Mavyret contains a combination of glecaprevir and pibrentasvir. Glecaprevir and pibrentasvir are antiviral medications that prevent hepatitis C virus (HCV) from multiplying in your body.

Mavyret is used to treat chronic hepatitis C in people with HCV genotype 1, 2, 3, 4, 5, or 6.

Mavyret is usually given after other medicines have been tried without success.

You should not use Mavyret if you have severe liver disease, or if you also take atazanavir or rifampin.

Take Mavyret exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Mavyret.

For adults and children over 12 years of age (or weighing at least 45kg), the usual dosage of Mavyret is three tablets taken at the same time once daily with food.

The recommended dosage of Mavyret in patients 3 years to less than 12 years of age is based on weight. Mavyret oral pellets are recommended for younger patients.

Dosage of glecaprevir/pibrentasvir based on weight.

• Less than 20 kg - three 50 mg/20 mg packets of oral pellets once daily
• 20 kg to less than 30 kg - four 50 mg/20 mg packets of oral pellets once daily
• 30 kg to less than 45 kg - five 50 mg/20 mg packets of oral pellets once daily
• 45 kg and greater OR 12 years of age and older - three 100 mg/40 mg tablets once daily.

Take Mavyret with food.

You will need frequent blood tests to check your liver function.

You should not stop using Mavyret suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine.

Use all hepatitis C medications as directed and read all medication guides you receive. Do not change your dose or stop using a medicine without your doctor's advice. Every person with hepatitis C should remain under the care of a doctor.

If you've ever had hepatitis B, this virus may become active or get worse in the months after you stop using Mavyret. You may need frequent liver function tests while using this medicine and for several months after your last dose.

Store this medicine in the original container at room temperature away from moisture and heat. Keep Mavyret in its original package until you are ready to take it.

Usual Adult Dose of Mavyret for Chronic Hepatitis C:

Glecaprevir 300 mg-pibrentasvir 120 mg (3 tablets) orally once a day

Duration of Therapy:
THERAPY-NAIVE PATIENTS:
HCV genotype 1, 2, 3, 4, 5, or 6:
-No cirrhosis: 8 weeks
-Compensated cirrhosis (Child-Pugh A): 8 weeks

THERAPY-EXPERIENCED PATIENTS:
HCV genotype 1 (prior therapy with regimen containing an NS5A inhibitor without prior therapy with an NS3/4A protease inhibitor):
-No cirrhosis: 16 weeks
-Compensated cirrhosis (Child-Pugh A): 16 weeks

HCV genotype 1 (prior therapy with regimen containing an NS3/4A protease inhibitor without prior therapy with an NS5A inhibitor):
-No cirrhosis: 12 weeks
-Compensated cirrhosis (Child-Pugh A): 12 weeks

HCV genotype 1, 2, 4, 5, or 6 (prior therapy with regimen containing PRS):
-No cirrhosis: 8 weeks
-Compensated cirrhosis (Child-Pugh A): 12 weeks

HCV genotype 3 (prior therapy with regimen containing PRS):
-No cirrhosis: 16 weeks
-Compensated cirrhosis (Child-Pugh A): 16 weeks

LIVER OR KIDNEY TRANSPLANT RECIPIENTS: 12 weeks
-HCV genotype 1 (NS5A inhibitor-experienced without prior therapy with an NS3/4A protease inhibitor) or HCV genotype 3 (PRS therapy-experienced): 16 weeks

Comments:
-Each fixed-dose combination tablet contains glecaprevir 100 mg and pibrentasvir 40 mg.
-Recommended for HCV monoinfected and HCV/HIV-1-coinfected patients with compensated liver disease (with or without cirrhosis); the manufacturer product information should be consulted regarding dose recommendations for coadministered HIV-1 antiviral agents (if applicable).
-NS5A: Nonstructural protein 5A; NS3/4A: Nonstructural protein 3/4A
-In clinical trials, patients with prior NS5A inhibitor experience were treated with regimens containing ledipasvir-sofosbuvir or daclatasvir with (peg)interferon and ribavirin.
-In clinical trials, patients with prior NS3/4A protease inhibitor experience were treated with regimens containing simeprevir with sofosbuvir, or simeprevir, boceprevir, or telaprevir with (peg)interferon and ribavirin.
-PRS: Prior treatment experience with regimens containing (peg)interferon, ribavirin, and/or sofosbuvir without prior treatment experience with an HCV NS3/4A protease inhibitor or NS5A inhibitor

Uses:
-For the treatment of patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)
-For the treatment of HCV genotype 1-infected patients with prior treatment using a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both

Usual Pediatric Dose of Mavyret for Chronic Hepatitis C:

3 to less than 12 years:
-Weight less than 20 kg: Glecaprevir 150 mg-pibrentasvir 60 mg (3 packets of oral pellets) orally once a day
-Weight 20 to less than 30 kg: Glecaprevir 200 mg-pibrentasvir 80 mg (4 packets of oral pellets) orally once a day
-Weight 30 to less than 45 kg: Glecaprevir 250 mg-pibrentasvir 100 mg (5 packets of oral pellets) orally once a day
-Weight at least 45 kg: Glecaprevir 300 mg-pibrentasvir 120 mg (3 tablets) orally once a day

12 years or older: Glecaprevir 300 mg-pibrentasvir 120 mg (3 tablets) orally once a day

Duration of Therapy:
THERAPY-NAIVE PATIENTS:
HCV genotype 1, 2, 3, 4, 5, or 6:
-No cirrhosis: 8 weeks
-Compensated cirrhosis (Child-Pugh A): 8 weeks

THERAPY-EXPERIENCED PATIENTS:
HCV genotype 1 (prior therapy with regimen containing an NS5A inhibitor without prior therapy with an NS3/4A protease inhibitor):
-No cirrhosis: 16 weeks
-Compensated cirrhosis (Child-Pugh A): 16 weeks

HCV genotype 1 (prior therapy with regimen containing an NS3/4A protease inhibitor without prior therapy with an NS5A inhibitor):
-No cirrhosis: 12 weeks
-Compensated cirrhosis (Child-Pugh A): 12 weeks

HCV genotype 1, 2, 4, 5, or 6 (prior therapy with regimen containing PRS):
-No cirrhosis: 8 weeks
-Compensated cirrhosis (Child-Pugh A): 12 weeks

HCV genotype 3 (prior therapy with regimen containing PRS):
-No cirrhosis: 16 weeks
-Compensated cirrhosis (Child-Pugh A): 16 weeks

LIVER OR KIDNEY TRANSPLANT RECIPIENTS: 12 weeks
-HCV genotype 1 (NS5A inhibitor-experienced without prior therapy with an NS3/4A protease inhibitor) or HCV genotype 3 (PRS therapy-experienced): 16 weeks

Comments:
-Each packet of oral pellets (a fixed-dose combination product) contains glecaprevir 50 mg and pibrentasvir 20 mg.
-Each fixed-dose combination tablet contains glecaprevir 100 mg and pibrentasvir 40 mg.
-Pediatric patients weighing at least 45 kg who are unable to swallow tablets may be administered 6 packets of oral pellets once a day; dosing with the oral pellets has not been studied in pediatric patients weighing more than 45 kg.
-Recommended for HCV monoinfected and HCV/HIV-1-coinfected patients with compensated liver disease (with or without cirrhosis); the manufacturer product information should be consulted regarding dose recommendations for coadministered HIV-1 antiviral agents (if applicable).
-NS5A: Nonstructural protein 5A; NS3/4A: Nonstructural protein 3/4A
-In clinical trials, patients with prior NS5A inhibitor experience were treated with regimens containing ledipasvir-sofosbuvir or daclatasvir with (peg)interferon and ribavirin.
-In clinical trials, patients with prior NS3/4A protease inhibitor experience were treated with regimens containing simeprevir with sofosbuvir, or simeprevir, boceprevir, or telaprevir with (peg)interferon and ribavirin.
-PRS: Prior treatment experience with regimens containing (peg)interferon, ribavirin, and/or sofosbuvir without prior treatment experience with an HCV NS3/4A protease inhibitor or NS5A inhibitor

Uses:
-For the treatment of patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)
-For the treatment of HCV genotype 1-infected patients with prior treatment using a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both

You should not use Mavyret if you are allergic to glecaprevir or pibrentasvir, or if:

• you have liver disease; or

• you also take atazanavir or rifampin.

To make sure Mavyret is safe for you, tell your doctor if you have ever had:

• hepatitis B;

• liver problems other than hepatitis;

• a liver or kidney transplant;

• HIV (human immunodeficiency virus); or

• an opioid addiction or past use of injected drugs.

Tell your doctor if you are pregnant or breastfeeding.

Mavyret should not be given to a child younger than 3 years old,

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Use the medicine as soon as you can, but skip the missed dose if you are more than 18 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, Mavyret may cause serious liver injury. Call your doctor right away if you have symptoms such as:

• right-sided upper stomach pain;

• nausea, vomiting, loss of appetite;

• confusion, tiredness, feeling light-headed;

• easy bruising or bleeding, vomiting blood;

• diarrhea, black or bloody stools;

• dark urine; or

• yellowing of your skin or eyes.

Common Mavyret side effects may include:

• headache; or

• tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs can interact with glecaprevir and pibrentasvir, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.