember at 9 p.m. that you forgot your morning dose, just wait and take your next dose the next morning at 8 a.m. Do not double up doses to make up for missed ones.

Overdose: What Happens If I Take Too Much Harvoni?

As long as you take Harvoni as prescribed, you don’t need to be too concerned about overdosing. Treatment for an overdose would most likely consist of monitoring your vital signs and general condition.

What Happens If I Overdose on Harvoni?

If you think you or someone else may have overdosed on Harvoni, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Harvoni, call 911 immediately.

911

Precautions

Drug Content Provided and Reviewed byIBM Micromedex®

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine together with ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using these medicines and for 6 months after your treatment ends, tell your doctor right away.

Using this medicine with amiodarone may cause bradycardia. Check with your doctor right away if you have chest pain or discomfort, lightheadedness, dizziness, or fainting, shortness of breath, slow or uneven heartbeat, or unusual tiredness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

What Are Reasons I Shouldn't Take Harvoni?

Your healthcare provider may not prescribe Harvoni for you if you:

  • Are also infected with hepatitis B virus (HBV): Harvoni has in some cases been shown to reactivate hepatitis B virus in individuals who have both hepatitis B and C viruses and are not taking medicine to treat HBV. Let your healthcare provider know if you have hepatitis B or if you are unsure whether you have it or not.
  • Are pregnant or breastfeeding: If you are pregnant or planning to become pregnant, you should let your healthcare provider know so that you can ask whether Harvoni is the best option during your pregnancy.
  • Also take amiodarone: Taking Harvoni while also taking a drug called amiodarone can cause serious bradycardia, or a heart rate that is too slow.
  • Also take drugs that are P-gp inducers: These drugs (such as rifampin or Saint-John’s-wort) can significantly lower the amount of Harvoni that gets absorbed into your system and, therefore, how well it works.

What Other Medications Interact With Harvoni?

Make sure the healthcare provider that is prescribing Harvoni for you is aware of all other medicines and supplements that you take. The following can interact with Harvoni:

  • Amiodarone is a drug that treats heart arrhythmias (abnormal heart rates). Taking amiodarone with Harvoni can result in significant bradycardia, or a heart rate that is too slow. Symptoms of bradycardia include fainting or feeling lightheaded, dizziness, weakness, excessive tiredness, shortness of breath, chest pain, or confusion. This can set in within hours of first taking Harvoni, or it can take a couple of weeks to begin. It usually resolves after stopping Harvoni.
  • P-gp inducers such as rifampin and Saint-John’s-wort may affect how much Harvoni gets absorbed into your system and may decrease how effective it is in treating your hepatitis C. Avoid taking these drugs while on Harvoni.

What Medications Are Similar to Harvoni?

Other direct-acting antiviral medications that treat HCV are available. Some are combination products containing two or three drugs and others contain just one drug.

Drugs that are similar to Harvoni include:

  • Epclusa (sofosbuvir/velpatasvir)
  • Zepatier (grazoprevir/elbasvir)
  • Mavyret (glecaprevir/pibrentasvir)
  • Daklinza (daclatasvir)
  • Sovaldi (sofosbuvir)
  • Vosevi (sofosbuvir, velpatasvir, voxilaprevir)

This is a list of drugs also used to treat hepatitis C. It is not a list of drugs recommended to take with Harvoni. In fact, you should not take these drugs together. Ask your pharmacist or a healthcare practitioner if you have questions.

Frequently Asked Questions

  • What is Harvoni used for?

    Harvoni is used to treat hepatitis C virus, an infectious liver disease that affects about 1% of the American population. The disease is passed between individuals most commonly via injection drug use and from an infected mother to a child.

  • How does Harvoni work?

    Harvoni works by inhibiting two different proteins in the hepatitis C virus that are essential for it to replicate and survive. Without these proteins, the amount of the virus in your blood decreases, with the goal of eventually being unable to detect the virus.

  • What are the side effects of Harvoni?

    The most common side effects of Harvoni include headache, fatigue, and weakness.

How Can I Stay Healthy While Taking Harvoni?

Hepatitis C is the most common illness in the United States caused by exposure to infected blood. A diagnosis of hepatitis C can sound scary and overwhelming, but the good news is that it can be cured. Treatments for hepatitis have come a long way over the last decade, requiring a fairly simple medication regimen without too many negative side effects.

Hepatitis C is considered cured when the virus is no longer detectable in your blood. This is also described as the RNA (viral) level being undetectable or having a sustained virologic response (SVR). Research has shown that people who maintain an SVR for 24 weeks after completing HCV therapy have about a 1% chance of experiencing a return of the virus.

It can be empowering to learn more about hepatitis and become an advocate for your health. Learn everything you can about the virus, its spread, and treatment options. When living with a condition like hepatitis, it’s also essential to prioritize your mental health. Exercising regularly, joining support groups, or seeking counseling if it feels necessary can all improve or maintain your mental well-being.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare professional. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

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