Precautions
For patients with both Hep C and HIV-1, the recommended HARVONI treatment regimen and length is the same as that for someone without HIV-1. Please refer to the charts on tabs 1 and 2 for treatment information for your specific genotype.
What is the recommended Harvoni treatment regimen for patients with HIV-1?
Harvoni is a brand-name prescription medication that’s used to treat hepatitis C. Harvoni contains two drugs: ledipasvir and sofosbuvir. It comes as a tablet that’s typically taken once daily for 12 weeks. Harvoni is a type of drug called a direct-acting antiviral (DAA).
What is Harvoni used to treat?
Subjects 3 Years to <6 Years of Age: Harvoni was evaluated in 34 subjects 3 years to <6 years of age with HCV genotype 1 (N = 33) or genotype 4 (N = 1) infection. All of the subjects were treatment-naïve and treated with Harvoni for 12 weeks.
How long is Harvoni used to treat human hepatocellular carcinoma?
Clinical and hepatic laboratory monitoring, as clinically indicated, is recommended for patients with decompensated cirrhosis receiving treatment with Harvoni and ribavirin [see Adverse Reactions (6.1)]. No specific antidote is available for overdose with Harvoni. If overdose occurs, the patient must be monitored for evidence of toxicity.
What is included in the monitoring of patients receiving Harvoni?
How do you 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 most commonly recommended treatment protocol for HCV?
Hepatitis C is treated using direct-acting antiviral (DAA) tablets. DAA tablets are the safest and most effective medicines for treating hepatitis C. They're highly effective at clearing the infection in more than 90% of people. The tablets are taken for 8 to 12 weeks.
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 cure hep C forever?
In most clinical studies for Harvoni, the success rate for curing hepatitis C was greater than 90 percent. This means that nearly all people who took Harvoni achieved a sustained virologic response (SVR). SVR means that they had no virus detected in their body 12 weeks or longer after treatment ended.
What is the newest treatment for hep C?
Recent advances in antiviral treatment have led to the development of new highly effective drugs for the treatment of all types of hepatitis C. The new hepatitis C treatments are sofosbuvir with ledipasvir (Harvoni); sofosbuvir (Sovaldi); daclatasvir (Daklinza); and ribavirin (Ibavyr).
What happens after hep C is cured?
After you clear your hep C (being cured) you won't have any immunity to protect you from catching it again. You can lower your risk of catching hep C again by avoiding blood-to-blood contact with other people.
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 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.
Does Harvoni affect your kidneys?
If you have mild kidney disease, you should be able to take Harvoni without any problems. Your doctor will likely prescribe the normal dosage for you. But if you have severe kidney disease, your body may not be able to process the drug well.
Can hep C go into remission?
The virus spreads mainly through intravenous drug use. Untreated hepatitis C can lead to serious liver problems, including cirrhosis and cancer. The good news is that the virus can go into remission with the right treatment. Doctors refer to remission as a sustained virological response (SVR).
Will I always test positive for hep C?
If you receive a positive hepatitis C antibody test it does not necessarily mean you are currently infected. Up to 20% of people clear the virus from their bodies naturally. This is called 'spontaneous clearance'. Although they have cleared the virus, tests will still show the presence of hepatitis C antibodies.
How long does it take for your liver to heal after hep C treatment?
If someone's liver has mild to moderate damage (fibrosis) and the hepatitis C virus is eliminated and no other liver damage effects are occurring, the liver can regenerate and heal within a few days up to 3-6 months, approximately.
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 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.
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 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 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 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).
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.
What is Harvoni a combination of?
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.
How old do you have to be to use Harvoni?
Harvoni is not approved for use by anyone younger than 3 years old.
What is the drug for hepatitis C?
The newest drugs for the treatment of hepatitis C include Mavyret (glecaprevir and pibrentasvir), Vosevi (sofosbuvir, velpatasvir, and voxilaprevir), and Epclusa (sofosbuvir and velpatasvir). All are FDA-approved for the treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A), as well as other uses. Continue reading
How long after taking antacids can you take Sofosbuvir?
If you also take an antacid: Wait at least 4 hours after taking the antacid before you take ledipasvir and sofosbuvir. If you also take a stomach acid reducer: You may need to wait 12 hours after taking the stomach acid medicine before you take ledipasvir and sofosbuvir.
Which is better, Mavyret or Harvoni?
Mavyret is reported to have some advantages over Harvoni including the number of hepatitis C virus (HCV) genotypes it covers, the length of treatment required, and the cost of a course of treatment. Continue reading
How long does it take to cure hepatitis C?
Over 90% of people infected with hepatitis C who have not received treatment can be cured with 8 to 12 weeks of oral medications, but treatment for hepatitis B, if needed, may be long-term or lifelong.
What are the conditions that can be treated with Sofosbuvir?
hepatitis B (you may be tested for this before you take sofosbuvir); liver problems other than hepatitis (including a liver transplant ); kidney disease (or if you are on dialysis); HIV or AIDS; a heart rhythm problem for which you take a medicine called amiodarone; or.
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.
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.
Does Harvoni increase digoxin?
Taking Harvoni with digoxin (Lanoxin) can increase the amount of digoxin in your body. Digoxin levels that are too high can lead to dangerous side effects.
Can Harvoni cause side effects?
Serious side effects from Harvoni aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.
What is Harvoni used for?
Harvoni is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) [see Dosage and Administration (2.2 and 2.3) and Clinical Studies (14)]: genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis.
How much Harvoni should I take?
Recommended Dosage in Adults. The recommended dosage of Harvoni in adults with genotype 1, 4, 5, or 6 HCV is one tablet (90 mg ledipasvir and 400 mg sofosbuvir) taken orally once daily with or without food [see Clinical Pharmacology (12.3)].
How many trials of Harvoni?
The efficacy and safety of Harvoni were evaluated in four trials in genotype 1 HCV mono-infected subjects including one trial exclusively in treatment-experienced subjects with compensated cirrhosis (Child-Pugh A); one trial in genotype 1 or 4 HCV/HIV-1 coinfected subjects; two trials in genotype 4, 5, or 6 HCV mono-infected subjects; two trials in genotype 1 or 4 HCV infected pretransplant subjects with decompensated cirrhosis (Child-Pugh B and C) or post-transplant with Metavir F0–F3 fibrosis, compensated cirrhosis, decompensated cirrhosis, or fibrosing cholestatic hepatitis (FCH); two trials in subjects with severe renal impairment (one of which included subjects requiring dialysis); and one trial in genotype 1 or 4 HCV pediatric subjects 3 years of age and older without cirrhosis or with compensated cirrhosis, as summarized in Table 10 [see Clinical Studies (14.2, 14.3, 14.4, 14.5, 14.6, and 14.7) ]:
What is the role of Ledipasvir in the replication of HCV?
Ledipasvir is an inhibitor of the HCV NS5A protein, which is required for viral replication. Resistance selection in cell culture and cross-resistance studies indicate ledipasvir targets NS5A as its mode of action.
How long does NS5A resistance-associated substitution persist?
NS5A resistance-associated substitutions for other NS5A inhibitors have been found to persist for >1 year in some patients. The long-term clinical impact of the emergence or persistence of virus containing ledipasvir or sofosbuvir resistance-associated substitutions is unknown.
What is the test for HBV?
Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with Harvoni [see Warnings and Precautions (5.1)].
Is Harvoni available as a tablet?
Harvoni is available as tablets or pellets for oral use . Each dosage form is available in two dose strengths.
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).
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 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 much does Harvoni cost?
For example, the heart medication amiodarone ( Pacerone, Cordarone) may not work well with it. Harvoni is expensive. The wholesale price is about $1,100 per pill.
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.
Testing Prior to the Initiation of Therapy
Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with HARVONI [see Warnings and Precautions (5.1)].
Recommended Dosage in Adults
The recommended dosage of HARVONI in adults with genotype 1, 4, 5, or 6 HCV is one tablet (90 mg ledipasvir and 400 mg sofosbuvir) taken orally once daily with or without food [see Clinical Pharmacology (12.3)].
How many patients are treated with Harvoni?
Harvoni treatment results in hepatitis C cures in roughly 95% to 99% of patients (95 to 99 out of every 100 patients). Your treatment regimen and length will vary according to your liver condition and whether or not you have received prior treatments. Most patients who have never had treatment, and without liver disease, ...
What is Harvoni used for?
Harvoni prevents 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. Harvoni comes as:
How much does Harvoni cost?
Harvoni is now available as an authorized generic option for the higher strength tablet, but can still run over $10,000 per month for the cash price. Prices may vary and you can print discount coupons here. The brand name price is over $32,000 per month.
How much cure rate for hepatitis C?
The hepatitis C franchise has been a strong money-maker for pharma, particularly with the advent of the all-oral, direct-acting antivirals that boast cure rates of up to 99%.
What is the treatment for chronic hepatitis C?
Many treatments for chronic hepatitis C virus (HCV) -- the blood-borne infectious disease that can lead to: chronic liver disease. liver inflammation and scarring. liver cancer. eventual liver transplant. have been the focus of ongoing research.
How long does it take to get rid of HCV?
Today, oral treatment regimens aim to be more tolerable, interferon-free, and with shorter treatment times -- some as short as 8 to 12 weeks. But how are these drugs used?
What do you need to know before you can be treated for HCV?
Before you can be treated for HCV, you'll need to know your genotype. A genotype is a particular gene set carried by an individual.
Medical uses
This medication is a combination of ledipasvir and sofosbuvir and is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It may sometimes be used with another antiviral medication (ribavirin).
May Treat: Chronic hepatitis C - genotype 1 · Chronic hepatitis C - genotype 4 · Chronic hepatitis C - genotype 5 · Chronic hepatitis C - genotype 6
Drug Class: Hepatitis C - NS5B Polymerase and NS5A Inhibitor Combinations
Availability: Prescription Required
Pregnancy: Consult a doctor before using
Lactation: Consult a doctor before using
May Treat: Chronic hepatitis C - genotype 1 · Chronic hepatitis C - genotype 4 · Chronic hepatitis C - genotype 5 · Chronic hepatitis C - genotype 6
Drug Class: Hepatitis C - NS5B Polymerase and NS5A Inhibitor Combinations
Availability: Prescription Required
Pregnancy: Consult a doctor before using
Lactation: Consult a doctor before using
Alcohol: Limit intake while taking this medication
Driving: May cause drowsiness or dizziness. Use caution
Manufacturer: GILEAD SCIENCES
- If available, read the patient package insert
- Take at the same time(s) daily as directed
- Take 4 hours before or 4 hours after antacids
- If available, read the patient package insert
- Take at the same time(s) daily as directed
- Take 4 hours before or 4 hours after antacids
- Lab tests may be ordered to monitor therapy
- Review all drugs you are taking with your doctor
- Can still spread virus to other people.
- May make diabetics more prone to low blood sugar
- For pellets in packet products : Store at room temperature Protect from moisture.
- For tablet products : Store tightly closed in the original container.
Contraindications
Administration
Prognosis
Treatment
Description
- Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with Harvoni [see Warnings and Precautions (5.1)]. No dosage recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] less than 30 …
Clinical significance
- The recommended dosage of Harvoni is one tablet (90 mg ledipasvir and 400 mg sofosbuvir) taken orally once daily with or without food [see Clinical Pharmacology (12.3)].
Pathophysiology
- Relapse rates are affected by baseline host and viral factors and differ between treatment durations for certain subgroups [see Clinical Studies (14)].
Management
- Table 1 shows the recommended Harvoni treatment regimen and duration based on patient population. Coadministration of amiodarone with Harvoni is not recommended. For patients taking amiodarone who have no other alternative, viable treatment options and who will be coadministered Harvoni: Patients who are taking Harvoni who need to start amiodarone therapy …
Side effects
- Harvoni is available as an orange colored, diamond shaped, film-coated tablet debossed with \"GSI\" on one side and \"7985\" on the other side of the tablet. Each tablet contains 90 mg ledipasvir and 400 mg sofosbuvir.
Symptoms
- Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive and also in patients wi…
Interactions
- HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level. In patients with resolved HBV infection, reappearance of HBsAg can occur. Reactivation of HBV replication may be accompanied by hepatitis, i.e., increases in aminotransferase levels and, in severe cases, increases in bilirubin levels, liver failure, and deat…
Results
- Test all patients for evidence of current or prior HBV infection by measuring HBsAg and anti-HBc before initiating HCV treatment with Harvoni. In patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV treatment with Harvoni and during post-treatment follow-up. Initiate appropriate patient manage…
Adverse effects
- Postmarketing cases of symptomatic bradycardia, as well as fatal cardiac arrest and cases requiring pacemaker intervention, have been reported when amiodarone is coadministered with Harvoni. Bradycardia has generally occurred within hours to days, but cases have been observed up to 2 weeks after initiating HCV treatment. Patients also taking beta blockers, or those with un…
Safety
- Patients who develop signs or symptoms of bradycardia should seek medical evaluation immediately. Symptoms may include near-fainting or fainting, dizziness or lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pains, confusion or memory problems [see Adverse Reactions (6.2), Drug Interactions (7.2)].