Glecaprevir / Pibrentasvir Dosage

Medically reviewed by Drugs.com. Last updated on Sep 28, 2020.

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Usual Adult Dose for Chronic Hepatitis C

3 tablets orally once a day with food

Duration of Therapy:
THERAPY-NAIVE PATIENTS:
HCV genotype 1, 2, 3, 4, 5, or 6:
-No cirrhosis: 8 weeks
-Compensated cirrhosis (Child-Pugh A): 8 weeks

THERAPY-EXPERIENCED PATIENTS:
HCV genotype 1 (prior therapy with regimen containing an NS5A inhibitor without prior therapy with an NS3/4A protease inhibitor):
-No cirrhosis: 16 weeks
-Compensated cirrhosis (Child-Pugh A): 16 weeks

HCV genotype 1 (prior therapy with regimen containing an NS3/4A protease inhibitor without prior therapy with an NS5A inhibitor):
-No cirrhosis: 12 weeks
-Compensated cirrhosis (Child-Pugh A): 12 weeks

HCV genotype 1, 2, 4, 5, or 6 (prior therapy with regimen containing PRS):
-No cirrhosis: 8 weeks
-Compensated cirrhosis (Child-Pugh A): 12 weeks

HCV genotype 3 (prior therapy with regimen containing PRS):
-No cirrhosis: 16 weeks
-Compensated cirrhosis (Child-Pugh A): 16 weeks

LIVER OR KIDNEY TRANSPLANT RECIPIENTS: 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:
-Recommended for HCV monoinfected and HCV/HIV-1-coinfected patients with compensated liver disease (with or without cirrhosis); the manufacturer product information should be consulted regarding dose recommendations for coadministered HIV-1 antiviral agents (if applicable).
-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 (peg)interferon and ribavirin.
-In clinical trials, patients with prior NS3/4A protease inhibitor experience were treated with regimens containing simeprevir with sofosbuvir, or simeprevir, boceprevir, or telaprevir with (peg)interferon and ribavirin.
-PRS: Prior treatment experience with regimens containing (peg)interferon, ribavirin, and/or sofosbuvir without prior treatment experience with an HCV NS3/4A protease inhibitor or NS5A inhibitor

Uses:
-For the treatment of patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)
-For the treatment of HCV genotype 1-infected patients with prior treatment using a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both

Usual Pediatric Dose for Chronic Hepatitis C

12 years and older or weighing at least 45 kg: 3 tablets orally once a day with food

Duration of Therapy:
THERAPY-NAIVE PATIENTS:
HCV genotype 1, 2, 3, 4, 5, or 6:
-No cirrhosis: 8 weeks
-Compensated cirrhosis (Child-Pugh A): 8 weeks

THERAPY-EXPERIENCED PATIENTS:
HCV genotype 1 (prior therapy with regimen containing an NS5A inhibitor without prior therapy with an NS3/4A protease inhibitor):
-No cirrhosis: 16 weeks
-Compensated cirrhosis (Child-Pugh A): 16 weeks

HCV genotype 1 (prior therapy with regimen containing an NS3/4A protease inhibitor without prior therapy with an NS5A inhibitor):
-No cirrhosis: 12 weeks
-Compensated cirrhosis (Child-Pugh A): 12 weeks

HCV genotype 1, 2, 4, 5, or 6 (prior therapy with regimen containing PRS):
-No cirrhosis: 8 weeks
-Compensated cirrhosis (Child-Pugh A): 12 weeks

HCV genotype 3 (prior therapy with regimen containing PRS):
-No cirrhosis: 16 weeks
-Compensated cirrhosis (Child-Pugh A): 16 weeks

LIVER OR KIDNEY TRANSPLANT RECIPIENTS: 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:
-Recommended for HCV monoinfected and HCV/HIV-1-coinfected patients with compensated liver disease (with or without cirrhosis); the manufacturer product information should be consulted regarding dose recommendations for coadministered HIV-1 antiviral agents (if applicable).
-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 (peg)interferon and ribavirin.
-In clinical trials, patients with prior NS3/4A protease inhibitor experience were treated with regimens containing simeprevir with sofosbuvir, or simeprevir, boceprevir, or telaprevir with (peg)interferon and ribavirin.
-PRS: Prior treatment experience with regimens containing (peg)interferon, ribavirin, and/or sofosbuvir without prior treatment experience with an HCV NS3/4A protease inhibitor or NS5A inhibitor

Uses:
-For the treatment of patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)
-For the treatment of HCV genotype 1-infected patients with prior treatment using a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both

Renal Dose Adjustments

Mild, moderate, or severe renal dysfunction: No adjustment recommended.

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): No adjustment recommended.
Moderate or severe liver dysfunction (Child-Pugh B or C) or any history of hepatic decompensation: Contraindicated

Comments:
-This drug has not been evaluated in HCV-infected patients with moderate or severe liver dysfunction or in those with any history of hepatic decompensation.
-Higher exposures of both components in subjects with severe liver dysfunction.

Precautions

US BOXED WARNING:
-RISK OF HBV REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV: All patients should be tested for evidence of current/prior HBV infection before starting this drug. HBV reactivation has been reported during or after completion of HCV direct-acting antiviral therapy in HCV/HBV-coinfected patients who were not receiving HBV antiviral therapy; some cases resulted in fulminant hepatitis, hepatic failure, and death. HCV/HBV-coinfected patients should be monitored for hepatitis flare or HBV reactivation during HCV therapy and posttherapy follow-up; appropriate patient management for HBV infection should be started as clinically indicated.

CONTRAINDICATIONS:
-Moderate or severe liver dysfunction (Child-Pugh B or C) or any history of hepatic decompensation
-Coadministration with atazanavir or rifampin

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

No adjustment recommended.

Other Comments

Administration advice:
-Before starting this drug, test all patients for evidence of current/prior HBV infection; measure hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).
-Administer the 3 tablets at the same time with food.
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-Store at or below 30C (86F).

General:
-Each fixed-dose combination tablet contains glecaprevir 100 mg and pibrentasvir 40 mg.

Monitoring:
-General: For clinical and laboratory signs of hepatitis flare or HBV reactivation in patients with serological proof of HBV infection (during HCV therapy with this drug and during posttreatment follow-up)
-Hepatic: Hepatic laboratory testing in patients with compensated cirrhosis or proof of advanced liver disease (as clinically indicated); for signs/symptoms of hepatic decompensation

Patient advice:
-Read the US FDA-approved patient information (Patient Information).
-Seek medical evaluation at once for symptoms of worsening liver problems (e.g., tiredness, yellowing of the skin/white part of the eyes, bleeding/bruising more easily than normal, confusion, loss of appetite, diarrhea, dark/brown urine, dark/bloody stool, swelling of the stomach area [abdomen]/pain in the upper right side of the stomach area, sleepiness, vomiting of blood).
-Avoid missing doses and complete the entire course of therapy.
-Important: Take all 3 tablets at the same time once a day with food.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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