Mavyret

What is Mavyret?

Mavyret is a combination of pibrentasvir and glecaprevir. Glecaprevir (and pibrentasvir) are antiviral drugs that stop the hepatitis C viruses from multiplying within your body.Mavyret treats chronic hepatitis C among people with HCV genotypes 1, 2, 3, 4, or 5. Mavyret can be prescribed after trying other medications without success.

Warnings

Mavyret should not be used if your liver is severely damaged or if atazanavir and rifampin are also being taken. Mavyret may make your hepatitis-B active or worsen if you have ever had it. For several months, you may need to have frequent liver function tests.

Before you take this drug

Mavyret should not be used if you have an allergy to pibrentasvir or glecaprevir.

• You have liver disease.
• You can also take rifampin or atazanavir.

Tell your doctor about any of the following to ensure Mavyret will be safe for you:

• hepatitis B;
• Other liver diseases other than hepatitis
• A liver or renal transplant is possible.
• HIV (human immunodeficiency virus);

Inform your doctor if you are pregnant or nursing. Mavyret is not recommended for children younger than three years of age Breast-feeding may not be possible while taking this medication. You should consult your doctor if you are concerned about any risks.

How to take Mavyret?

Follow the directions on your prescription label and read all medication guides or instructions sheets. Read all the instructions on the prescription label.You will be tested by your doctor to ensure that you are not suffering from any conditions that would make it unsafe for you to use Mavyret. Mavyret can be taken by adults and children older than 12 years (or who weigh at least 45kg) in the form of three tablets, which are taken together once a day with food. Mavyret dosage is determined by weight for patients aged 3 to 12 years. For younger patients, Mavyret oral tablets are recommended.

Dosage of glecaprevir and pibrentasvir based on weight

• If you weigh less than 20 kg, take three oral pellets, each of 50 mg and 20 mg, once daily.
• If you weigh less than 20 kg, take four oral pellets in the 50 mg/20 mg dosage once daily.
• If you weigh less than 30 kg, take five oral pellets of 50 mg or 20 mg once a day.
• If you weigh more than 45 kg or are 12 years old, take three 100 mg/40mg tablets daily.

Take Mavyret along with your food. Your liver will require frequent blood tests.

Do not stop taking Mavyret abruptly. This could make it harder for you to get the antiviral medication that treats hepatitis C. Read all the medication guides and follow all instructions for hepatitis C treatment. You should not stop taking a medication or change the dose without consulting your doctor. Everyone with hepatitis should be under the care and supervision of a physician. You might need to have frequent liver function tests during treatment and even for several months afterwards.Keep this medicine at room temperature, away from heat and moisture. Mavyret should be kept in the original packaging until you're ready to use it.

Details on dosage

Adult dose of Mavyret to treat chronic hepatitis C:

Glecaprevir-pibrentasvir (300 mg/120 mg): 3 tablets, orally, once per day.

Duration of treatment:
THERAPY-NAIVE PATIENTS:
No cirrhosis in 8 weeks
-Compensated Cirrhosis: Child-Pugh A: 8 weeks

THERAPY-EXPERIENCED PATIENTS:
HCV genotype 1, prior treatment with a regimen containing NS5A without prior therapy using an NS3/4A protease inhibitor:
No cirrhosis at 16 weeks
-Compensated Cirrhosis: Child-Pugh A: 16 weeks

HCV genotype 1, prior treatment with a regimen containing NS3/4A protease inhibitors without prior therapy using an NS5A antagonist:
No cirrhosis in 12 weeks
-Compensated Cirrhosis: Child-Pugh A 12 weeks

HCV genotype 1, 2, 4, or 6 (previous therapy with a regimen containing the PRS)
No cirrhosis in 8 weeks
-Compensated Cirrhosis: Child-Pugh A 12 weeks

HCV genotype 3, prior therapy with a PRS-containing regimen:
No cirrhosis at 16 weeks
-Compensated Cirrhosis: Child-Pugh A: 16 weeks

Recipients of a liver or kidney transplant: 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 tablet contains pibrentasvir and glecaprevir.
The manufacturer's product information is recommended for HCV-infected or HCV/HIV-1 co-infected patients who have compensated liver disease, with or without cirrhosis. If applicable, the dose recommendation for HIV-1 antiviral drugs should be reviewed.
-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 peginterferon and ribavirin.
In clinical trials, patients who had previously used NS3/4A proase inhibitors were treated with regimens containing either simeprevir and sofosbuvir or simeprevir, boceprevir, or telaprevir along with (peg-)interferon or ribavirin.
PRS: Previous treatment experience with regimens containing ribavirin and/or (peg) interferon without prior experience with an HCV NS3/4A or NS5A protease inhibitor

Uses:
for treatment of chronic HCV genotypes 1, 2, 3, 4, or 5 infection without cirrhosis or compensated cirrhosis.
For the treatment of HCV-infected genotype 1 patients who have previously received a regimen that contains an HCV protease inhibitor, NS3/4A or NS5A, but not both

The usual pediatric dose of Mavyret to treat chronic hepatitis C

3 years and less:
Weight less than 20 kg: Glecaprevir 150 mg-Pibrentasvir 60 mg (3 packets of oral pellets), orally, once per day
Weight 20 kg to 30 kg: Glecaprevir-pibrentasvir (four packets of oral tablets) once daily.
Weight: 30 kg to less than 45kg: glecaprevir 500 mg; pibrentasvir 50 mg (5 packets of oral pellets), orally, once per day.
Weight at least 45 kg: Glecaprevir-pibrentasvir-120 mg (3 tablets), orally, once per day

Glecaprevir-pibrentasvir (three tablets): 300 mg/120 mg orally, once per day.

Duration of treatment:
THERAPY-NAIVE PATIENTS:
HCV genotype 1, 2, 3, 4, or 6
No cirrhosis in 8 weeks
-Compensated Cirrhosis: Child-Pugh A: 8 weeks

THERAPY-EXPERIENCED PATIENTS:
HCV genotype 1, prior treatment with a regimen containing NS5A without prior therapy using an NS3/4A protease inhibitor:
No cirrhosis at 16 weeks
-Compensated Cirrhosis: Child-Pugh A: 16 weeks

HCV genotype 1, prior treatment with a regimen containing NS3/4A protease inhibitors without prior therapy using an NS5A antagonist:
No cirrhosis in 12 weeks
-Compensated Cirrhosis: Child-Pugh A 12 weeks

HCV genotype 1, 2, 4, or 6 (prior treatment with a regimen containing the PRS)
No cirrhosis in 8 weeks
-Compensated Cirrhosis: Child-Pugh A 12 weeks

HCV genotype 3, prior therapy with a PRS-containing regimen:
No cirrhosis at 16 weeks
-Compensated Cirrhosis: Child-Pugh A: 16 weeks

Recipients of a liver or kidney transplant: 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 tablets (a fixed-dose combination product) contains 50 mg of glecaprevir and 20 mg of pibrentasvir.
Each fixed-dose tablet contains pibrentasvir and glecaprevir.
Oral pellets can be given to pediatric patients who cannot swallow tablets and weigh at least 45kg. Dosing oral pellets in patients over 45 kg has not been tested.
The manufacturer's product information is recommended for HCV-infected or HCV/HIV-1 co-infected patients who have compensated liver disease, with or without cirrhosis. If applicable, the dose recommendation for HIV-1 antiviral drugs should be reviewed.
-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 peginterferon and ribavirin.
In clinical trials, patients who had previously used NS3/4A proase inhibitors were treated with regimens containing either simeprevir and sofosbuvir or simeprevir, boceprevir, or telaprevir along with (peg-)interferon or ribavirin.
PRS: Previous treatment experience with regimens containing ribavirin and/or (peg) interferon without prior experience with an HCV NS3/4A or NS5A protease inhibitor

Uses:
for treatment of chronic HCV genotypes 1, 2, 3, 4, or 5 infection without cirrhosis or compensated cirrhosis.
For the treatment of HCV-infected genotype 1 patients who have previously received a regimen that contains an HCV protease inhibitor (NS3/4A) or an HCV NS5A antagonist, but not both

What happens if I miss the dose?

If you miss a dose by more than 18 hours, you should skip it. Never take two doses of the same medicine at once.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

Avoid these mistakes

This medicine does not stop the spread of your illness. Share razors and toothbrushes. Speak to your doctor about the best ways to prevent HCV from being transmitted during sex. Even healthy people should never share syringes or needles.

Side effects of Mavyret 

If you experience any of the following: hives, difficulty breathing, swelling of your lips, face, tongue, or throat, please seek emergency medical attention.

Mavyret can cause liver damage in rare cases.

• Right-sided upper abdominal pain
• Nausea, vomiting, and loss of appetite
• Feeling confused, fatigued, or light-headed is a common symptom.
• Easy bruising and bleeding; vomiting of blood
• Diarrhea, bloody, or black stools
• Dark urine
• Yellowing of the skin or eyes.

Mavyret may cause side effects such as:

• headache
• tiredness.

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Interaction with other drug

It is sometimes not safe to take certain medications together. Some drugs may affect the blood levels of drugs that you are taking, which can increase side effects and make them less effective. Some drugs should never be taken together with glecaprevir or pibrentasvir. Inform your doctor of all the medicines you are taking and those that you have stopped using. Included are prescription and over-the-counter medicines, vitamins, and herbal products. This list does not include all possible interactions.