Glecaprevir / Pibrentasvir Dosage

Medically reviewed by Drugs.com. Last updated on Apr 4, 2025.

Applies to the following strengths: 50 mg-20 mg; 100 mg-40 mg

Usual Adult Dose for Chronic Hepatitis C

Glecaprevir 300 mg-pibrentasvir 120 mg (3 tablets) orally once a day

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:

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

3 to less than 12 years:

Weight less than 20 kg: Glecaprevir 150 mg-pibrentasvir 60 mg (3 packets of oral pellets) orally once a day
Weight 20 to less than 30 kg: Glecaprevir 200 mg-pibrentasvir 80 mg (4 packets of oral pellets) orally once a day
Weight 30 to less than 45 kg: Glecaprevir 250 mg-pibrentasvir 100 mg (5 packets of oral pellets) orally once a day
Weight at least 45 kg: Glecaprevir 300 mg-pibrentasvir 120 mg (3 tablets) orally once a day

12 years or older: Glecaprevir 300 mg-pibrentasvir 120 mg (3 tablets) orally once a day

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:

Each packet of oral pellets (a fixed-dose combination product) contains glecaprevir 50 mg and pibrentasvir 20 mg.
Each fixed-dose combination tablet contains glecaprevir 100 mg and pibrentasvir 40 mg.
Pediatric patients weighing at least 45 kg who are unable to swallow tablets may be administered 6 packets of oral pellets once a day; dosing with the oral pellets has not been studied in pediatric patients weighing more than 45 kg.
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 3 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 with food.
Oral pellets: Consult the manufacturer product information (Instructions for Use) for details regarding administration.
Administer the oral pellets together once a day with food; sprinkle the oral pellets for the total daily dose on a small amount of soft food with a low water content that will stick to a spoon (e.g., peanut butter, chocolate hazelnut spread, cream cheese, thick jam, Greek yogurt) and swallow without chewing.
Swallow the entire mixture of food and oral pellets within 15 minutes of preparation; do not crush or chew the oral pellets.
Do not use liquids or foods that would drip or slide off the spoon as the drug may dissolve quickly and become less effective.
Tablets: It is important to administer all 3 tablets at the same time once a day with food.
Consult the manufacturer product information regarding missed doses.

Storage requirements:

Store at or below 30C (86F).

Reconstitution/preparation techniques:

Oral pellets: The manufacturer product information (Instructions for Use) should be consulted.

General:

Each fixed-dose combination tablet contains glecaprevir 100 mg and pibrentasvir 40 mg.
Each packet of oral pellets (a fixed-dose combination product) contains glecaprevir 50 mg and pibrentasvir 20 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 and Instructions for Use).
Seek medical evaluation at once for symptoms of worsening liver problems (e.g., nausea, 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.
Oral pellets: Read and follow the Instructions for Use for preparing the correct dose.
Tablets: It is important to take all 3 tablets at the same time once a day with food.