Drug Label Information
| Adult Patient Population | Regimen and Duration | |
| Genotype 1 | Treatment-naïve without cirrhosis or wit ... | HARVONI 12 weeks |
| Genotype 1 | Treatment-experienced without cirrhosis | HARVONI 12 weeks |
| Genotype 1 | Treatment-experienced with compensated c ... | HARVONI 24 weeks |
| Genotype 1 | Treatment-naïve and treatment-experience ... | HARVONI + ribavirin 12 weeks |
What is the success rate of Harvoni treatment?
Mar 21, 2022 · ION I Trial 18. This phase 3, open-label, multicenter, randomized trial included treatment-naïve patients with chronic HCV genotype 1 infection. The 865 patients were randomized in a 1:1:1:1 ratio into one of four treatment arms: ledipasvir/sofosbuvir for 12 weeks, ledipasvir/sofosbuvir plus ribavirin for 12 weeks, ledipasvir/sofosbuvir for 24 weeks, or …
How effective is Harvoni for hepatitis C?
Jun 28, 2021 · The safety, pharmacokinetics, and efficacy of HARVONI for treatment of HCV genotype 1 and 4 infection in treatment-naïve and treatment-experienced pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis have been established in an open-label, multicenter clinical trial (Study 1116, N=226; 186 treatment ...
How many doses are in a Harvoni tablet?
Jun 14, 2021 · 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, will only have to take ...
What are the effects of Harvoni on decompensated cirrhosis?
Nov 05, 2015 · Patients will be reviewed at monthly intervals as per standard of care. At each clinic visit, patients with have blood tests including complete blood count, renal function, electrolytes, liver enzyme and liver function tests, HCV RNA will be done at week 4, week 12, week 24 during treatment, and then again at week 12 post completion of treatment.
What is the success rate of Harvoni?
The cure rate for Harvoni is 94% to 99% when you don't have other serious illnesses. Harvoni might not work as well if: You have advanced liver disease. Your liver has some scarring (fibrosis).May 30, 2020
How many people have been treated for HCV?
In 2014, 109,110 people were treated; in 2015, 164,247 people were treated; in 2016, 134,287 people were treated; in 2017, 114,419 people were treated; in 2018, 122,666 people were treated; in 2019, 114,893 people were treated; in 2020, 83,740 people were treated.Nov 8, 2021
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.
What is the success rate of hep C treatment?
How likely is it that the treatment will cure my hepatitis C virus? Hepatitis C treatment regimens have extremely high success rates. There is roughly a 95 percent cure (SVR) rate overall.
Can a woman get hep C from a man?
The hepatitis C virus is unlikely to be spread through sex. Still, some sexual activities do increase the risk.Sep 16, 2019
Which hepatitis is not curable?
How to prevent hepatitis B. Hepatitis B is a liver infection caused by a virus (called the hepatitis B virus, or HBV). It can be serious and there's no cure, but the good news is it's easy to prevent.
Do hep C antibodies ever go away?
After a successful course of treatment for hepatitis C, the hepatitis C antibody remains detectable, but the hepatitis C RNA will be undetectable. If you plan to donate blood, you will be tested for the hepatitis C antibody and will be turned away even if you do not have an active infection.
Can the liver repair itself after hepatitis?
Reversing liver damage Liver Basics Barring complications, the liver can repair itself completely and, within a month, the patient will show no signs of damage. However, sometimes the liver gets overwhelmed and can't repair itself completely, especially if it's still under attack from a virus, drug, or alcohol.Aug 26, 2019
Will you always test positive for hep C?
A reactive or positive antibody test means you have been infected with the hepatitis C virus at some point in time. Once people have been infected, they will always have antibodies in their blood. This is true if they have cleared the virus, have been cured, or still have the virus in their blood.
Is hep C curable 2021?
Today, chronic HCV is usually curable with oral medications taken every day for two to six months. Still, about half of people with HCV don't know they're infected, mainly because they have no symptoms, which can take decades to appear.Aug 31, 2021
Which is better Epclusa vs Harvoni?
Which is more effective: Epclusa or Harvoni? Although both Epclusa and Harvoni are effective for treating hepatitis C, Epclusa may cure a greater percentage of people than Harvoni does. Epclusa was approved in 2016 and was the first medication approved that was effective at treating all six hepatitis C genotypes.May 11, 2020
What is the best hep C treatment?
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.
What is the drug Harvoni?
HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C virus (HCV ) in adults and pediatric patients 3 years of age and older:
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.
Can you take Harvoni with food?
HARVONI oral pellets can be taken right in the mouth without chewing, or with food. If HARVONI pellets are taken with food, sprinkle the pellets on one or more spoonfuls of non-acidic soft food at or below room temperature. Examples of non-acidic foods include pudding, chocolate syrup, mashed potato, and ice cream.
What is genotype 1?
genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin. genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin. Close. 2 DOSAGE AND ADMINISTRATION.
Can amiodarone cause bradycardia?
Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone with HARVONI is not recommended.
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 often should I take Harvoni?
Harvoni Dosing and Side Effects. Harvoni is given by mouth once daily with or without food. It's best to get in a routine and take it the same time every day. Don't change your dose or stop taking your medicine unless directed to do so by your doctor.
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:
What is genotype 1?
genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis. genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin. genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin.
How many genotypes are there for HCV?
There are six different genotype classifications for HCV, and at least 50 subtypes, based on the genetic material in the RNA. Generally, patients are only infected with one genotype, but genotypes can mutate quickly and become drug resistant.
Is Epclusa a polymerase inhibitor?
Epclusa is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination that treats all major HCV genotypes 1 through 6 without cirrhosis or with compensated cirrhosis OR with decompensated cirrhosis for use in combination with ribavirin. It is approved for adults and children 3 years of age and older. Dosing in children is weight based. It is also used in patients with HCV/HIV-1 coinfection.
Is HCV covered by insurance?
The Harvoni manufacturer Gilead may be able to offer copay coupons or other assistance to patients who cannot afford their medication. In addition, many HCV treatments are covered by insurance or Medicare.
What is Harvoni used for?
Harvoni is a combination of two direct-acting antivirals (ledipasvir and sofosbuvir) that prevents the hepatitis C virus from copying and multiplying themselves, allowing the body to clear the virus from their systems and be cured of HCV infection.
How effective is HCV treatment?
There are now several licensed drug treatments for patients with HCV infection. These medications have been shown to be very effective in getting rid of the virus in patients with HCV infection including those with early stages of cirrhosis without complications known as compensated cirrhosis, with a greater than 90% cure rate.
What is the most common cause of liver cirrhosis?
Hepatitis C virus (HCV) is one of the most common causes of liver cirrhosis worldwide. The progression of liver cirrhosis can lead to a myriad of complications including ascites, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, and hepatocellular carcinoma.
Does cirrhosis improve survival?
However, patients with decompensated cirrhosis due to hepatitis B infection who received effective anti-viral therapy not only improved their overall clinical status, many of these patients reverted from a decompensated to a compensated state, associated with improved survival.
Can cirrhosis be decompensated?
With a >90% cure rate, many patients with compensated cirrhosis, once treated, will not progress further to develop decompensation. With the passage of time, the liver cirrhosis may even regress to a non-cirrhotic state. Published data on treatment of decompensated cirrhosis with hepatitis C infection is still scanty.
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 Harvoni used for?
1. Indications and Usage. 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.
What is genotype 1?
genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin. genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin. 2. Dosage and Administration.
Does Harvoni decrease ledipasvir?
The concomitant use of HARVONI and P-gp inducers may significantly decrease ledipasvir and sofosbuvir plasma concentrations and may lead to a reduced therapeutic effect of HARVONI. Therefore, the use of HARVONI with P-gp inducers (e.g., rifampin, St. John's wort) is not recommended [see Drug Interactions (7.2)].
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.
Is Harvoni contraindicated for pregnant women?
If HARVONI is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. Refer to the ribavirin prescribing information for more information on ribavirin-associated risks of use during pregnancy.
What is ION 4?
ION-4 was an open-label clinical trial that evaluated the safety and efficacy of 12 weeks of treatment with HARVONI without ribavirin in HCV treatment-naïve and previously treated adult subjects with genotype 1 or 4 HCV infection who were coinfected with HIV-1 . Treatment-experienced subjects had failed prior treatment with Peg-IFN + ribavirin, Peg-IFN + ribavirin + an HCV protease inhibitor, or sofosbuvir + ribavirin. Subjects were on a stable HIV-1 antiretroviral therapy that included emtricitabine + tenofovir disoproxil fumarate, administered with efavirenz, rilpivirine, or raltegravir.
What are the side effects of Harvoni?
Harvoni side effects. Get emergency medical help if you have signs of an allergic reaction to Harvoni: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have new or worsening symptoms such as: jaundice (yellowing of the skin or eyes), and not feeling well.
What is Harvoni used for?
Harvoni is used to treat chronic hepatitis C in adults and children who are at least 3 years old. Harvoni is sometimes given in combination with another medicine called ribavirin . Harvoni treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you.
What are the new drugs for hepatitis C?
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), and Epclusa (sofosbuvir and velpatasvir).
Can you chew a pellet?
Do not chew the oral pellets. To take with food, you may mix the pellets with a non-acidic soft food (pudding, chocolate syrup, mashed potato, ice cream) that is at room temperature or below. Swallow the mixture without chewing, no more than 30 minutes after mixing. Do not save the mixture for later use.
Can you have both hepatitis B and C?
Hepatitis B and C are different viruses, but you can have both hepatitis B and hepatitis C at the same time. 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.
Can Harvoni be used with ribavirin?
Harvoni is sometimes used in combination with ribavirin. Both men and women using ribavirin should use effective birth control to prevent pregnancy. Ribavirin can harm an unborn baby or cause birth defects if the mother or father is using the medicine.
How long does it take for hepatitis C to cure?
Previous drug treatments for hepatitis C took longer and had lower cure rates. On average, treatment took two to four months with a cure rate of 50 to 80 percent. Harvoni cures 93 to 100 percent of patients in just 12 weeks. Harvoni causes few side effects compared with previous drugs.
How to tell if you are taking a med?
Bradycardia typically occurs up to two weeks after you start taking these drugs together. It can cause multiple symptoms because a slow heart rate can prevent your body from getting the oxygen it needs. These symptoms can include: 1 feeling like you’re going to faint, or actually fainting 2 lightheadedness 3 tiredness 4 weakness 5 shortness of breath 6 chest pains 7 confusion or memory problems
Does Harvoni make you tired?
One of the main side effects of Harvoni is tiredness. This tends to increase the longer you take the drug. Tiredness may be related to an interaction with other drugs that can slow your heart rate. If you feel tired while taking Harvoni, talk with your doctor about how you can increase your energy level.
Does Harvoni cause headaches?
Some people have headaches when they take Harvoni. This side effect generally gets worse the longer you take the drug. If you have headaches during your Harvoni treatment, ask your doctor about ways to increase your comfort. For a small number of people, Harvoni causes insomnia (trouble sleeping).
Does Harvoni cause stomach problems?
Digestive system. Like many drugs, Harvoni can cause some stomach problems. A small number of patients have reported nausea and diarrhea while taking the drug. Like some other side effects, these tend to get a little worse the longer you take the drug.
Can you take Harvoni if you have kidney disease?
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. This could lead to increased amounts of the drug in your body, and increased risk of side effects.
Can you take Harvoni while pregnant?
You should take Harvoni only if the potential benefits outweigh the risks to your pregnancy. Talk with your doctor about your health and how this drug could affect your pregnancy. If you decide to have treatment while pregnant, you may be able to enroll in a pregnancy registry.