Precautions
What is Harvoni? Harvoni contains a combination of ledipasvir and sofosbuvir. Ledipasvir and sofosbuvir are antiviral medications that prevent the hepatitis C virus (HCV) from multiplying in your body. Harvoni is used to treat chronic hepatitis C in adults and children who are at least 3 years old.
What is Harvoni used for?
Length of treatment with HARVONI. Most patient types are recommended to receive 12 weeks of treatment, although 8 or 24 weeks may also be prescribed. Your Hep C Specialist will determine your treatment regimen and length based on your individual case.
What is the length of treatment with Harvoni?
The U.S. Food and Drug Administration approved Harvoni in 2014. In studies, Harvoni has been shown to be up to 99 percent effective. A typical course of treatment lasts 12 weeks. Hepatitis C is a potentially life-threatening disease of the liver.
How effective is Harvoni for hepatitis C?
In the United States, Harvoni is approved for HIV-negative and HIV-positive people with hepatitis C genotypes 1, 4, 5, and 6 who are over 18 years old. Harvoni is also approved for people with HCV genotype 1 who have advanced (called decompensated) cirrhosis, and for liver transplant recipients who have HCV genotype 1 or 4.
Is Harvoni approved in the United States?
What does Harvoni do to your body?
Harvoni prevents the hepatitis C virus (HCV) from multiplying in the body. It is a single combination pill that is given by mouth once a day for 8, 12, or 24 weeks, depending upon your HCV status.
Does Harvoni completely cure hep C?
HARVONI transformed hepatitis C (Hep C) treatment as the first cure that's one pill, once a day for the majority of patients. Cure means the Hep C virus is not detected in the blood when measured 3 months after treatment is completed.
How long do you take Harvoni for?
How is Harvoni used? Harvoni is taken once daily, with or without food, for 8 to 24 weeks. Treatment length depends on HCV treatment history, whether a person has cirrhosis, and the amount of hepatitis C virus in a person's bloodstream (called HCV RNA or viral load).
Does Harvoni have any side effects?
Tiredness, headache, nausea, diarrhea, or difficulty sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects.
Can hep C come back after Harvoni treatment?
It's possible, but rare, for hepatitis C infection to reappear after apparently successful treatment. Relapses usually occur in the first few months after blood testing to confirm that the virus is no longer detectable.
Does Harvoni cure liver cirrhosis?
Harvoni is used to treat people with HCV genotypes 1, 4, 5, and 6. Harvoni has been shown to cure up to 99 percent of people (without cirrhosis) who take it for 12 weeks.
How much is Harvoni per pill?
Meet Harvoni, which launched in October and costs $1,125 per pill, or $94,500 for a 12-week course of treatment. The drug comes from Gilead Sciences, which earlier this year broke records with $2.3 billion in first quarter sales of Sovaldi.
Does Harvoni make you gain weight?
Weight gain has not been reported as a side effect of Harvoni in clinical trials. However, some individuals on blog posts report gaining weight (from two to 12 pounds); however, this was temporary and easily lost once treatment with Harvoni finished.
What is the price of Harvoni?
Harvoni costs $94,500 for a 12-week treatment. Mavyret costs $39,600 for a 12-week treatment.
Does Harvoni cause kidney damage?
Rarely, it can cause nausea, diarrhea and insomnia. We describe a case of cirrhosis of liver secondary to HCV and alcohol. The patient received Harvoni but 4 weeks after receiving Harvoni he became extremely fatigued and developed acute renal failure with elevated transaminases.
Can you drink alcohol on Harvoni?
Can you drink alcohol while taking Harvoni? The answer from several leading organizations is: no. You should not drink alcohol while taking this drug. The HCV Advocate is a nonprofit support group that offers advice for hepatitis C patients.
What is the generic name for Harvoni?
HARVONI is a fixed-dose combination tablet containing ledipasvir and sofosbuvir for oral administration. Ledipasvir is an HCV NS5A inhibitor and sofosbuvir is a nucleotide analog inhibitor of HCV NS5B polymerase.
What is the difference between hepatitis B and C?
Some of the main differences between hepatitis B and C are: Hepatitis B virus can be prevented with a vaccine, but not hepatitis C. Hepatitis B and...
Is Mavyret better than Harvoni?
Mavyret is reported to have some advantages over Harvoni including the number of hepatitis C virus (HCV) genotypes it covers, the length of treatme...
What are the new drugs for the treatment of hepatitis C?
The newest drugs for the treatment of hepatitis C include Mavyret (glecaprevir and pibrentasvir), Vosevi (sofosbuvir, velpatasvir, and voxilaprevir...
Do I need to follow a special diet while taking Harvoni?
No, there is no special diet required while you take Harvoni. However, if you experience nausea or stomach pain as a side effect of Harvoni, it may...
How long will Harvoni take to get rid of my hepatitis C?
Harvoni will start working right away to fight the virus. However, in order to get rid of hepatitis C, you will need to take Harvoni for the full l...
What is the cure rate for Harvoni?
The cure rate for Harvoni depends on certain aspects of your hepatitis C. This includes whether or not you have cirrhosis, what hepatitis C treatme...
Can hepatitis C come back after taking Harvoni?
If you take Harvoni every day as directed by your doctor and you maintain a healthy lifestyle, the virus shouldn’t return. However, it’s possible t...
What is a hepatitis C genotype?
There are six different strains, or types, of hepatitis C viruses that are known to infect people. These strains are called genotypes. Genotypes ar...
What is Harvoni used for?
Harvoni is FDA-approved to treat hepatitis C in adults with genotypes 1, 4, 5, or 6. It can also be used to treat children with these genotypes who are aged 12 and up or who weigh at least 77 pounds.
Why is it important to take Harvoni?
This is because following your treatment plan increases your chances of curing your hepatitis C (HCV). It also helps reduce your risk of the long-term effects of HCV, which include cirrhosis and liver cancer.
How long does it take for Harvoni to go away?
Most of these side effects may go away within a few days or a couple of weeks.
Is Harvoni the same as Zepatier?
Harvoni and Zepatier are similar medications and their effects on the body are alike. Therefore, they cause many of the same side effects. Below are some examples of their side effects.
Does Sovaldi have side effects?
Because of this, the side effects seen with Sovaldi treatment depend on the drug it’s used with. Common and serious side effects for Harvoni and Sovaldi are shown below. The Sovaldi side effects described are seen when Sovaldi is used with other hepatitis C drugs such as ribavirin and pegylated interferon.
Is Epclusa the same as Harvoni?
Harvoni and Epclusa are both drugs called direct-acting antivirals and have similar effects in the body. Because of this, they cause many of the same side effects. Below are some examples of these side effects.
Can interferons be used for hepatitis C?
For these reasons, today interferons aren’t typically used to treat hepatitis C.
How does Harvoni work?
The hepatitis C virus spreads most commonly through needles shared by drug users, but sexual contact can also pass it on. Harvoni is a combination of two drugs. Each one blocks a protein that the hep c virus needs in order to grow: Ledipasvir blocks a protein called NS5A.
What is the cure rate for Harvoni?
It means there is no virus in your blood 12 weeks after your treatment is over. The cure rate for Harvoni is 94% to 99% when you don’t have other serious illnesses. You have advanced liver disease. Your liver has some scarring (fibrosis).
What is Harvoni hep C?
Risks and Side Effects. Cost. Ledipasvir-sofosbuvir ( Harvoni) is an antiviral medication that attacks the hepatitis C virus. It's one of the most effective treatments for hep C.
How long does Harvoni last?
Harvoni is a pill you take once a day for 2 to 6 months. How long you'll take it depends on how much of the virus is in your blood (your doctor might call it your viral load), as well as: Talk to your doctor if you have any questions about how to take your medications.
Does insurance cover Harvoni?
Check with your provider to be sure. If your insurance doesn't cover your prescription, there are groups that may be able to provide Harvoni for little or no charge. Other discounts may also apply.
Does Harvoni work with Moderiba?
In some treatment plans, Harvoni may team with another drug called ribavirin ( Moderiba). The majority of those who take Harvoni don’t have side effects. But some people have headaches or get more tired than usual. Tell your doctor if you have hepatitis B because it can flare up or reactivate if you take Harvoni.
How often should I take Harvoni?
Take HARVONI 1 time each day and at the same time each day. Take HARVONI with or without food. It is important that you do not miss or skip doses of HARVONI during treatment. If you take too much HARVONI, call your healthcare provider or go to the nearest hospital emergency room right away.
What is the name of the drug that is used to treat hepatitis C?
HARVONI gives you what you need. HARVONI transformed hepatitis C (Hep C) treatment as the first cure that’s one pill, once a day for the majority of patients. Cure means the Hep C virus is not detected in the blood when measured 3 months after treatment is completed. HARVONI is a prescription medicine used to treat adults with chronic hepatitis C ...
Can you take ribavirin with harvoni?
If you take HARVONI with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.
Can you change your dose of Harvoni?
Do not change your dose unless your healthcare provider tells you to. Do not stop taking HARVONI without first talking with your healthcare provider. If you think there is a reason to stop taking HARVONI, talk to your healthcare provider before doing so. Take HARVONI 1 time each day and at the same time each day.
What is Harvoni for?
What is Harvoni? Harvoni is two HCV-fighting drugs (sofosbuvir and ledipasvir) in one pill. In the United States, Harvoni is approved for HIV-negative and HIV-positive people with hepatitis C genotypes 1, 4, 5, and 6 who are over 18 years old. Harvoni is also approved for people with HCV genotype 1 who have advanced (called decompensated) ...
How long does Harvoni last?
Harvoni is taken once daily, with or without food, for 8 to 24 weeks. Treatment length depends on HCV treatment history, whether a person has cirrhosis, and the amount of hepatitis C virus in a person’s bloodstream (called HCV RNA or viral load ). Some people will need to add another drug, called ribavirin (RBV), twice daily with Harvoni.
How long does HCV resistance last?
Most people who are not cured have resistance to one or more of the HCV drugs they’ve taken. Resistance to certain hepatitis C drugs can disappear within months. But resistance to certain drugs, including Harvoni, can last for years and may limit re-treatment options.
How long does ribavirin stay in your system?
Ribavirin stays in a person’s body for months. Women and their male partners should avoid pregnancy for six months after they have stopped taking ribavirin. Using two forms of birth control to prevent pregnancy while taking ribavirin—and for six months afterwards—is recommended.
Can Harvoni be used with HIV?
Yes. In clinical trial of 335 HIV/HCV-coinfected people, 321 (96%) were cured after 12 weeks of Harvoni. Harvoni cannot be used with certain HIV drugs (see Harvoni and other medications, below).
What is support path for harvoni?
The criteria differ depending on the type of coverage and the state it is issued in. Support Path is Gilead’s patient assistance program for Harvoni. People with private insurance may be eligible for assistance with copayments. Uninsured people may be eligible for medication at no charge. Information about Support Path is available online at: http://www.gilead.com/responsibility/us-patientaccess/ support%20path%20for%20sovaldi%20and%20harvoni. Information about Support Path is also available by phone at 1.855.769.7284, Monday through Friday between 9:00 a.m. and 8:00 p.m. (Eastern Time), or online at: https://www.harvoni.com/support.
Can Harvoni be used in pregnancy?
Harvoni is under study in children (ages 3 to 18). Ribavirin causes birth defects, and it can be fatal to unborn babies. Ribavirin should not be used by pregnant women, or by male partners of pregnant women. Ribavirin stays in a person’s body for months.
How effective is Harvoni?
What Harvoni Means for Hepatitis C Treatment 1 The U.S. Food and Drug Administration approved Harvoni in 2014. 2 In studies, Harvoni has been shown to be up to 99 percent effective. 3 A typical course of treatment lasts 12 weeks.
How long does Harvoni last?
Harvoni has been shown to cure up to 99 percent. Trusted Source. of people (without cirrhosis) who take it for 12 weeks.
What is the genotype of HCV?
A genotype is the particular strain of a virus. HCV strains include genotypes 1, 2, 3, 4, 5, and 6. Genotype 1 is the most common in the United States. These new drugs, called direct-acting antivirals (DAAs), can directly attack HCV and prevent the virus from replicating.
How long does it take for Harvoni to clear your system?
Harvoni is proving to be an expensive but effective drug. If it’s taken correctly, this medication can clear the virus from your system in as little as 12 weeks. If you’ve been diagnosed with HCV, you should discuss your treatment options with your doctor as soon as possible.
How long does it take to take Harvoni?
Harvoni is an oral tablet that’s taken once per day, with or without food. A typical course of Harvoni treatment takes 12 weeks. For some people who’ve never been treated for HCV before, 8 weeks of treatment might be enough. For people with cirrhosis of the liver, treatment may last 24 weeks.
When was Harvoni approved?
Approval of Harvoni. The FDA approved Harvoni in 2014. Harvoni was the first combination pill that allowed people with genotype 1 to follow an all-oral medication regimen. Harvoni is a combination pill made up of the drugs ledipasvir and sofosbuvir.
When will Harvoni be available for generic?
Your doctor or pharmacist may also know of other programs to help cover the cost of treatment. A generic version of Harvoni is coming out in 2019.
What is the HARVONI med?
HARVONI is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype (GT) 1, 4, 5 or 6 infection with or without cirrhosis (compensated).
How to contact the FDA about Harvoni?
Visit www.fda.gov/medwatchor call 1-800-FDA-1088. Please see Important Facts about HARVONI including Important Warning. Tap for Use and Important Safety Information about HARVONI including Important Warning on hepatitis B reactivation. Now may be the time to .
Can amiodarone cause slow heart rate?
Slow heart rate (bradycardia):HARVONI, when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause slow heart rate, which in some cases has led to death or the need for a pacemaker.
Is Harvoni used with ribavirin?
In those with GT 1 and advanced cirrhosis (decompensated) or with GT 1 or 4 with or without cirrhosis (compensated) who have had a liver transplant, HARVONI is used with ribavirin. Important Safety Information.
What is Harvoni?
Harvoni is a prescription medicine used to treat adults and children 3 years of age and older with chronic (lasting a long time) hepatitis C virus (HCV):
What is the most important information I should know about Harvoni?
Important: If you take Harvoni with ribavirin, you should also read the Medication Guide for ribavirin.
What should I tell my healthcare provider before taking Harvoni?
Before taking Harvoni, tell your healthcare provider about all of your medical conditions, including if you:
How should I take Harvoni?
Take Harvoni exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to.
How should I give Harvoni oral pellets to my child?
Administer Harvoni oral pellets exactly as instructed by your healthcare provider.
General information about the safe and effective use of Harvoni
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Harvoni for a condition for which it was not prescribed. Do not give Harvoni to other people, even if they have the same symptoms you have. It may harm them.
What are the ingredients in Harvoni?
Tablets: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.