Risks And Side Effects
The majority of those who take Harvoni donât have side effects. But some people have headaches or get more tired than usual.
Other rare side effects include:
Tell your doctor if you have hepatitis B because it can flare up or reactivate if you take Harvoni. They’ll likely test you for this before you start on the drug. Tell your doctor about any medications you take because they could affect how well Harvoni works for you and even if it’s safe for you to take. For example, the heart medication amiodarone may not work well with it.
Financial And Insurance Assistance
If you need financial support to pay for Harvoni, or if you need assistance understanding your insurance coverage, help is available.
Gilead Sciences, Inc., the manufacturer of Harvoni, offers a program called Harvoni Support Path. For more information and to find out if youre eligible for support, call 855-769-7284 or visit the program website.
The Food and Drug Administration approves prescription drugs such as Harvoni to treat certain conditions.
Harvoni is FDA-approved for treating hepatitis C virus . Harvoni can be prescribed for:
- Adults and children who:
- have HCV genotype 1, 4, 5, or 6. Genotypes are different strains, or types, of the virus.
- have or dont have compensated cirrhosis. Cirrhosis is serious scarring in the liver that prevents it from working properly. Compensated cirrhosis is cirrhosis that generally doesnt cause symptoms.
This table illustrates who is eligible for Harvoni treatment:
| Genotype 1 |
Harvoni A Hepatitis C Drug From Gilead Wins Fda Approval
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The first complete treatment for hepatitis C that requires taking only a once-a-day pill won approval Friday from the Food and Drug Administration.
The drug, called Harvoni from Gilead Sciences, could shorten the duration of treatment and provide the first all-oral regimen for many patients.
The new drug also appears to be a bit less expensive for some patients than Gileads existing blockbuster hepatitis C drug, Sovaldi, which has become the poster child for those complaining that the cost of medicines is out of control.
Sovaldi costs $1,000 a pill, or $84,000 for a typical 12-week course of treatment, but it must be used with other drugs. Harvoni is even more expensive at $1,125 a pill, or $94,500 for a 12-week course of treatment. But that is roughly in line with the total cost for Sovaldi and the drugs used with it. Many patients will be able to take Harvoni for only eight weeks, at a cost of about $63,000.
This will probably not mollify insurance companies and Medicaid programs, many of which are restricting the use of Sovaldi to the most seriously ill patients.
He said the patients eligible for the shorter regimen are also the ones least in need of treatment.
But some patient advocates hope the pricing will persuade payers to relax their restrictions.
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Which Drugs Or Supplements Interact With Harvoni
Acid reducing agents which are commonly used to treat heartburn, indigestion, and GERD may decrease the effectiveness of Harvoni treatment by decreasing blood levels of ledipasvir. Examples of acid reducing agents include antacids, histamine 2 receptor antagonists, for example, famotidine , and proton pump inhibitors , for example, omeprazole .
Antacid and Harvoni administration should be separated by 4 hours. Doses of histamine 2 receptor antagonists equivalent to famotidine 40 mg twice daily or less and doses of proton pump inhibitors equivalent to 20 mg of omeprazole or lower may be given at the same time as Harvoni.
Co-administration of Harvoni and amiodarone is not recommended because the combination may cause serious heart-related side effects including symptomatic bradycardia.
Anti-seizure medications including carbamazepine , phenytoin , phenobarbital , and oxcarbazepine may increase the breakdown of Harvoni, leading to reduced therapeutic effectiveness.
Taking St. John’s Wort or rifampin with Harvoni may also reduce the effectiveness of treatment and is not recommended.
Certain medication used to treat tuberculosis infection may decrease the effectiveness of Harvoni treatment. Patients taking rifampin, rifabutin, or rifapentine should consult with their doctor or pharmacist before starting Harvoni.
Hcv: Show Me The Money
There’s no question that Harvoni is a blockbuster drug. In fact, all of the new HCV oral agents are very expensive, and usually out of reach for patients without adequate insurance. If you are not able to afford your medications, be sure to contact the manufacturer and ask about any available Patient Assistance Programs.
It may be worthwhile to check with your health insurance before you and your doctor decide upon Harvoni as your treatment of choice to be sure it is a preferred regimen. Most insurance plans and Medicare are now inlcuding oral direct-acting HCV agents on their formulary .
Millions of people worldwide are still untreated or undiagnosed for HCV, with a need to be cured. These drugs are important to bring a cure to HCV, but they must be financially accessible, as well.
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Pharmacist Tips For Harvoni
Make sure you take your prescribed dose every day at the same time with or without food. Make sure you continue to take the medication until your provider instructs you to stop.
If you happen to be hospitalized during your course of heptitis C treatment, make sure you bring your antiviral medications with you to the hospital. Most hospitals do not have hepatitis C medications in stock because they are expensive. They have procedures in place to administer your home medications so that your treatment will not be interupted.
Tell your hepatitis C provider about all the medications you are taking. Harvoni interacts with a lot of common medications like famotidine , omeprazole , cholesterol-lowering statins, and HIV antiretrovirals. The interacting medications may need their dose lowered or scheduled around your Harvoni dose.
Headaches are a common side effect. You can use over-the-counter acetaminophen to treat them, but be sure to take less than 2000 mg a day to prevent liver damage. NSAIDs like ibuprofen and naproxen are not recommended in people with severe liver problems.
Do not chew the oral pellets. They can either be taken directly from the packet or sprinkled on non-acidic soft food. Non-acidic soft food include: pudding, chocolate syrup, mashed potatoes, and ice cream.
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Harvonis Mechanism Of Action
Harvoni is a combination of two antiviral drugs, ledipasvir and sofosbuvir. It contains 90mg of ledipasvir and 400mg sofosbuvir, which act as a HCV NS5A inhibitor and nucleotide analogue inhibitor of HCV NS5B polymerase respectively. Harvoni is available in the form of a film-coated tablet in orange colour and diamond shape for oral administration.
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Frequently Asked Questions About Harvoni
Does Harvoni cure hepatitis C?
Yes, a successful treatment with antivirals is considered a cure for heptitis C. In clinical trials, Harvoni cured 94% to 100% cases of hepatitis C genotype 1.
Can hep C come back after taking Harvoni ?
It’s not likely that heptitis C will come back after achieving “SVR,” which is considered a cure. However, treatment of hepatitis C doesn’t make you immune to the virus, so it’s possible to become reinfected. After treatment it’s important to continue to protect yourself from hepatitis C and not receive unclean tattoos or share things like razors and needles.
Can you drink alcohol while taking Harvoni ?
Avoid alcohol while taking Harvoni . It’s not known if alcohol interacts with the medication, but alcohol and hepatitis C can both damage the liver.
Who makes Harvoni ?
In the U.S., Gilead makes branded Harvoni . Asegua Therapeutics makes the authorized generic of Harvoni.
Which is better, Epclusa or Harvoni ?
Both antiviral medications are very good at curing hepatitis C. Epclusa works for all genotypes of hepatitis C, while Harvoni works for 4 out of 6 types. Harvoni can cure hepatitic C in just 8 weeks for certain types of people the shortest course of Epclusa is 12 weeks.
What Are Epclusa And Harvoni Used For
Epclusa and Harvoni are both used to treat hepatitis C. This is a liver infection caused by the hepatitis C virus . There are six different genotypes of HCV.
- Epclusa can be used in people with any of the six genotypes of HCV, whether or not they have cirrhosis* .
- Harvoni can be used in people with genotypes 1, 4, 5, and 6. For each of these genotypes, there are specific circumstances in which Harvoni can be used. It depends on whether the person has cirrhosis, as well as other factors.
For more details, see the prescribing information for Epclusa and Harvoni. Also, see the Epclusa vs. Harvoni section of this article.
* People with severe cirrhosis will need to take ribavirin with Epclusa to treat hepatitis C.
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How Important Is It To Stick To Treatment
All medications work best when they are taken exactly as prescribed and directed. People taking Harvoni should take their pills every day, as prescribed by their healthcare provider. It is very important to finish the entire course of treatment. This gives the treatment the best chance of working to cure hepatitis C.
What Are The Dosage And Forms Of Epclusa And Harvoni
Both Epclusa and Harvoni come as tablets that are taken by mouth once per day. Theyre both used as short-term treatments.
Epclusa comes as a tablet that contains 100 milligrams of velpatasvir and 400 mg of sofosbuvir. Its also available as a tablet that contains 50 mg of velpatasvir and 200 mg of sofosbuvir. Epclusa is used for 12 weeks.
Harvoni comes as a tablet. These are available in two strengths: 90 mg of ledipasvir with 400 mg of sofosbuvir, and 45 mg of ledipasvir with 200 mg of sofosbuvir.
In addition, Harvoni also comes as pellets, which can be easier to swallow. These pellets may be swallowed on their own or mixed with nonacidic soft foods, such as mashed potatoes, pudding, or ice cream.
The typical length of Harvoni treatment is 12 weeks. However, some people may take it for either 8 weeks or 24 weeks, depending on their hepatitis C virus genotype and other factors. If you use Harvoni, your doctor will determine how long your treatment should last.
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How Effective Are Epclusa And Harvoni
You may wonder if Epclusa or Harvoni would be effective at treating your condition.
Studies have found both drugs to be highly effective at treating hepatitis C. And hepatitis C treatment guidelines recommend both drugs as first-choice treatment options.
To learn about how each drug performed in clinical studies, see the prescribing information for Epclusa and Harvoni. The manufacturer websites for Epclusa and Harvoni also provide information about each drugs effectiveness.
Epclusa and Harvoni may not be right for you if you have certain medical conditions or other factors that affect your health. Before using either drug, talk with your doctor about your health history.
Harvoni And Other Medications:
Harvoni should not be used with certain drugs. Combining medications can increase or lower drug levels . Increasing drug levels can make side effects from each drug worse. If drug levels get too low, a drug can stop working, putting people at risk for drug resistance or not being cured.
Harvoni should not be used with a medication called amiodarone because it can cause life-threatening heart problems. For people who must take amiodarone, intensive heart monitoring in a hospital is recommended for 48 hours after starting Harvoni, and daily monitoring for at least 2 weeks afterwards.
Talk with your health care provider before starting or stopping any medications, supplements, or herbal remedies.
Some drugs should be switched, stopped or avoided while using Harvoni. More information is available in Harvonis prescribing information and at: www.hep-druginteractions.org.
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Were talking about a much lower cost to Medicaid for a substantial number of people, and to me thats a game changer, said Ryan Clary, executive director of the National Viral Hepatitis Roundtable, a coalition of organizations that receives some funding from drug companies.
Gilead defended the price. We believe the price of Harvoni reflects the value of the medicine, it said in a statement. Unlike long-term or indefinite treatments for other chronic diseases, Harvoni offers a cure at a price that will significantly reduce hepatitis C treatment costs now and deliver significant health care savings to the health care system over the long term.
Harvoni is a combination of sofosbuvir, the ingredient in Sovaldi, and a new medicine from Gilead called ledipasvir, which is not available as a stand-alone product. The two drugs attack the virus in different ways.
Gilead estimates that over the long run as many as half of the patients might be able to receive only eight weeks of treatment.
Compared with that off-label combination, Harvoni is far less expensive, which could mean lower sales for Johnson & Johnsons drug.
Harvoni And Other Medications
Below is a list of medications that can interact with Harvoni. This list doesnt contain all drugs that may interact with Harvoni.
Before taking Harvoni, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Antacids
Taking Harvoni with antacids, such as Mylanta or Tums, can reduce the amount of Harvoni your body absorbs. This can make Harvoni less effective. To prevent this interaction, separate the dose of Harvoni and antacids by at least four hours.
H2 blockers
Taking Harvoni with drugs called H2 blockers can decrease the amount of Harvoni thats absorbed into your body. This can cause Harvoni to be less effective at fighting the hepatitis C virus.
If you need to take an H2 blocker with Harvoni, you should either take them at the same time or take them 12 hours apart. Taking them at the same time allows the drugs to dissolve and be absorbed by your body before the effects of the H2 blocker kicks in. Taking them 12 hours apart also allows each drug to be absorbed by your body without interacting with the other drug.
Examples of H2 blockers include famotidine and cimetidine .
Amiodarone
Digoxin
Seizure medications
Examples of seizure medications to avoid while taking Harvoni include:
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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 persons bloodstream . Some people will need to add another drug, called ribavirin , twice daily with Harvoni.
Harvoni And Omeprazole Or Other Ppis
Taking Harvoni with omeprazole or other proton pump inhibitors can decrease the amount of Harvoni in your body. This could make Harvoni less effective.
If possible, avoid taking Harvoni with this class of drugs. If you need a PPI while youre taking Harvoni, you should take Harvoni and the PPI at the exact same time on an empty stomach.
Examples of other PPIs include:
During your treatment with Harvoni, check with your doctor before taking any new herbs or supplements.
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What Medicines Should I Avoid With Harvoni
It is always important to make your doctor and pharmacist aware of any medicines you take to ensure that they are compatible with Harvoni. This includes any recreational, over-the-counter or herbal medications. Before starting any new medications you must check they are safe to take with your clinic nurse, doctor or pharmacist.
Important Information
You must not stop, or allow anyone else to stop, your treatment unless discussed with the doctor or nurse in charge of your Hepatitis C treatment.
What To Expect During Treatment
Harvoni is an oral tablet thats taken once per day, with or without food.
A typical course of Harvoni treatment takes 12 weeks. For some people whove 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. You may have the best results if you take the drug at the same time every day.
Be sure to follow your doctors prescription about dosage. Taking a smaller or larger dose than the one prescribed may make the drug less effective.
Its important to note that you can still pass the virus to another person while youre taking Harvoni. Be sure to follow your doctors orders about safety and preventing transmission of HCV.
Your doctor may order frequent blood tests throughout your treatment to determine whether the virus has been eliminated.
- fatigue
Other side effects include nausea and vomiting, diarrhea, and trouble sleeping.
There are some drug interactions that can occur in people taking Harvoni. For example, you shouldnt take an antacid within four hours of taking a Harvoni pill.
You should also avoid the herbal supplement St. Johns wort and the antibiotic rifampin, which is usually prescribed to treat tuberculosis.
There are many other interactions that can occur between Harvoni and different medications. If you take other medications, tell your doctor before starting treatment with Harvoni.
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