Treatment of patients (aged 12 and older) with chronic hepatitis C virus (HCV). FDA approved for use in HIV/HCV co-infection.
One tablet once daily without regard to food. Tablet contains 90 mg of ledipasvir and 400 mg of sofosbuvir. Duration of therapy is 12 or 24 weeks, depending upon treatment experience and level of cirrhosis. In some cases, an 8-week treatment duration is possible. See treatment table for this page online. Ribavirin may be added in patients with decompensated cirrhosis or liver transplant patients without cirrhosis. See treatment duration table for this page online. The number of weeks on treatment depends on such things as cirrhosis status and previous therapy. Harvoni is FDA-approved for use in children age 12 and older or weighing at least 77 pounds (35 kg).
Sofosbuvir-based regimens are not recommended in people with creatinine clearance (CrCl) less than 30 mL/min.
Take missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose.
BLACK BOX WARNING
Before starting treatment with any direct-acting antiviral (DAA), including Harvoni, patients should take a blood test to check for hepatitis B (HBV) infection. HBV infection could get worse or reactivate during or after DAA treatment, potentially leading to serious liver problems, including liver failure or death. Patients with current or past HBV infection should be monitored during HCV DAA treatment, and some may need to take HBV treatment.
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Harvoni is generally well tolerated, and very few people in clinical trials discontinued treatment due to side effects (1% or less). The most commonly reported side effects are fatigue, headache, nausea, diarrhea, and insomnia, and are all considered to be mild in severity. Additional side effects observed in patients with decompensated cirrhosis or after liver transplant were thought to be due to their medical condition rather than the medication. Harvoni has not been studied in pregnant or nursing women, so the impact it may have on fetal development or nursing babies is unknown.
Pregnant women or women who are trying to become pregnant should avoid use if the addition of ribavirin is required.
Before starting Harvoni, be sure to tell your medical provider or pharmacist about all of the medications, supplements, and herbal products you take, whether they are prescribed, over-the-counter, or illicit. It is also important to inform them of any changes as they happen during treatment. Harvoni should not be taken within 4 hours of antacids. If taking H2-receptor antagonists, take Harvoni at the same time or separate by 12 hours at a dose that does not exceed doses comparable to famotidine 40 mg twice per day. Use of proton pump inhibitors (PPI) is not recommended, but if medically necessary, Harvoni should be taken at the same time as a PPI comparable to omeprazole 20 mg or lower under fasted conditions (on an empty stomach). Use caution and monitor renal function when taking Harvoni with tenofovir disoproxil fumarate (TDF). Avoid use if patient is taking TDF with an HIV protease inhibitor, ritonavir, or cobicistat due to possible increase in TDF concentrations resulting in adverse reactions. Do not take Harvoni with St. John’s wort, and in general, herbal products should be avoided due to lack of information regarding potential for interaction. It should not be taken with the rifamycin antimicrobials, such as rifabutin, rifampin, or rifapentine, nor should it be taken with the anticonvulsants carbamazepine, phenytoin, phenobarbital, or oxcarbazepine, as they reduce the concentrations of sofosbuvir and may reduce its effectiveness. There are no interactions with methadone or other common medications used for opioid, alcohol, or nicotine dependency. Use with certain statins (cholesterol medicine) may cause increased risk of muscle pain (myopathy) or muscle breakdown (rhabdomyolysis). Your doctor should decide if your statin should be continued or changed during treatment with Harvoni. No sofosbuvir-based HCV regimens are to be used with amiodarone due to possible symptomatic bradycardia. Signs of bradycardia include fainting, dizziness, lightheadedness, weakness, excessive fatigue, shortness of breath, chest pains, and confusion or memory problems. Consult a medical provider should any of these symptoms occur.
Harvoni was an exciting development for treating HCV in 2014 as it was the first one-pill, once-daily regimen with minimal side effects and high rates of SVR12 with treatment durations ranging from 8 to 24 weeks. Although there are now many treatment options available, Harvoni is still commonly used. Harvoni was the first of two combination DAAs that have been FDA-approved for use in children (age 12 or older or at least 77 pounds) with HCV genotypes 1, 4, 5, and 6 with either no cirrhosis or compensated cirrhosis.
Go to hcvguidelines.org for additional information on clinical studies and treatment recommendations.
Taking your Harvoni tablets exactly as your doctor prescribes is extremely important. That’s because following your treatment plan increases your chances of curing your hepatitis C (HCV). It also helps reduce your risk of long-term effects of HCV, such as cirrhosis and liver cancer.
Missing doses can interfere with how well Harvoni treats your hepatitis C. In some cases, if you miss doses, your HCV may not be cured.
So be sure to follow your doctor’s instructions and take one Harvoni tablet every day for the duration of your treatment. Using a reminder tool can be helpful in making sure you take Harvoni each day.
If you have any questions or concerns about your treatment, talk with your doctor or pharmacist. They can help resolve any issues for you and help you get the most out of your treatment.
Our pharmacists are experts in treating hepatitis C, medication therapy and finding valuable treatment resources. We keep Harvoni in stock for the duration of your treatment so you never have to wait to receive your medication. If you have any issues with your insurance plan or coverage, we’ll find a solution so you don’t miss a dose. You can rest assured that you have picked a partner who will work with you and your doctor to achieve your treatment goals.
Drug Mart offers free prescription delivery to any location (home or office) in New Jersey, New York or Pennsylvania.
Drug Mart is licensed in New Jersey, New York and Pennsylvania. If you live in one of these States, complete the form at Get Started, and our pharmacy team will handle the rest.
Gilead, the maker of Harvoni has a prescription copay assistance program. Our staff is trained to find these savings and help lower the price you pay for your prescription. In most cases, patients pay zero dollar out-of-pocket for their Harvoni prescription.
Harvoni is a prescription brand-name medication that’s used to treat hepatitis C virus (HCV) in adults and children ages 12 and older or who weigh at least 77 pounds. Harvoni can treat hepatitis C genotypes 1, 4, 5, and 6.
The duration of treatment for Harvoni is either 8, 12, or 24 weeks. How long you take Harvoni will depend on your genotype, or type of hepatitis C and your liver function. It will also depend on your past hepatitis C treatments.
Harvoni can be taken at any time of the day. However, you should try to take Harvoni at the same time every day. This can help you remember to take it and help keep a consistent amount of the drug in your system.
If you experience fatigue during your treatment with Harvoni, try taking the drug at night. That might help you avoid that side effect.
Harvoni can be taken with or without food. If you experience nausea after taking Harvoni, you may avoid that side effect by taking the drug with food.
It’s important to take Harvoni every day, to give you the best chance of curing your hepatitis C.
But if you do miss a dose, take it as soon as you remember. If it’s almost time for your next dose, only take one dose. Taking two doses at once can increase your risk of side effects.
It’s not known whether it’s safe to crush Harvoni tablets, so it’s best to avoid crushing them. If you have trouble swallowing Harvoni tablets, talk with your doctor about other medications that may work better for you.
Harvoni is a direct-acting antiviral (DAA). These types of drugs treat HCV by stopping the virus from reproducing (making copies of itself). Viruses that can’t make copies eventually die and are cleared from the body.
Clearing the virus from your body will decrease liver inflammation and prevent additional liver scarring.
Some people start feeling better within a few days or weeks of starting treatment with Harvoni. However, you’ll still need to take Harvoni for the entire time that your doctor prescribes.
In clinical studies, more than 86 percent of people who took Harvoni were cured after three months of treatment.
Your doctor will test your blood for the virus before and during treatment. They will also test it 12 weeks after you finish treatment. If there is no detectable virus in your body 12 weeks after your treatment ends, you have achieved sustained virologic response (SVR). Achieving SVR means you’re considered cured of hepatitis C.
There haven’t been enough studies in humans to know if Harvoni is safe to take during pregnancy. In animal studies, there was no harm to the fetus seen when the mother received Harvoni. However, animal studies don’t always predict what will happen in humans.
If you’re pregnant or planning to become pregnant, talk to your doctor about whether Harvoni is right for you.
It isn’t known if Harvoni passes into human breast milk. In animal studies, Harvoni was found in breast milk but didn’t cause harmful effects in offspring. However, animal studies don’t always predict what will happen in humans.
If you’re breastfeeding or planning to breastfeed, talk with your doctor about the potential risks and benefits of taking Harvoni while breastfeeding.
The cure rate for Harvoni depends on certain aspects of your hepatitis C. This includes whether or not you have cirrhosis, what hepatitis C treatments you have tried in the past, and what genotype of the virus you have.
In clinical studies of Harvoni, between 86 percent and 100 percent of people with different medical histories were cured of hepatitis C.
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 to relapse (have the infection reappear). This happens when a medication has cured a person of hepatitis C, but blood tests detect the virus again months to years after treatment. In clinical trials, up to 6 percent of people treated with Harvoni had a relapse.
Also, if you’re exposed to hepatitis C again after you take any hepatitis C medication, including Harvoni, you can become reinfected with the virus. Reinfection can occur in the same way the original infection was contracted.
Sharing needles used for injecting drugs and having intercourse without a condom are possible routes of reinfection. Avoiding these behaviors can help prevent reinfection with hepatitis C.
There are six different types, or strains, of hepatitis C viruses that infect people. These strains are called genotypes.
Genotypes are identified by differences in the genetic code of the viruses. Genotype 1 is the most common hepatitis C strain in the United States, but other strains are also seen in this country.
Your doctor will do a blood test to figure out which genotype you have. Your hepatitis C genotype will help your doctor choose the right medication for you.
Yes, you can. Harvoni can be safely used to treat hepatitis C in people who are also infected with HIV. Your doctor may change your HIV regimen for the duration of the treatment.
Drinking alcohol while taking Harvoni can increase the risk of certain side effects from Harvoni. These side effects include:
In addition, both hepatitis C and excessive alcohol use cause scarring and inflammation in your liver. Combining the two increases your risk of cirrhosis and liver failure.
Alcohol may also make you less able to take your medication as directed by your doctor. For instance, it may cause you to forget to take your medication at the right time. Missing doses of Harvoni could make it less effective in treating your HCV.
For all of these reasons, you should avoid drinking alcohol when you have hepatitis C. This is especially true when you’re being treated with Harvoni. If you have trouble avoiding alcohol, talk with your doctor.
If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.
Call us at the pharmacy and we’ll be glad to answer any questions. You can reach us at (800) 877-0337.