Pibrentasvir

Mechanism of Action MAVYRET is a fixed-dose combination of glecaprevir and pibrentasvir, which are direct-acting antiviral agents against the hepatitis C virus [see Microbiology ( 12.4 ) ] .

• 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 [see Dosage and Administration ( 2.2 ) and Clinical Studies ( 14 )].ICD-10: B18.2

• 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 [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )] . MAVYRET is contraindicated with atazanavir or rifampin [see Drug Interaction ( 7.3 ) and Clinical Pharmacology ( 12.3 )] .contraindicated

Testing Prior to the Initiation of Therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc. ( 2.1 ) See recommended treatment duration for patients 3 years and older in tables below. ( 2.2 ) Treatment-Naïve Patients 1 HCV Genotype Treatment Duration No Cirrhosis Compensated Cirrhosis (Child-Pugh A) 1, 2, 3, 4, 5, or 6 8 weeks 8 weeks Treatment-naïve patients are those who have not received treatment for the current infection. Treatment-Experienced Patients 1 Treatment Duration HCV Genotype Patients Previously Treated With a Regimen Containing: No Cirrhosis Compensated Cirrhosis (Child-Pugh A) 1 An NS5A inhibitor 2 without prior treatment with an NS3/4A protease inhibitor (PI) 16 weeks 16 weeks An NS3/4A PI 3 without prior treatment with an NS5A inhibitor 12 weeks 12 weeks 1, 2, 4, 5, or 6 PRS 4 8 weeks 12 weeks 3 PRS 4 16 weeks 16 weeks Treatment-experienced patients are those who previously received treatment for the current infection. Treated with prior regimens containing ledipasvir and sofosbuvir or daclatasvir with (peg) interferon and ribavirin. Treated with prior regimens containing simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with (peg) interferon and ribavirin. PRS=Prior treatment experience with regimens containing (peg) interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor. 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.

Risk of Hepatitis B Virus Reactivation: 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. ( 5.1 ) Risk of Hepatic Decompensation/Failure in Patients with Evidence of Advanced Liver Disease: 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. ( 5.2 ) 5.1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure and death. Cases have been reported in patients who are HBsAg positive and also in patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and anti-HBc positive). HBV reactivation has also been reported in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV direct-acting antivirals may be increased in these patients.

In subjects receiving MAVYRET, the most commonly reported adverse reactions (greater than 10%) are headache and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of MAVYRET cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Overall Adverse Reactions in Subjects with Chronic HCV Infection without Cirrhosis or with Compensated Cirrhosis (Child-Pugh A) The adverse reactions data for MAVYRET in subjects without cirrhosis or with compensated cirrhosis (Child-Pugh A) were derived from nine registrational Phase 2 and 3 trials which evaluated approximately 2,300 adults infected with genotype 1, 2, 3, 4, 5, or 6 HCV who received MAVYRET for 8, 12 or 16 weeks [see Clinical Studies ( 14 ) ] . The overall proportion of subjects who permanently discontinued treatment due to adverse reactions was 0.1% for subjects who received MAVYRET for 8, 12 or 16 weeks. The most common adverse reactions, all grades, observed in greater than or equal to 5% of subjects receiving 8, 12, or 16 weeks of treatment with MAVYRET were headache (13%), fatigue (11%), and nausea (8%). In subjects receiving MAVYRET who experienced adverse reactions, 80% had an adverse reaction of mild severity (Grade 1). One subject experienced a serious adverse reaction.

8.1 Pregnancy Risk Summary No adequate human data are available to establish whether or not MAVYRET poses a risk to pregnancy outcomes. In animal reproduction studies, no adverse developmental effects were observed when the components of MAVYRET were administered separately during organogenesis at exposures up to 53 times (rats; glecaprevir) or 51 and 1.5 times (mice and rabbits, respectively; pibrentasvir) the human exposures at the recommended dose of MAVYRET (see Data ) . No definitive conclusions regarding potential developmental effects of glecaprevir could be made in rabbits, since the highest achieved glecaprevir exposure in this species was only 7% (0.07 times) of the human exposure at the recommended dose. There were no effects with either compound in rodent pre/post-natal developmental studies in which maternal systemic exposures (AUC) to glecaprevir and pibrentasvir were approximately 47 and 74 times, respectively, the exposure in humans at the recommended dose (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

The pharmacokinetic properties of the components of MAVYRET in healthy subjects are provided in Table 7 . The steady-state pharmacokinetic parameters of glecaprevir and pibrentasvir in subjects with chronic HCV infection without cirrhosis are provided in Table 8 .

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.

• Aug 3, 2017NDANDA209394Abbvie
• Jun 10, 2021NDANDA215110Abbvie

1. 1Fatigue2,56324%
2. 2Headache2,20420%
3. 3Nausea1,13210%
4. 4Pruritus6546.0%
5. 5Diarrhoea4774.4%
6. 6Vomiting3132.9%
7. 7Rash3112.9%
8. 8Dizziness2312.1%
9. 9Death2242.1%
10. 10Pain2111.9%
11. 11Insomnia2011.8%
12. 12Abdominal Discomfort1971.8%
13. 13Drug Ineffective1871.7%
14. 14Asthenia1581.5%
15. 15Abdominal Pain Upper1491.4%

The 10 most recently updated of 77 ClinicalTrials.gov registrations naming Pibrentasvir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Feasibility and Acceptability of HCV Treatment in Pregnancy
  Recruiting · Observational · 50 enrolled · Washington University School of Medicine
  NCT06367465updated 2026-06-09
• Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV
  Recruiting · Phase 1 · Phase 2 · Interventional · 30 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT07040319updated 2026-06-09
• Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs
  Terminated · Interventional · 21 enrolled · Kirby Institute
  NCT03981211updated 2026-05-26
• Study of Glecaprevir/Pibrentasvir to Assess Safety Through Real-World Data
  Recruiting · Observational · 2,000 enrolled · AbbVie
  NCT07419347updated 2026-04-16
• Rapid HCV Treatment Access for Persons Who Use Drugs
  Completed · Interventional · 198 enrolled · Johns Hopkins University
  NCT04677153updated 2026-04-13
• A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients
  Active not recruiting · Phase 4 · Interventional · 200 enrolled · Mayo Clinic
  NCT04508907updated 2025-12-17
• A Study of the Safety, Effectiveness and Clinical Use of Maviret in Adolescent Patients With Chronic Hepatitis C Virus
  Completed · Observational · 50 enrolled · AbbVie
  NCT04214028updated 2025-07-20
• Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder
  Recruiting · Phase 2 · Phase 3 · Interventional · 92 enrolled · White River Junction Veterans Affairs Medical Center
  NCT05637879updated 2025-04-24
• 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)
  Completed · Phase 3 · Interventional · 286 enrolled · AbbVie
  NCT04903626updated 2025-04-06
• HCV Test and Treat Utilizing Simplified HCV Patient Education
  Terminated · Phase 4 · Interventional · 8 enrolled · Weill Medical College of Cornell University
  NCT05582681updated 2025-02-27

Frequently asked questions

How does Pibrentasvir work?

Mechanism of Action MAVYRET is a fixed-dose combination of glecaprevir and pibrentasvir, which are direct-acting antiviral agents against the hepatitis C virus [see Microbiology ( 12.4 ) ] .

What is Pibrentasvir used for?

According to FDA labeling, Pibrentasvir carries indications including: 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 [see Dosage and Administration ( 2.2 ) and Clinical Studies ( 14 )].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Pibrentasvir?

Pibrentasvir is classified as Hepatitis C Virus NS5A Inhibitor, Breast Cancer Resistance Protein Inhibitors, Cytochrome P450 1A2 Inhibitors, Cytochrome P450 3A Inhibitors, Organic Anion Transporting Polypeptide 1B1 Inhibitors, Organic Anion Transporting Polypeptide 1B3 Inhibitors, P-Glycoprotein Inhibitors, UGT1A1 Inhibitors, Nucleic Acid Replication Alteration.

What are the brand names for Pibrentasvir?

Pibrentasvir is marketed under brand names including Mavyret.

What are the contraindications for Pibrentasvir?

Pibrentasvir labeling lists contraindications including: 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 [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )] . MAVYRET is contraindicated with atazanavir or rifampin [see Drug Interaction ( 7.3 ) and Clinical Pharmacology ( 12.3 )] .. Always consult the full prescribing information and a clinician.