Sara is a clinical pharmacist that believes everyone should understand their medications, and aims to achieve this through her writing.
Erika Prouty, PharmD, is a professional community pharmacist who aids patients in medication management and pharmacy services in North Adams, Massachusetts.
Risk of hepatitis B virus reactivation in people coinfected with HCV and HBV. Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death.
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.
Generic Name: Ledipasvir and sofosbuvir
Active Ingredient: Ledipasvir and sofosbuvir
Dosage Form: Tablet, oral pellets
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.
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.
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.
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).
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 when taking Harvoni include:
Potential side effects of Harvoni that were rarer in clinical trials but potentially more severe include:
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.
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.
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).
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.
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.
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.
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.
Harvoni has been established as safe and effective in treating hepatitis C in children 3 years of age and older.
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.
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.
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.
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.
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.
Your healthcare provider may not prescribe Harvoni for you if you:
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:
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:
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.
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.
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.
The most common side effects of Harvoni include headache, fatigue, and weakness.
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.
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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Food and Drug Administration. Harvoni (ledipasvir/sofosbuvir) package insert.
Centers for Disease Control and Prevention. Hepatitis C questions and answers for health professionals.
Simmons B, Saleem J, Hill A, Riley RD, Cooke GS. Risk of late relapse or reinfection with hepatitis C virus after achieving a sustained virological response: A systematic review and meta-analysis. Clin Infect Dis. 2016;62(6):683-694.
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