glecaprevir/pibrentasvir, or G/P
Treatment of patients (aged 12 and older) with chronic hepatitis C virus (HCV). FDA approved for HIV/HCV co-infection.
Three tablets once daily with food. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir for a total daily dose of 300 mg/120 mg. It is important to take all three tablets at the same time (do not separate throughout the day). The number of weeks on treatment depends on such things as cirrhosis status and previous therapy. Mavyret is FDA-approved for use in children age 12 and weighing at least 99 pounds (45 kilograms).
Mavyret can be used in severe renal impairment, including in patients on hemodialysis. NS3/4A protease inhibitors, such as glecaprevir, are contraindicated in patients with moderate or severe liver impairment (Child-Pugh B, C), which is also called decompensated cirrhosis. Using Mavyret in decompensated cirrhosis may cause significantly higher amounts of glecaprevir in the blood and may increase ALT (liver enzyme).
Take your 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 Mavyret, 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.
Mavyret is a very well-tolerated medication with minimal side effects. In clinical trials, very few people (about 0.1%) discontinued Mavyret due to side effects. Only headaches and fatigue were reported by clinical trial participants at rates higher than 10% (16 and 11%, respectively), with even fewer reporting nausea or diarrhea. Rates of side effects are not affected by treatment duration, presence of cirrhosis, HIV/HCV co-infection, history of kidney transplant, and adolescence. There are no serious lab abnormalities expected. Mavyret has not been studied in pregnant women or nursing mothers, so the impact it may have on fetal development or nursing babies is unknown.
Before starting Mavyret, be sure to tell your medical provider or pharmacist about all 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. Mavyret should not be taken with HIV medications that require ritonavir as a booster to increase the drug levels in the body, such as atazanavir and darunavir. Mavyret should also not be taken with the HIV medications efavirenz or etravirine. 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 Mavyret. There are no interactions with methadone or other common medications used for opioid, alcohol, or nicotine dependency. Use of ethinyl estradiol (estrogen)-containing birth control is not recommended due to potential increase in ALT (liver enzyme). Mavyret should not be used with cyclosporine doses higher than 100 mg daily. It cannot be taken with St. John’s wort, and in general, herbal products should be avoided due to lack of information regarding potential for interaction.
Mavyret marks an exciting development in HCV treatment: it’s the first pan-genotypic regimen that cures most people without ribavirin in as few as 8 weeks of treatment. Some people may need to take Mavyret for up to 16 weeks depending on previous treatment experience and presence of cirrhosis. The overall cure rate (sustained virologic response, or SVR) across all genotypes was 97.5%, but when you remove genotype 3, that number improves to more than 99% (GT 3 still achieves a 95% SVR). It also appears to be an excellent regimen for people with kidney disease, curing 98% of patients with severe kidney disease with 12 weeks of treatment (EXPEDITION-4) as well as for patients post-liver or kidney transplant, having cured 99% of people (MAGELLAN-2). In April 2019, Mavyet received FDA approval for use in liver and/or kidney transplants. Mavyret is the second combination DAA that has been FDA-approved for use in children age 12 and older or weighing at least 99 pounds (45 kg) for genotypes 1, 2, 3, 4, 5, and 6 with either no cirrhosis or compensated cirrhosis. For all of this great news, Mavyret is not recommended for people with moderate to severe liver damage, and alternative DAAs are better choices. For more information, go to hcvguidelines.org.
Taking your Mavyret 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 Mavyret 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 three Mavyret tablets every day for the duration of your treatment. Using a reminder tool can be helpful in making sure you take Mavyret 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 Mavyret 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.
Abbvie, the maker of Mavyret 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 Mavyret prescription.
Mavyret is indicated for the treatment of chronic hepatitis C virus (HCV) genotypes 1, 2, 3, 4, 5, and 6. Mavyret is approved for use in adults and children ages 12 years and older, or those who weigh at least 45 kg.
It should only be used in patients without cirrhosis, or in those with compensated cirrhosis.
Mavyret is also indicated to treat genotype 1 hepatitis C virus infection in people whose previous treatments were unsuccessful. These prior treatments should include either an HCV NS5A inhibitor or an NS3/4A protease inhibitor.
In clinical trials, adults with HCV (types 1, 2, 3, 4, 5, and 6) who had never been treated for the virus were given Mavyret. Of these people, 98% to 100% were cured after 8 to 12 weeks of treatment.
It doesn’t matter what time of day you choose to take Mavyret, but you should take it at about the same time each day. This helps the medication work the right way inside your body.
Mavyret should be taken with food. This helps your body to better absorb the medication.
If you miss a dose of Mavyret, here’s what you should do:
- If it’s less than 18 hours from when you should’ve taken Mavyret, go ahead and take your dose as soon as you remember. Then, take your next dose at the usual time.
- If it’s more than 18 hours from when you should’ve taken Mavyret, just skip that dose. You can take your next dose at the usual time.
To help make sure you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.
No, Mavyret shouldn’t be split, crushed, or chewed. The tablets are meant to be swallowed whole. Splitting, crushing, or chewing them can decrease the amount of drug that gets into your body. This can cause Mavyret to not work as well in treating your hepatitis C infection.
Mavyret contains two drugs: glecaprevir and pibrentasvir. It works by stopping the hepatitis C virus from multiplying (making more virus) inside your body. Because the virus isn’t able to multiply, it will eventually die off.
Once all of the virus has died, and it’s no longer inside your body, your liver can begin to heal. Mavyret works to treat all six types (1, 2, 3, 4, 5, and 6) of HCV.
During clinical studies, 92% to 100% people with HCV were cured after taking Mavyret for their prescribed length of time. This length of time ranged from 8 to 16 weeks.
If you’ve tried other medications for your hepatitis C that haven’t worked (cured your infection), you can likely still use Mavyret. Depending on what drugs you’ve used in the past, your treatment length with Mavyret could be anywhere from 8 to 16 weeks.
If you have questions about whether you can use Mavyret, talk with your doctor.
Before you start treatment with Mavyret, your doctor will test your blood for hepatitis B virus (HBV). If you have HBV, it can reactivate (flare up) during Mavyret treatment. Reactivation of HBV can cause severe liver problems, including liver failure and death.
If you have HBV, your doctor will recommend blood tests during your Mavyret treatment to check for HBV reactivation. You may need to be treated for HBV before you start taking Mavyret.
You may be able to, but it depends on how severe your cirrhosis (liver scarring) is.
Mavyret can be used if you have compensated (mild) cirrhosis. With this condition, your liver has scarring, but you don’t have any symptoms of the condition and your liver is still working normally.
Mavyret is not yet approved for use in people with decompensated cirrhosis. With this condition, your liver has scarring and you have symptoms of the condition. Symptoms can include:
- yellowing of your skin or the whites of your eyes
- extra fluid in your belly
- enlarged blood vessels in your throat, which may cause bleeding
If you have cirrhosis but aren’t sure what kind, talk with your doctor.
It’s not known whether Mavyret can affect a developing pregnancy. In animal studies, Mavyret did not cause harm when used during pregnancy. However this result may be different in humans. For more information, speak to your doctor or pharmacist.
It’s not known if Mavyret passes into human breast milk, or if it harms a breastfeeding child. In animal studies, Mavyret did pass into breast milk, but it did not cause harm to animals who consumed the breast milk. However, this result may be different in humans.
Mavyret has been shown to be very effective in curing hepatitis C virus (HCV) infections. In clinical trials, between 98% and 100% of people taking Mavyret were cured of HCV.
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.
Mavyret doesn’t have any known interactions with alcohol. However, you shouldn’t drink alcohol if you have hepatitis C virus (HCV). Alcohol makes HCV worse, which can lead to severe scarring (cirrhosis) in your liver.
If you drink alcohol, and you’re concerned about how to stop drinking, talk with your doctor.
Using more than the recommended dosage of Mavyret can lead to serious side effects. Never take more than the dosage your doctor prescribes for you.
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.