Pronunciation: MAV-ih-reht
Generic name: glecaprevir and pibrentasvir
Dosage form: oral tablets, oral pellets
Drug class: Antiviral combinations
What is Mavyret?
Mavyret is an oral combination medicine containing fixed doses of 2 antivirals, glecaprevir, and pibrentasvir, that may be used to treat adults and children 3 years of age and older with:
- chronic (lasting a long time) hepatitis C virus (HCV) genotypes 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis.
- HCV genotype 1 infection who have been previously treated with a regimen that contained an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.
The 2 ingredients in Mavyret, glecaprevir and pibrentasvir, work in different ways to prevent the replication of the HCV virus. Glecaprevir inhibits an enzyme called NS3/4A protease which is essential for cleavage of HCV into its mature forms. Pibrentasvir inhibits NS5A, a protein that also plays a key role in HCV RNA replication. Cure rates of 95% to 99% after 8 weeks of treatment have been reported in people with hep C who took Mavyret.
Mavyret was first FDA-approved on August 3, 2017.
Mavyret side effects
The most common side effects of Mavyret affecting 10% or more people who take it are headache and tiredness.
These are not all the possible side effects of Mavyret. Call your doctor for medical advice about side effects. You may report side effects to the FDA
Warnings
Do not use if you:
- have moderate to severe liver disease (Child-Pugh B or C) or with a history of liver decompensation
- take atazanavir or rifampin.
Mavyret can cause serious side effects, including:
Hepatitis B virus reactivation. If you have ever had a hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment for the hepatitis C virus with Mavyret. Hepatitis B virus that becomes active again (called reactivation) may cause serious liver problems including liver failure and death. Before starting treatment, your healthcare provider will do blood tests to check for hepatitis B virus infection and will monitor you if you are at risk for hepatitis B virus reactivation during and after treatment.
A rare risk of worsening liver problems, liver failure, and death in people who had or have advanced liver problems before starting treatment. Your healthcare provider will check you for signs and symptoms of worsening liver problems during treatment with Mavyret. Tell your healthcare provider right away if you have any of the following signs and symptoms:
- nausea
- tiredness
- yellowing of your skin or the white part of your eyes
- bleeding or bruising more easily than normal
- confusion
- dark, black, or bloody stools
- loss of appetite
- diarrhea
- dark or brown (tea-colored) urine
- swelling or pain on the upper right side of your stomach area (abdomen)
- sleepiness
- vomiting of blood
- lightheadedness.
It is unknown if Mavyret is safe and effective in children under 3 years of age.
Before taking
Do not take Mavyret if you:
- have certain liver problems
- also take atazanavir or rifampin
Before taking Mavyret, tell your healthcare provider about all of your medical conditions, including if you:
- have had hepatitis B virus infection
- have liver problems other than hepatitis C virus infection.
- have HIV-1 infection
- have had a liver or a kidney transplant
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Pregnancy
It is not known if Mavyret will harm your unborn baby.
Breastfeeding
It is not known if Mavyret passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby.
How should I take Mavyret?
Take Mavyret exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking it unless your healthcare provider tells you to.
The dosage of Mavyret varies depending on age, HIV coinfection, kidney disease, and some other factors.
- Usual Mavyret dosage for adults and children aged 12 years and older or weighing at least 99 pounds (45 kg): 3 tablets (each tablet contains glecaprevir 100 mg and pibrentasvir 40 mg) once a day.
- Usual Mavyret dosage for children aged 3 to less than 12 years: dosing is based on weight. See the prescribing information.
The length of time Mavyret is taken depends on the HCV genotype and the presence or absence of Cirrhosis.
- The usual treatment duration in treatment naïve patients with HCV genotype 1,2,3,4,5, or 6 is 8 weeks.
- Treatment durations of 12 weeks or 16 weeks are recommended for others depending on previous treatments or the presence of compensated cirrhosis (Child-Pugh A).
Take Mavyret with food or a snack.
Try to take it at around the same time each day.
How should I give Mavyret oral pellets to my child?
Administer Mavyret oral pellets exactly as instructed by your healthcare provider.
Give them once a day just before or after a snack or meal.
- Do not open the packet until your child or the person you are looking after who has been prescribed Mavyret is ready to take their dose.
Mix the pellets with a small amount of recommended food, such as peanut or nut butter, strawberry jam, yogurt, or hazelnut spread, in a small bowl and swallow. Do not attempt to crush or dissolve the pellets in soft food because they will taste bitter.
- The Mavyret pellet/food mixture should be taken right away. Tell your child not to chew the pellets. Add more food to the bowl and mix until every pellet has been taken.
If you wait more than:
- 5 minutes before taking the pellet/food mixture, it will taste bitter.
- 15 minutes before taking the pellet/food mixture, it will be less effective.
Follow up the medication with a snack or a meal.
Do not store any leftover mixture for use at a later time. Throw away any unused portion.
What happens if I miss a dose?
If you miss a dose of Mavyret and:
- Less than 18 hours have passed from the time you usually take it, take the missed dose with food as soon as possible. Then take your next dose at your usual time
- It is less than 6 hours till your next dose, do not take the missed dose. Take your next dose as usual with food.
What happens if I overdose?
If you take too much Mavyret, call your healthcare provider or go to the nearest hospital emergency room right away.
What other drugs will affect Mavyret?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may reduce the effectiveness of Mavyret or may cause side effects. Keep a list of your medicines to show your healthcare provider and pharmacist. Especially tell your healthcare provider if you take:
- Carbamazepine
- Dabigatran
- Digoxin
- Ethinylestradiol-containing medications, such as combined oral contraceptives
- HIV antivirals such as atazanavir, darunavir, efavirenz, lopinavir, or ritonavir
- Immunosuppressives, such as cyclosporine
- Rifampin
- St. John’s wort
- Statins, such as atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin
- Other medications which are metabolized through the liver, such as warfarin, because clearance of HCV infection with Mavyret may lead to changes in liver function. Your healthcare provider should monitor your medications for any change in effect.
