Mavyret

The active ingredient in Mavyret is Mavyret is a direct-acting antiviral treatment option that contains a protease inhibitor (glecaprevir) and an NS5A inhibitor (pibrentasvir), which means that it works in two specific ways. Overall, it works to stop the hepatitis C virus from copying itself in your body by attacking two different proteins within the virus.

Mavyret uses two different medications because, often, your body will develop a defense against antivirals if only one medication is used to help fight the spread of the hepatitis C virus. It is a ribavirin-free treatment.

After 16 weeks of treatment, the overall cure rate (tested by sustained virologic response, or SVR) across all genotypes was 97.5%.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Mavyret. However, the following is a synopsis of the general guidelines for the use of Mavyret:

• You should take Mavyret with food and should not skip or miss a dose or stop taking Mavyret without your doctor’s permission
• Your dosage or number of oral pellets will depend on your weight and age. Often, oral pellets will be prescribed to children
• Try to find a time of day that works for you that is easy to remember. If you’ve never taken medication for Hepatitis C, you most likely will take Mavyret for eight weeks. If this is not your first HCV treatment, your treatment duration will most likely be longer
• If you happen to miss a dose, take the missed dose as soon as you remember, unless it is more than 18 hours from the time you usually take Mavyret. If it has been more than 18 hours, skip the missed dose and take your next dose at the usual time
• During treatment with Mavyret, you most likely will have blood tests done if your healthcare provider is worried about your liver health. If you’re not presenting any negative symptoms, you most likely will get your HCV levels checked toward the end of your treatment and 12 weeks after finishing treatment with Mavyret

The most common side effects of Mavyret seen in clinical trials as compared to placebo include:

• Nausea
• Headache
• Loss of appetite
• Tiredness
• Diarrhea
• Rash

Some individuals may experience serious side effects while using Mavyret. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Hepatitis B virus reactivation
• Patients with HBV reactivation should not be treated with antiviral medication.
• This may cause serious liver problems.
• Worsening liver problems, liver failure, or death.
• This is specific to people who have already had (severe) liver problems before.
• Worsening signs of liver disease such as stomach bloating, bleeding and/or bruising more easily than usual, dark or brown urine, bloody or back stool, or yellowing of your skin or the white part of your eyes.

These are not all of the possible side effects of Mavyret. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Mavyret, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Liver function issues other than Hepatitis C, such as liver cancer
• Mavyret should not be used if you have preexisting severe liver problems.
• If you have mild to moderate preexisting liver problems, your healthcare provider may decide to keep a closer look at your liver during treatment with Mavyret.
• HIV-1 infection
• Have had a kidney transplant

Boxed Warning

There is a risk of hepatitis B reactivation if patients have been infected with both HCV and HBV. This sometimes can result in hepatitis, liver failure, and death.

Mavyret (glecaprevir/pibrentasvir) is a combination antiviral medication used to treat hepatitis C. Its contraindications include:

• Severe liver impairment (Child-Pugh class C)
• Co-administration with atazanavir or rifampin, as these drugs can interact with Mavyret, leading to reduced efficacy or increased risk of side effects.
• Hypersensitivity to glecaprevir, pibrentasvir, or any of the components of Mavyret.

Mavyret typically takes 8 to 12 weeks for full treatment, with improvement often seen within the first few weeks. A sustained virologic response is usually confirmed after completing the full course.

When Mavyret is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Carbamazepine
• Efavirenz
• St. John’s wort

Mavyret (glecaprevir/pibrentasvir) comes as an oral tablet or pellet.

• Tablets come as 100 mg glecaprevir and 40 mg pibrentasvir.
• Oral pellets come as 50 mg glecaprevir and 20 mg pibrentasvir.
• Oral pellets are often a good option for children.

You should store both Mavyret pellets and Mavyret tablets below 86°F. Keep it in its original package until you’re ready to use it. Do not keep or store any leftover medication.

Mavyret is manufactured by AbbVie, a global biopharmaceutical company.

Currently, there is no generic available for Mavyret in the United States.

To stop taking Mavyret, follow your doctor's instructions, as it is typically taken for 8 to 12 weeks depending on your condition. Do not stop the medication prematurely, as this can reduce its effectiveness and may lead to the hepatitis C virus returning.

It is not known whether Mavyret will harm your unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is not known if Mavyret is found in breast milk or what effects it may have on your breastfed infant. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.