Brand Name
Mavyret
Generic Name
Glecaprevir
View Brand Information FDA approval date: August 03, 2017
Classification: Hepatitis C Virus NS3/4A Protease Inhibitor
Form: Pellet, Tablet
What is Mavyret (Glecaprevir)?
MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis . MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor , but not both [see Dosage and Administration.
Approved To Treat
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Brand Information
Mavyret (Glecaprevir and Pibrentasvir)
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with MAVYRET. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated [see Warnings and Precautions (5.1)].
1INDICATIONS AND USAGE
MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A).
MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both
2DOSAGE FORMS AND STRENGTHS
MAVYRET is available as tablets or pellets for oral use.
- Tablets: pink, oblong-shaped, film-coated, and debossed with “NXT” on one side. Each tablet contains 100 mg glecaprevir and 40 mg of pibrentasvir.
- Oral pellets: pink and yellow coated pellets in unit-dose packets. Each packet contains 50 mg glecaprevir and 20 mg pibrentasvir.
3CONTRAINDICATIONS
- MAVYRET is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of prior hepatic decompensation
- MAVYRET is contraindicated with atazanavir or rifampin
4OVERDOSAGE
In case of overdose, the patient should be monitored for any signs and symptoms of toxicities. Appropriate symptomatic treatment should be instituted immediately. Glecaprevir and pibrentasvir are not significantly removed by hemodialysis.
5DESCRIPTION
MAVYRET contains glecaprevir, a HCV NS3/4A PI, and pibrentasvir a HCV NS5A inhibitor. MAVYRET is available as a fixed dose combination tablet or coated pellets in unit-dose packets for oral administration.
Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets
Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. Glecaprevir and pibrentasvir are presented as a co-formulated, fixed-dose combination, immediate release bilayer tablet.
The tablet contains the following 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.
Glecaprevir/Pibrentasvir Coated Oral Pellets
MAVYRET oral pellets are small, pink and yellow and supplied in unit-dose packets for oral administration. Each unit-dose of MAVYRET oral pellets in packets contains 50 mg glecaprevir and 20 mg pibrentasvir and the following 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.
Glecaprevir drug substance:
The chemical name of glecaprevir is (3a
The molecular formula is C
Pibrentasvir drug substance:
The chemical name of pibrentasvir is Methyl {(2
The molecular formula is C
6HOW SUPPLIED/STORAGE AND HANDLING
MAVYRET Tablets
MAVYRET tablets are pink-colored, film-coated, oblong biconvex shaped, debossed with “NXT” on one side.
Store at or below 30°C (86°F).
MAVYRET Oral Pellets
MAVYRET oral pellets are dispensed in child-resistant unit-dose packets in cartons. Each carton contains 28 packets. Each packet contains 50 mg glecaprevir/20 mg pibrentasvir pink and yellow oral pellets. The NDC number is 0074-2600-28.
Store at or below 30°C (86°F).
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV
Inform patients that HBV reactivation can occur in patients coinfected with HBV during or after treatment of HCV infection. Advise patients to tell their healthcare provider if they have a history of hepatitis B virus infection
Risk of Hepatic Decompensation/Failure in Patients with Evidence of Advanced Liver Disease
Advise patients to seek medical evaluation immediately for symptoms of worsening liver problems such as nausea, tiredness, yellowing of the skin or white part of the eyes, bleeding or bruising more easily than normal, confusion, loss of appetite, diarrhea, dark or brown urine, dark or bloody stool, swelling of the stomach area (abdomen) or pain in the upper right side of the stomach area, sleepiness, or vomiting of blood
Drug Interactions
Inform patients that MAVYRET may interact with some drugs; therefore, patients should be advised to report to their healthcare provider the use of any prescription, non-prescription medication or herbal products
Administration
For MAVYRET oral pellets, advise patients or caregivers to read and follow the Instructions for Use for preparing the correct dose
Inform patients it is important to take all three tablets at the same time once daily with food as directed. Inform patients that it is important not to miss or skip doses and to take MAVYRET for the duration that is recommended by the physician
If a dose is missed and it is:
- Less than 18 hours from the usual time that MAVYRET should have been taken – advise the patient to take the dose as soon as possible and then to take the next dose at the usual time.
- More than 18 hours from the usual time that MAVYRET should have been taken – advise the patient not to take the missed dose and to take the next dose at the usual time.
Manufactured by AbbVie Inc., North Chicago, IL 60064
MAVYRET and its design are trademarks of AbbVie Inc.
© 2025 AbbVie Inc. All rights reserved.
20092779
8PRINCIPAL DISPLAY PANEL
NDC 0074-2625-28
Rx only
Mavyret®
(glecaprevir and pibrentasvir)
100mg / 40mg
Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg
abbvie
9PRINCIPAL DISPLAY PANEL
NDC 0074-2625-01
Rx only
Mavyret
(glecaprevir and pibrentasvir)
100mg / 40mg
Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg
abbvie
10PRINCIPAL DISPLAY PANEL
NDC 0074-2625-28
Rx only
4-WEEK SUPPLY
Mavyret®
(glecaprevir and pibrentasvir)
100mg / 40mg
Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg
11PRINCIPAL DISPLAY PANEL
NDC 0074-2625-80
Rx only
MAVYRET®
glecaprevir/pibrentasvir tablets
100 mg/40 mg
For Institutional Use Only84 Tablets
abbvie
Do not accept if seal over bottle opening is broken or missing.
12PRINCIPAL DISPLAY PANEL
NDC 0074-2600-28
Rx only
MAVYRET®
(glecaprevir/pibrentasivir) Oral Pellets
50 mg/20 mg
Each packet contains pink and yellow oral pellets.
abbvie
13PRINCIPAL DISPLAY PANEL
NDC 0074-2625-84
Rx only
MAVYRET®
glecaprevir/pibrentasvir tablets
100 mg/40 mg
84 Tablets
Do not accept if seal over bottle opening is broken or missing.
abbvie
