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Mavyret (GLECAPREVIR)
Mavyret works by blocking the NS3/4A protease enzyme, preventing the hepatitis C virus from replicating.
Mavyret (glecaprevir) is a small molecule Hepatitis C Virus NS3/4A Protease Inhibitor developed by AbbVie Inc. It was FDA-approved in 2017 for the treatment of chronic hepatitis C and compensated cirrhosis. Mavyret works by inhibiting the NS3/4A protease enzyme, which is essential for the replication of the hepatitis C virus. As a patented medication, AbbVie Inc. retains commercial rights. Key safety considerations include potential interactions with other medications and monitoring for liver function.
At a glance
| Generic name | GLECAPREVIR |
|---|---|
| Sponsor | AbbVie |
| Drug class | Hepatitis C Virus NS5A Inhibitor [EPC] |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2017 |
Mechanism of action
Mechanism of Action MAVYRET is fixed-dose combination of glecaprevir and pibrentasvir, which are direct-acting antiviral agents against the hepatitis virus [see Microbiology 12.4 ].
Approved indications
- Chronic hepatitis C
- Compensated cirrhosis
Boxed warnings
- 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 )] . WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV See full prescribing information for complete boxed warning. Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.1 )
Common side effects
- Headache
- Fatigue
- Nausea
- Diarrhea
- Pruritus
- Asthenia
Key clinical trials
- Study of Glecaprevir/Pibrentasvir to Assess Safety Through Real-World Data
- Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV (PHASE1,PHASE2)
- Feasibility and Acceptability of HCV Treatment in Pregnancy
- A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients (PHASE4)
- Rapid HCV Treatment Access for Persons Who Use Drugs (NA)
- A Study of the Safety, Effectiveness and Clinical Use of Maviret in Adolescent Patients With Chronic Hepatitis C Virus
- Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder (PHASE2,PHASE3)
- Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB) (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Mavyret CI brief — competitive landscape report
- Mavyret updates RSS · CI watch RSS
- AbbVie portfolio CI