Glecaprevir; pibrentasvir

What is Glecaprevir;Pibrentasvir ?

Glecaprevir;Pibrentasvir (MAVYRET) is a fixed-dose combination of glecaprevir, a hepatitis C virus (HCV) NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor used to treat hepatitis C.

Pibrentasvir

Glecaprevir

What are the uses of this medicine?

This medicine is 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 and have been previously treated with a regimen that contained an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.

How does this medicine work?

• MAVYRET is a fixed-dose combination of glecaprevir and pibrentasvir, which are direct-acting antiviral agents against the hepatitis C virus.

Glecaprevir

• Glecaprevir is an inhibitor of the HCV NS3/4A protease, which is necessary for the proteolytic cleavage of the HCV encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication.
• In a biochemical assay, glecaprevir inhibited the proteolytic activity of recombinant NS3/4A enzymes from clinical isolates of HCV genotypes 1a, 1b, 2a, 2b, 3a, 4a, 5a, and 6a with IC50 values ranging from 3.5 to 11.3 nM.

Pibrentasvir

• Pibrentasvir is an inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly.
• The mechanism of action of pibrentasvir has been characterized based on cell culture antiviral activity and drug resistance mapping studies.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have certain liver problems
• also take any of the following medicines:

atazanavir rifampin

What drug interactions can this medicine cause?

• Coadministration of carbamazepine, efavirenz containing regimens, and St. John’s wort with MAVYRET is not recommended.
• Clearance of HCV infection with direct-acting antivirals may lead to changes in hepatic function, which may impact safe and effective use of concomitant medications. Frequent monitoring of relevant laboratory parameters (INR or blood glucose) and dose adjustments of certain concomitant medications may be necessary.

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

• Test all patients for HBV infection by measuring HBsAg and anti-HBc.

Recommended Dosage: Recommended dosage in adults:

• Three tablets taken at the same time orally once daily (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) with food.

Recommended dosage in pediatric patients 3 years and older:

• Pediatric Patients 3 Years to Less than 12 Years Old: Dosing is based on weight which is shown below:

Body Weight (kg)
or Age (yrs)	Daily Dose of glecaprevir/pibrentasvir	Dosing of MAVYRET
Less than 20 kg	150 mg/60 mg per day	Three 50 mg/20 mg packets of oral pellets once daily
20 kg to less than 30 kg	200 mg/80 mg per day	Four 50 mg/20 mg packets of oral pellets once daily
30 kg to less than 45 kg	250 mg/100 mg per day	Five 50 mg/20 mg packets of oral pellets once daily
45 kg and greater
OR
12 years of age and older	300 mg/120 mg per day	Three 100 mg/40 mg tablets once daily1 (see Recommended Dosage in Adults)

Pediatric Patients 12 Years of Age and Older, or Pediatric Patients Weighing at Least 45 kg:

• three tablets taken at the same time orally once daily (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) with food.

Hepatic Impairmentː

• MAVYRET is contraindicated in patients with moderate or severe hepatic impairment

Liver or Kidney Transplant Recipients:

• MAVYRET is recommended for 12 weeks in patients 3 years and older who are liver or kidney transplant recipients.
• A 16-week treatment duration is recommended in genotype 1-infected patients who are NS5A inhibitor-experienced without prior treatment with an NS3/4A PI or in genotype 3-infected patients who are PRS treatment-experienced.

Administration

• Take MAVYRET exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to.
• Do not stop taking MAVYRET without first talking with your healthcare provider.
• Take MAVYRET with food.
• It is important that you do not miss or skip doses of MAVYRET during treatment.
• For adults, adolescents 12 years and older, or children weighing at least 99 pounds (45 kg), the usual dose of MAVYRET is 3 tablets at one time each day.
• For children 3 years to less than 12 years of age and weighing less than 99 pounds (45 kg), your child’s healthcare provider will prescribe the right dose of MAVYRET oral pellets based on your child’s body weight.
• ◦ If your child’s healthcare provider prescribes MAVYRET oral pellets for your child, see “How should I give MAVYRET oral pellets to my child.”
• If you miss a dose of MAVYRET and it is:
• ◦ Less than 18 hours from the time you usually take MAVYRET, take the missed dose with food as soon as possible. Then take your next dose at your usual time.
• ◦ More than 18 hours from the time you usually take MAVYRET, do not take the missed dose. Take your next dose as usual with food.
• If you take too much MAVYRET, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 100 mg glecaprevir and 40 mg pibrentasvir.
• Oral Pellets: 50 mg glecaprevir and 20 mg pibrentasvir.

This medicine is available in fallowing brand namesː

• MAVYRET

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• tirednes

MAVYRET can cause serious side effects, including:

• Hepatitis B virus reactivation
• rare risk of worsening liver problems, liver failure and death

What special precautions should I follow?

• Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment.
• Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
• Hepatic decompensation/failure, including fatal outcomes, have been reported mostly in patients with cirrhosis and baseline moderate or severe liver impairment (Child-Pugh B or C). Monitor for clinical and laboratory evidence of hepatic decompensation. Discontinue MAVYRET in patients who develop evidence of hepatic decompensation/failure.

What to do in case of emergency/overdose?

• In case of overdose, the patient should be monitored for any signs and symptoms of toxicities.

Management for overdosage:

• Appropriate symptomatic treatment should be instituted immediately.
• Glecaprevir and pibrentasvir are not significantly removed by hemodialysis.

Can this medicine be used in pregnancy?

• No adequate human data are available to establish whether or not MAVYRET poses a risk to pregnancy outcomes.

Can this medicine be used in children?

• The safety and effectiveness of MAVYRET in children less than 3 years of age have not been studied.

What are the active and inactive ingredients in this medicine?

MAVYRET tabletsː

• Active ingredients: glecaprevir and pibrentasvir
• Inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, lactose monohydrate, polyethylene glycol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, and vitamin E (tocopherol) polyethylene glycol succinate. The tablets do not contain gluten.

MAVYRET oral pellets:

• Active ingredients: glecaprevir and pibrentasvir
• Inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol/macrogol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, vitamin E (tocopherol) polyethylene glycol succinate. The oral pellets do not contain gluten.

Who manufactures and distributes this medicine?

• Manufactured by AbbVie Inc., North Chicago, IL 60064.
• MAVYRET is a trademark of AbbVie Inc.

What should I know about storage and disposal of this medication?

• Store MAVYRET at or below 86°F (30°C).
• Keep MAVYRET in its original package until you are ready to take it.
• Keep MAVYRET and all medicines out of the reach of children.

• Dailymed label info on Glecaprevir; pibrentasvir
• FDA Glecaprevir; pibrentasvir

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