Mavyret

Generic name: Glecaprevir And Pibrentasvir
Drug class: Antiviral combinations

Usage of Mavyret

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.

Mavyret side effects

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.

Before taking Mavyret

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.

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How to use Mavyret

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

Warnings

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

If you've ever had hepatitis B, it may become active or get worse after you stop using Mavyret. You may need frequent liver function tests for several months.

What other drugs will affect Mavyret

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.

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